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The DGTX CAL is an in vitro diagnostic product for the calibration of digitoxin on the Dimension Vista® System.

The DGTX CAL is a liquid bovine serum based product containing digitoxin.

The provided 510(k) summary for the Dimension Vista® DGTX CAL is for a calibrator device for an in vitro diagnostic system, not a device that involves image analysis or human interpretation. Therefore, many of the typical acceptance criteria and study components related to machine learning performance (e.g., sample size for test sets, data provenance, ground truth experts, MRMC studies, standalone performance, training set details) are not applicable to this type of medical device submission.

This submission focuses on demonstrating substantial equivalence to a predicate calibrator device (Dimension® Drug Calibrator II) by comparing their features, intended use, and formulation. The "study" here is essentially a comparison of product characteristics rather than a clinical performance study.

Here's a breakdown of the requested information, adapted for this specific device type:

1. Table of Acceptance Criteria and Reported Device Performance

For calibrators, the primary "acceptance criterion" is typically substantial equivalence to a legally marketed predicate device. Performance is demonstrated by showing that the new device has comparable characteristics and performs its intended function (calibration) in a similar manner.

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

• Sample Size: Not applicable in the context of a clinical test set. The "test" here involves comparing the characteristics of the new calibrator to the predicate device. This is a descriptive comparison, not a statistical sampling of patient data.
• Data Provenance: Not applicable. The "data" are the specifications and formulation details of the new device and the predicate device.

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

• Number of Experts: Not applicable. Ground truth in the sense of clinical interpretations or diagnoses is not involved. The "truth" here is the chemical composition and physical properties of the calibrator.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There is no ambiguous clinical data requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• MRMC Study: No. This type of study is relevant for diagnostic devices where human readers interpret output, often with AI assistance. A calibrator does not involve human interpretation in this manner.
• Effect Size of Human Readers Improvement with AI vs. without AI assistance: Not applicable.

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

• Standalone Study: No. This concept is for AI algorithms. A calibrator is a chemical reagent, not an algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for this submission is the physical and chemical specifications, intended use, and formulation details of both the new calibrator and the legally marketed predicate device. The claim is that they are identical or highly similar in relevant aspects.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. Calibrators are not "trained" like AI algorithms.

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

• How Ground Truth for Training Set Was Established: Not applicable.

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