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Aptima BV Assay: The Aptima BV Assay is an in vitro nucleic acid amplification test that utilizes real time Transcription-Mediated Amplification (TMA) technology for detection and quantitation of ribosomal RNA from bacterial vaginosis (BV), including Lactobacillus (L. gasseri, L. crispatus, and L. jenseni), Gardnerella vaginalis), and Atopobium vaginae (A. vaginae). The assay reports a qualitative result for BV and does not report results for individual organisms. The assay is intended to aid in the diagnosis of BV on the automated Panther System using clinician-collected and patient-collected vaginal swab specimens from females with a clinical presentation consistent with vaginitis and/or vaginosis.

Aptima CV/TV Assay: The Aptima CV/TV Assay is an in vitro nucleic acid amplification of RNA from microorganisms associated with vulvovaginal candidiasis and trichomoniasis. The assay utilizes real time Transcription-Mediated Amplification (TMA) technology to detect and qualitatively report results for the following organisms: Candida species group (C. albicans, C. tropicalis, C. parapsilosis, C. dubliniensis), Candida glabrata (C. glabrata), Trichomonas vaginalis (TV). The assay differentiates between C. glabrata and the Candida species group (C spp) by targeting the RNA component of RNAse P ribonucleoprotein; the assay does not differentiate among C spp. For TV, the assay targets ribosomal RNA (rRNA) and differentiates the results for C. glabrata and C spp. The assy is intended to aid in the diagnosis of vulvovaginal candidiasis and trichomoniasis on the automated Panther System using clinician-collected and patientcollected vaginal swab specimens from females with a clinical presentation consistent with vagintis.

Aptima BV Assay: Like the Aptima BV assay 100 test kit, the Aptima BV assay 250 test kit is an in vitro nucleic acid amplification test for the detection and quantitation of rRNA from bacteria associated with bacterial vaginosis in women with a clinical presentation consistent with vaginitis/vaginosis. The Aptima BV assay utilizes the automated Panther system to provide qualitative results to aid in the diagnosis of bacterial vaginosis.

Aptima CV/TV Assay: Like the Aptima CV/TV assay 100 test kit, the Aptima CV/TV assay 250 test kit is an in vitro nucleic acid amplification test for the detection and quantitation of RNA from microorganisms associated with vaginitis, trichomoniasis, and vulvovaginitis, in women with a clinical presentation consistent with vaginitis, trichomoniasis, and vulvovaginitis. The Aptima CV/TV assay utilizes the automated Panther system to provide qualitative results to aid in the diagnosis of vulvovaginal candidiasis and trichomoniasis.

The provided document, a 510(k) summary for the Hologic Aptima BV Assay and Aptima CV/TV Assay, describes the device's technical specifications and a general statement regarding performance data for substantial equivalence. However, it does not contain the detailed acceptance criteria and a comprehensive study report with specific performance metrics (like sensitivity, specificity, PPV, NPV against a clinical gold standard) that would typically be expected for demonstrating a device meets acceptance criteria in a clinical validation context.

Specifically, the document focuses on demonstrating substantial equivalence of a new kit configuration (250 tests) to an already cleared kit configuration (100 tests) by showing similar analytical performance, particularly Limit of Detection (LoD). It does not present a de novo clinical study with pre-defined acceptance criteria for diagnostic accuracy against a true clinical ground truth.

Therefore, many of the requested items (e.g., number of experts, adjudication method, MRMC studies, training set details) are not applicable or not provided in this specific type of submission, which is for a modification to an already cleared device, not a novel device requiring full clinical validation from scratch.

Here's an attempt to answer the questions based only on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria and reported device performance in terms of diagnostic accuracy (e.g., sensitivity, specificity) against a clinical reference for the 250-test kit. Instead, it asserts equivalence by confirming L.O.D. for the new kit configuration.

The primary acceptance criteria for the new 250-test kit configuration, as implied by the performance data section, is that it must meet the established Limit of Detection (LoD) of the previously cleared 100-test kit configuration.

