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BVBLUE is an enzyme activity test for use in the detection of vaginal fluid specimens for sialidase activity, an enzyme produced by bacterial pathogens such as Gardnerella vaginalis, Bacteroides spp., Prevotella spp., and Mobiluncus spp.

BVBLUE is indicated for use in women suspected of having Bacterial Vaginosis (BV) infection, e.g., women with vaginal discharge typical of BV and/or women with previous history of BV, as an aid in the diagnosis of BV infection. BVBLUE test results should be considered in conjunction with other clinical and patient information (see Limitations of the Procedure).

For In Vitro Diagnostic Use Only. BVBLUE is indicated for professional use only and may be used at the point of care and/or physician's offices. It is not intended for home-use.

BVBLUE is an enzyme activity test for use in the detection of vaginal fluid specimens for sialidase activity.

The provided text is a 510(k) clearance letter from the FDA for a device called BVBLUE®. It discusses the regulatory classification and approval process but does not contain any information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria using only the provided text. The document states "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent...", which implies a study was conducted, but none of the details of that study are present in this document.

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BVBLUE™ is an enzyme activity test for use in the detection of vaginal fluid specimens for sialidase activity, an enzyme produced by bacterial pathogens such as Gardnerella vaginalis, Bacteroides spp., Prevotella spp., and Mobiluncus spp.

BVBLUE™ is indicated for use in women suspected of having Bacterial Vaginosis (BV) infection, e.g., women with vaginal discharge typical of BV and/or women with previous history of BV, as an aid in the diagnosis of BV infection. BVBLUE™ test results should be considered in conjunction with other clinical and patient information (see Limitations of the Procedure).

For In Vitro Diagnostic Use Only. BVBLUE™ is indicated for professional use only and may be used at the point of care and/or in physician's offices. It is not intended for home use.

The BVBLUE™ Test contains a chromogenic substrate of sialidase enzyme, IBX-4041. The chromogenic substrate is provided in each of the BVBLUE™ Testing Vessels as a solution containing 0.25 mg IBX-4041 in 0.5 mL aqueous potassium acetate solution (49.0 mg/mL; 0.5 M, pH 5.5-6.0). When the solution containing the solubilized chromogenic substrate is exposed to sialidase enzyme, the substrate is hydrolyzed to yield sialic acid and IBX-4050. Upon the addition of one of more drops of the BVBLUE™ Developer Solution [an aqueous sodium hydroxide solution (40 mg/mL; 1.0 M; pH>11.0)], IBX-4050 exhibits an intense blue color. In the absence of sialidase enzyme, the chromogenic substrate is not hydrolyzed and exhibits a vellow color upon the addition of one or more drops of the BVBLUE'M Developer Solution.

Materials Provided:
10 BVBLUE™ Units per Package:

• Ten (10) BVBLUE™ Testing Vessels each containing 0.25 mg IBX-4041 . component in 0.5 mL of an aqueous potassium acetate buffer solution (49.0 mg/mL; 0.5 M; pH 5.5-6.0).
• One (1) BVBLUE™ Developer Solution Tube containing 0.5 mL of an . aqueous sodium hydroxide solution (40.0 mg/mL; 1.0 M; pH>11.0).
• Instructions for Use .

Here's a detailed breakdown of the acceptance criteria and study information for the BVBLUE™ device, based on the provided text:

BVBLUE™ Device: Acceptance Criteria and Study Details

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a separate section with specific numerical targets prior to presenting results. Instead, performance metrics are reported, and the conclusion states that these demonstrate substantial equivalence. Based on the provided performance numbers, the implied acceptance criteria would be those achieved or exceeded in the studies.

2. Sample Size and Data Provenance

• Non-Clinical Test Set:

  • Analytical Samples: 207 replicates (69 positive, 138 negative) of coded sialidase solutions.
  • Inter-operator Reproducibility: 90 replicates (18 positive, 72 negative) of coded sialidase solutions.
  • Provenance: Analytical laboratory setting. Country of origin not specified, but implied domestic (USA) where the company is located. These are retrospective as they are prepared solutions, not patient samples.

• Clinical Study 1 Test Set:

  • Total Sample Size: 502 women.
  • Test Set Size (BVBLUE vs. Amsel): 502 samples.
  • Test Set Size (Reproducibility): 50 vaginal fluid samples from 25 women.
  • Provenance: Conducted at 5 separate clinical sites. Country of origin not specified, but implied domestic (USA). This was a prospective study where samples were collected and tested.

