(251 days)
The Scanostics UTI Check Application test system consists of the Scanostics UTI Check Application and the URS-2L (UTI) Urine Test Strips. The test system is intended for the qualitative detection of nitrite and leukocytes in urine as an aid in the screening of urinary tract infections (UTI). It is intended for over-the-counter home use only.
The Scanostics UTI Check Application test system consists of the Scanostics UTI Check Application and the URS-2L (UTI) Urine Test Strips. The Scanostics UTI Check Application measures the colour developed in two reaction zones (leukocytes and nitrite pads) on the UTI test strip following application of a urine sample. The developed colors are then compared to calibration colours located on the Scanostics backing material and the result for each pad is determined based on the minimum colour distance between the developed colours and calibration colours.
The URS-2L UTI Test Strip comprises of two reagent pads areas, which are absorbent material saturated with chemically active substances, then dried and affixed to the plastic strip with double-sided adhesive.
The backing card comprises of thirty-two (32) calibration colour blocks and three (3) black and white alignment squares printed onto a rigid card stock and die cut to provide a groove for the strip (preventing strip misalignment). The use of the backing card is primarily to compensate for different lighting environments as it allows the calibration colours and the test strip to be subjected to the same conditions as the reagent pads for comparison - this would not be possible if the calibration colours were stored within the application itself.
The representative platform for the test system is the iPhone 6 with iOS 9. The application has been proven to be compatible on the iPhone 6S (iOS 9) and iPod touch (8th gen with iOS 8 and iOS 9). The application's core technology is based on four (4) patents held by Teco Diagnostics (US 8655009, 8877140, 8911679 and 8506901).
Here's an analysis of the provided text to extract the acceptance criteria and study details for the Scanostics UTI Check Application Test System.
Please note: The provided text is a 510(k) summary, which is a regulatory document. It summarizes the findings rather than presenting the full study report. Therefore, some information like specific statistical metrics for acceptance criteria and the exact number of participants in all study phases might not be explicitly detailed.
Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria (e.g., sensitivity > X%, specificity > Y%). Instead, it indicates that the device should perform "comparably" to the predicate device in the hands of lay users and "satisfactorily" in non-clinical studies. The ultimate acceptance criterion implicitly relies on the demonstration of substantial equivalence to the legally marketed predicate device, Clinistrip (URS-10).
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Obtain comparable testing data to a trained HCP using predicate device | "Results indicate that the intended users were able to obtain comparable testing data when using the Scanostics UTI Check Application as a trained HCP using the Clinistrip (URS-10)." This implies that the performance in the hands of lay users matches that of a healthcare professional using the established predicate. The specific metrics (e.g., positive agreement, negative agreement) are not provided in this summary. |
| Satisfactory performance in non-clinical studies | "Testing results indicate that the Scanostics UTI Check application test system performs satisfactorily when used appropriately." This covers method comparison, precision, detection limit, interference, specificity, shelf life and stress studies, and several flex studies, but specific quantitative results or thresholds are not detailed. |
| Substantial equivalency to predicate device | "The study results demonstrate a substantial equivalency on performance between the Scanostics UTI Check application test system and the predicate device, Clinistrip (URS-10) test strips." This is the overarching conclusion of the submission. |
Study Details
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated for specific metrics like sensitivity/specificity studies. The "lay user studies were performed at three sites," suggesting a multicenter approach, but the number of participants or urine samples is not provided in detail.
- Data Provenance: The document does not specify the country of origin of the data. It seems to be a prospective study, as it describes "lay user studies were performed," implying new data collection rather than retrospective analysis.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document implies a comparison against "a trained HCP using the Clinistrip (URS-10)" as a reference for the lay user study. However, it does not specify the number of HCPs, their qualifications, or how a definitive "ground truth" was established for each sample (e.g., if a definitive culture result was also used). Given the nature of a 510(k) submission focusing on substantial equivalence, the "ground truth" for the test set often stems from the established predicate device's performance.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not described in the provided text.
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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:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study in the traditional sense was not performed. This device is an AI-powered reader for a diagnostic strip, intended for over-the-counter home use only by lay users. The comparison was between the lay user with the Scanostics app and a "trained HCP using the Clinistrip (URS-10)" (the predicate device). The focus is on enabling accurate interpretation by lay users, not improving expert reader performance.
- Therefore, an "effect size of how much human readers improve with AI vs without AI assistance" is not applicable in the context of this study design as presented.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- The "Scanostics UTI Check Application test system" inherently involves the app (algorithm) reading the test strip. The "lay user studies" describe the performance when the human (lay user) operates the system. However, the non-clinical studies ("method comparison, precision, detection limit, interference, specificity, shelf life and stress studies as well as several flex studies") would largely assess the standalone performance of the algorithm's ability to read the strips under various controlled conditions, separate from a human's interpretation error. The document states these studies found the device performers "satisfactorily," implying the algorithm itself functions as intended.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The primary ground truth for comparison in the lay user study appears to be the results obtained by a "trained HCP using the Clinistrip (URS-10)" (the predicate device). For the non-clinical studies, the "ground truth" would likely be established through controlled laboratory testing with known concentrations for precision, detection limit, specificity, etc., but this is not explicitly detailed. It does not mention pathology or outcomes data as direct ground truth for this device's performance.
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The sample size for the training set:
- The document does not provide information about the sample size used for the training set of the Scanostics UTI Check Application's algorithm.
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How the ground truth for the training set was established:
- This information is not provided in the 510(k) summary. Training set ground truth would typically be established through expertly-read images of a large number of test strips, potentially correlated with laboratory-confirmed analyte concentrations, but these details are absent.
§ 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.