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The Access HYPERsensitive hTSH assay provides in vitro quantitative measurement of human thyroid stimulating hormone (hTSH) in human serum or plasma. The Access HYPERsensitive hTSH assay is indicated for use with patients where an evaluation of their thyroid status is desired.

The Access® HYPERsensitive hTSH assay consists of the reagent pack, calibrators, and diluent. Consumables required for the assay include substrate and wash buffers.

The provided text describes the 510(k) premarket notification for the "Access HYPERsensitive hTSH assay." This submission focuses on demonstrating substantial equivalence to a previously cleared device, specifically by adding plasma as a sample type. The information provided is primarily related to the regulatory submission process and not a detailed clinical study demonstrating device performance against specific acceptance criteria in the context of AI/ML or complex diagnostic scenarios like image analysis.

However, I can extract the relevant information regarding the study that was conducted to demonstrate substantial equivalence, although it doesn't fit the typical structure of acceptance criteria for AI models.

Here's an analysis of the provided text based on your request, highlighting what is present and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document states that a "method correlation study, using paired plasma and serum samples, was conducted," but it does not specify the sample size for this study.
• Data Provenance: The document does not explicitly state the country of origin or whether the study was retrospective or prospective. It only mentions "human serum and plasma."

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

This type of information is not applicable or provided in this submission. This is a chemiluminescent immunoassay for quantitative determination of hTSH, not an AI/ML device relying on human expert interpretation for ground truth establishment. The "ground truth" would be the measured hTSH levels in the samples.

4. Adjudication Method for the Test Set

This information is not applicable or provided. Since it's a quantitative measurement assay, there wouldn't typically be an adjudication method in the way it's described for expert-based diagnoses.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI devices assisting human readers (e.g., radiologists interpreting images). This submission pertains to a standalone in vitro diagnostic assay.
• Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: Not applicable, as no AI assistance is involved.

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

Yes, in a sense, the entire evaluation concerns the standalone performance of the assay device (the Access HYPERsensitive hTSH assay) in quantitatively measuring hTSH levels. There is no human-in-the-loop component for the measurement itself. The study specifically focused on the device's ability to produce consistent quantitative results across different sample types (serum vs. plasma).

7. The type of Ground Truth Used

The ground truth implicitly used for the correlation study would be the quantitative hTSH levels obtained from the Access HYPERsensitive hTSH assay itself, specifically comparing measurements in paired serum and plasma samples. It's a comparison of the device's own performance across different matrices, rather than against an external gold standard like pathology or outcome data in the context of a new diagnostic. The predicate device's performance on serum and plasma is also part of the established "ground truth" for demonstrating substantial equivalence.

8. The Sample Size for the Training Set

The document does not specify a separate "training set" as this is not an AI/ML device that requires machine learning training. The "supporting data" refers to the method correlation study performed for regulatory submission, not a machine learning training phase.

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

Not applicable, as there is no training set in the AI/ML context.

Summary of the Study for Substantial Equivalence:

The study conducted was a method correlation study designed to demonstrate that the expanded use of the "Access® HYPERsensitive hTSH assay" to include human plasma samples produces results substantially equivalent to its performance with human serum samples. The primary finding was that the study results showed "good correlation between the plasma and serum samples." This finding, along with the assay utilizing the same methodology, being the same product type, being quantitative, and sharing the same components as the previously cleared predicate device, supported the determination of substantial equivalence by the FDA. The specifics of the sample size, data provenance, and detailed statistical analyses were not provided in this 510(k) summary.

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