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The Dade Behring Dimension® ALDL Calibrator is an in vitro diagnostic product intended to be used to calibrate low density lipoprotein cholesterol on Dade Behring Dimension® clinical chemistry systems.
The Dade Behring Dimension® ALDL Calibrator is an in vitro diagnostic device intended for use on Dade Behring Dimension® clinical chemistry systems for medical purposes to establish points of reference that are used in determination of low density lipoprotein cholesterol in human serum and plasma

The Dade Behring Dimension® ALDL Calibrator is a 3 level, lyophilized product. The carton consists of six vials; two at each of three levels. Lot specific Value Assignment is made according to the process outlined in ATTACHMENT C. The Stability Testing Protocol established for determining long-term, real-time stability is provided in ATTACHMENT D. Shelf-life stability (Expiration Dating) dating reflects the real-time stability data available at commercialization and is on file at Dade Behring.

The provided text is a 510(k) summary for the Dade Behring Dimension® ALDL Calibrator. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance criteria or a standalone study as would be expected for a novel diagnostic device's clinical performance.

Therefore, many of the requested details regarding acceptance criteria, study sizes, expert qualifications, and ground truth establishment cannot be fully extracted from this document as presented. This document is a regulatory submission for a calibrator, which establishes reference points for a diagnostic test, not the diagnostic test itself. The performance of the calibrator is more about its stability, value assignment, and consistent behavior within the system, rather than diagnostic accuracy against a ground truth.

However, I can provide information based on what is available and explain why other information is missing.

Acceptance Criteria and Study for Dade Behring Dimension® ALDL Calibrator

As this document is a 510(k) premarket notification for a calibrator, the "acceptance criteria" and "device performance" are framed in terms of its ability to properly calibrate the associated clinical chemistry system, not in terms of diagnostic accuracy on patient samples. The study described is a comparison to a predicate calibrator to establish substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria here are implicitly met by demonstrating similarity in design and function to the predicate device, specifically another calibrator (AHDL Calibrator). The document does not provide quantitative performance metrics for calibration accuracy or precision, but rather states that the value assignment and stability testing processes were followed and data is on file.

2. Sample Size Used for the Test Set and Data Provenance

This document describes a regulatory submission for a calibrator, not a diagnostic device that analyzes patient samples as a "test set." Therefore, the concept of a "test set" from patient data with ground truth does not directly apply in the way it would for a diagnostic algorithm.

• Sample Size (for Calibrator Development/Validation): Not explicitly stated in terms of patient samples. The document refers to "Lot specific Value Assignment" and "Stability Testing Protocol," implying internal testing on calibrator lots and stability samples.
• Data Provenance: Not applicable in the context of patient data. The development and testing would have been conducted by Dade Behring Inc.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. As this is a calibrator, "ground truth" refers to the assigned values of the calibrator levels, which are likely established through a highly controlled, traceable process, possibly involving reference methods and metrology, rather than expert interpretation of patient samples. Experts would be involved in the analytical and manufacturing processes, not in establishing a "ground truth" for a diagnostic outcome.

4. Adjudication Method for the Test Set

Not applicable, as there is no "test set" of patient data requiring expert adjudication mentioned in this document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. The device in question is a laboratory calibrator.

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

Not applicable. The device is a physical calibrator product for a clinical chemistry system, not an algorithm. Its "performance" relates to its chemical and physical properties and its ability to establish reference points for an automated instrument.

7. The Type of Ground Truth Used

The "ground truth" for a calibrator refers to the assigned concentration values for each level of the calibrator. This is established through a rigorous "Value Assignment" process (referenced as ATTACHMENT C), which would typically involve:

• Reference measurement procedures.
• Traceability to higher-order international standards if available.
• Internal validation and quality control procedures.

It is not expert consensus on patient samples, pathology, or outcomes data.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML algorithm that requires a training set of data.

9. How the Ground Truth for the Training Set was Established

Not applicable. This is not an AI/ML algorithm that requires a training set.

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