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The DRUG 3 CAL is an in vitro diagnostic product for the calibration of Cyclosporine (CSA) method on the Dimension Vista™ System.

DRUG 3 CAL is a frozen, liquid, human whole blood hemolysate containing cyclosporine. The kit consists of six vials, three vials of Calibrator A, and three vials of Calibrator B which are frozen. The volume for Calibrator A is 2.0 mL per vial and for Calibrator B is 1.5 mL per vial. Intermediate levels are automatically prepared and corresponding values calculated by the Dimension Vista™ System.

Here's an analysis of the provided information regarding the Dimension Vista™ System Drug 3 Calibrator (DRUG 3 CAL - KC430), broken down by your requested categories:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: The document does not explicitly state the specific numerical sample size for the stability testing (e.g., number of vials, number of runs). It mentions "vials are opened/punctured on day zero" and testing on "days 8, 15, 22 and 32 versus freshly opened vials." This implies a prospective design for the open-vial stability studies. For the 12-month shelf life, it refers to "real-time data on file," suggesting a prospective study conducted over time.
• Data Provenance: The document does not specify the country of origin for the data. Given Dade Behring Inc.'s location in Newark, DE, USA, the testing was likely conducted in the United States. The studies are described as prospective, with real-time data for shelf life and specific timelines for open-vial stability.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable: This device is a calibrator material, not an AI/imaging diagnostic device that requires expert interpretation for ground truth. The "ground truth" here is the assigned value of Cyclosporine A, which is established gravimetrically against a reference material (USP Cyclosporine A Reference Material) and verified by LC/MS testing and instrument-based verification.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable: Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in medical imaging or clinical assessment where subjective interpretation is involved. For a calibrator, the "truth" is based on the traceable reference material and quantitative analytical methods, not human consensus.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable: This device is a calibrator for an in vitro diagnostic test, not an AI-powered diagnostic tool requiring human readability or interpretation. Therefore, MRMC studies and "human readers improve with AI" metrics are irrelevant.

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

• Yes (inherently): The performance of the calibrator itself is standalone. It's a physical material with defined properties. Its "performance" refers to its stability and its ability to properly calibrate the associated Cyclosporine (CSA) method on the Dimension Vista™ System. The characteristics reported (stability, traceability, bottle value assignment) are intrinsic to the calibrator material and not dependent on human intervention during its use in calibrating the instrument.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Traceable Reference Material and Analytical Methods: The ground truth for the calibrator's values is established through traceability to United States Pharmacopeia (USP) Cyclosporine A Reference Material. This involves:
  • Gravimetric weighing of Cyclosporine Reference Material into drug-free whole blood hemolysate.
  • Verification against weighed-in Master Pool values.
  • Verification by LC/MS testing (Liquid Chromatography-Mass Spectrometry).
  • Verification using an instrument calibrated with Master Pools.

8. The sample size for the training set

• Not Applicable: As a calibrator material, there is no "training set" in the context of machine learning or AI. The product manufacturing involves creating stock solutions and commercial lots using established gravimetric and analytical methods. The stability studies and value assignments are performance validations, not training.

9. How the ground truth for the training set was established

• Not Applicable: See point 8. There is no training set for this type of device. The "ground truth" for the calibrator's assigned values is established through the robust analytical methods and traceability described in point 7.

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