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The DRUG 1 CAL is an in vitro diagnostic product for the calibration of Digoxin (DIG), Lithium (LI), Phenobarbital (PHNO), Phenytoin (PTN) and Theophylline (THEO) methods on the Dimension Vista™ System.

DRUG 1 CAL is a liquid, multi-analyte, human serum based product containing digoxin, lithium, phenobarbital, phenytoin, and theophylline. 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). This same product, the Dimension VistaTM System Drug 1 Calibrator (KC410), was previously cleared (K051087) for the calibration of the Phenobarbital (PHNO) method on the Dimension Vista™ System. The calibrator formulation has not changed. However, additional analytes are being assigned values and included in the intended use. The volume in the vials has also changed from 2.0 mL to 2.5 mL and the claim for punctured vial shelf life is reduced to one day.

This document describes the Dimension Vista™ System Drug 1 Calibrator (DRUG 1 CAL - KC410), which is an in vitro diagnostic product used for the calibration of Digoxin, Lithium, Phenobarbital, Phenytoin, and Theophylline methods on the Dimension Vista System. The information provided focuses on the performance characteristics, particularly stability and traceability, rather than a clinical study involving human patients or complex AI algorithms. Therefore, some of the requested information types (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance for an algorithm, training set details) are not directly applicable to this type of device and study.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The main performance characteristic discussed is shelf-life stability.

Additional Stability Claims:

• Target Shelf Life: 12 months (determined by real-time data on file at Dade Behring, Inc.)
• Punctured Vial (on instrument): 1 day
• Open Vial (recapped, refrigerated): 31 days

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

• Test Set (for stability testing): The document states that for stability testing, "The method is calibrated from this stored material. The 4°C material values are recovered versus the calibration. Recovery versus time is monitored and percent change over time is determined."
  • For the main shelf-life study, specific sample sizes (e.g., number of calibrator vials or measurements) are not explicitly stated in the provided text. However, for the bottle value assignment, it mentions "N = 45 replicates per level" for verifying the final assigned values of a commercial lot. This is for manufacturing quality control rather than a clinical test set.
• Data Provenance: The studies are internal performance evaluations conducted by Dade Behring Inc. for regulatory submission. Details on country of origin are not specified, but it's an industry setting. It is a prospective study in the sense that they are testing the stability of newly manufactured calibrator lots over time.

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

This section is not applicable. For a calibrator, the "ground truth" for the analyte concentrations is established through traceability to recognized standards and gravimetric preparation, not through expert interpretation in the way it would be for a diagnostic image or clinical case.

4. Adjudication Method for the Test Set

This section is not applicable as there is no expert adjudication process for calibrator stability and value assignment. The assessment is based on quantitative measurements against pre-defined criteria.

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

This section is not applicable. The device is a calibrator, not an AI-powered diagnostic device, and therefore, an MRMC study and AI performance metrics are not relevant.

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

This section is not applicable, as this is a calibrator (a consumable chemical reagent) and not an algorithm or software.

7. The Type of Ground Truth Used

The ground truth for the calibrator values is established through traceability to reference materials and gravimetric preparation:

• Analyte Source: Digoxin, Phenobarbital, Phenytoin, Theophylline are traced to USP (United States Pharmacopeia) reference materials. Lithium is traced to NIST SRM (National Institute of Standards and Technology Standard Reference Material) 924.
• Master Pool and Stock Solution Preparation: Made by "weighing in" or "adding reference materials gravimetrically" to drug-free normal human serum.
• Verification: Master Pool values are compared against "previously approved Master Pool values," and stock solution values are verified against "previously approved Master Pool values."

8. The Sample Size for the Training Set

This section is not applicable. This device is a calibrator, not a machine learning model, so there is no "training set" in the context of AI or algorithm development. The manufacturing process involves controls and verification, which is distinct from training an algorithm.

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

This section is not applicable, as there is no training set for this type of device.

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