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The BD MAX Vaginal Panel performed on the BD MAX System is an automated qualitative in vitro diagnostic test for the direction of DNA targets from bacteria associated with bacterial vaginosis (qualitative results reported based on detection and quantitation of targeted organism markers), Candida species associated with vulvovaginal candidiasis, and Trichomonas vaginalis from vaginal swabs in patients who are symptomatic for vaginitis/vaginosis. The test utilizes real-time polymerase chain reaction (PCR) for the amplification of specific DNA targets and utilizes fluorogenic target-specific hybridization probes to detect and differentiate DNA from:

• . Bacterial vaginosis markers (Individual markers not reported)
  Lactobacillus spp. (L. crispatus and L. jensenii) Gardnerella vaginalis Atopobium vaginae Bacterial Vaginosis Associated Bacteria-2 (BVAB-2) Megasphaera-1
• . Candida spp. (C. albicans, C. tropicalis, C. parapsilosis, C. dubliniensis)
• Candida glabrata
• Candida krusei
• . Trichomonas vaginalis

The BD MAX Vaginal Panel is intended to aid in the diagnosis of vaginal infections in women with a clinical presentation consistent with bacterial vaginosis, vulvovaginal candidiasis and trichomoniasis.

The BD MAX System and the BD MAX Vaginal Panel are comprised of an instrument with associated hardware and accessories, disposable microfluidic cartridges, master mixes, unitized reagent strips, and extraction reagents. The instrument automates sample preparation including target lysis, DNA extraction and concentration, reagent rehydration, target nucleic acid amplification and detection using real-time PCR. The assay includes a Sample Processing Control (SPC) that is present in the Extraction Tube. The SPC monitors DNA extraction steps, thermal cycling steps, reagent integrity and the presence of inhibitory substances. The BD MAX System software automatically interprets test results. For the BD MAX Vaginal Panel, a test result may be called as POS, NEG or UNR (Unresolved) based on the amplification status of the targets and of the Sample Processing Control. IND (Indeterminate) or INC (Incomplete) results are due to BD MAX System failure.

This is an FDA 510(k) summary for the BD MAX Vaginal Panel for detecting microorganisms associated with vaginitis and bacterial vaginosis. The document describes the device, its intended use, and its equivalence to a predicate device. While it mentions performance standards, it does not contain detailed acceptance criteria, device performance data, information on the study design (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods), or any multi-reader multi-case (MRMC) study results.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can be extracted and what is missing:

1. Table of acceptance criteria and the reported device performance:

• Acceptance Criteria: Not explicitly stated in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy thresholds). The document broadly refers to "Performance Standards" based on the Class II Special Controls Guideline for NAAT assays for Trichomonas vaginalis.
• Reported Device Performance: Not provided in this document. This summary focuses on substantial equivalence based on technological characteristics and intended use.

2. Sample size used for the test set and the data provenance: Not mentioned.

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): Not mentioned.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.

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: Not applicable. This is a molecular diagnostic test, not an AI-assisted imaging device or a test involving human readers in the interpretation loop.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device is a standalone molecular diagnostic assay. The results are "automatically interpreted" by the BD MAX System software, which indicates algorithm-only performance. However, specific standalone performance metrics (sensitivity, specificity etc.) are not provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not mentioned for the studies supporting this 510(k) submission. For molecular tests, ground truth typically involves culture or a validated composite reference method.

8. The sample size for the training set: Not mentioned.

9. How the ground truth for the training set was established: Not mentioned.

Summary Table of Available Information:

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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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