(21 days)
The IMMULITE Turbo CK-MB is for in vitro diagnostic use with the IMMULITE Analyzer – for the quantitative measurement of creatine kinase isoenzyme MB (CK-MB) in serum or heparinized plasma, as an aid in patient management and the assessment of prognosis of myocardial infarction.
IMMULITE Turbo CK-MB is a solid-phase, two-site chemiluminescent enzyme immunometric assay for use with the IMMULITE Automated Analyzer.
Here's a breakdown of the acceptance criteria and study information for the IMMULITE® Turbo CK-MB device, based on the provided text:
Based on the provided document, the device is the IMMULITE® Turbo CK-MB, a diagnostic assay for the quantitative measurement of creatine kinase isoenzyme MB (CK-MB) in serum or heparinized plasma, intended as an aid in patient management and the assessment of prognosis of myocardial infarction.
Unfortunately, the provided 510(k) summary does not contain explicit acceptance criteria or details of a specific study proving the device meets those criteria. The document focuses on establishing substantial equivalence to a predicate device and describing the technology. It mentions "data presented in this summary of safety and effectiveness is the data that the Food and Drug Administration used in granting DPC substantial equivalence," but it does not present that data.
Therefore, many of the requested details cannot be extracted from this document alone.
Here's what can be inferred or directly stated from the provided text:
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A table of acceptance criteria and the reported device performance
This information is not provided in the document. The document primarily describes the device, its intended use, and its technology, and then states that it has been found substantially equivalent to a predicate device (IMMULITE CK-MB, K004002). Typically, detailed performance data, including acceptance criteria, would be in a separate, more comprehensive study report or a different section of the 510(k) submission.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document.
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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)
This information is not provided in the document.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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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
This is an in vitro diagnostic (IVD) assay, not an imaging device typically involving human "readers" in the context of MRMC studies as understood for AI-powered image analysis. Therefore, an MRMC study as described (human readers improving with AI assistance) is not applicable to this type of device and is not mentioned or implied.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is an in vitro diagnostic (IVD) assay, which by its nature is a standalone test performed by an automated analyzer. The "algorithm only" concept applies as the device's performance is determined by the chemical reaction and light output measurement, not by human interpretation or intervention in the direct result calculation. The document describes the technical process of the assay, stating: "The bound complex - and thus also the photon output, as measured by the luminometer - is proportional to the concentration of CK-MB in the sample." This indicates a standalone, automated measurement.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For an IVD assay measuring CK-MB, the "ground truth" would typically be established by comparison to a recognized gold standard method for CK-MB quantification (e.g., a reference method, another validated commercial assay, or clinical correlation with myocardial infarction diagnosis based on clinical signs, symptoms, ECG changes, and other biomarker levels). However, the specific type of ground truth used for performance evaluation is not explicitly stated in this summary.
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The sample size for the training set
This information is not provided in the document as it focuses on clinical validation, not machine learning model training.
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How the ground truth for the training set was established
This information is not provided in the document, as it focuses on clinical validation, not machine learning model training.
Summary of what is known from the document regarding a "study":
The document states: "The data presented in this summary of safety and effectiveness is the data that the Food and Drug Administration used in granting DPC substantial equivalence for IMMULITE Turbo CK-MB." This implies that a study or set of studies was conducted and reviewed by the FDA, but the details of those studies (sample sizes, methodologies, specific performance metrics, and acceptance criteria) are not included in this 510(k) summary. The summary is intended to provide an overview and demonstrate substantial equivalence, not to detail the full scientific evidence.
§ 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.