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ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System: The ZEUS ELISA Borrelia VIsE1/pepC10 IgG/IgM Test System is intended for the qualitative detection of IgG and IgM class antibodies to VlsE1 and pepC10 antigens from Borrelia burgdorferi in human serum. The assay is intended for testing serum samples from symptomatic patients or those suspected of having Lyme disease. Positive and equivocal test results with the ZEUS ELISA Borrelia VIsE1/pepC10 IgG/IgM Test System for the presence of Borrelia burgdorferi antibodies must be confirmed through additional testing by one of the following methods: (1) Standard two-tier test methodology (STTT) using IgG or IgM Western blot testing following current interpretation guidelines; or (2) Modified two-tier test methodology (MTTT) using one of the following three ELISA-based assays: - ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System - ZEUS ELISA Borrelia burgdorferi IgM Test System - ZEUS ELISA Borrelia burgdorferi IgG Test System Positive test results by either the STTT or MTTT methodology are supportive evidence for the presence of antibodies and exposure to Borrelia burgdorferi, the cause of Lyme disease. A diagnosis of Lyme disease should be made based on the presence of Borrelia burgdorferi antibodies, history, symptoms, and other laboratory data.

Zeus ELISA Borrelia burgdorferi IgG/IgM Test System: The ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of IgG and IgM class antibodies to Borrelia burgdorferi in human serum. The assay is intended for testing serum samples from symptomatic patients or those suspected of Lyme Disease. Positive and equivocal test results with the ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System for the presence of Borrelia burgdorferi antibodies must be confirmed through additional testing by one of the following methods: (1) Standard two-tier test methodology (STTT) using IgG or IgM Western blot testing following current interpretation guidelines; or (2) Modified two-tier test methodology (MTTT) using the ZEUS ELISA Borrelia VIsE1/pepC10 IgG/IgM Test System. Positive test results by either the STTT or MTTT methodology are supportive evidence for the presence of antibodies and exposure to Borrelia burgdorferi, the cause of Lyme disease. A diagnosis of Lyme disease should be made based on the presence of Borrelia burgdorferi antibodies, history, symptoms, and other laboratory data.

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This document is an FDA 510(k) clearance letter for two ELISA Borrelia test systems. While it outlines the intended use and regulatory classifications, it does not contain the detailed study information required to answer your questions about acceptance criteria, device performance, sample sizes, ground truth establishment, or expert involvement in a study.

Therefore, I cannot provide the requested information based solely on the provided text. To answer your questions, I would need access to the actual 510(k) summary or the full submission data, which would typically contain the results of performance studies.

The document primarily focuses on regulatory approval and equivalence to predicate devices, not the detailed scientific performance data from the clinical studies.

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ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System: The ZEUS ELISA Borrelia VIsE1/pepC10 IgG/IgM Test System is intended for the qualitative detection of IgG and IgM class antibodies to VlsE1 and pepC10 antigens from Borrelia burgdorferi in human serum. The assay is intended for testing serum samples from symptomatic patients or those suspected of having Lyme disease. Positive and equivocal test results with the ZEUS ELISA Borrelia VIsE1/pepC10 IgG/IgM Test System for the presence of Borrelia burgdorferi antibodies must be confirmed through additional testing by one of the following methods (1) Standard two-tier test methodology (STTT) using IgG or IgM Western blot testing following current interpretation guidelines; or (2) Modified two-tier test methodology (MTTT) using one of the following three ELISA-based assays: - ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System - ZEUS ELISA Borrelia burgdorferi IgM Test System - ZEUS ELISA Borrelia burgdorferi IgG Test System Positive test results by either the STTT or MTTT methodology are supportive evidence for the presence of antibodies and exposure to Borrelia burgdorferi, the cause of Lyme disease. A diagnosis of Lyme disease should be made based on the presence of Borrelia burgdorferi antibodies, history, symptoms, and other laboratory data.

ZEUS ELISA Borrelia burgdorferi IgG Test System: The ZEUS ELISA Borrelia burgdorferi IgG Test System is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of IgG class antibody to Borrelia burgdorferi in human serum. The assay is intended for testing serum samples from symptomatic patients or those suspected of Lyme Disease. Positive and equivocal test results with the ZEUS ELISA Borrelia burgdorferi IgG Test System for the presence of Borrelia burgdorferi antibodies must be confirmed through additional testing by one of the following approaches: (1) Standard two-tier test methodology (STTT) using IgG Western blot testing following current interpretation guidelines; or (2) Modified two-tier test methodology (MTTT) using the ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System. Positive test results by either the STTT or MTTT methodology are supportive evidence for the presence of antibodies and exposure to Borrelia burgdorferi, the cause of Lyme disease. A diagnosis of Lyme disease should be made based on the presence of Borrelia burgdorferi antibodies, history, symptoms, and other laboratory data.

