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The CK CAL is an in vitro diagnostic product for the calibration of Creatine Kinase (CK) method on the Dimension Vista™ System.

CK CAL is frozen, liquid, bovine serum albumin based product containing creatine kinase from porcine heart. The kit consists of six vials, three vials of Calibrator A, and three vials of Calibrator B. The volume per vial is 1.0 mL.

This document describes the 510(k) submission for the Dimension Vista™ System Creatine Kinase Calibrator (CK CAL - KC340). As such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a traditional clinical study with acceptance criteria often seen for diagnostic algorithms.

However, we can extract details about the performance characteristics and the internal studies conducted to ensure the calibrator meets its intended purpose.

1. Table of Acceptance Criteria and Reported Device Performance

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

Since this is a calibrator, the "test set" in the context of diagnostic algorithms doesn't directly apply. However, we can analyze the data used for performance characterization.

• Stability Studies:
  • Shelf-life stability: "Recovery versus time is monitored and percent change over time is determined..." The exact number of samples or data points is not specified, but it's an ongoing monitoring process.
  • Open vial stability: Vials are opened/punctured on day zero and tested on days 1, 8, 15, 22, and 32. The number of vials tested on these specific days is not explicitly stated.
• Value Assignment:
  • Master Pool: N = 45 replicates (measurements) on multiple instruments.
  • Commercial Calibrator Lot: N = 45 total replicates (measurements) on multiple instruments.

Data Provenance: The document does not explicitly state the country of origin for the data. However, as Dade Behring Inc. is based in Newark, DE (USA), it is highly likely the studies were conducted within the US. The studies are prospective in the sense that they are specifically designed experiments to characterize the calibrator's performance.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable to a calibrator product. The "ground truth" for a calibrator is its assigned value, which is established through a rigorous, metrologically sound process rather than expert-derived diagnoses.

4. Adjudication Method

Not applicable to a calibrator product. Adjudication is typically used in clinical studies where expert consensus is needed to establish a definitive diagnosis or outcome.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is not a diagnostic device that requires human interpretation, nor is it an AI-assisted diagnostic tool.

6. Standalone Performance Study

Yes, the performance characteristics described are for the standalone calibrator device. The stability, traceability, and value assignment studies are all evaluations of the calibrator itself, independent of human intervention other than the procedures for testing it. For example, the stability studies determine how the calibrator's values change over time under various storage conditions.

7. Type of Ground Truth Used

The "ground truth" for the calibrator's assigned values is based on:

• Gravimetric addition: For preparing the Master Pool and stock solutions, quantities of creatine kinase are gravimetrically added to the base material to achieve target concentrations. This provides an initial "true" concentration based on precise measurement of mass.
• Comparison to previously approved Master Pool lot: The new Master Pool is verified against an existing, approved Master Pool, establishing a reference point.
• Dimension® clinical chemistry system values: The assigned values are traceable to the Dimension® clinical chemistry system, implying that the system itself, when properly calibrated, serves as the reference measurement.

Essentially, the ground truth is established through a hierarchical metrological traceability chain, starting with fundamental physical measurements (gravimetric) and then validated against established reference materials and methods within the manufacturer's system.

8. Sample Size for the Training Set

Not applicable. This is a calibrator, not a machine learning algorithm that requires a "training set."

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

Not applicable, as there is no training set for a calibrator.

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