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The Dimension® TACR Calibrator is an in vitro diagnostic product intended to be used to calibrate the Tacrolimus (TACR) method for the Dimension® clinical chemistry system.

The Dimension® TACR Calibrator is a stabilized human whole blood hemolysate product containing tacrolimus. The kit consists of two vials of each calibrator level 1-5. The target concentrations are approximately 0, 3, 6, 12, 32.5 ng/mL tacrolimus.

The provided text describes the 510(k) summary for the Dimension® TACR Calibrator. However, it does not contain the specific details required to fully address your request regarding acceptance criteria, study results, sample sizes, expert qualifications, or ground truth establishment.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not contain any explicit acceptance criteria or reported device performance data. It focuses on the device description, intended use, and substantial equivalence to a predicate device. For diagnostic/calibrator devices, acceptance criteria would typically involve metrics like accuracy, precision, linearity, stability, and possibly bias relative to a reference method, but these are not present in this summary.

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

The document does not mention any specific test set, sample size, or data provenance (e.g., country of origin, retrospective/prospective study) from primary performance studies.

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

The document does not describe the establishment of ground truth by experts for a test set. As a calibrator, its "ground truth" would likely be the reference concentration of tacrolimus used in its manufacturing, not expert consensus on diagnostic images or clinical outcomes.

4. Adjudication Method for the Test Set:

Since no test set or expert evaluation is described, there is no mention of an adjudication method.

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

A MRMC study involves human readers interpreting cases, often with and without AI assistance, to assess the AI's impact on human performance. This type of study is not applicable to a device like the Dimension® TACR Calibrator, which is an in vitro diagnostic calibrator and not an AI-powered diagnostic imaging tool. Therefore, no such study was performed or is relevant here, and no effect size for human improvement with AI is mentioned.

6. Standalone (Algorithm Only) Performance:

The Dimension® TACR Calibrator is a physical product (stabilized human whole blood hemolysate containing tacrolimus) used to calibrate an instrument. It is not an algorithm or software that would have "standalone performance" in the way an AI diagnostic tool would. Its performance is related to its ability to accurately provide known concentrations for calibration. The document does not present any standalone performance data in terms of accuracy, precision, etc., but rather focuses on its composition and intended use.

7. Type of Ground Truth Used:

The "ground truth" for a calibrator like this would be the known, manufactured concentrations of tacrolimus in each calibrator level. The document states: "The target concentrations are approximately 0, 3, 6, 12, 32.5 ng/mL tacrolimus." This indicates the intended values used for calibration. It's not expert consensus, pathology, or outcomes data.

8. Sample Size for the Training Set:

This device is a calibrator, not a machine learning model that requires a "training set" of data in the conventional sense. The concept of a training set does not apply here.

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

As there is no training set, this question is not applicable. The "ground truth" (target concentrations) for the calibrator itself would be established through a carefully controlled manufacturing process using highly accurate reference materials and methods.

Summary of Missing Information in the Provided Text:

The provided 510(k) summary is a high-level regulatory document intended to demonstrate substantial equivalence, not a detailed scientific study report. It specifically lacks:

• Quantitative acceptance criteria for the calibrator's performance.
• Results from any performance studies (e.g., accuracy, precision, stability).
• Details on test sets, sample sizes, or data provenance for performance evaluation.
• Information on expert involvement or ground truth establishment related to diagnostic accuracy, as it's a calibrator.

To get the detailed information you are seeking regarding performance metrics and study specifics for the Dimension® TACR Calibrator, you would typically need to consult the full submission to the FDA, product manuals, or other technical documentation that would be more extensive than this 510(k) summary.

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