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The provided FDA 510(k) clearance letter and Indications for Use statement do not contain the detailed information necessary to answer all aspects of your request regarding acceptance criteria and a specific study proving device performance. This document primarily focuses on the regulatory clearance process and the intended use of the devices, rather than the raw performance data from clinical or analytical studies.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for the test set.
• Data provenance (country of origin, retrospective/prospective).
• Number and qualifications of experts for ground truth.
• Adjudication method for the test set.
• Information about Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or effect sizes for human reader improvement with AI.
• Details about standalone (algorithm-only) performance studies.
• Sample size for the training set.
• How ground truth for the training set was established.

The document states one of the devices is "ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System." ELISA is an Enzyme-Linked Immunosorbent Assay, which is a laboratory assay for detecting antibodies, not an AI or digital imaging device. Therefore, questions related to "human readers improving with AI" or "standalone algorithm performance" are not applicable to these specific devices as described.

The document indicates the following regarding ground truth:

• Type of Ground Truth: The device is intended to detect IgG and IgM class antibodies. Positive and equivocal results "must be confirmed through additional testing by one of the following methods: (1) Standard two-tier test methodology (STTT) using IgG or IgM Western blot testing following current interpretation guidelines; or (2) Modified two-tier test methodology (MTTT) using one of the following three ELISA-based assays..." This implies that the 'ground truth' or confirmatory standard is based on established laboratory diagnostic protocols (Western blot or other ELISA assays), rather than expert consensus on images, pathology, or direct outcome data in the context of an AI device.

To obtain the specific performance data, acceptance criteria, and study details you're looking for, you would typically need to consult the full 510(k) submission, clinical study reports, or peer-reviewed publications related to these specific devices, which are not included in the provided text. The FDA clearance letter summarizes the regulatory decision and the intended use, but not the detailed underlying performance data.

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The ZEUS ELISA Borrelia VIsE1/pepC10 IgG/IgM Test System is intended for the qualitative detection of IgG and IgM class antibodies to VlsE1 and pepC10 antigens from Borrelia burgdorferi in human serum. The assay is intended for testing serum samples from symptomatic patients or those suspected of having Lyme disease.

Positive and equivocal test results with the ZEUS ELISA Borrelia VIsE1/pepC10 IgG/IgM Test System for the presence of Borrelia burgdorferi antibodies must be confirmed through additional testing by one of the following approaches:

(1) Standard two-tier test methodology (STTT) using IgG or IgM Western blot testing following current interpretation guidelines;

or

(2) Modified two-tier test methodology (MTTT) using one of the following three ELISA-based assays:

• ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System
• · ZEUS ELISA Borrelia burgdorferi IgM Test System
• ZEUS ELISA Borrelia burgdorferi IgG Test System

Positive test results by either the STTT or MTTT methodology are supportive evidence for the presence of antibodies and exposure to Borrelia burgdorferi, the cause of Lyme disease. A diagnosis of Lyme disease should be made based on the presence of B. burgdorferi antibodies, history, symptoms, and other laboratory data.

ZEUS ELISA Borrelia burgdorferi IgM Test System

The ZEUS ELISA Borrelia burgdorferi IgM Test System is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of IgM class antibodies to Borrelia burgdorferi in human serum. The assay is intended for testing serum samples from symptomatic patients or those suspected of Lyme Disease.

Positive and equivocal test results with the ZEUS ELISA Borrelia burgdorferi IgM Test System for the presence of Borrelia burgdorferi antibodies must be confirmed through additional testing by one of the following approaches:

(3) Standard two-tier test methodology (STTT) using IgM Western blot testing following current interpretation guidelines; or

(4) Modified two-tier test methodology (MTTT) using the ZEUS ELISA Borrelia VIsE1/pepC10 IgG/IgM Test System.

Positive test results by either the STTT or MTTT methodology are supportive evidence for the presence of antibodies and exposure to Borrelia burgdorferi, the cause of Lyme disease. A diagnosis of Lyme disease should be made based on the presence of Borrelia burgdorferi antibodies, history, symptoms, and other laboratory data.

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I apologize, but the provided text from the FDA 510(k) clearance letter does not contain the specific information required to complete your request. The document is primarily a formal notification of substantial equivalence for a medical device (ELISA test systems for Lyme disease) and outlines its intended use and regulatory details.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Details about the sample size used for a test set, data provenance, or information about training sets.
• Mention of experts establishing ground truth, adjudication methods, or multi-reader multi-case (MRMC) studies.
• Information on standalone algorithm performance or the type of ground truth used in validation studies.

To get this information, you would typically need to refer to the actual 510(k) submission document or the device's Instructions For Use (IFU), which would contain the detailed studies and performance data submitted to the FDA for clearance. The provided text is merely the FDA's decision letter based on that submission.

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