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IMMULITE® Thyroid Autoantibody Control Module is an assayed, bi-level control intended for use with the IMMULITE® Anti-TPO Ab assay. It is intended strictly for in vitro diagnostic use.

AI/ML Overview

Here's an analysis of the provided 510(k) summary, specifically focusing on acceptance criteria and a study to prove device performance:

Unfortunately, the provided 510(k) summary for the "IMMULITE® Thyroid Autoantibody Control Module" does not contain the information requested regarding acceptance criteria, a study proving device performance, sample sizes, expert qualifications, or ground truth establishment.

The document explicitly states "Clinical Studies: Not applicable." This is typical for control materials, as their purpose is to monitor the performance of an assay, not to diagnose patients directly. Therefore, the detailed clinical study information asked for in your prompt would not be found in such a submission.

However, based on the nature of the device (a quality control material), we can infer what would typically be the "acceptance criteria" and the type of "study" to prove performance for such a product, even if not explicitly detailed in this short summary.

Here's a breakdown of what we can glean and what is missing, presented in the requested format:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred for a Quality Control)	Reported Device Performance (Not explicitly stated in summary for this device)
Analyte Concentration Stability: The control material must maintain its stated target concentration for the duration of its shelf life and within specified storage conditions.	The summary does not provide specific stability data or acceptance ranges. However, general quality control principles would dictate that the product is stable for its intended use.
Homogeneity: Individual aliquots of the control material must have consistent analyte concentrations.	Not explicitly stated.
Inter-Lot Consistency: Different manufacturing lots of the control material should yield comparable results when run on the target assay.	Not explicitly stated.
Matrix Effects: The control matrix should not interfere with the performance of the target assay (IMMULITE® Anti-TPO Ab assay).	Not explicitly stated.
Assay-Specific Performance: When run on the IMMULITE® Anti-TPO Ab assay, the control values should consistently fall within the established acceptable ranges for that assay.	The device is "an assayed, bi-level control," implying established ranges exist. However, the specific performance data for validating these ranges are not included in this summary.

2. Sample size used for the test set and the data provenance

Not Applicable. The summary explicitly states "Clinical Studies: Not applicable." For a quality control material, the "test set" would typically refer to the internal validation studies conducted by the manufacturer to establish the material's characteristics (stability, homogeneity, inter-lot consistency). This information is not present in the brief 510(k) summary provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. As no clinical studies were performed, there was no "ground truth" for patient samples established by experts in this context. The "ground truth" for a control material is its accurately assigned value, determined through rigorous analytical testing and potentially comparison to reference methods, not clinical expert consensus.

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

Not Applicable. No clinical studies or test set requiring expert adjudication are mentioned.

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 quality control material, not an AI diagnostic device. Therefore, MRMC studies and AI assistance are irrelevant to its function.

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

Not Applicable. This device is a quality control material, not an algorithm or an AI system.

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

For a control material, the "ground truth" would be the assigned value or target value for each analyte level (bi-level, as stated in the description). This value is established through:
- Reference Methods: Often comparing results to highly accurate, usually more labor-intensive, methods.
- Gravimetric/Volumetric Preparation: For some controls, the concentration can be precisely known by the amount of substance added.
- Extensive Internal Testing: Running the control on multiple instruments/assays over time to establish a consensus mean and acceptable range.
The summary does not specify how the ground truth for the assigned values of the IMMULITE® Thyroid Autoantibody Control Module was established.

8. The sample size for the training set

Not Applicable. This device is not an AI algorithm and therefore does not have a "training set."

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

Not Applicable. This device is not an AI algorithm.

In summary of the provided text:

The 510(k) K971051 describes a quality control material, the IMMULITE® Thyroid Autoantibody Control Module. For such a device, the focus of the submission is typically on its manufacturing quality (ISO certification mentioned), stability, and its ability to provide reliable monitoring of the IMMULITE® Anti-TPO Ab assay. The summary explicitly states "Clinical Studies: Not applicable," meaning that the extensive clinical validation data (with acceptance criteria, patient sample sizes, expert ground truth) usually associated with diagnostic devices is not relevant or included for a control product.

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