Aptima BV Assay (250 Test Kit):

Aptima CV/TV Assay (250 Test Kit):

The conclusion states: "The performance study results demonstrate that the Aptima BV assay 250 Test Kit on the Panther system performs comparably to the predicate device that is currently marketed for the same intended use." and "The Aptima BV 100 Test Kit LoD was confirmed in the Aptima BV 250 Test Kit configuration." (Similar statements are made for the CV/TV assay).

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: For the LoD confirmation study for both assays, at least 20 replicates per concentration, per reagent lot, using three lots were tested. This totals to at least 60 replicates per strain (for BV) or per organism (for CV/TV).
• Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It describes analytical sensitivity studies using prepared dilutions of cell lysates/suspensions. For the CV/TV assay, the use of "Natural Vaginal Swab Matrix (NVSM)" and "Simulated Vaginal Swab Matrix (SVSM)" is mentioned for dilutions.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided and is not applicable to the type of analytical study performed. The LoD confirmation uses known concentrations of target organisms, not clinical samples requiring expert interpretation for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided and is not applicable to an analytical LoD confirmation study.

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

This information is not provided and is not applicable. The device is a diagnostic assay (in vitro nucleic acid amplification test), not an AI-assisted imaging device that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

The device itself is a standalone diagnostic assay (an in vitro nucleic acid amplification test) run on an automated system (Panther system). Its performance (LoD) was confirmed without human interpretation of raw signals, as the Panther system software interprets the amplification signal emergence times to generate results.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth used for this specific study (LoD confirmation) was known concentrations of purified target organisms/cell lysates. This is an analytical ground truth, not a clinical ground truth derived from expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This information is not provided and is not applicable. This is not an AI/ML device that requires a training set in the conventional sense. The "training" for the assay involves internal optimization and validation during development, but the document does not detail these earlier stages.

9. How the ground truth for the training set was established

This information is not provided and is not applicable, as it's not an AI/ML device with a distinct training set and ground truth establishment methodology in the context of this submission.

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The Aptima CV/TV assay is an in vitro nucleic acid amplification of RNA from microorganisms associated with vulvovaginal candidiasis and trichomoniasis. The assay utilizes real time transcription-mediated amplification (TMA) to detect and qualitatively report results for the following organisms:

• Candida species group (C. albicans, C. tropicalis, C. parapsilosis, C. dubliniensis)
• Candida glabrata
• Trichomonas vaginalis

The assay differentiates between Candida glabrata and the Candida species group (C spp) by targeting the RNA component of RNAse Pribonucleoprotein; the assay does not differentiate among C spp. For Trichomonas vaginalis, the assay targets ribosomal RNA (rRNA) and differentiates the results for Candida glabrata and C spp. The assay is intended to aid in the diagnosis of vulvovaginal candidiasis and trichomoniasis on the automated Panther system using clinician-collected and patient-collected vaginal swab specimens from females with a clinical presentation consistent with vaginitis or vulvovaginitis.

The Aptima CV/TV assay is an in vitro nucleic acid amplification test for the detection and quantitation of RNA from microorganisms associated with vulvovaginal candidiasis and trichomoniasis in women with a clinical presentation consistent with vaginitis or vulvovaginitis. The Aptima CV/TV assay utilizes the automated Panther system to provide qualitative results to aid in the diagnosis of vulvovaginal candidiasis and trichomoniasis. The assay involves three main steps, all of which take place in a single tube on the Panther system: target capture, target amplification by TMA, and detection of the amplification products (amplicon) by fluorescent labeled probes (torches). The assay incorporates an internal control (IC) in every test to monitor nucleic acid capture, amplification and detection.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" for clinical performance in a table format with specific numerical thresholds the device must meet. Instead, it presents the achieved performance metrics (sensitivity, specificity, PPV, NPV) from the clinical study, implying these demonstrated statistics were considered acceptable for clearance. For analytical studies, acceptance is demonstrated by successfully meeting the goals of the study (e.g., all strains detected for inclusivity, no cross-reactivity beyond a certain concentration).

Therefore, for the clinical performance, the reported performance is the demonstration of meeting implied acceptance.

Note: For a medical device, acceptance criteria are typically predefined thresholds in a study protocol that the device performance must surpass. Since these aren't explicitly stated as hard "criteria" with target numbers, I'll present the reported device performance from the clinical study tables.

