Search Results

The ZEUS Solinas Borrelia VIsE1/pepC10 IgG/IgM Test System uses chemiluminescent immunoassay (CLIA) technology for the qualitative detection of IgGlgM antibodies to Borrelia burgdorferi in human serum. This assay is intended for use on samples from patients with signs and symptoms consistent with or patients suspected of having Lyme disease to assess the presence of IgG/IgM antibodies.

Positive results with the ZEUS Solinas Borrelia VIsE1/pepC10 IgG/IgM Test System should be supplemented with additional testing with a Standard two-tier test (STTT) methodology using an IgG and/or IgM Borrelia burgdorferi immunoblot assay following current guidelines.

Positive supplemental results are supportive evidence of antibodies and exposure to Borrelia burgdorferi and may be used along with patient history, symptoms and other laboratory data to support a clinical diagnosis of Lyme disease.

Negative results by the ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System should not be used to exclude Lyme disease. The test must be performed on the ZEUS Solinas instrument.

The ZEUS Solinas Borrelia VIsE1/pepC10 IgG/IgM Control Kit is intended for use as assayed quality control samples to monitor the performance of the ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System. The performance characteristics of the ZEUS Solinas Borrelia VIsE1/pepC10 IgG/IgM Control Kit have not been established for any other assays or instrument platforms.

Not Found

This document is an FDA 510(k) clearance letter for the ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System. It describes a diagnostic test for Lyme disease. The information provided does not contain details about acceptance criteria, study data, sample sizes, expert qualifications, or ground truth establishment typically found in a clinical study report for an AI/ML medical device.

The questions you've asked are most relevant to AI/ML device approval processes, where the device "learns" from data. This document describes a Chemiluminescent Immunoassay (CLIA) technology, which is a laboratory-based diagnostic test, not an AI/ML algorithm. Therefore, the concepts of training sets, test sets, human readers assisting AI, adjudication methods, and expert consensus for AI ground truth do not directly apply to this type of device.

This clearance is based on substantial equivalence to legally marketed predicate devices, meaning it has similar indications for use and technological characteristics to devices already on the market. The performance of such a device is typically assessed through analytical and clinical performance studies, comparing its results to a reference method or clinical diagnosis, rather than through AI-specific metrics like those you've inquired about.

To directly answer your request based on the provided document, I cannot fill in the table or provide the requested details because the document describes a traditional diagnostic assay, not an AI/ML device.

Here's why each of your points cannot be addressed with the provided text:

• 1. A table of acceptance criteria and the reported device performance: This document is the clearance letter, not the study report. It states the device is substantially equivalent but does not present the raw performance data or acceptance criteria that were met.
• 2. Sample sizes used for the test set and the data provenance: Not present in this document.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable to a CLIA assay in the context typically asked for AI/ML. Ground truth for a diagnostic test usually refers to clinical diagnosis, a gold standard lab test, or patient outcomes, not expert image annotation.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable to a CLIA assay.
• 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: Not applicable, as this is not an AI-assisted device for human interpretation.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a laboratory test, not an algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): While not detailed, for a diagnostic test like this, ground truth would typically be established based on a combination of clinical diagnosis, other established laboratory tests, and possibly follow-up outcomes, not expert consensus in the way it's used for AI image interpretation.
• 8. The sample size for the training set: Not applicable, as this is not an AI/ML device that requires a "training set."
• 9. How the ground truth for the training set was established: Not applicable for the same reason as above.

In summary, the provided document is an FDA 510(k) clearance letter for a traditional in-vitro diagnostic test, not an AI/ML medical device submission. Therefore, the specific questions related to AI/ML study design and performance metrics cannot be answered from this document.

Ask a specific question about this device