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The BioCheck Myoglobin ELISA is intended for the quantitative determination of myoglobin in human serum. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease.

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The provided text is a 510(k) premarket notification letter for a Myoglobin Enzyme Immunoassay Test Kit. It focuses on regulatory approval and substantial equivalence to a predicate device, rather than detailed performance studies against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth cannot be extracted from this document.

Here's a breakdown of what can be inferred or what is explicitly missing:

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

• Acceptance Criteria: Not explicitly stated in this document. The 510(k) process focuses on demonstrating "substantial equivalence" to a predicate device, meaning the new device is as safe and effective as a legally marketed device. Specific performance acceptance criteria are typically detailed in the full 510(k) submission, not in the FDA's decision letter.
• Reported Device Performance: Not included in this document. The letter confirms review and determination of substantial equivalence, but it doesn't present the actual performance data (e.g., sensitivity, specificity, accuracy, precision) that led to that determination.

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

• Sample Size: Not mentioned in this document.
• Data Provenance: Not mentioned in this document.

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)

• Number of Experts: Not mentioned in this document.
• Qualifications of Experts: Not mentioned in this document.

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

• Not mentioned in this document.

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 device is an in-vitro diagnostic (IVD) immunoassay test kit, not an AI-assisted diagnostic imaging device. Therefore, a multi-reader multi-case (MRMC) study involving human readers and AI assistance is not applicable.

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

• This question is not applicable as the device is an immunoassay test kit, not an algorithm. Its performance is inherent to the assay chemistry and instrumentation, not an "algorithm only" in the context of AI.

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

• For an immunoassay for myoglobin, the "ground truth" would typically be established by a reference method for myoglobin quantification or clinical diagnosis of heart or renal disease, confirmed by other established clinical markers or gold standard diagnostic procedures. However, the specific method used is not mentioned in this document.

8. The sample size for the training set

• This device is an immunoassay, not a machine learning model. Therefore, the concept of a "training set" in the context of AI/ML is not applicable.

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

• This question is not applicable as the device is an immunoassay, not a machine learning model.

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