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The Zeus Scientific, Inc., B. burgdorferi Western Blot Test System is designed for the qualitative detection of IgG class antibodies to specific proteins associated with B. burgdorferi, the causative agent of Lyme Disease. The test system is intended to be used for testing human serum samples which have been found to be positive or equivocal by an EIA or IFA screening procedure. The test is therefore intended to provide supportive evidence of infection of Borrelia burgdorferi.

Borrelia burgdorferi IgG Western Blot Test System

This document is a 510(k) clearance letter from the FDA for a diagnostic device, not a study report or clinical trial summary. Therefore, most of the requested information regarding acceptance criteria, device performance, study details, and ground truth establishment is not present in the provided text.

However, based on the information that is available:

1. A table of acceptance criteria and the reported device performance:

This information is not provided in the FDA clearance letter. The letter confirms substantial equivalence but does not detail the specific performance metrics or acceptance criteria used to achieve that equivalence.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This information is not provided in the FDA clearance letter.

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):

This information is not provided in the FDA clearance letter.

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

This information is not provided in the FDA clearance letter.

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 an in vitro diagnostic device (a test system), not an AI-assisted imaging or clinical decision support tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this type of device and is not mentioned.

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

This is an in vitro diagnostic test system, which by its nature operates "stand-alone" in producing a result. However, the clearance letter does not discuss the performance of the "algorithm only" as if it were a separate component, but rather the full test system. The device is intended for the "qualitative detection of IgG class antibodies," suggesting a definitive test result without human interpretation being part of the device's output.

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

This information is not explicitly stated in the FDA clearance letter. For a diagnostic test like this, the ground truth would typically be established by a reference method (e.g., culture, PCR, or a highly validated serological method) or clinical diagnosis, but the letter does not elaborate on this. The device is intended to provide "supportive evidence of infection of Borrelia burgdorferi," implying it's part of a diagnostic workup, not necessarily a sole definitive diagnosis.

8. The sample size for the training set:

This information is not provided in the FDA clearance letter.

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

This information is not provided in the FDA clearance letter.

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