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The DRUG 2 CAL is an in vitro diagnostic product for the calibration of acetaminophen (ACTM), carbamazepine (CRBM), digitoxin (DGTX), gentamicin (GENT), lidocaine (LIDO), Nacetylprocainamide (NAPA), procainamide (PROC), tobramycin (TOBR), valproic acid (VALP), and vancomycin (VANC) methods on the Dimension Vista TM System.

DRUG 2 CAL is a multi-analyte, liquid, bovine serum based product containing acetaminophen, carbamazepine, digitoxin, gentamicin, lidocaine, N-acetylprocainamide, procainamide, tobramycin, valproic acid, and vancomycin. 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 2.5 mL. Intermediate levels are automatically prepared and corresponding values calculated by the Dimension Vista™ System.

Here's the breakdown of the acceptance criteria and study information for the Dimension Vista™ System Drug 2 Calibrator (DRUG 2 CAL - KC420), based on the provided text:

Acceptance Criteria and Reported Device Performance

• Method: Comparison of product stored at 4°C with control stored at -20°C.
• Acceptance Threshold: Percent change should be less than or equal to 5%.
• Performance: Shelf-life stability (expiration) dating at commercialization reflects real-time data on file at Dade Behring, Inc. (Implies performance met the ≤ 5% change criteria for the assigned shelf life). |
  | Stability (On-board) | * Acceptance Threshold: Stable for 24 hours when a vial is punctured by the instrument and stored on-board. |
  | Stability (Open Vial - Recapped & Refrigerated) | * Acceptance Threshold: Stable for 31 days when an open vial is not on the instrument but recapped and stored in a refrigerator (2-8°C).
• Test Points: Vials opened/punctured on day zero were tested on days 0, 1, 2, 8, and 32 against freshly opened vials. |
  | Bottle Value Assignment (Verification of Master Pool values) | * Method: Master Pool values are compared against previously approved Master Pool values.
• Performance: Previously approved Master Pool values were assigned with an instrument calibrated with the corresponding standard reference material. (Implies verification was successful.) |
  | Bottle Value Assignment (Verification of Stock Solution) | * Method: Verified on an instrument calibrated with a previously approved Master Pool. (Implies verification was successful.) |
  | Bottle Value Assignment (Commercial Lot Concentration Verification) | * Method: Verified by using an instrument calibrated with Master Pools. (Implies verification was successful.) |
  | Bottle Value Assignment (Final Bottle Values) | * Method: Assigned and verified using multiple instruments by testing N = 20 replicates per level. A previously released commercial lot is used as a control. (Implies verification was successful based on the use of controls and multiple instruments.) |
  | Traceability | * Acceptance Criteria: Traceable to United States Pharmacopeia (USP) Reference Materials for all analytes except NAPA, which is traceable to Alltech-Applied Sciences Reference Standards.
• Performance: Met. |

Study Details

1. Sample Size used for the test set and the data provenance:

   • Stability Studies: Not explicitly stated as a single "test set" sample size for the entire study. Instead:
     • For shelf-life stability, the product was stored at 4°C and compared to a control stored at -20°C. The duration was determined to support a 12-month shelf life.
     • For open vial/on-board stability, vials were opened/punctured on day zero and tested on days 0, 1, 2, 8, and 32. The number of vials or samples per time point is not specified beyond "a quantity sufficient for multiple calibrations."
   • Bottle Value Assignment: N = 20 replicates per level were tested for the final bottle value assignment of the commercial lot. The text doesn't specify if these 20 replicates were from one lot or across multiple lots for performance evaluation, but it was for each level of a commercial lot.
   • Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be internal validation studies conducted by Dade Behring Inc.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Ground truth for this device (a calibrator) is established through traceability to reference materials and gravimetric preparation rather than expert consensus on clinical readings.
   • The "experts" in this context would be the analytical chemists or personnel responsible for weighing reference materials (USP and Alltech-Applied Sciences), preparing master pools and stock solutions, and performing calibrations, whose qualifications are not detailed in this summary.

3. Adjudication method for the test set:

   • Not applicable in the traditional sense of human reader adjudication for diagnostic imaging or clinical interpretation. Performance is assessed against quantitative analytical criteria (e.g., percent change, recovery, comparison to reference materials).

4. 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 is a calibrator for in vitro diagnostic tests, not an AI-powered diagnostic device requiring human interpretation of results.

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

   • Not applicable. While the Dimension Vista™ System is an automated instrument, this submission is for the calibrator material used by the system, not the system's analytical algorithm itself. The calibrator's performance is standalone in the sense that it meets specifications independent of user intervention once used correctly, but it's not an algorithm.

6. The type of ground truth used:

   • Reference Materials: The primary ground truth for the analytes is established through United States Pharmacopeia (USP) Reference Materials (for most analytes) and Alltech-Applied Sciences Reference Standards (for NAPA). These are highly purified, well-characterized chemical substances used as analytical standards.
   • Gravimetric Preparation: Concentrations of stock solutions and commercial lots are based on precise gravimetric (weighing) additions of these reference materials.
   • Previously Approved Master Pools: For verification steps, comparison against "previously approved Master Pool values" established using the corresponding standard reference material serves as a form of internal ground truth or validated standard.

7. The sample size for the training set:

   • Not applicable. This is a calibrator, not an AI/ML algorithm that requires a "training set" in the conventional sense. The "training" for such a product involves establishing the manufacturing process, quality control, and ensuring consistency with reference standards.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no "training set" for this type of device. The accuracy of the calibrator relies on the traceability of its components to internationally recognized reference standards (USP) and carefully controlled gravimetric preparation.

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