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QUALITROL TUMOR MARKER CONTROL, Levels 1 and 2, is a lyophilized human serum based assayed quality control material intended to monitor the naman of clinical immunological test procedures that analyze for tumor associated antigens.

QUALITROL TUMOR MARKER CONTROL, Levels 1 and 2, is a lyophilized human serum based assayed quality control material.

The provided document is a 510(k) clearance letter from the FDA for the Qualitrol Tumor Marker Control, Levels 1 and 2. It states that the device is substantially equivalent to a legally marketed predicate device. This type of regulatory document does not typically contain detailed information about the acceptance criteria and the comprehensive study results of the kind requested in the prompt.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: This document only states that the device is "substantially equivalent" and provides its indications for use. It does not detail specific performance metrics or acceptance thresholds.
2. Sample size used for the test set and the data provenance: Not available in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available in this document.
4. Adjudication method for the test set: Not available in this document.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: This is a control material, not an AI-assisted diagnostic device, so an MRMC study is not relevant and not discussed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable as it's a control material.
7. The type of ground truth used: Not available in this document.
8. The sample size for the training set: Not applicable/available for this type of device and regulatory submission.
9. How the ground truth for the training set was established: Not applicable/available for this type of device and regulatory submission.

Summary based on the provided document:

The document concerns the Qualitrol Tumor Marker Control, Levels 1 and 2, described as a "lyophilized human serum based assayed quality control material intended to monitor the performance of clinical immunological test procedures that analyze for tumor associated antigens."

The FDA's decision is that the device is substantially equivalent to legally marketed predicate devices. This implies that the device has met the regulatory requirements by demonstrating it performs as safely and effectively as a predicate device, but the specific performance demonstration data is not included in this letter.

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