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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 BV assay is an in vitro nucleic acid amplification test that utilizes real time transcription-mediated amplification (TMA) for detection and quantitation of ribosomal RNA from bacteria associated with bacterial vaginosis (BV), including Lactobacillus (L. gasseri, L. crispatus, and L. jensenii), Gardnerella vaginalis, and Atopobium 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.

The Aptima BV assay 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. 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. The Aptima BV assay is provided as a 100-test kit containing 8 reagents, 1 calibrator, and 2 controls.

Here's a summary of the acceptance criteria and study details for the Aptima BV Assay based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally inferred from the "Brief Description of Analytical (Non-Clinical) Studies" and "Brief Description of Clinical Studies" sections, focusing on the demonstrated acceptable performance. Specific numerical acceptance criteria are not explicitly stated as pass/fail thresholds in percentage terms, but rather performance results are reported which are presumably acceptable for clearance.

2. Sample Size Used for the Test Set and Data Provenance

• Clinical Performance Study (Symptomatic Subjects):

  • Evaluable Subjects: 1417 symptomatic women.
  • Patient-collected Aptima vaginal swab samples: 1405
  • Clinician-collected Aptima vaginal swab samples: 1413
  • Data Provenance: Prospectively-collected patient- and clinician-collected vaginal swab samples from women ≥14 years in 21 geographically diverse US private and academic family practice, obstetric-gynecologic, family planning, public health, STI, medical group clinics, and clinical research centers.

• Clinical Performance Study (Asymptomatic Subjects):

  • Evaluable Subjects: 172 asymptomatic women.
  • Clinician-collected Aptima vaginal swab samples: 172
  • Data Provenance: Prospectively-collected clinician-collected vaginal swab samples from asymptomatic women in 21 geographically diverse US sites (same as symptomatic subjects).

• Within Laboratory Precision:

  • Replicates: A minimum of 20 replicates per panel member for LoD. For precision, each operator performed 2 runs per day, with 3 replicates of each of the 11 panel members per run, across 21 days. (Total N = 168 or 165 for some panels due to exclusions).
  • Data Provenance: Laboratory study using synthetic panels (SVSM).

• Reproducibility:

  • Replicates: 3 replicates of each of the 7 panel members per run. Testing performed for at least six days at each of three sites. (Total N = 108 for each panel member).
  • Data Provenance: Multi-site laboratory study using synthetic panels (SVSM).

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

The document does not explicitly state the number or specific qualifications of experts (e.g., "radiologist with 10 years of experience"). However, it mentions that for the clinical performance study, the ground truth for BV infection status was established using Nugent score evaluation, and modified Amsel criteria if necessary. This implies trained laboratory personnel and clinicians performing these established diagnostic methods.

4. Adjudication Method for the Test Set

• Clinical Performance Study:
  • "A Nugent interpretation established positive and negative BV reference status, except in cases of intermediate determinations. For intermediate Nugent interpretations, BV reference status was established using modified Amsel criteria."
  • This indicates a hierarchical adjudication or ground truth establishment method where Nugent scoring was primary, and Amsel criteria served as a secondary method for intermediate Nugent results. The document does not describe a multi-reader adjudication process in the sense of multiple experts independently reviewing and then reaching a consensus for the ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, the document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus without AI assistance. The study evaluates the standalone performance of the Aptima BV Assay against established clinical criteria (Nugent score/Amsel criteria).

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the studies presented are standalone performance evaluations of the Aptima BV Assay (an in vitro nucleic acid amplification test performed on the automated Panther system). The results (BV positive or negative status) are generated by the system's software based on signal emergence times and calibration information, without human interpretation of the assay's output for diagnostic purposes in the performance studies. Its performance is compared to a ground truth established by clinical methods.

7. The Type of Ground Truth Used

• Clinical Performance Study:

  • The primary ground truth for Bacterial Vaginosis (BV) infection status was established using Nugent score evaluation.
  • For cases with intermediate Nugent interpretations, modified Amsel criteria were used to establish the BV reference status.

• Analytical and Reproducibility Studies:

  • Ground truth was based on the known composition of the synthetic panels (Simulated Vaginal Swab Matrix - SVSM) spiked with specific concentrations of target organism lysates.

8. The Sample Size for the Training Set

The document does not provide information on the sample size used for the training set of the Aptima BV Assay. This is because the Aptima BV Assay is a nucleic acid amplification test, a type of IVD, that relies on biochemical reactions and calibrated thresholds rather than machine learning algorithms that typically require explicit training data sets for model development. The "calibration information" mentioned in the description of the Panther system suggests a pre-defined set of parameters, likely established through analytical studies.

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

As noted above, for this type of in-vitro diagnostic device, there isn't typically a "training set" in the machine learning sense with an associated ground truth established by experts.

Instead, the assay's operational parameters (e.g., thresholds for positivity based on signal emergence times) would be established through a rigorous process of analytical validation (like the LoD and precision studies described) using samples with known concentrations of targets. This ensures the assay's performance characteristics (sensitivity, specificity) meet predefined criteria. The "calibration information" is central to how the device makes its determination.

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