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Mission Olympus AU ISE Calibrators are intended to provide calibration points for Na+, K+ and Cl- electrodes on the Olympus AU4xx and AU6xx instruments. For in-vitro diagnostics use.

Mission Olympus AU ISE Calibrators are intended to serve as a direct replacement to Olympus AU ISE Calibrators. They are aqueous solutions of salts & preservatives, containing NO human or animal materials, packaged in plastic bottles.

This is a 510(k) submission for in-vitro diagnostic calibrators, not an AI/ML device. Therefore, many of the typical acceptance criteria and study elements requested (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable.

Here's an interpretation of the provided information in the context of the requested structure:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not explicitly stated as this is a calibrator submission, not a study involving patient data. The "test set" here refers to the calibrator units and possibly instrument runs. The submission mentions testing across different instruments.
• Data Provenance: Not applicable in the sense of patient data. The provenance relates to the manufacturing and testing of the calibrator solutions and their evaluation on Olympus AU4xx and AU6xx instruments.

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

• This concept is not applicable for this type of device (calibrators). Ground truth for calibrators is typically established through analytical methods and metrological traceability to reference materials, not through expert consensus on medical images or diagnostic outcomes.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication typically refers to resolving discrepancies among expert readers, which is not relevant for calibrator performance studies.

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

• No, an MRMC study was not done. This type of study is relevant for AI-powered diagnostic aids that assist human readers in interpreting data (e.g., medical images). This submission is for physical calibrator solutions.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Not applicable. This is not an algorithm, but a physical diagnostic calibrator. Its performance is inherent to the chemical composition and manufacturing, and its functional performance is assessed on the intended instruments.

7. The Type of Ground Truth Used

• The "ground truth" for calibrators relates to their assigned values for Na+, K+, and Cl- parameters, which are established through precise analytical methods, typically traceable to higher-order reference measurement procedures or certified reference materials. The submission implies that the 'ground truth' for comparison was the performance of the predicate (OEM) Olympus AU ISE Calibrators.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/ML device, so there is no "training set" in the context of machine learning.

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

• Not applicable, as there is no training set for this type of device.

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