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The Boston Biomedica, Inc. (BBI) Borrelia burgdorferi IgM and IgG Western Blot Kit is an in vitro qualitative assay for the detection of IgM and IgG antibodies to Borrelia burgdorferi in human serum. It is intended for use in testing human serum samples that have been found positive or equivocal using an enzyme immunoassay (EIA) or immunofluorescence assay (FA) test procedure for B. burgdorferi antibodies.

The Boston Biomedica, Inc. (BBI) Borrelia burgdorferi IgM and IgG Western Blot Test Kit is an in vitro qualitative assay for the detection of IgM and IgG antibodies to Borrelia burgdorferi in human serum. This device is composed of the reagents, controls and test strips intended for use in Western blot testing of human serum samples for the presence of IgM and/or IgG antibodies to B. burgdorferi. The device is similar in composition to the previously approved BBI Biotech Research Laboratories Borrelia burgdorferi IgM Western Blot Test Kit. The kit also includes Blot Reading Guides, report forms and a Package Insert.

Below is a summary of the acceptance criteria and study information for the Boston Biomedica, Inc. Borrelia burgdorferi IgM and IgG Western Blot Test Kit based on the provided document.

Acceptance Criteria and Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of specific sensitivity and specificity thresholds. However, it implies that the device's performance was evaluated by comparing it against various sample types and the predicate device, aiming for performance that supports the intended use.

No explicit table of acceptance criteria and reported device performance is provided in the document. The document describes the clinical performance data without numerical targets or direct comparisons in a table format against predetermined criteria.

Study Information

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

   • Test Set Description: The device was evaluated using:
     • Samples from patients who were culture-positive for B. burgdorferi.
     • Samples that had tested IgG EIA positive.
     • The CDC Lyme panel.
     • A commercially available panel of Lyme positive samples (PTL202).
     • Serum samples from random blood donors from Lyme endemic and non-endemic regions.
     • Samples from patients with ten other infectious diseases and conditions (e.g., syphilis, rheumatoid arthritis, systemic lupus erythematosus).
   • Sample Size: The exact sample sizes for each of these categories are not provided in the document.
   • Data Provenance: The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective, beyond mentioning "Lyme endemic and non-endemic regions."

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not specified. The document does not provide details on the number or qualifications of experts involved in establishing the ground truth for the test set.

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

   • Not specified. The document does not describe any adjudication method used for the test set.

4. 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 study was not done. This device is an in vitro diagnostic test kit (Western Blot), not an AI-assisted diagnostic tool that would involve human readers and AI assistance in the way a typical MRMC study evaluates. The comparison was primarily between the applicant device and a predicate device, and various clinical sample types.

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

   • The "device" in this context is a laboratory test kit (Western Blot), which is inherently "standalone" in its technical performance, meaning the chemical and biological reactions produce a result. However, the interpretation of the Western Blot bands to determine a positive or negative result would typically involve a trained laboratory professional. The document does not report on a "standalone" algorithm performance in the way it would for imaging or computational AI. The "summary of clinical performance data" describes the device's accuracy in different clinical scenarios.

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

   • The ground truth appears to be established using a combination of methods:
     • Culture-positive for B. burgdorferi: This is a definitive microbiological confirmation for Borrelia burgdorferi infection.
     • CDC Lyme panel: This is a characterized panel often used for test validation.
     • Commercially available panel of Lyme positive samples (PTL202): Another characterized panel.
     • IgG EIA positive: This acts as a reference for B. burgdorferi antibody presence, although the Western Blot is intended as a confirmatory test for EIA/IFA positive or equivocal samples.
     • Patient samples from random blood donors from Lyme endemic and non-endemic regions: These serve as healthy controls or general population samples.
     • Samples from patients with other infectious diseases and conditions: Used to assess specificity and cross-reactivity.

7. The sample size for the training set:

   • Not applicable/Not specified. As an in vitro diagnostic kit based on biological reagents, there isn't a "training set" in the context of machine learning or AI algorithms. The kit's design and optimization would have relied on research and development data, but this is not analogous to an algorithm's training set as typically described in AI studies.

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

   • Not applicable/Not specified. Given that there is no explicit "training set" in the context of an algorithm, the method for establishing ground truth for such a set is not detailed. The development of the kit's components and interpretation criteria would have been based on established scientific principles and studies on B. burgdorferi antigens and antibody responses.

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