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The VALIDATE Chem 5 Calibration Verification Test Set is used by trained I the VALIDATE onomals for quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated, semi-automated and manual chemistry systems for the following analyte: iron.

Device Description

VALIDATE Chem 5 Calibration Verification Test Set is a liquid, human serum based calibration verification test set containing multiple levels used establish the relationship between theoretical operation and actual performance of the included analyte Each set contains one bottle each of six (6) levels, including zero. Each bottle contains 5 milliliters.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the VALIDATE Chem 5 Calibration Verification Test Set, based on the provided 510(k) summary:

This device is not an AI/ML device but rather a calibration verification test set used in clinical chemistry. Therefore, many of the requested fields related to AI performance, such as MRMC studies, human reader improvement with AI, and standalone algorithm performance, are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance (VALIDATE Chem 5)	Relevant Section
Analyte Equivalence	Demonstrated substantial equivalence to predicate device for Iron (FE).	Section 2, Table 2
Correlation Coefficient (for Iron)	0.99999 (compared to predicate's 0.99992)	Section 2, Table 2
Regression Equation (for Iron)	1.498 + 0.992(X) (compared to predicate's -3.464 + 1.021(X))	Section 2, Table 2
Functional Equivalence	"Has been shown to be functionally equivalent for calibration verification and linearity assessment to DOCUMENT Iron/Magnesium/Triglyceride CAL•VER."	Section 2, Summary

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

Sample Size: The document states that "The analyte was tested in triplicate." This refers to each level of the calibration verification test set, but not a total number of patient samples. For a calibration verification device, the "sample" is the reference material itself. There are 6 levels for the VALIDATE Chem 5.
Data Provenance: Not explicitly stated, but the study was conducted internally by Maine Standards Company using pre-production lots of their own device. As it's a calibration material, geographical origin of "data" in the sense of patient samples is not relevant. The testing was done on a specific instrument system (Roche Diagnostics Hitachi 911).
Retrospective/Prospective: Not applicable in the traditional sense for a calibration material. The testing involves running the calibration material on an instrument.

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

Not Applicable. For a calibration verification test set, the "ground truth" (i.e., the true concentration of the analyte at each level) is established through rigorous analytical methods and traceability to reference standards, not by expert interpretation. The purpose of these materials is to verify the performance of an instrument, not to be interpreted by an expert.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication is typically used for subjective clinical interpretations (e.g., image reading) where disagreement among experts might occur. This is a quantitative analytical device.

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/ML device, nor does it involve human readers.

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

Not Applicable. This is not an AI/ML device with an algorithm for diagnosis or prediction.

7. The Type of Ground Truth Used

Reference Standards/Certified Values. For calibration verification materials, the "ground truth" for each level's analyte concentration is established through highly accurate analytical methods, often traceable to international reference standards, by the manufacturer. The document doesn't explicitly detail the method for establishing these values but states it's for "quantitatively verifying calibration," implying a known, reference value for each level.

8. The Sample Size for the Training Set

Not Applicable. This device does not use machine learning, therefore, there is no "training set."

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

Not Applicable. As there is no training set for an AI/ML model, there is no ground truth established for one.

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