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Prealbumin Calibrator is an in vitro diagnostic product intended to be used to calibrate the Prealbumin (PALB) method on the Dimension® clinical chemistry system. This product was designed to meet the needs of users to assure accurate results over the assay range of this method.

Prealbumin (PALB) Calibrator for the Dimension® clinical chemistry system is a liquid product. The Level 1 calibrator is bovine albumin based with no detectable prealbumin. Levels 2 through 5 contain human prealbumin in a bovine albumin base. The kit consists of ten vials; two at each of five levels, containing 1 mL each.

The provided text is related to a 510(k) submission for a medical device: "Prealbumin (PALB) Calibrator." This summary focuses on the substantial equivalence of the calibrator to a predicate device and its intended use. It does not describe a study with acceptance criteria and device performance in the context of an AI/ML or diagnostic imaging device.

Therefore, I cannot fulfill your request for detailed information regarding acceptance criteria and study results in the specified format, as the provided text doesn't contain that kind of performance data. The document confirms regulatory clearance based on substantial equivalence, which is a different type of evaluation.

Here's why the specific questions cannot be answered from the provided text:

• Acceptance Criteria and Reported Device Performance: This document establishes the device as a calibrator and compares it to a predicate device based on characteristics like "intended use," "analyte," "matrix," "form," "volume," and "levels." It does not provide any performance metrics (e.g., sensitivity, specificity, accuracy, precision, etc.) against specific acceptance criteria.
• Sample Size (Test Set), Data Provenance, Number of Experts, Adjudication Method, MRMC Study, Standalone Performance, Type of Ground Truth, Training Set Size, Training Set Ground Truth: All these points relate to performance studies, especially those for AI/ML or diagnostic devices where performance is measured against a ground truth. Since this is a calibrator and the submission focuses on substantial equivalence, no such performance studies or associated details are included.

The closest information provided is:

• Device Name: Prealbumin (PALB) Calibrator
• Intended Use: To calibrate the Prealbumin method on the Dimension® clinical chemistry system.
• Comparison to Predicate Device: The table provided lists comparative features between the Dimension® Prealbumin Calibrator and the SPQ™ Prealbumin Calibrator. This is the basis for the "substantial equivalence" claim, not a performance study.

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