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For in vitro quantitative determination of Apolipoprotein B in serum and plasma. Apolipoprotein B measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

The device is an immunoturbidimetric test for the quantitative determination of Apolipoprotein B in serum and plasma for use on the INTEGRA family of analyzers.

This 510(k) submission describes a modification to an existing device, the INTEGRA Reagent Cassette for Apolipoprotein B. The key difference is the addition of plasma as an acceptable specimen type. The submission focuses on demonstrating substantial equivalence to the predicate device.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The provided document does not explicitly state acceptance criteria in a quantitative table format. Instead, it relies on demonstrating substantial equivalence to an existing predicate device. The claim is that the performance characteristics of the modified device are equivalent to the predicate device.

Explanation: The phrase "Performance characteristics, including precision, analytical sensitivity, calibration interval, and limitations statements for the two devices are equivalent" ({2}) serves as the core claim of meeting acceptance criteria through substantial equivalence. There are no numerical targets or ranges provided for these characteristics in this document.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample size used for the test set, nor does it specify the data provenance (e.g., country of origin, retrospective or prospective nature of the studies). It generally refers to "Specific data on the performance of the test" being incorporated into the draft labeling ({1}).

3. 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. The device is an in vitro diagnostic for quantitative determination of Apolipoprotein B, not an imaging device or one that requires expert interpretation to establish ground truth in the same way. The "ground truth" for such a device would likely be accurate reference material values or established clinical samples with known Apolipoprotein B concentrations, rather than expert consensus on interpretations.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided and is generally not applicable to the evaluation of an in vitro diagnostic device that quantifies a biomarker. Adjudication methods like 2+1 or 3+1 are typically used in studies where human readers are interpreting images or clinical data, and there's a need to resolve discrepancies in their assessments.

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

An MRMC study was not done. This device is an in vitro diagnostic for quantitative biomarker measurement, not an AI-assisted diagnostic tool that would involve human readers interpreting results in a comparative effectiveness study.

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

This concept is not applicable in the context of this traditional in vitro diagnostic device. The INTEGRA Reagent Cassette for Apolipoprotein B is a chemical reagent system used on an analyzer, not an algorithm. Its performance is inherent to the chemical reactions and the instrument's measurement capability. The "standalone" performance would be its analytical accuracy and precision in measuring Apolipoprotein B from a sample.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document does not explicitly state the "type of ground truth" used. For an in vitro diagnostic device measuring a biomarker quantitatively, the ground truth would typically be established using:

• Reference measurement procedures: Highly accurate and precise methods to determine the true concentration of Apolipoprotein B in control samples or patient samples.
• Certified reference materials: Materials with an accurately assigned value for Apolipoprotein B concentration.
• Comparison to a clinically established "gold standard" method: While the submission emphasizes substantial equivalence to the predicate device, internal validation would likely involve comparison to established methods or reference values for accuracy.

8. The sample size for the training set

This information is not provided and is generally not applicable in the context of this device. The INTEGRA Reagent Cassette for Apolipoprotein B is a reagent system, not a machine learning model that requires a "training set." The development of such a system involves formulation, optimization, and validation, but not typically in the sense of a dataset to train an algorithm.

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

This information is not provided and is generally not applicable for the reasons mentioned in point 8.

Summary of Study Type:

This submission describes a substantial equivalence study for a modification to an in vitro diagnostic reagent. The study's primary goal is to demonstrate that the modified device, which now accepts both serum and plasma, performs equivalently to the previously cleared device, which only accepted serum. The "study" involves generating performance data (precision, analytical sensitivity, etc.) on the modified device and showing that these characteristics are comparable to the predicate device's established performance. The document explicitly states that "Specific data on the performance of the test have been incorporated into the draft labeling in Section V of this submission," but these detailed results are not included in the provided snippets.

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