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The OPUS T3 Controls are intended for use as quality control material to monitor the precision and accuracy of the OPUS T3 assay.

The OPUS T3 Controls are liquid controls containing known levels of T3 in processed human serum with anti-microbial agents and sodium azide as preservatives. The control is provided at three levels (low, mid and high). The OPUS T3 control is only for use with the OPUS T3 assay and has not been evaluated for use with other assays.

This K96 1206 document describes the submission of an in-vitro diagnostic device, "OPUS T3 Controls," for 510(k) clearance. It is specifically a quality control material and as such, the general criteria for evaluating its performance are related to its stability and ability to provide consistent (precise) and accurate readings within the context of the assay it's designed to monitor.

Given the nature of this device (a quality control material for an immunoassay), the acceptance criteria and study designs are different from, for example, an AI-powered diagnostic imaging tool. Therefore, some of the requested information (like number of experts, adjudication methods, multi-reader multi-case studies, standalone performance of an algorithm) are not applicable here.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note on Acceptance Criteria: For a quality control material, the acceptance criteria are largely focused on its precision (reproducibility) when used within the assay. While accuracy of the control material against its stated "known values" is fundamental, it's often established during the manufacturing and characterization of the control material itself, rather than an explicit "acceptance criteria" for its 510(k) submission. The document emphasizes precision performance.

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

• Sample Size:
  • Intra-assay precision: "n=20 with each level of the OPUS controls." This means 20 measurements for the low, 20 for the mid, and 20 for the high control levels.
  • Inter-assay precision: "Duplicate determinations for each level of control twice per day (AM and PM) for five days to total an n=20." This implies a total of (2 determinations/day * 2 times/day * 5 days) = 20 determinations per control level.
• Data Provenance: Not explicitly stated (e.g., country of origin). The study was conducted on an "OPUS Immunoassay System." It is a prospective evaluation setup specifically for this submission, as the tests were performed to evaluate the "Proposed Device Performance Characteristics."

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

• Not Applicable. For a quality control material, "ground truth" for the test set is established by the known concentrations of the analyte (T3) within the control material itself during its manufacturing and characterization process. This doesn't involve external medical experts determining a clinical outcome or diagnosis. The "known levels of T3" serve as the reference.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods (like 2+1, 3+1) are typically used when multiple human readers interpret results (e.g., medical images) and their agreement needs to be resolved to establish a consensus ground truth. This is not relevant for the performance evaluation of a quality control material where objective instrument readings are taken.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. This type of study assesses how AI assistance impacts human reader performance (e.g., radiologists, pathologists). It is not relevant for evaluating the performance of a laboratory quality control material.

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

• Yes, in essence. The precision studies evaluated the performance of the OPUS T3 Controls when processed by the "OPUS Immunoassay System" without direct human interpretation of the result itself for diagnostic purposes. The device is a consumable, and its performance is measured by the readings generated by the automated assay system. While a human initiates the test and reviews the generated data, the performance metrics (CVs) are "standalone" results of the control material within the automated system.

7. The Type of Ground Truth Used

• Known concentrations/values. The ground truth for the OPUS T3 Controls is the "known levels of T3" contained within the liquid controls. These values are established during the manufacturing and characterization of the control material itself, and "lot specific values" are provided to users.

8. The Sample Size for the Training Set

• Not Applicable / Not provided. For a quality control material like this, there isn't a "training set" in the context of machine learning algorithms. The formulation and characterization of the control material itself (establishing the "known levels of T3") is a manufacturing process, not an AI training process.

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

• Not Applicable. As there is no "training set" in the AI sense, this question is not relevant. The "known levels of T3" that form the basis of the control material's reference values would have been established through a primary assay or reference methodology during the internal development and manufacturing of the control product.

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