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The CSAE CAL is an in vitro diagnostic product for the calibration of CSAE method on the Dimension Vista® system.

The Dimension Vista® Cyclosporine Extended Range Calibrator contains cyclosporine in a preserved whole blood hemolysate. The kit consists of three vials of Calibrator A (200 ng/mL) and three vials of Calibrator B (2000 ng/mL). The intermediate calibrator levels (400. 800 and 1400 ng/mL) are prepared on-board the Dimension® Vista analyzer.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Dimension Vista® Cyclosporine Extended Range Calibrator:

Note: This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It does not contain a detailed formal study report with specific acceptance criteria beyond general statements about "pre-defined acceptance criteria" for stability. The primary "study" described here is a comparison of technological characteristics to a predicate device, rather than a clinical performance study with human subjects or a standalone analytical performance study with specific quantitative acceptance metrics.

Acceptance Criteria and Device Performance

Study Details

Given that this is a 510(k) summary for a calibrator, the "study" is primarily focused on demonstrating substantial equivalence through a comparison of technological characteristics and confirmation of performance aspects like stability and traceability. It is not a traditional clinical study or standalone performance validation with a large test set and ground truth established by experts in the same way a diagnostic algorithm would be evaluated.

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

   • Test Set: For stability, testing was conducted on "3 lots of product." The specific number of individual calibrator vials or measurements within each lot is not provided.
   • Data Provenance: Not explicitly stated, but assumed to be internal laboratory data generated by the manufacturer (Siemens Healthcare Diagnostics Inc. in Newark, DE, USA). The studies are retrospective from the perspective of this 510(k) submission, as they were conducted to support the submission.

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

   • Not applicable in the context of this device. The "ground truth" for a calibrator is established by its manufacturing process, purity of its components (USP cyclosporine A), and its assigned values confirmed by analytical techniques like LC/MS/MS, not by human expert interpretation of results. Therefore, no external experts were used for this purpose on the test set.

3. Adjudication method for the test set:

   • Not applicable. The "test set" here refers to the calibrator lots themselves and their analytical performance. Adjudication methods are typically relevant for human interpretation tasks or complex diagnostic outcomes.

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:

   • No MRMC comparative effectiveness study was done. This device is a calibrator, an in vitro diagnostic product, not a diagnostic algorithm or AI intended for human interpretation or assistance.

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

   • This is not applicable in the sense of an "algorithm" as commonly understood in AI. However, the performance characteristics (stability, traceability) of the calibrator itself were evaluated in a standalone manner, independent of a specific human operator interpreting patient results. The calibrator's function is purely analytical within the Dimension Vista® system. The analytical performance of the calibrator itself forms the basis of its "standalone" evaluation.

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

   • The ground truth for the calibrator's values is established by analytical measurement and traceability to a primary standard. Specifically, the calibrator is traceable to an internal master pool containing USP (United States Pharmacopeia) cyclosporine A, with values confirmed by LC/MS/MS (Liquid Chromatography-Mass Spectrometry/Mass Spectrometry). This is a highly accurate and precise analytical method for determining concentration.

7. The sample size for the training set:

   • Not applicable. There is no "training set" in the context of a calibrator product. This is not a machine learning model.

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

   • Not applicable as there is no training set.

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