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Intended for use with Olympus reagents for the establishment of reference points used in the determination of values for specific constituents found in human serum. The five constituents are ceruloplasmin, alpha-l-acidglycoprotein, alpha-2-macroglobulin, haptoglobin, and beta-2-microglobulin.

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This document is a marketing clearance letter from the FDA for the Olympus® Serum Protein Multicalibrator 2. It does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the way a clinical performance study for an AI/ML medical device would.

The letter states that the device is "substantially equivalent" to predicate devices, which is the basis for its 510(k) clearance. This type of clearance generally relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than requiring new clinical studies to prove performance against pre-defined acceptance criteria for a novel technology.

Therefore, I cannot provide the requested information from this document. The sections you asked for, such as:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth
4. Adjudication method
5. Multi Reader Multi Case (MRMC) comparative effectiveness study
6. Standalone performance
7. Type of ground truth used
8. Sample size for the training set
9. How the ground truth for the training set was established

Are typically found in performance studies for diagnostic devices (especially those involving AI/ML) that are subject to more rigorous performance evaluations, often for PMA applications or novel 510(k) devices that don't have suitable predicates for substantial equivalence.

In summary, this document is a regulatory clearance based on substantial equivalence, not a performance study report with acceptance criteria.

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