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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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