Verification Testing

Below are the completed verification studies.

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1. Comfortability

• Design Input Addressed: The device must be comfortable for the patient.
• Verification Activity: Material hardness test on the urine collection cup. (Shore A Hardness of 30 ± 1.0)
• Acceptance Criteria: ≥ 90% accuracy → PASS

• Statistical Analysis: Run two, one sample t-tests for each position on the cup, and compare to 30 ± 1.0 with a confidence interval of 95%.

	Inner Side	Center Back	Edge
N	10	10	10
Average	30.25 ± 0.677	29.85 ± 0.669	30.15 ± 0.626
P-value (29)	1.24×10-4	1.51×10-3	1.28×10-4
P-value (31)	3.34×10-3	1.00×10-3	2.06×10-4
Pass/Fail	Pass	Pass	Pass

2. Volume Verification
   • Design Input Addressed: The device must collect an acceptable urine sample volume.
   • Verification Activity: Run first peristaltic pump to collect a volume ≥ 2.0 mL.
   • Acceptance Criteria: Collected volume ≥ 2.0 mL with 95% accuracy → PASS

• Statistical Analysis: Run one sample t-test, compare to 10 mL necessary to complete testing where α = 0.05 and a C.I. of 95%.

N	10
Average	14.78 ± 0.249
P-value	<0.0001
Pass/Fail	Pass

3. Biomarker Detection Accuracy

• Design Input Addressed: The device must be able to detect the presence of bioburden associated with UTIs.
• Verification Activity: Using prepared urine samples with known nitrite and leukocyte concentrations, a colorimetric sensor measures dye intensity resulting from the Griess reaction (nitrites) and a two-step chemical reaction (leukocyte esterase), with sensor readings compared to spectrophotometer results.
• Acceptance Criteria: ≥ 95% accuracy across trials → PASS

• Statistical Analysis: Run McNemar’s test based on the varying concentrations, compare to α = 0.01.

N	15
P-value	1.0
Accuracy	40%
Pass/Fail	Fail

N	15
P-value	0.014
Accuracy	60%
Pass/Fail	Fail

4. Electrical Safety

• Design Input Addressed: The device must meet electrical safety standards IEC 60601-1.
• Verification Activity: Run the device and measure leakage current using a digital multimeter to confirm compliance with IEC 60601-1 standards.
• Acceptance Criteria: ≤ 500 μA → PASS

• Statistical Analysis: Run one sample t-test, compare to 500 μA where α = 0.05 and a C.I. of 95%.

N	10
Average	24 ± 5.16 μA
P-value	<0.0001
Pass/Fail	Pass

5. Sanitization Effectiveness

• Design Input Addressed: The device must be sanitizable.
• Verification Activity: Run a cleaning sequence after a positive sample, then test with a negative sample to confirm no residual contamination.
• Acceptance Criteria: ≥ 95% accuracy across trials → PASS

• Statistical Analysis: Run McNemar’s test based on two possible outcomes: Positive or Negative, compare to α = 0.05.

N	20
P-value	0.0117
Accuracy	95%
Pass/Fail	Pass

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Validation Testing

Below are the completed validation studies.

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1. Comfortability

• Design Input Addressed: The device must be comfortable for the patient.
• Validation Activity: Survey a group of subjects to test for comfortability based on a 1-5 scale.

• Statistical Analysis: A non-parametric sign test was conducted to assess whether the subjects’ responses were significantly greater than the acceptance score of a 3 with a C.I. of 95%.

	Comfort with cup flushed to skin	Comfort with silicone in hands	Comfort with touching genitals
N	20	20	20
Average	4.25 ± 0.55	5.00 ± 0.00	4.00 ± 0.65
P-value	< 0.0001	< 0.0001	< 0.0001
Pass/Fail	Pass	Pass	Pass

2. Volume Validation

• Design Input Addressed: The device must collect an acceptable urine sample volume.
• Validation Activity: Run a sample collection experiment with the load cell and pump with 95% sample collection accuracy.

• Statistical Analysis: Run one sample t-test, compare to 5 mL necessary to complete reach testing where α = 0.05 and a C.I. of 95%.

	Load Cell 1	Load Cell 2
N	10	10
Average	5.24± 0.19	5.19± 0.19
P-value	0.01676	0.01174
Pass/Fail	Pass	Pass

3. Biomarker Detection Accuracy

• Design Input Addressed: The device must be able to detect the presence of bioburden associated with UTIs.
• Validation Activity: Run urinalysis test with positive and negative samples with 95% accuracy.
• Statistical Analysis: Run McNemar’s test based on two possible outcomes: Positive or Negative, compare to α = 0.01.

N	20
P-value	1
Accuracy	70%
Pass/Fail	Fail

N	20
P-value	0.0832
Accuracy	85%
Pass/Fail	Fail

4. Communication of Results

• Design Input Addressed: The device must communicate the levels of bioburden detected in the urine sample.
• Validation Activity: Create positive, caution, and negative samples to test if the results displayed correlate with the level of bacteria detected.
• Statistical Analysis: Run Chi-Square test based on three possible outcomes: Positive, Caution, and Negative, compare to α = 0.01.

N	20
P-value	<0.001
Accuracy	80%
Pass/Fail	Fail

5. Timing

• Design Input Addressed: The device must be able to provide results in a clinically relevant amount of time.
• Validation Activity: Run full testing sequence and time it.
• Statistical Analysis: Run one sample t-test, compared to 900 seconds (15 minutes) where
  α = 0.05 and a C.I. of 95%.

N	20
Average	183.7± 1.49
P-value	<0.0001
Pass/Fail	Pass

6. Waste Disposal

• Design Input Addressed: The device must be sanitizable.
• Validation Activity: Survey subjects on observed cleaning sequence and subsequent trial run on a scale of 1-5.

• Statistical Analysis: A non-parametric sign test was conducted to assess whether the subjects’ responses were significantly greater than the acceptance score of a 4 with a C.I. of 99%.

	Disposure Procedure	Second Sample Effect	Cross Contamination
N	20	20	20
Average	4.70 ± 0.55	4.75 ± 0.44	4.60 ± 0.50
P-value	<0.0001	< 0.0001	< 0.0001
Pass/Fail	Pass	Pass	Pass