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The APTIMA Trichomonas vaginalis Assay is an in vitro qualitative nucleic acid amplification test (NAAT) for the detection of ribosomal RNA (rRNA) from Trichomonas vaginalis to aid in the diagnosis of trichomoniasis using the TIGRIS DTS System.

The assay may be used to test the following specimens from symptomatic or asymptomatic women: clinician-collected endocervical swabs, clinician-collected vaginal swabs, female urine specimens, and specimens collected in PreservCyt solution.

The ATV assay is a nucleic acid amplification test intended for the in vitro qualitative detection of ribosomal RNA from T. vaginalis in patient-collected first catch urine and clinician collected vaginal swabs, endocervical swab and ThinPrep Pap Test specimens collected in Cytyc Preservcyt solution. The assay may be used to test specimens from symptomatic and asymptomatic individuals to aid in the diagnosis of trichomoniasis using the TIGRIS DTS System automated analyzer.

There are 4 kits (1 master and 3 ancillary) that are required to perform the ATV assay on the TIGRIS DTS System. The Master Kit contains 9 reagents and 2 controls and is made up of 3 boxes. Box 1 - the Refrigerated box contains ATV amplification reagent, ATV enzyme reagent, ATV probe reagent and ATV Target Capture reagent-B. Box 2 - the Room Temperature box contains ATV amplification reconstitution solution, ATV enzyme reconstitution reagent, ATV probe reconstitution reagent, ATV selection reagent and ATV target capture reagent. Box 3-the Controls kit box contains ATV positive and negative controls. The three ancillary kits consist of the APTIMA Assay Fluids kit, the APTIMA Auto Detect Reagents kit and APTIMA System Fluids Preservative kit. In addition to the reagents provided in the kit, the assay utilizes four specimen collection kits - the APTIMA unisex swab specimen collection kit for endocervical and male urethral swab specimens, APTIMA vaginal swab specimen collection kit, APTIMA urine specimen collection kit for male and female urine specimens and the APTIMA specimen transfer kit.

Here's an analysis of the provided text to extract the acceptance criteria and study details for the Aptima Trichomonas vaginalis (ATV) assay.

Acceptance Criteria and Device Performance for Aptima Trichomonas vaginalis (ATV) Assay

The Aptima Trichomonas vaginalis (ATV) assay is a qualitative nucleic acid amplification test (NAAT) designed for the detection of ribosomal RNA (rRNA) from T. vaginalis. Its performance was evaluated through various analytical and clinical studies.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the ATV assay are implicitly defined by the reported performance characteristics which are deemed sufficient for reclassification to Class II. The primary performance metrics are related to the accuracy of T. vaginalis detection across different specimen types.

2. Sample Size and Data Provenance for the Test Set (Clinical Study)

• Sample Size: 1025 symptomatic and asymptomatic women were enrolled.
  • Evaluable specimens:
    • Urine: 738 (3 had final invalid results)
    • Vaginal Swabs: 877 (2 had final invalid results)
    • Endocervical Swabs: 922 (2 had final invalid results)
    • PreservCyt solution liquid Pap specimens: 813
• Data Provenance: The study was a "pivotal prospective multicenter clinical trial" conducted with women enrolled from 9 US clinical sites, including obstetric and gynecology, family planning, and STD clinics. This indicates prospective data collection from a diverse US population.

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly state the number or specific qualifications of individuals who interpreted the predicate tests to establish the ground truth. However, it indicates:

• "2 of the vaginal swab specimens were tested with a commercially available culture system and wet mount microscopic exam to establish infected status."
• This suggests that the ground truth was established by laboratory professionals and/or clinicians skilled in performing and interpreting these traditional diagnostic methods. The document does not specify their level of experience (e.g., radiologist with 10 years of experience).

4. Adjudication Method for the Test Set

The ground truth was established using a "patient infected status algorithm":

• At least one positive reference result (from culture and/or wet mount microscopic exam) established an "infected patient status."
• Both reference tests were required to be negative to establish a "non-infected patient status."

This effectively acts as an adjudication, where discordant results between the two reference methods (culture and wet mount) are resolved by prioritizing a positive finding from either method for "infected" status, and requiring both to be negative for "non-infected" status.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or described in this document. The study focuses on comparing the assay's performance against traditional diagnostic methods, not on human reader improvement with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

Yes, the study describes the standalone performance of the APTIMA Trichomonas vaginalis Assay. The assay is an in vitro diagnostic device, and its results are automatically interpreted by the TIGRIS DTS System APTIMA Trichomonas vaginalis Software. The reported sensitivity, specificity, PPV, and NPV are characteristics of the automated assay's performance alone, without human interpretation or intervention in the diagnostic call process beyond initial specimen collection and loading.

7. Type of Ground Truth Used

The ground truth used for the clinical study was based on a composite reference standard:

• Expert Consensus (implied by method): "commercially available culture system and wet mount microscopic exam"
• Algorithm-based Patient Infected Status: An algorithm designated a subject as "infected" if at least one of the two reference methods (culture or wet mount) was positive, and "non-infected" if both were negative. This combines established diagnostic methods to form a "gold standard" for the study.

8. Sample Size for the Training Set

The document does not specify a separate training set or its sample size. The description of the clinical trial refers to a "pivotal prospective multicenter clinical trial" where all collected specimens were used for performance evaluation. For in vitro diagnostic assays, developers typically use internal data for assay development and optimization (which can be considered the "training phase"), but this internal data is not usually described in the same detail as the independent clinical validation (the "test set" in AI/ML terminology).

9. How the Ground Truth for the Training Set was Established

Since a specific "training set" is not explicitly mentioned or detailed in the context of this 510(k) submission, the method for establishing its ground truth is also not provided. If an internal "training set" was used during assay development, it would have likely relied on similar established methods (culture, wet mount, or other validated laboratory techniques) to determine the T. vaginalis status of samples for optimizing the assay's parameters.

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