Search Results

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/or Trichomonas vaginalis. 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 (BV) markers (Individual markers are not reported)
  • o Lactobacillus spp. (L. crispatus and L. jensenii)
  • o Gardnerella vaginalis
  • o Atopobium vaginae
  • o Bacterial Vaginosis Associated Bacteria-2 (BVAB-2)
  • o Megasphaera-1
• · Vulvovaginal candidiasis (VVC) markers (Markers are reported in the following groups)

o Candida spp. (C. albicans, C. tropicalis, C. parapsilosis, C. dubliniensis)

• o Candida glabrata
• o Candida krusei
• · Trichomonas vaginalis (TV)

The assay may be used to detect DNA associated with BV, VVC, and TV, or a subset of these conditions per clinician order, in vaginal swab specimens collected from patients who are symptomatic for vaginitis/vaginosis. 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.

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 bacterial vaginosis (qualitative results reported based on detection and of targeted organism markers), Candida species associated with vulvovaginal candidiasis, and/or Trichomonas vaginalis. 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)
  • o Lactobacillus spp. (L. crispatus and L. jensenii)
  • o Gardnerella vaginalis
  • o Atopobium vaginae
  • o Bacterial Vaginosis Associated Bacteria-2 (BVAB-2)
  • o Megasphaera-1
• · Vulvovaginal candidiasis (VVC) markers (markers are reported in the following groups)
  • o Candida spp. (C. albicans, C. tropicalis, C. parapsilosis, C.dubliniensis)
  • o Candida glabrata
  • o Candida krusei
• • Trichomonas vaginalis (TV)

The assay may be used to detect BV, VVC, and/or TV, or a subset of these conditions per clinician order, in vaginal swab specimens collected from patients who are symptomatic for vaginitis/vaginosis. The BD MAX™ Vaginal 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 an automated, qualitative in vitro diagnostic test for bacterial vaginosis markers. Candida species associated with vulyovaginal candidiasis, and Trichomonas vaginalis. From a single specimen, a vaginal swab collected from a patient who is symptomatic for vaginitis or vaginosis, the test provides qualitative (positive) results for the presence of the following conditions and/or organisms:

• Bacterial vaginosis (based on detection of Lactobacillus spp. (L. crispatus and L. . jensenii), Gardnerella vaginalis, Atopobium vaginae, Bacterial Vaginosis Associated Bacteria-2, and Megasphaera-1)
• Candida spp. (C. albicans, c. tropicalis, C. parapsilosis, and C. dubliniensis) .
• Candida glabrata ●
• Candida krusei ●
• Trichomonas vaginalis ●

The BD Vaginal Panel is available for use with the BD MAX™ System or the BD COR™ System under the trade names BD MAX™ Vaginal Panel and BD Vaginal Panel, respectively. The assay previously provided results for all five targets for every specimen run, regardless of whether the ordering clinician desires evaluation of all reported conditions. After clearance of this 510(k) submission, BD will release updates to the BD MAX™ and BD COR ™ software to allow users the versatility to mask results, per specimen, based on the order received from the clinician. This change allows a laboratory to use the BD Vaginal Panel to test a specimen for an individual target group (BV, VVC, or TV) or any two of the three targeted conditions, in addition to the current configuration that reports all three conditions simultaneously.

The provided text describes a 510(k) premarket notification for the BD Vaginal Panel, an in vitro diagnostic test. While the document details the device's intended use, technological principles, and comparison to a predicate device, it does not contain specific acceptance criteria and detailed study results in the format usually provided for device performance evaluation against such criteria. Instead, it states that "The clinical utility of the Vaginal Panel is unchanged from the clinical utility described in DEN160001" and that enabling a subset of results to be masked "has no clinical impact," implying that performance data was previously established and still applies.

Therefore, I cannot extract a table of acceptance criteria and reported device performance from the provided text, nor can I provide specific details on sample sizes, ground truth establishment, or expert involvement for the test set.

However, I can describe the basis for the claim of continued performance and what typically would be found in a complete submission to address these points.

Based on the provided text, here's what can be inferred and what information is missing:

Inferred Information Regarding Acceptance Criteria and Study to Prove Device Meets Them:

The core of the argument for "acceptance" in this submission (K243725) is that the changes to the BD Vaginal Panel (specifically, the ability to mask results for certain conditions based on clinician order) do not impact the analytical or clinical performance that was already established for the predicate device (BD Vaginal Panel, referenced by DEN160001, K191957, K201017, K223653).

The text states:

• "The clinical utility of the Vaginal Panel is unchanged from the clinical utility described in DEN160001."
• "BD has determined that introducing the capability to order a subset of the conditions evaluated by the Vaginal Panel while masking the results for those conditions that are not ordered has no clinical impact."
• "Enabling the assay to report results for only a subset of the conditions does not change the specimen type, the test conditions, or the logic that is used to determine whether a specimen is positive or negative for the associated condition: conditions that are not ordered are simply not reported to the user."
• "Therefore, analytical and clinical performance of the assays is not impacted."

This implies that the previous submissions (DEN160001, K191957, K201017, K223653) would contain the detailed study data that established the acceptance criteria and demonstrated the device's performance against them. The current submission is a modification where the manufacturer asserts that the modification does not alter the already proven performance.

Unavailable Information from the Provided Text:

Since this submission argues "no impact" on performance rather than providing new performance data, the following specific details are not present in the provided document:

1. A table of acceptance criteria and the reported device performance: This information would be in the predicate device's summary (e.g., DEN160001). The current submission leverages the established performance.
2. Sample sizes used for the test set and the data provenance: Not provided for this submission's changes, as it relies on previous data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided for this submission's changes.
4. Adjudication method for the test set: Not provided for this submission's changes.
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 is a molecular diagnostic test, not an AI-assisted diagnostic imaging device. Therefore, an MRMC study is not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is described as an "automated qualitative in vitro diagnostic test," meaning its performance is its standalone performance without continuous human interpretation of raw data. The "human-in-the-loop" aspect here is the clinician receiving the final positive/negative result. The change highlighted in this 510(k) is masking results, not altering the fundamental detection algorithm.
7. The type of ground truth used: Not explicitly stated for this submission's changes, but for molecular diagnostics, ground truth typically involves a combination of clinical diagnosis, other laboratory methods (e.g., microscopy, culture, or other validated molecular assays), and sometimes expert clinical assessment.
8. The sample size for the training set: Not applicable as this is not an AI/ML device that requires a separate "training set" in that context. The "training" in molecular diagnostics refers to assay development and optimization, which isn't sample-size driven in the same way.
9. How the ground truth for the training set was established: See point 8.

Summary of what is present in the document relevant to the assertion of continued performance:

The basis of acceptance for this 510(k) submission (K243725) is that the modifications to the BD Vaginal Panel (specifically, the software update to allow result masking) do not compromise the established performance of the predicate device. The detailed performance data, acceptance criteria, study designs, and ground truth methodologies would be found in the original and subsequent predicate device submissions (DEN160001, K191957, K201017, K223653). The current submission serves to inform the FDA that a software change introducing result masking does not require new efficacy studies because it does not alter the underlying test's analytical or clinical capability to detect the specified targets.

Ask a specific question about this device

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.

Ask a specific question about this device