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Architect Free T4 MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range on the Abbott Architect i System

Architect Free T4 MasterCheck Level 0 contains human serum Architect Free T4 MasterCheck Levels 1, 2 and 3 contain Free T4 prepared in human serum. Preservative: Sodium Azide.

The provided text is a 510(k) summary for a medical device called "Architect FreeT4 MasterCheck." This document focuses on the regulatory submission and comparison of the device to a predicate device, rather than a clinical study evaluating its acceptance criteria and performance against a specific ground truth.

Therefore, many of the requested details about acceptance criteria, study data, ground truth, and expert involvement are not available in the provided text.

Here's an analysis of what information can be extracted and what is missing:

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

• Acceptance Criteria: Not explicitly stated in terms of quantitative targets for performance (e.g., sensitivity, specificity, accuracy). The intended use is for "verification of sensitivity, calibration linearity, and reportable range on the Abbott Architect i System." This implies that the device itself is a control or calibrator, and its "performance" would be its stability, consistency, and ability to challenge the assay being verified.
• Reported Device Performance: No quantitative performance metrics (e.g., specific values for sensitivity, linearity) are reported for the Architect FreeT4 MasterCheck itself in the context of a study. The document describes its composition (human serum, Free T4) and storage claims.

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

• Not Available. The document does not describe a test set or clinical study for the Architect FreeT4 MasterCheck's performance. It is a regulatory submission for a control material.

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/Not Available. As there's no described test set or ground truth establishment process for the device's performance, this information is not present.

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

• Not Applicable/Not Available. Same as above.

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 device is a diagnostic control/calibrator, not an AI-assisted diagnostic tool for human readers.

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

• Not Applicable. This device is a diagnostic control/calibrator, not a standalone algorithm.

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

• Not Applicable/Not Available. There is no described study to establish ground truth for the device's performance. The "ground truth" for a control material often relates to its assigned target values, which are typically established through well-characterized reference methods or manufacturing processes. This detail is not provided.

8. The sample size for the training set

• Not Applicable/Not Available. This device is a diagnostic control/calibrator, not a machine learning model requiring a training set.

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

• Not Applicable/Not Available. Same as above.

Summary of Available Information from the Provided Text:

• Device Name: Architect FreeT4 MasterCheck
• Intended Use: Verification of sensitivity, calibration linearity, and reportable range on the Abbott Architect i System.
• Device Type: Diagnostic control/calibrator (specifically, "Single (Specified) Analyte Controls (Assayed and Unassayed)").
• Composition: Level 0 contains human serum; Levels 1, 2, and 3 contain Free T4 prepared in human serum. Preservative: Sodium Azide.
• Regulatory Status: 510(k) clearance (K984070) based on substantial equivalence.
• Predicate Device: Casco Standards Document Serum Multi-Analyte Verification Test Set (K950469).
• Comparison to Predicate: A table outlines similarities (intended use, form, matrix) and differences (specific analytes, open vial claim, specific assay calibration).
• Storage Claims: 2-8°C (Open Vial: 3 days at 2-8°C).

Conclusion:

The provided 510(k) summary focuses on the regulatory filing for a diagnostic control material rather than a performance study that would generate the detailed data requested about acceptance criteria, test sets, ground truth, and expert involvement. Such information would typically be found in a separate validation study report, not in a 510(k) summary for this type of device.

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