For Analytical Studies, acceptance was indicated by:

• Analytical Sensitivity (LoD): Predicted detection limits established through probit analysis (Table 6).
• Analytical Inclusivity: All Candida strains and 8/9 T. vaginalis strains detected at 3X LoD, with one T. vaginalis at 4X LoD.
• Cross-Reactivity and Microbial Interference: No cross-reactivity or microbial interference observed for 64 organisms and human cell lines at specified concentrations (Table 7), with minor exceptions noted for Candida famata, Tioconazole, Vaginal Moisturizing Gel, and Glacial Acetic Acid at higher concentrations than the tested limits.
• Within Laboratory Precision: 100% agreement with expected positivity for all positive and negative panel members (Table 9). Signal variability (CV%) for TTime was reported and considered acceptable (Table 10).
• Co-Infection: 100% detection for both targets present in co-infection panels (Table 11), with further testing confirming low C. glabrata and high T. vaginalis detection.
• Reproducibility: 100% agreement with expected results for all panel members across three sites (Table 21). Total %CV values for TTime ranged from 5.64% to 6.77% across organisms/panel members (Table 22), and from 4.29% to 6.89% for controls (Table 23).

Study Details

1. Sample Size Used for the Test Set and Data Provenance:

   • Total Subjects Enrolled: 1519 symptomatic women.
   • Evaluable Subjects: 1496.
   • Sample Types: Clinician-collected and patient-collected vaginal swab specimens.
   • Data Provenance:
     • Country of Origin: Geographically diverse US clinical sites (21 sites).
     • Retrospective/Prospective: Prospectively-collected.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

   • The document does not explicitly state the number of experts used to establish the ground truth.
   • Qualifications of Experts: Not specified. The reference methods are described (Candida culture, PCR/bi-directional sequencing, FDA-cleared molecular TV assay, FDA-cleared culture-based TV test), but the individuals interpreting these results to form the ground truth are not detailed.

3. Adjudication Method for the Test Set:

   • The document describes how the reference results for Candida and T. vaginalis were established:
     • Candida species group and C. glabrata: Based on a combination of Candida growth in culture, as well as PCR/bi-directional sequencing of both Aptima swab samples (leftover after testing) for subjects with positive Candida culture results.
     • T. vaginalis: A patient infected status (PIS) determined for each subject based on results from an FDA-cleared molecular TV assay and an FDA-cleared culture-based TV test.
   • This indicates a composite reference standard approach (multiple tests combined) rather than a simple 2+1 or 3+1 expert adjudication for diagnostic imaging, which is not applicable here.

4. 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, an MRMC comparative effectiveness study was not done. This refers to a medical device for in vitro diagnostic testing (nucleic acid amplification test) rather than an AI-assisted diagnostic imaging device/software the question implies. The study evaluates the performance of the assay itself against established reference methods.

5. If a Standalone (i.e., algorithm only without human-in-the loop performance) was done:

   • Yes, this was a standalone performance study. The Aptima CV/TV assay is an in vitro diagnostic test performed on an automated Panther system. Its performance (sensitivity, specificity) is evaluated directly against reference methods without human interpretation of the assay's output as an "assistance" to a physician. The "Panther system software uses an Aptima CV/TV assay-specific algorithm that interprets the amplification signal emergence times to generate a Positive or Negative status for each target organism in the sample." This is a completely automated interpretation by the device.

6. The Type of Ground Truth Used:

   • Composite Reference Standard / Expert Consensus (implied by combining tests):
     • For Candida species group and C. glabrata: Ground truth was established by combining Candida growth in culture and PCR/bi-directional sequencing.
     • For T. vaginalis: Ground truth (Patient Infected Status - PIS) was established using an FDA-cleared molecular TV assay and an FDA-cleared culture-based TV test.

7. The Sample Size for the Training Set:

   • The document does not provide information on a separate training set or its sample size. This is common for IVD assays where "training" refers more to assay development and optimization rather than machine learning model training on a specific clinical dataset. The clinical performance study described serves as the validation dataset.

8. How the Ground Truth for the Training Set Was Established:

   • Since no separate training set is detailed, information on how its ground truth was established is not provided. The ground truth for the clinical validation described above was established using composite reference standards, as per point 6.

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