• Clinical Study 2 Test Set:

  • Total Sample Size: 118 women.
  • Test Set Size (BVBLUE vs. Amsel or Gram's Stain): 118 samples for Amsel, Gram's Stain, Morphotpyes, and quantitative sialidase.
  • Test Set Size (BVBLUE vs. Culture): 55 samples.
  • Test Set Size (Clinical Diagnosis & Sialidase Activity): 255 clinical samples (clinical diagnosis comparison), 118 clinical samples (quantitative sialidase activity).
  • Provenance: Conducted at 2 separate clinical sites. Country of origin not specified, but implied domestic (USA). This was a prospective study.

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly state the number or qualifications of "experts" used to establish ground truth in the traditional sense of independent readers reviewing cases. Instead, the ground truth for clinical studies was established using recognized diagnostic methods:

• Amsel Criteria: This is described as the "Gold Standard Method of clinically diagnosing bacterial vaginosis as recommended by the CDC." It involves a set of clinical signs and symptoms evaluated by a clinician, along with specific laboratory findings (e.g., pH, amine odor). The personnel involved in applying Amsel Criteria were "site personnel" (18 in Study 1, 4 in Study 2) and "company employees" (2 in Study 1, 1 in Study 2). Their specific qualifications (e.g., experience as physicians, nurses, lab technicians) are not detailed, but their role in applying a "Gold Standard" implies medical or laboratory training.
• Gram's Stain: Described as "a second Gold Standard Method of clinically diagnosing bacterial vaginosis." The personnel performing and interpreting Gram's stain are not specifically detailed for their qualifications, but would typically be trained laboratory technologists or physicians.
• Semi-Quantitative Identification of Morphotpyes, Genital Culture, Anaerobic Culture: These are laboratory-based diagnostic methods requiring trained laboratory personnel.

4. Adjudication Method for the Test Set

The document mentions "reconciled comparison" in Clinical Study 2 for BVBLUE™ vs. Amsel Criteria and BVBLUE™ vs. Gram's Stain. This implies some form of adjudication for discordant cases between the BVBLUE™ test and the reference standard. However, the specific method of adjudication (e.g., a third expert review, consensus among original reviewers, or specific protocol for resolving discrepancies) is not detailed. For Clinical Study 1, it is explicitly stated that "The first clinical study did not provide for the evaluation of discordant samples via a second reference method..." indicating no explicit adjudication for discordant results in that study beyond the initial comparison.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done to evaluate the effect size of how much human readers improve with AI vs without AI assistance. The BVBLUE™ is a diagnostic test kit to be used by trained personnel, not an AI assistance tool for human interpretation. The "inter-operator reproducibility studies" evaluated the consistency of the test kit results when performed by different individuals, not a human reader's diagnostic performance with or without AI.

6. Standalone (Algorithm Only) Performance

Yes, the BVBLUE™ device performance as a standalone test kit for detecting sialidase activity (and thus aiding in BV diagnosis) was evaluated. The performance metrics presented for sensitivity and specificity against the ground truth (Amsel Criteria, Gram's Stain, etc.) represent the standalone performance of the device without explicit human-in-the-loop diagnostic assistance for interpretation beyond performing the test itself and reading its color change.

7. Type of Ground Truth Used

The ground truth for the clinical studies was primarily established by:

• Expert Consensus/Clinical Standard: Amsel Criteria, which combines clinical observation and simple lab tests (pH, amines). This is explicitly called the "Gold Standard" as recommended by the CDC.
• Laboratory Standard: Gram's stain, also described as a "Gold Standard" for bacterial vaginosis diagnosis, involving microscopic evaluation by trained personnel.
• Other Laboratory Methods: Semi-quantitative identification of morphotypes, genital cultures, and anaerobic cultures were also used as reference methods in Clinical Study 2.
• Clinical Diagnosis: Comparison against a broader clinical diagnosis of various vaginal conditions (bacterial vaginosis, candidiasis, trichomoniasis, gonorrhea, herpes).
• Quantitative Sialidase Enzyme Activity: Used to establish the quantitative levels of the target enzyme in different clinical conditions and compare them to the device's cutoff.

8. Sample Size for the Training Set

The document does not explicitly state details about a "training set" for the device in the context of machine learning or algorithm development. The BVBLUE™ is described as an enzyme activity test with a chromogenic substrate to identify sialidase. It is not an algorithm that would typically undergo a separate "training" phase with a dataset. The non-clinical studies (analytical sensitivity/specificity, inter-operator reproducibility) could be considered part of the initial validation and refinement.

9. How Ground Truth for the Training Set Was Established

As noted above, there is no explicit "training set" in the context of an algorithm. For the non-clinical studies concerning analytical performance and reproducibility, the ground truth was established by preparation of coded sialidase solutions with known concentrations (e.g., ≥0.25 µg or <0.25 µg of sialidase enzyme).

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