(112 days)
The OSOM® Trichomonas Rapid Test is intended for the qualitative detection of Trichomonas vaginalis ("Trichomonas") antigens from vaginal swabs and from the saline solution prepared when making wet mounts from vaginal swabs. This test is intended for use in patients with symptoms of vaginosis/vaginitis or suspected exposure to the Trichomonas pathogen. This device is intended for use in physicians' offices as well as clinical laboratories.
The OSOM Trichomonas Rapid Test uses color immunochromatographic, capillary flow, "dipstick" technology with antibodies coated on a nitrocellulose membrane. The test procedure requires the solubilization of Trichomonas proteins from a vaginal swab by placing it in a Sample Buffer. The OSOM Trichomonas Rapid Test is then placed in the Sample Buffer, and the mixture migrates along the membrane surface. If Trichomonas is present in the sample, it will form a complex with the primary anti-Trichomonas antibody conjugated to colored particles (blue). The complex will then be bound by the second anti-Trichomonas capture antibody. The appearance of a visible blue test line together with the red control line indicates a positive result.
Here's an analysis of the provided text to extract the acceptance criteria and study details for the OSOM® Trichomonas Rapid Test:
Acceptance Criteria and Device Performance for OSOM® Trichomonas Rapid Test
The provided document describes the performance of the OSOM® Trichomonas Rapid Test against a composite reference standard (CRS) that includes wet mount microscopy and culture. The acceptance criteria themselves are not explicitly stated as distinct numerical targets required for approval, but rather the observed performance metrics are presented. For the purpose of this response, I will interpret the reported agreement, sensitivity, and specificity as the metrics against which the device's performance was judged.
1. Table of Acceptance Criteria and Reported Device Performance
| Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Sensitivity | Sufficiently high for diagnosis | 83% (85/102) |
| Specificity | Sufficiently high for diagnosis | 99% (331/335) |
| Agreement | Sufficiently high for diagnosis | 95% (416/437) |
Note: The document does not specify explicit numerical "acceptance criteria" that were pre-defined. The "acceptance criteria (implied)" column reflects the general expectation for diagnostic assays to demonstrate high sensitivity and specificity for their intended use.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): 437 samples (102 positive, 335 negative based on composite reference standard).
- Data Provenance: Not explicitly stated. The document does not mention the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not specified. The ground truth was established using an objective composite reference standard (wet mount microscopy and culture), not solely based on expert interpretation. While these diagnostic methods are performed by trained personnel, the document doesn't detail the number of individuals involved or their specific qualifications for this study.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
- Adjudication Method: A composite reference standard (CRS) was used. This means that a sample was classified as positive if it tested positive by either wet mount microscopy or culture. Conversely, a sample was classified as negative only if it tested negative by both wet mount microscopy and culture. This method effectively adjudicates discrepancies by prioritizing positive findings from either established method as indicative of true positivity.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done: No. The study described is a standalone performance evaluation of the OSOM® Trichomonas Rapid Test against a reference standard. There is no mention of human readers or comparing their performance with and without AI assistance.
6. Standalone Performance Study
- Standalone Performance Study Done: Yes. The reported performance metrics (sensitivity, specificity, and agreement) are for the OSOM® Trichomonas Rapid Test itself, without human-in-the-loop interaction for interpretation beyond the initial sample preparation and visual reading of the test line.
7. Type of Ground Truth Used
- Type of Ground Truth: Composite Reference Standard (CRS). This standard combined the results of:
- Wet mount microscopy
- InPouch TV™ culture (BioMed Diagnostics Inc.)
A sample was considered positive if either wet mount or culture was positive, and negative if both were negative.
8. Sample Size for the Training Set
- Sample Size (Training Set): Not applicable. This device is a rapid immunochromatographic test, not an AI/machine learning algorithm requiring a separate training set. Its performance is based on its inherent biochemical and immunological properties.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for this type of device.
§ 866.2660 Microorganism differentiation and identification device.
(a)
Identification. A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.(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 § 866.9.