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The IMMULITE 2500 CK-MB is for in vitro diagnostic use with the IMMULITE 2500 Analyzer - for the quantitative measurement of creatine kinase isoenzyme MB (CK-MB) in heparinized plasma or serum, as an aid in patient management and the assessment of prognosis of myocardial infarction.

The IMMULITE 2500 Myoglobin is for in vitro diagnostic use with the IMMULITE 2500 Analyzer - for the quantitative measurement of myoglobin in serum and heparinized plasma, as an aid in the diagnosis of acute myocardial infarction (AMI).

The IMMULITE 2500 STAT Troponin I is for in vitro diagnostic use with the IMMULITE 2500 Analyzer - for the quantitative measurement of troponin I in serum, heparinized or EDTA plasma, as an aid in the diagnosis of acute myocardial infarction (AMI).

IMMULITE 2500 CK-MB is a solid-phase, two-site IMMULITE chemiluminescent enzyme immunoassay for use with the IMMULITE 2500 Automated Analyzer.

IMMULITE 2500 Myoglobin is a solid-phase, two-site chemiluminescent enzyme immunoassay for use with the IMMULITE 2500 Automated Analyzer.

IMMULITE 2500 STAT Troponin I is a solid-phase, two-site chemiluminescent enzyme immunoassay for use with the IMMULITE 2500 Automated Analyzer.

Please note that the provided text describes an in vitro diagnostic (IVD) device, which measures biomarkers in patient samples. Such devices are evaluated based on analytical performance criteria (e.g., accuracy, precision, linearity, limits of detection) rather than clinical performance criteria like those for AI/ML-driven diagnostic aids. Therefore, many of the requested fields (multi-reader multi-case studies, expert adjudication, ground truth definition for training sets, effect size of human readers improving with AI) are not applicable to this type of device and will be marked as "N/A".

Here's an analysis of the provided text based on your request:

Device Name: IMMULITE® 2500 CK-MB, IMMULITE® 2500 Myoglobin, IMMULITE® 2500 STAT Troponin I

Device Type: In vitro diagnostic (IVD) chemiluminescent enzyme immunoassays for the quantitative measurement of cardiac biomarkers.

Intended Use:

• IMMULITE 2500 CK-MB: Quantitative measurement of creatine kinase isoenzyme MB (CK-MB) in heparinized plasma or serum, as an aid in patient management and the assessment of prognosis of myocardial infarction.
• IMMULITE 2500 Myoglobin: Quantitative measurement of myoglobin in serum and heparinized plasma, as an aid in the diagnosis of acute myocardial infarction (AMI).
• IMMULITE 2500 STAT Troponin I: Quantitative measurement of troponin I in serum, heparinized or EDTA plasma, as an aid in the diagnosis of acute myocardial infarction (AMI).

1. Table of Acceptance Criteria and the Reported Device Performance

The provided 510(k) summary documents typically focus on demonstrating substantial equivalence to a predicate device based on similar intended use and technological characteristics, and often summarize the analytical performance data without listing specific pre-defined acceptance criteria values alongside achieved performance. The document states that "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." This implies that the presented data met the FDA's requirements for substantial equivalence, which would include acceptable analytical performance.

However, specific quantitative acceptance criteria (e.g., "bias must be less than X%", "CV must be less than Y%") are not explicitly stated in this summary document. The document refers to the data being sufficient for FDA clearance rather than providing a detailed breakdown of acceptance criteria and performance against those criteria.

Note: For IVD devices, acceptance criteria typically include parameters like:

• Precision/Reproducibility: Within-run, between-run, total precision (e.g., %CV at various concentrations).
• Accuracy/Method Comparison: Correlation and agreement with a reference method or predicate device (e.g., Deming regression analysis, absolute bias).
• Linearity/Analytical Measurement Range: The range over which results are proportional to the analyte concentration.
• Limit of Detection (LoD) / Limit of Quantitation (LoQ): The lowest concentration that can be reliably detected/quantified.
• Interferences: Effects of common interfering substances (hemolysis, lipemia, icterus, etc.).
• Specificity: Cross-reactivity with structurally similar compounds.
• Stability: Reagent and calibration stability.

Since these specific quantitative criteria and results are not detailed in the provided text, a comprehensive table cannot be generated. The document only confirms that "The data presented [...] is the data that the Food and Drug Administration used in granting DPC substantial equivalence."

2. Sample size used for the test set and the data provenance

The document does not explicitly state the sample sizes used for the analytical performance studies (test sets) or the provenance (country of origin, retrospective/prospective nature) of the samples. For IVD devices, samples are typically patient samples (serum, plasma) collected under defined protocols to assess analytical performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

N/A. For IVD assays measuring biomarkers, "ground truth" is typically established by reference methods, comparison to predicate devices, or clinical diagnosis. The analytical performance studies do not involve experts establishing a "ground truth" in the way a radiological image interpretation study would.

4. Adjudication method for the test set

N/A. Adjudication methods (like 2+1 or 3+1) are common in image interpretation studies or clinical trials where expert consensus is needed to define a ground truth from subjective assessments. This is not applicable to quantitative biomarker measurements in IVD devices.

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

N/A. This is an IVD device measuring biomarkers, not an AI-driven image analysis tool or decision support system that would involve human "readers" or AI assistance.

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

Yes, in a sense, the device operates in a standalone manner as an automated immunoassay system. The analytical performance studies evaluate the device's ability to accurately and precisely measure the target biomarkers in biological samples without direct human-in-the-loop interpretational performance being part of the primary evaluation. The "performance" here refers to the analytical performance of the assay itself.

7. The type of ground truth used

For these IVD products, the "ground truth" for evaluating analytical performance is typically:

• Reference methods: Highly accurate and precise laboratory methods.
• Predicate device comparison: Measurement of the same samples on a legally marketed, substantially equivalent predicate device.
• Assigned values: For quality control materials or calibrators, values might be assigned through rigorous consensus or characterization methods.
• Clinical diagnosis: While not directly establishing "ground truth" for the biomarker level itself, samples may be derived from patients with confirmed clinical diagnoses (e.g., AMI positive, non-AMI negative) to assess clinical performance characteristics (e.g., diagnostic sensitivity and specificity), though this specific detail is not provided in the summary.

The document implicitly suggests that the ground truth was established through comparison with the predicate devices (IMMULITE/IMMULITE 1000 Turbo CK-MB, IMMULITE/IMMULITE 1000 Turbo Myoglobin, IMMULITE/IMMULITE 1000 Turbo Troponin I), common practice for demonstrating substantial equivalence.

8. The sample size for the training set

N/A. This is an immunoassay kit, not an AI/ML device that requires a training set in the computational sense. The "training" of such a system involves the development and optimization of the chemical reagents and assay protocols.

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

N/A. As above, the concept of a "training set" and establishing ground truth for it is not applicable to a traditional immunoassay. Assay development involves optimizing reagents and parameters to achieve desired analytical performance characteristics.

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