(285 days)
UriTest- Nitrite in Urine is a nonquantitative test to identify nitrite in urine. Nitrite identification is used for the detection of Urinary Tract Infection.
UriTest - Nitrite in Urine is a reagent strip test used to measure the presence of Nitrite in urine. Nitrite is produced by most organisms commonly associated with urinary tract infection. Nitrite is used to detect urinary tract infection.
Here's a breakdown of the acceptance criteria and study details for the Uri-Test - Nitrite in Urine, based on the provided text:
Acceptance Criteria and Device Performance
The provided document does not explicitly state pre-defined acceptance criteria (e.g., "The device must achieve a sensitivity of at least X%"). Instead, it presents the performance of the UriTest and implies that these results are considered acceptable because they demonstrate substantial equivalence to the predicate device (Bayer Multistix).
| Metric | Acceptance Criteria (Implied) | Reported Device Performance (Professional User) | Reported Device Performance (Lay User) |
|---|---|---|---|
| Sensitivity | Substantially equivalent to Bayer Multistix (Predicate Device) | 100.00% | 100.00% |
| Specificity | Substantially equivalent to Bayer Multistix (Predicate Device) | 91.76% | 89.41% |
| Accuracy | Substantially equivalent to Bayer Multistix (Predicate Device) | 93.07% | 91.09% |
Note: The "Spiked Samples" section also shows a 100% sensitivity and accuracy, but "Specificity = Not Valid" due to the nature of the artificial positive-only sample. This test appears to confirm the device's ability to detect nitrite when present.
Study Details
2. Sample size used for the test set and the data provenance
- Sample Size:
- Professional User & Lay User Tests: 101 samples (derived from the sum of positives and negatives in the Bayer arm: 16+7+0+78 for professional, 16+9+0+76 for lay user, though the tables are not identical, it sums to 101. The discrepancies in specific cells between professional and lay user suggest separate analyses or slightly different interpretations of the same base data for the negative group).
- Spiked Samples: 33 samples (all positive).
- Data Provenance: Not explicitly stated. However, given the context of a 510(k) submission, it is highly likely that these were prospective clinical samples collected for the purpose of this comparison study. The document does not specify the country of origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The "ground truth" for the comparison studies was established by the predicate device, Bayer Multistix, itself. For the "Professional User" test, a professional presumably read both the UriTest and Bayer Multistix. For the "Lay User" test, a lay user read the UriTest, and a professional likely read the Bayer Multistix as the reference.
4. Adjudication method for the test set
- Adjudication Method: Not applicable or not specified. In this comparison study, the Bayer Multistix serves as the reference standard (the "ground truth"). The UriTest's results are compared directly to the results obtained from the Bayer Multistix for the same samples. There's no indication of an independent adjudication process for discrepancies between the two devices, as the predicate device's reading is assumed to be correct.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No, this was not an MRMC study and does not involve AI assistance. The study compares a new device (UriTest) to a predicate device (Bayer Multistix) for detecting nitrite in urine. The users are either "Professional User" or "Lay User" directly interpreting the test strips.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Study: No, this is not an algorithm-only device. It's a reagent strip that requires human interpretation (either professional or lay user) to read the color change.
7. The type of ground truth used
- Type of Ground Truth: The ground truth for the comparison studies was established by the predicate device, Bayer Multistix, on the same urine samples. For the spiked samples, the ground truth was the known presence of bacteria (leading to nitrite production) in the spiked urine.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This type of device (reagent strip) does not typically involve a "training set" in the machine learning sense. The performance data is derived from clinical comparison and spiked sample testing.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable, as there is no training set in the machine learning sense. The performance of the device is assessed against a predicate device and known positive (spiked) samples.
§ 862.1510 Nitrite (nonquantitative) test system.
(a)
Identification. A nitrite (nonquantitative) test system is a device intended to identify nitrite in urine. Nitrite identification is used in the diagnosis and treatment of uninary tract infection of bacterial origin.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.