(42 days)
Stanbio Laboratory's Creatine Kinase (CK) Liqui-UV is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in serum. Serum creatine kinase (CK) levels have proven valuable in the assessment of cardiac and skeletal muscle diseases, including myocardial infarction and muscular dystrophy.
The device test kit is comprised of two reagents, CK Buffer (R1) and CK Enzyme (R2). A working reagent is prepared by combining five parts CK Buffer (R1) to one part CK Enzyme (R2).
Here's an analysis of the provided text regarding the Creatine Kinase (CK) Liqui-UV device, focusing on acceptance criteria and supporting studies:
This document is a 510(k) summary for a clinical laboratory device, specifically an in-vitro diagnostic (IVD) test kit. The information provided is primarily for demonstrating substantial equivalence to a predicate device rather than a comprehensive performance study for a novel medical AI device. Therefore, many of the requested categories (e.g., number of experts for ground truth, adjudication methods, MRMC studies, training set details) are not applicable or not provided in the context of an IVD submission of this nature.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implied/Stated) | Reported Device Performance |
|---|---|---|
| Method Comparison (Substantial Equivalence) | Correlation coefficient indicating strong agreement with predicate device. Linear regression showing proportional bias and intercept close to zero. | Correlation Coefficient: 0.999 (with Boehringer Mannheim CK/NAC) |
| Regression Equation: y = 1.027x - 0.65 | ||
| Precision | Acceptable variability/reproducibility of results. | "Results of these tests were found to be acceptable." (No specific metrics provided in the summary) |
| Linearity | Acceptable performance across a range of analyte concentrations. | "Results of these tests were found to be acceptable." (No specific metrics provided in the summary) |
| Sensitivity | Ability to detect low levels of the analyte. | "Results of these tests were found to be acceptable." (No specific metrics provided in the summary) |
| Stability | Acceptable performance over time under specified conditions. | "Results of these tests were found to be acceptable." (No specific metrics provided in the summary) |
| Interference | Acceptable performance in the presence of common interfering substances. | "Results of these tests were found to be acceptable." (No specific metrics provided in the summary) |
Study Details
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Sample size used for the test set and the data provenance:
- The document does not specify the sample size used for the method comparison or other performance studies.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, for IVD studies of this type, it's typically a controlled laboratory study using patient samples or spiked samples. It's prospective in the sense that the study was conducted specifically for this submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of this IVD device. The "ground truth" for method comparison is the measurement obtained from the predicate device (Boehringer Mannheim CK/NAC). The performance of the predicate device itself would have been established through its own validation studies. This isn't an image-based AI device requiring expert adjudication.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. There's no expert adjudication process described for establishing ground truth for an IVD test's quantitative results.
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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. This is an in-vitro diagnostic test kit that directly measures a biochemical marker, not an AI-assisted diagnostic imaging or interpretation tool that involves human "readers."
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This device is a "standalone" laboratory test in the sense that its performance is evaluated independent of a human's interpretive input beyond running the assay and reading the result. Its assessment is purely on its analytical performance (accuracy, precision, etc.) in a laboratory setting. There is no "algorithm" in the AI sense for this type of chemical assay.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for demonstrating substantial equivalence and analytical performance is the results obtained from the legally marketed predicate device (Boehringer Mannheim CK/NAC) for method comparison. For other studies like linearity and precision, the "ground truth" is typically established by reference materials, known analyte concentrations, or statistical measures against repeated measurements.
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The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that requires a training set.
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How the ground truth for the training set was established:
- Not applicable. As above, there is no training set for this type of IVD device.
§ 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.
(a)
Identification. A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.(b)
Classification. Class II.