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The CHEM III CAL is an in vitro diagnostic product for the calibration of Ammonia (AMM), Carbon Dioxide (EC02) and Ethyl Alcohol (ETOH) assays on the Dimension® clinical chemistry system.

The Chemistry III Calibrator (CHEM III CAL) is a three level, liquid calibrator. It is packaged as a kit of six vials, two vials each of Levels 1, 2 and 3 with 2.5 mL per vial. CHEM III CAL is a multianalyte, aqueous product containing ammonium bicarbonate, sodium carbonate and ethyl alcohol.

The provided text describes a 510(k) premarket notification for a medical device, the Dimension® Chemistry III Calibrator (CHEM III CAL). It details the device's intended use and compares it to a predicate device for substantial equivalence. However, it does not contain information about acceptance criteria or a study that specifically proves the device meets those criteria in the way typically expected for an AI/CADe device.

This document is for a calibrator, which is a reference material used to ensure the accuracy of assays on a clinical chemistry system. The performance characteristics discussed here relate to the stability of the calibrator itself, not to the diagnostic performance of an AI algorithm based on patient data.

Therefore, many of the requested fields (like sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, type of ground truth, training set size, and how training ground truth was established) are not applicable to this type of device and FDA submission.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance:

The document describes performance characteristics related to the stability of the calibrator, which can be interpreted as demonstrating its functional acceptance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not Applicable. This device is a calibrator, and its performance is evaluated in terms of its stability and ability to maintain assigned values over time and under specific storage conditions. It does not analyze patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not Applicable. Ground truth for this device relates to the accurately assigned values of the analytes within the calibrator (Ammonia, Carbon Dioxide, Ethyl Alcohol), which are established through certified reference materials and analytical chemistry methods, not expert consensus on patient data. The traceability to ASC Grade Ammonium Sulfate, NIST SRM 351, and USP Grade Ethyl Alcohol for the analytes (AMM, ECO2, ETOH) is mentioned, indicating the origin of the referent values.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not Applicable. Adjudication methods are relevant for subjective interpretations of data, typically in AI/CADe diagnostic device studies. This is a chemical calibrator.

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:

• Not Applicable. This is not an AI/CADe device.

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

• Not Applicable. This is not an AI/CADe device or an algorithm.

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

• The closest equivalent to "ground truth" for this device is the traceability of the analyte values to recognized standards:
  • AMM - ASC Grade Ammonium Sulfate
  • EC02 - NIST SRM 351
  • ETOH - USP Grade Ethyl Alcohol
    These standards ensure the accuracy of the assigned values in the calibrator.

8. The sample size for the training set:

• Not Applicable. This device does not use a training set in the context of machine learning.

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

• Not Applicable. This device does not use a training set.

Study/Evidence that Proves the Device Meets Acceptance Criteria:

The document states: "The shelf life of the Dimension® CHEM III CAL is 12 months." and "For opened products, once the cap is removed, assigned values are stable for 7 days . stored on the Dimension® clinical chemistry system." and "Once cap is removed, assigned values are stable for 30 days when recapped immediately after use and stored at 2-8°C."

The "study" or evidence for these claims would typically involve a stability study, designed according to recognized guidelines such as CLSI EP25-A, "Evaluation of Stability of In Vitro Diagnostic Reagents." This guideline, which is referenced in the document, outlines protocols for determining the shelf life and in-use stability of diagnostic reagents and calibrators by measuring the analyte concentrations at various time points under different storage conditions and comparing them to initial values or reference standards. The acceptance criteria would be that the measured values remain within a pre-defined acceptable range (e.g., ±X% of the assigned value) throughout the claimed stability period.

While the document references the CLSI guideline, it does not provide the specific raw data, methodology details of the stability study (e.g., number of lots tested, analytical methods used for measurements), or the exact acceptance limits used to determine the stated stability claims (7 days, 30 days, 12 months). It only reports the results of such studies.

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