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The LIPID CAL is an in vitro diagnostic product for the calibration of high density lipoprotein cholesterol (HDLC) and low density lipoprotein cholesterol (LDLC) methods on the Dimension Vista™ System.

LIPID CAL is a liquid, multi-analyte, human albumin based product containing human lipoproteins and bovine gamma globulins. The kit consists of six vials, three vials of Calibrator A, and three vials of Calibrator B which are ready for use (no preparation is required). The volume per vial is 1.5 mL.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Dimension Vista™ System Lipid Calibrator:

This document describes a diagnostic calibrator, not a device with a single performance metric like accuracy or sensitivity against a clinical outcome. Therefore, the "acceptance criteria" here refer to the stability of the calibrator material itself and its ability to consistently produce accurate values when used with the Dimension Vista™ System. The primary "study" described is a stability study and a batch value assignment and verification process.

1. Table of Acceptance Criteria and Reported Device Performance

For this calibrator, the performance is described primarily through its stability and the rigorous process for assigning its values.

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

• Test Set Sample Size: For the Bottle Value Assignment, which can be considered a test of the commercial lot's performance, N=90 replicates were tested.
• Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given the context of a 510(k) submission by Dade Behring Inc. in Newark, DE, USA, it's highly probable the studies were conducted in the USA and were prospective studies specifically designed for regulatory submission.

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

• Number of Experts: This type of calibrator does not typically involve "experts" in the sense of clinical decision-making. Instead, its "ground truth" (assigned values) is established through traceability to reference methods and reference laboratories.
  • For HDLC: "Human HDL ... with Abel-Kendall values are used to produce a standard curve for the assignment of the Master Pool." (Abel-Kendall is a CDC reference method for cholesterol).
  • For LDLC: "LDL human serum pools with values from reference laboratories (CRMNL) are used to produce a standard curve for assignment of the Anchor Pool." (CRMNL likely refers to the CDC Reference Methods for Novel Lipoproteins).
• Qualifications of Experts: The "experts" are the established reference methods and laboratories (e.g., NCEP, Abel-Kendall, CRMNL), which are recognized for their accuracy and precision in lipid measurements. No specific individual expert qualifications are provided, as the expertise resides in the methodology and certified laboratories.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used for subjective clinical interpretations (e.g., imaging studies where experts disagree). For a quantitative calibrator, adjudication as commonly understood is not applicable. The "ground truth" is established by the agreement to reference measurement procedures and subsequent statistical verification (N=90 replicates for bottle value assignment). Discrepancies would be handled through re-measurement against the reference or investigation of the measurement system.

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

No, an MRMC comparative effectiveness study was not done. MRMC studies are relevant for devices where a human observer's performance (e.g., reading an X-ray) is being evaluated, often with or without AI assistance. This document describes a calibrator material, which is used to ensure the accuracy of an automated measurement system, not to aid human interpretation or diagnosis directly in an MRMC setting.

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

This question is framed for an AI algorithm. For a calibrator, the "standalone" performance would refer to its inherent stability and the accuracy of its assigned values when measured by the target instrument.

• The stability studies (shelf-life, on-board, open-vial) evaluate the calibrator's performance over time without human intervention in the measurement process itself, other than preparing the initial setup and reading the results from the automated Dimension Vista™ System.
• The bottle value assignment process involved "testing N=90 replicates" on "multiple instruments," which demonstrates confidence in the calibrator's performance when used in an automated environment.

So, while not an "algorithm" in the AI sense, the testing conducted is essentially "standalone" in that it verifies the calibrator's properties and its ability to function correctly with the Dimension Vista™ System without requiring human judgment to interpret the calibrator's 'output.'

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the calibrator's values is established through traceability to internationally recognized reference methods and reference laboratories.

• NCEP (National Cholesterol Education Program) reference method for both HDLC and LDLC.
• More specifically for establishment of Master/Anchor Pools:
  • Abel-Kendall values for HDL (a CDC reference method).
  • Values from reference laboratories (CRMNL) for LDL.

This is a form of "reference measurement procedure" or "primary standard" ground truth, which is the highest level of accuracy for quantitative analytes.

8. The Sample Size for the Training Set

This question is typically for AI algorithms that learn from data. For a calibrator, there isn't a "training set" in the traditional machine learning sense. The material itself is manufactured, and its properties are characterized.

However, if we adapt the concept, the "training" for the assignment curve of the Master Pool/Anchor Pool would involve the collection of "human HDL serum samples with Abel-Kendall values" and "LDL human serum pools with values from reference laboratories (CRMNL)." The document does not specify the sample size of these reference samples used to create the initial standard curves for the Master/Anchor Pools.

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

As noted above, for a calibrator, "ground truth" is typically its assigned value based on highly accurate reference methods.

• Ground truth for the HDL Master Pool was established using human HDL serum samples with Abel-Kendall values. The Abel-Kendall method is a CDC reference method, considered the "ground truth" standard for HDL-C measurement.
• Ground truth for the LDL Anchor Pool was established using LDL human serum pools with values from reference laboratories (CRMNL). These reference labs adhere to highly stringent methods, representing the "ground truth" for LDL-C.

These reference values are then used to "produce a standard curve for the assignment" of the respective Master/Anchor Pools.

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