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The VALIDATE Chem 2 Calibration Verification Test Set is used by trained laboratory professionals for quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated, semi-automated and manual chemistry systems for the following analytes: carbon dioxide, uric acid, glucose, and urea nitrogen.

VALIDATE Chem 2 Calibration Verification Test Set contains purified chemicals in an aqueous base. Multiple levels are provided to establish the relationship between theoretical operation and actual performance of each of the included analytes. Each set contains one bottle each of six (6) levels, including zero. Each bottle contains 5 milliliters.

Here's a breakdown of the acceptance criteria and study details for the VALIDATE Chem 2 Calibration Verification Test Set, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for substantial equivalence in this context are not explicitly stated as numerical benchmarks for the device's performance in the typical sense of accuracy, sensitivity, or specificity. Instead, the acceptance criterion for this type of calibrator verification test set is demonstrating functional equivalence and strong correlation to predicate devices. The "reported device performance" is the correlation and regression analysis results achieved during the comparison study.

Note on Acceptance Criteria: For calibrators and verification materials, the primary method to demonstrate safety and effectiveness for a 510(k) submission is typically by showing substantial equivalence to a legally marketed predicate device. This involves demonstrating that the new device performs similarly in its intended use, often through linearity and correlation studies. A correlation coefficient close to 1 (e.g., >0.99) and a regression slope close to 1 with an intercept close to 0 typically indicate strong agreement and functional equivalence.

2. Sample Sizes and Data Provenance

• Test Set Sample Size: "Each analyte was tested in triplicate." This implies that for each analyte within the VALIDATE Chem 2 set (Glucose, BUN, CO2, UA), three measurements were taken. Since the set contains 6 levels, this would mean 6 levels * 3 replicates = 18 data points per analyte for the VALIDATE Chem 2 set. The predicate devices also have multiple levels (5 levels typically), which would also be tested similarly.
• Data Provenance: Not explicitly stated, but typically such studies for regulatory submissions are conducted in a controlled laboratory setting (e.g., at the manufacturer's facility or a contract lab). The use of a "Roche Diagnostics Hitachi 911 instrument system" is mentioned. The data is retrospective in the sense that it's generated from pre-production lots for the purpose of demonstrating equivalence, not collected from ongoing clinical use. The country of origin is implicitly the United States, given the submitter is a US company and the submission is to the FDA.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This device is a calibration verification test set, not a diagnostic device that requires expert interpretation of results. The "ground truth" for calibrators relates to their assigned values and their performance in establishing linearity, which is determined by analytical methods, not human experts.

4. Adjudication Method

Not applicable for this type of device and study. Adjudication is relevant for studies involving human interpretation or subjective assessments.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC study was not done. This type of study is relevant for diagnostic imaging devices or other tools where human readers interpret results, and the AI's role is to assist or replace human interpretation. The VALIDATE Chem 2 device is a laboratory reagent for instrument calibration.

6. Standalone (Algorithm Only) Performance

Not applicable. The device itself is a physical reagent (test set) used by laboratory instruments. There is no "algorithm only" performance to evaluate. The performance noted ("Correlation Coefficient (r)" and "Regression Equation") reflects how well the combined system (instrument + VALIDATE Chem 2) performs compared to the combined system (instrument + predicate device).

7. Type of Ground Truth Used

The ground truth used here is the assigned values/concentrations of the calibrator materials (both the VALIDATE Chem 2 and the predicate devices) and their pre-established linearity in verifying instrument performance. The study aims to show that the new device measures these known values in a way that correlates strongly with how predicate devices measure them, thereby establishing its own suitability for linearity determination.

8. Sample Size for the Training Set

Not applicable. This device is a chemical reagent and not an AI/ML algorithm that requires a separate training set. The study describes the performance of the final product (pre-production lots).

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

Not applicable, as there is no training set in the context of an AI/ML model for this device. The "ground truth" for calibrator values is established through rigorous analytical chemistry methods for assaying the concentrations of the constituents in the calibrator solution.

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