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The BD Vaginal Panel is an automated qualitative in vitro diagnostic test for the direct detection 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 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 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 Vaginal Panel is available for use with the BD MAX™ System or the BD COR™ System.

As with the existing BD Vaginal Panel for use with the BD MAX™ System (K201017), the BD COR™ PX/MX (BD COR) high throughput system conducts sample extraction steps to isolate and concentrate DNA which is then amplified to detect specific sequences for diagnostic purposes.

The BD COR™ System is designed to allow the user to place clinical specimens directly into designated transport racks to be loaded into the System. Once the specimens are loaded, the System will perform the necessary pre-analytical steps such as vortexing, aliquoting into a molecular tube with the correct diluent, sorting/grouping of the secondary samples for testing by assay, pre-warming and cooling of the sample (where required), and transport of the sample into a molecular analyzer, where extraction, amplification and detection will take place.

Additionally, the steps of ordering tests on the instrument for specific samples will be managed directly by the user interaction with the Laboratory Information System (LIS), which communicates drectly with the instrument.

Once the clinical specimens are received in the laboratory and loaded into the transport racks, the user will not be required to directly handle the specimen again reporting and removal from the system.

The BD Vaginal Panel is an automated qualitative in vitro diagnostic test for the direct detection 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 vaginosis.

The study aimed to demonstrate the equivalence of the BD Vaginal Panel on the BD COR™ System to its performance on the BD MAX™ System, which is the legally marketed predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample sizes used for the test set and the data provenance:

   • Precision Study: Panel members (spiked in simulated vaginal matrix) were tested in 12 days, 2 runs/day, 2 replicates/panel, for a total of 48 runs. This resulted in varying numbers for total N for each target and level (e.g., 288 for BV True Negative, 48 for Candida Low Positive, etc.; see Table 3 for details). Data provenance is internal laboratory testing.
   • Reproducibility Study: Similar panel members to the precision study. Tested at 3 sites (2 external, 1 internal) over 8 days, with 2 operators performing 2 runs on alternate days, for a total of 48 runs. This resulted in varying numbers for total N for each target, level, and site (e.g., 192 for BV True Negative per site, 32 for BV High Negative per site; see Table 6 for details). Data provenance is internal and external laboratory testing.
   • Analytical Sensitivity Confirmation Study: 20 panels of Vaginosis and/or Vaginitis targets at varying concentration levels (1.99x LoD, 5x LoD, C5) with 48 replicates each. Samples were prepared by spiking organisms into simulated vaginal matrix. Data provenance is internal laboratory testing.
   • Cross-Contamination Study: 543 negative samples (interspersed with high positive samples). Data provenance is internal laboratory testing.
   • Clinical Agreement Study: 700 panel members. These included:
     • Clinical vaginal specimens from internal collections.
     • Pooled previously collected clinical specimens.
     • High positive clinical specimens spiked.
     • Contrived samples created by spiking organisms into negative vaginal matrix or simulated vaginal matrix.
     • BV Contrived panel members prepared with different BV marker combinations using simulated vaginal matrix.
     • BV Natural samples derived from Cgroup, TV, and negative vaginitis panel members in natural vaginal matrix.
     • Data provenance is a mix of internal collections and contrived samples.

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):

   The document does not mention the use of experts or their qualifications for establishing ground truth. For the analytical studies (precision, reproducibility, analytical sensitivity, cross-contamination), ground truth was established by spiking known concentrations of target organisms/DNA into simulated or negative matrices. For the clinical agreement study, "BD MAX™ results served as the reference" meaning the predicate device's results were used as the comparator, not human expert consensus.

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

   For the clinical agreement study, the positive or negative status of a panel member using the BD MAX™ System (the reference) was defined by ">2 out of 3 evaluable results obtained on the BD MAX™". This suggests a form of 3-reader consensus (with the BD MAX™ itself acting as a 'reader' in triplicate, or at least three independent runs determining the status). Equivocal BD MAX™ comparator results were defined as "one positive, one negative, and one non-evaluable result from the BD MAX™." No human adjudication is 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:

   No MRMC comparative effectiveness study was done or reported in this document. The device is an automated in vitro diagnostic test (nucleic acid amplification test) and does not involve human readers interpreting images or other data with or without AI assistance. The comparison is between two automated systems (BD COR™ vs. BD MAX™).

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

   Yes, the entire study focuses on the standalone performance of the BD Vaginal Panel on the BD COR™ System. The device is an automated diagnostic test, meaning it operates "algorithm only" without human-in-the-loop performance for result generation. The human role is in sample loading and result interpretation (based on the device's output), not in forming the initial diagnostic call.

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

   • Analytical Studies (Precision, Reproducibility, Analytical Sensitivity, Cross-Contamination): Laboratory-contrived ground truth through spiking known concentrations of target organisms/DNA into simulated vaginal matrix or negative matrix.
   • Clinical Agreement Study: The results from the predicate device (BD MAX™ System) were used as the reference ("ground truth") for comparison. For panel member status, a consensus method of ">2 out of 3 evaluable results obtained on the BD MAX™" was used.

8. The sample size for the training set:

   The document does not explicitly mention a "training set" in the context of machine learning or AI algorithm development. The BD Vaginal Panel is a PCR-based assay. The performance studies described are for analytical and clinical validation of the device, not for training a new algorithm. The development of the assay (e.g., probe design, primer selection) would have involved extensive R&D, but the concept of a "training set" as typically used in AI/ML is not applicable here.

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

   As a PCR-based diagnostic, it's not an AI system that relies on a "training set" in the conventional sense to learn to make predictions. The "ground truth" for developing such an assay typically relies on purified nucleic acid from known organisms, synthetic controls, and well-characterized clinical samples to ensure the primers and probes are specific and sensitive for the intended targets. The document does not describe the specific methods for establishing ground truth during the assay development phase.

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