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The BioStar® AB FLU OIA® assay is an Optical ImmunoAssay (OIA) test for the qualitative, rapid detection of influenza A and B viral antigen (nucleoprotein) from nasal aspirate, nasopharyngeal swab, throat swab, or sputum specimens. This test is intended for in vitro diagnostic use to aid in the diagnosis of influenza A and B viral infections. The AB FLU OIA test is not intended to detect influenza C. Negative test results should be confirmed by cell culture.

The AB FLU OIA test involves the extraction and detection of a protein antigen unique to influenza A or B (nucleoprotein). The Opical ImmunoAssay technology enables the direction of a physical change in the optical thickness of molecular thin films. This change is a result of antigen-antibody binding on an optical surface (silicon wafer). When extracted specimen is placed directly on the optical surface, the immobilized specific antibodies capture the antigen. After washing, the substrate is added, increasing the thickness (Mass Enhancement) of the molecular thin film. This change in thickness alters the reflected light path and is visually perceived as a color change. Slight changes in optical thickness produce a distinct visible color change. A positive result appears as a purple spot on the predominant gold background. When antigen is not present in the specimen, no binding takes place. Therefore, the optical thickness remains unchanged and the original gold indicating a negative result.

Here's an analysis of the provided text regarding the acceptance criteria and study for the BioStar® AB FLU OIA Test Kit:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of specific sensitivity and specificity thresholds. Instead, it presents the "relative sensitivity" and "relative specificity" as the results of the clinical study for different specimen types. The conclusion states that these results, combined with analytical sensitivity and specificity, demonstrate that the device is safe and effective. Therefore, the reported performance itself serves as the basis for acceptance. I will present the reported clinical performance.

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

• Sample Size for Test Set: 184 individuals exhibiting influenza-like symptoms.
• Data Provenance:
  • Country of Origin: United States (indicated by "Rocky Mountain region," "Midwest region," and "Southwestern region" for the three study sites).
  • Retrospective or Prospective: Prospective, as specimens were collected from individuals exhibiting symptoms as part of the evaluation.

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

The document does not specify the number or qualifications of experts used to establish the ground truth. It states that the ground truth was determined by "confirmed culture from any specimen type." This implies trained laboratory personnel performed and interpreted the cultures, but their specific qualifications (e.g., years of experience, specific certifications) are not provided.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (like 2+1 or 3+1) for discordant results between the device and the ground truth (cell culture). The "relative sensitivity and specificity" were calculated by comparing the AB FLU OIA assay results directly to the 14-day culture results.

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, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed or described. This is an in vitro diagnostic device (test kit) meant for laboratory use, not a device that directly assists human readers/clinicians in interpreting images or data. The comparison is between the test kit and a conventional laboratory method (cell culture).

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

Yes, this study represents a standalone performance evaluation of the device. The AB FLU OIA assay is a laboratory test kit, and its performance was assessed independently against cell culture without direct human interpretation influencing its results.

7. The Type of Ground Truth Used

The primary ground truth used for determining clinical performance (relative sensitivity and specificity) was cell culture (specifically, "14-day culture"). For analytical sensitivity, the ground truth was also cell culture (TCID/test values estimated by inoculating dilutions into cell culture).

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" for the device, as it describes a finished diagnostic test kit rather than a machine learning algorithm that undergoes a distinct training phase with a specific dataset. The evaluation presented focuses on the device's performance characteristics.

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

As no specific training set is identified in the context of machine learning, this question is not directly applicable. If considering the development process of the assay, the ground truth for establishing acceptable performance characteristics (e.g., antibody binding, optical properties) would have been determined through internal validation using known positive and negative controls, spiked samples, and reference strains, likely confirmed by gold standard methods (like cell culture or genetic sequencing) during the assay's development. However, these specific developmental "training" details are not provided in this 510(k) summary.

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