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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 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 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 document describes the 510(k) premarket notification for the BD MAX Vaginal Panel for use with the BD MAX System. The purpose of this submission is to demonstrate the substantial equivalence of the modified device, particularly the BD Molecular Swab Collection Kit, to its predicate device, the BD MAX Vaginal Panel (DEN160001 and K191957) which used the BD MAX UVE Specimen Collection Kit.

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text focuses on demonstrating the substantial equivalence of the collection kit for an already cleared device, rather than establishing initial performance for a novel diagnostic device. Therefore, explicit acceptance criteria in terms of sensitivity, specificity, PPV, and NPV for the BD MAX Vaginal Panel itself are not directly stated in this section, as those would have been established during the original clearances (DEN160001 and K191957).

However, the performance is evaluated in comparison to the predicate's collection kit. The reported performance for the comparison study between the cleared collection device (BD MAX UVE Specimen Collection Kit) and the new collection device (BD Molecular Swab Collection Kit) demonstrated the following:

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

• Sample Size for Comparison Study: The document states that a "comparison study of performance between the cleared collection device and the new collection device tested with the BD MAX Vaginal Panel on the BD MAX System with clinical specimens" was conducted. However, the exact number of clinical specimens used in this comparison study is not explicitly provided in the text.
• Data Provenance: The data used for the comparison study are from "clinical specimens." The country of origin is not specified, and it is stated as a retrospective or prospective study.

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

The document does not describe the establishment of a ground truth by experts for the comparison study of the collection kits. For molecular diagnostic assays like the BD MAX Vaginal Panel, the "ground truth" for the original device's performance validation is often established using methods such as:

• Culture: For culturable organisms like Candida species or Trichomonas vaginalis.
• Microscopy (e.g., Amsel's criteria, Nugent scoring): For bacterial vaginosis.
• Reference molecular methods: For organisms difficult to culture or quantify.

Since the focus here is on the collection kit equivalence, the ground truth would inherently refer to the original diagnostic results obtained using the predicate device's collection kit, which are then compared to the results from the new collection kit. The text does not mention any independent expert panel establishing ground truth specifically for these comparison studies.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method (such as 2+1, 3+1, or none) for the test set used in the comparison study. The comparison is between the performance of two collection kits with the same diagnostic panel, suggesting a direct comparison of results rather than an adjudication process involving multiple human readers to establish a reconciled truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for imaging or interpretation tasks where human readers play a significant role. The BD MAX Vaginal Panel is an automated in vitro diagnostic test, and its results are interpreted by the BD MAX System software, not human readers in a diagnostic capacity that would warrant an MRMC study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

Yes, the BD MAX Vaginal Panel operates as a standalone (algorithm-only) device. The device description explicitly states: "The BD MAX System software automatically interprets test results." There is no human-in-the-loop performance described for the interpretation of the test results themselves. The studies confirm the analytical and clinical performance of the automated system with the new collection kit.

7. The Type of Ground Truth Used

For the comparison study, the "ground truth" for evaluating the new collection kit's performance would implicitly be the results obtained when the same clinical specimens were tested using the predicate device's collection kit (BD MAX UVE Specimen Collection Kit) with the BD MAX Vaginal Panel. This is because the study aims to show the collections kits are equivalent and the performance of the BD MAX Vaginal Panel is already established with the predicate kit.

The initial ground truth for the diagnostic panel itself (BD MAX Vaginal Panel, cleared as DEN160001 and K191957) would have been established through a combination of:

• Clinical diagnosis and criteria: For example, Amsel's criteria or Nugent score for bacterial vaginosis, or clinical signs and symptoms for vaginitis.
• Culture: For culturable pathogens.
• Reference molecular methods: For specific DNA targets.

8. The Sample Size for the Training Set

The document does not provide information regarding a "training set" or its sample size. This is typical for an IVD device submission that is demonstrating substantial equivalence of a component (collection kit) for an already cleared diagnostic system. The algorithms for the BD MAX System and the Vaginal Panel would have been developed and "trained" (in a broad sense of model development) prior to the original 510(k) clearances (DEN160001 and K191957). This document does not detail the development phase of the assay.

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

As no training set is discussed in this document, the method for establishing its ground truth is also not described. As mentioned above, the development and establishment of ground truth for the original assay would have occurred during its prior 510(k) clearances.

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