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The Boehringer Mannheim Elecsys CalCheck PSA is used to verify the calibration assignment for the Boehringer Mannheim Elecsys PSA assay.

The Elecsys® CalCheck™ PSA is a three level single analyte set of lyophilized, human based materials. After reconstitution, they are assayed in triplicate and the results compared to the target values.

The provided text describes a medical device called "Elecsys® CalCheck™ PSA," a calibration verification material. However, the document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the way described in the request (e.g., performance metrics, sample sizes, ground truth establishment, expert adjudication, or MRMC studies).

The text focuses on establishing substantial equivalence to a predicate device (Elecsys® CalCheck™ TSH) based on configuration, intended use, and general performance characteristics like value assignment and stability, but it does not detail the quantitative performance of the Elecsys® CalCheck™ PSA against predefined acceptance criteria.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them from the provided text for the following reasons:

1. No Acceptance Criteria Table or Reported Performance: The document does not explicitly state any quantitative acceptance criteria for the Elecsys® CalCheck™ PSA's performance. It mentions "specific data on the performance of the test have been incorporated into the draft labeling," but this data is not included in the provided text.
2. No Study Details for Test Set: There is no mention of a specific study to prove performance against acceptance criteria, including sample sizes, data provenance (country of origin, retrospective/prospective), or how a test set was constructed.
3. No Expert Details or Adjudication: The concept of "experts" to establish ground truth or "adjudication methods" is not applicable to this type of device (calibration verification material) as described in the provided text. Its function is to verify calibration, meaning its "ground truth" would be its assigned value, not an expert interpretation of, for example, an image.
4. No MRMC or Standalone Study: The device is a calibration material, not an AI or diagnostic imaging device that would typically undergo Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or standalone algorithm performance studies.
5. Type of Ground Truth: The "ground truth" for a calibration material is its assigned value, determined through a specific manufacturing and assay process, not expert consensus, pathology, or outcomes data.
6. No Training Set Details: Since this is a calibration verification material and not an AI algorithm, there is no concept of a "training set" or "how ground truth for the training set was established" in the context of the provided information.

In summary, the provided document is a 510(k) summary for a calibration verification material, which focuses on demonstrating substantial equivalence to a predicate device for its intended use rather than presenting a performance study against specific acceptance criteria in the manner requested.

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