(52 days)
Intended for the In Vitro, quantitative determination of creatine kinase (CK) in human serum on automated chemistry analyzers.
Creatine kinase measurements are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.
This Reagent is intended for the in vitro quantitative determination of creatine kinase in human serum.
Here's an analysis of the provided text regarding the acceptance criteria and study for the JAS Creatine Kinase (CK-NAC) Liquid Reagent:
Important Note: The provided document is a 510(k) summary for a medical device (a laboratory reagent), not a typical AI/ML device submission. Therefore, many of the requested categories like "multi-reader multi-case (MRMC) comparative effectiveness study," "effect size of how much human readers improve with AI vs without AI assistance," and "standalone (i.e. algorithm only without human-in-the-loop performance)" are not applicable as this is not an AI-powered diagnostic device. The evaluation of this device focuses on its chemical performance and equivalence to existing reagents, not the performance of an algorithm.
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|---|
| Intended Use | Identical to predicate devices. | "The JAS Creatine Kinase (CK-NAC) Liquid Reagent's intended use is identical to predicate Devices." |
| Performance | "Acceptable result comparisons" with predicate devices. | "Correlation studies on human serum demonstrated acceptable result comparisons between these methods" |
| and | ||
| "it's performance acceptable on the automated chemistry analyzers tested." | ||
| Normal Ranges | Similar normal ranges to predicate devices. | "which all use similar normal ranges." |
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document mentions "correlation studies on human serum" but does not provide a specific number of samples or subjects.
- Data Provenance: "human serum." The country of origin is not specified, but given the submitter's address in Miami, Florida, USA, it is likely from the United States. The studies appear to be retrospective or prospective clinical validation studies comparing the new reagent's performance against predicate devices.
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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. For a chemical reagent, "ground truth" is typically established by the reference method or comparison to established, legally marketed predicate devices, not by expert interpretation in the way it would be for an image-based AI diagnostic. The comparison is against established laboratory testing methods.
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Adjudication method for the test set:
- Not Applicable. As this is a chemical reagent, there's no "adjudication" in the sense of resolving disagreements between human readers or experts. The comparison is quantitative data obtained from automated chemistry analyzers.
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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:
- No. This is a chemical reagent, not an AI-powered diagnostic device, so an MRMC study is not relevant or applicable.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a lab reagent; there is no "algorithm" in the sense of AI. Its performance is measured as a component of an in vitro diagnostic test system.
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The type of ground truth used:
- Reference Method/Comparative Performance: The ground truth for evaluating this reagent's performance is established by comparing its results to those obtained using legally marketed predicate devices (Roche Diagnostics CK NAC Reagent and Pointe Scientific Creatine Kinase (CK) Reagent) on automated chemistry analyzers. The aim is to demonstrate "acceptable result comparisons" and "similar normal ranges."
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The sample size for the training set:
- Not Applicable. This is a chemical reagent; there is no "training set" in the context of machine learning. The term "training set" is typically used for AI/ML models.
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How the ground truth for the training set was established:
- Not Applicable. See point 7.
§ 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.