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For the qualitative presumptive detection of total (IgG/IgM) antibodies to Borrelia burgdorferi in human serum. This ELISA should only be used for patients with signs and symptoms that are consistent with Lyme disease. Equivocal or positive results must be supplemented by testing with a standardized Western blot procedure. Positive supplemental results are supportive evidence of exposure to B. burgdorferi and can be used to support a clinical diagnosis of Lyme disease. The test can be performed either manually or in conjunction with the MAGO TM PLUS Automated EIA Processor.

The & Borrelia burgdorferi IgG/IgM ELISA Kit is an enzyme-linked immunosorbent assay (ELISA) for the detection of IgG/IgM to Borrelia burgdorferi antigen in human serum.

The provided 510(k) summary for the "Borrelia burgdorferi IgG/IgM ELISA Kit" details performance characteristics but does not explicitly state specific acceptance criteria in terms of numerical thresholds for sensitivity, specificity, or precision that the device had to meet for clearance. Instead, it presents the device's performance results across various studies and implies that these results were considered acceptable by the FDA for substantial equivalence to a predicate device.

However, based on the presented data, we can infer the reported device performance.

1. Table of Acceptance Criteria and Reported Device Performance

As specific acceptance criteria were not explicitly stated, the reported performance is presented as demonstrated.

2. Sample Sizes and Data Provenance

• Clinical Sensitivity and Specificity (Test Set 1 - CDC Panel):

  • Sample Size: 47 sera (8 >1 Yr, 20 for 3-12 Months, 9 for 1-2 Months, 5 for <1 Month, 5 Negatives).
  • Data Provenance: Obtained from the CDC (Centers for Disease Control and Prevention), tested by Diamedix Corp. Retrospective.

• Clinical Sensitivity and Specificity (Test Set 2 - Wisconsin Lab Panel):

  • Sample Size: 72 sera (3 >1 Yr, 13 for 3-12 Months, 13 for 1-2 Months, 43 for <1 Month).
  • Data Provenance: Obtained from a clinical laboratory in Wisconsin, assayed by Diamedix. Retrospective.

• Prospective Sample Study (Test Set 3):

  • Sample Size: 173 prospective sera.
  • Data Provenance: From patients of various ages and gender from an endemic area, submitted to a clinical laboratory for B. burgdorferi antibody testing. Prospective.

• Precision Studies (Manual & Automated):

  • Sample Size: 6 sera (4 positive, 2 negative) for each site's manual precision (tested 10 times in 3 runs).
  • Sample Size: 6 sera (4 positive, 2 negative) for automated precision (tested 10 times in 3 runs).
  • Data Provenance: Not explicitly stated, but likely laboratory-prepared control samples for an in-house study.

• Specificity with Potentially Cross-Reactive Sera (Test Set 4):

  • Sample Size: Total not explicitly given, but individual groups are: 20 RPR+, 15 ds-DNA+, 5 RF+, 5 Lipemic+, 5 Bilirubin+, 4 Elevated ESR, 5 Elevated CRP, 7 EBV+, 6 CMV+, 4 Rocky MT Spotted Fever (total 76 unique samples, assuming no overlap).
  • Data Provenance: Not explicitly stated, likely sourced from clinical laboratories or specialized panels.

• Correlation of Manual and MAGO Plus Results:

  • Sample Size: 296 sera.
  • Data Provenance: Not explicitly stated, but implies concurrent testing of patient samples or a diverse set of samples.

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly state the number of experts or their qualifications for establishing ground truth.

• For the CDC Panel and Wisconsin Lab Panel: The sera are described as "characterized sera" or "sera with a clinical diagnosis of Lyme disease." This implies that the diagnosis was established by clinicians or epidemiologists based on clinical presentation and potentially other laboratory tests, but expert qualifications are not detailed.
• For the Prospective Study: The ground truth for positive and equivocal EIA results was established by "testing with a Western Blot method." The interpretation of Western Blot results usually involves adherence to standardized criteria, which are often overseen by qualified laboratory personnel, but no specific number or qualifications of experts are given.

4. Adjudication Method for the Test Set

• Clinical Sensitivity and Specificity (CDC & Wisconsin Panels): The samples were "characterized." No explicit adjudication method (e.g., 2+1, 3+1) is described for resolving discrepancies in these panels. However, a key point is mentioned: "Note that equivocal samples were considered positive for the above calculations due to the fact that all equivocal samples would be tested by immunoblotting in a 2-step system." This reflects a specific decision logic for the primary analysis.
• Prospective Sample Study: Positive and equivocal results from both EIAs were "supplemented by testing with a Western Blot method." This acts as the confirmatory or adjudicating test for initial EIA findings. No human adjudicators for the Western Blot results are mentioned; it's implied that the Western Blot itself serves as the definitive test in a two-step algorithm.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done. This device is an ELISA kit, which is a laboratory assay for detecting antibodies, not an imaging or diagnostic AI algorithm that humans interact with to make decisions. Therefore, the concept of "human readers improving with AI vs without AI assistance" is not applicable to this type of device.

6. Standalone Performance Study

• Yes, a standalone performance study was done. The entire clinical sensitivity and specificity evaluation, prospective sample study, precision study, and cross-reactivity study demonstrate the performance of the "Borrelia burgdorferi IgG/IgM ELISA Kit" as a standalone diagnostic assay. The results presented are exclusively based on the device's output. The "correlation of Manual and MAGO Plus Results" section also shows the device's performance in both manual and automated standalone modes.

7. Type of Ground Truth Used

• Expert Consensus/Clinical Diagnosis/Reference Method (with further confirmation):
  • Clinical Sensitivity/Specificity Panels (CDC & Wisconsin): "Characterized sera" with a "clinical diagnosis of Lyme disease" and "normal sera." This implies a ground truth established by clinical diagnosis and possibly backed by other diagnostic markers.
  • Prospective Study: The primary ground truth for confirmation for an EIA result was a standardized Western Blot procedure. This is a commonly accepted reference method for Lyme disease serology in a two-tier testing algorithm.
  • Specificity with Potentially Cross-Reactive Sera: Ground truth was based on the "laboratory results" for specific conditions (e.g., RPR+, ds-DNA+), meaning a confirmed diagnosis of those conditions or positive results on tests for those conditions.

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI development. As this is an ELISA kit (a chemical/biological assay), the concept of a separate training set as used in AI development is not directly applicable.

However, if "training set" is implicitly referring to the samples used during the development and optimization of the assay before formal clinical validation, that information is not provided in this 510(k) summary. The presented data falls under validation and verification studies.

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

As no explicit "training set" distinct from the validation/test sets is mentioned for an AI/machine learning context, the method for establishing ground truth for such a set is not detailed. The ground truth for the validation sets (as described in point 7) was established through clinical characterization and standardized Western Blot testing.

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