(14 days)
IMMULITE® Turbo CK-MB is a two-site chemiluminescent enzyme immunometric assay for use with the IMMULITE Automated Analyzer and designed for the quantitative measurement of creatine kinase isoenzyme MB (CK-MB) antigen in serum or heparinized plasma. It is intended strictly for in vitro use as an aid in patient management and the assessment of prognosis of myocardial infarction.
IMMULITE® Turbo CK-MB is a clinical device for use with the IMMULITE® Automated Immunoassay Analyzer.
The provided text is a 510(k) summary for the IMMULITE® Turbo CK-MB device. It details the device's intended use and the regulatory process, but it does not contain specific information about detailed acceptance criteria or a dedicated study proving the device meets those criteria, as one would expect for an AI/ML medical device submission.
This document is from 1999 and pertains to an immunoassay for measuring CK-MB, which is a laboratory diagnostic. At that time, the regulatory requirements and types of studies for such devices were different from those for AI/ML-based diagnostic devices. The summary focuses on establishing "substantial equivalence" to a predicate device, which is a common pathway for traditional IVDs.
Therefore, many of the requested details, particularly those related to a "device" in the context of AI/ML performance, sample sizes, expert ground truth, adjudication methods, multi-reader multi-case studies, and standalone performance for AI, are not applicable or available in this document.
However, I can extract the information that is present:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state acceptance criteria in the format of a typical AI/ML study (e.g., minimum sensitivity, specificity, or AUC). Instead, for an immunoassay, the "performance" is demonstrated through its ability to accurately measure CK-MB antigen, and the overall conclusion is that the data presented allowed the FDA to grant "substantial equivalence." This implies that the performance was deemed acceptable in comparison to a predicate device, likely based on analytical performance data (precision, accuracy, linearity, etc.) which is not detailed in this summary document but would have been part of the full 510(k) submission.
Therefore, a table cannot be constructed with explicit acceptance criteria and corresponding reported performance metrics in the AI/ML sense. The conclusion of the document is: "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 serves as the overarching "reported device performance" against the implicit "acceptance criteria" for substantial equivalence.
2. Sample size used for the test set and the data provenance:
- Sample size for test set: Not explicitly stated in this 510(k) summary. The summary refers to "data presented," but does not break down the clinical study or test set sizes.
- Data provenance: Not explicitly stated. For an IVD from this era, it would likely involve clinical samples collected from a relevant patient population, but the country of origin or whether it was retrospective/prospective is not mentioned in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This concept of "experts establishing ground truth" is not directly applicable to a quantitative immunoassay like IMMULITE® Turbo CK-MB in the same way it applies to diagnostic imaging or AI interpretation. The "ground truth" for an immunoassay is typically the actual concentration of the analyte (CK-MB) in the sample, determined by a reference method or validated analytical techniques (which would be used for method comparison studies).
- No information about experts establishing ground truth is provided.
4. Adjudication method for the test set:
- Not applicable as there is no "adjudication" in the context of expert review for this type of quantitative immunoassay.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a standalone laboratory immunoassay analyzer, not an AI-assisted diagnostic tool that would involve human readers interpreting images or data with and without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, in concept. The IMMULITE® Turbo CK-MB is a standalone analytical device (an automated immunoassay analyzer) that measures CK-MB levels. Its "performance" is its ability to accurately and precisely quantify CK-MB antigen in serum or plasma, independent of human interpretation beyond pipetting and result reporting. This summary, however, does not detail the analytical performance study results (e.g., precision, accuracy, linearity studies) that would demonstrate this standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for a quantitative immunoassay like this would be the true concentration of the analyte (CK-MB) in the patient samples. This is typically established using a highly accurate and precise reference method or a thoroughly validated comparative method.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a "training set" in the computational sense. The device is a reagent system and an automated analyzer. Its development involves chemical and biological optimization, calibration, and analytical validation rather than machine learning training.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
§ 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.