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IMMULITE Thyroglobulin is a two-site chemiluminescent enzyme immunometric assay for use with the IMMULITE Analyzer and designed for the quantitative measurement of thyroglobulin in serum or heparinized plasma. It is intended strictly for in vitro diagnostic use as an aid in monitoring patients who have undergone thyroidectomy.

IMMULITE Thyroglobulin is a clinical device for use with the IMMULITE Automated Immunoassay Analyzer. It is a two-site chemiluminescent enzyme-labeled immunometric assay, based on ligand-labeled monoclonal antibody and separation by anti-ligand-coated solid phase.

Here's an analysis of the provided 510(k) summary, structured to address your specific questions about acceptance criteria and the supporting study:

The provided document describes the IMMULITE® Thyroglobulin device, an in vitro diagnostic assay. It directly compares its performance to a predicate device, the ORGenTec Thyroglobulin ELISA, to demonstrate substantial equivalence, rather than setting explicit "acceptance criteria" against generalized standards.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't define explicit acceptance criteria in terms of numerical thresholds for sensitivity, specificity, or overall agreement that the device must meet. Instead, it presents the results of a method comparison study between the IMMULITE Thyroglobulin and a predicate device (Kit A, which is ALPCO's ORGenTec). The implied acceptance is based on demonstrating comparable performance to the predicate.

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

• Sample Size (Test Set): 150 samples.
• Data Provenance: The document does not explicitly state the country of origin. The data is retrospective, as it involves samples from patients with existing conditions (Hashimoto's disease, Graves disease, post-thyroidectomy patients) and euthyroid individuals, which were then tested with both devices.

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

This type of in vitro diagnostic device (an immunoassay) does not typically rely on "experts" to establish a ground truth in the same way an imaging AI device might. Instead, the "ground truth" for the test set is effectively derived from the predicate device's measurements (Kit A) and the clinical diagnoses of the patients from whom the samples were obtained.

• Number of Experts: Not applicable in the context of human interpretation of data for ground truth.
• Qualifications of Experts: Not applicable. The comparison is between two quantitative assays. The clinical status of the patients (e.g., Hashimoto's disease, post-thyroidectomy) provides the context for evaluating the assay's performance, which would have been established by medical professionals, but this isn't detailed as "experts establishing ground truth for the test set" in the document's context.

4. Adjudication Method for the Test Set

Not applicable. This is a direct comparison between two quantitative laboratory assays. There is no human interpretation or adjudication of individual test results in the way there would be for, say, diagnostic image review. The comparison is based on the numerical outputs of each assay.

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 devices that assist human interpretation (e.g., AI for radiology). The IMMULITE Thyroglobulin is a standalone diagnostic assay that provides a quantitative measurement, not an AI assistance tool for human readers.

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

Yes, a standalone performance study was done for the IMMULITE Thyroglobulin. The entire method comparison study evaluates the performance of the IMMULITE device on its own, comparing its readings directly against another standalone device (the predicate). There is no human "in the loop" for the assay's performance itself; it's an automated immunoassay.

7. The Type of Ground Truth Used

The "ground truth" in this context is established by:

• Predicate Device Results: The ORGenTec Thyroglobulin ELISA (Kit A) serves as the primary reference for comparison, essentially acting as the standard against which the new device's measurements are judged.
• Clinical Diagnoses/Patient Status: The samples were collected from patients with known clinical conditions (Hashimoto's disease, Graves disease, post-thyroidectomy) and euthyroid individuals, providing a clinical context for evaluating the agreement, sensitivity, and specificity of the assays. This implies that the clinical status, confirmed by other diagnostic means (though not explicitly detailed in the summary), contributes to the "ground truth" for categorizing samples.

8. The Sample Size for the Training Set

Not applicable. The IMMULITE Thyroglobulin is an immunoassay, not an AI/machine learning algorithm that requires a "training set" to develop its model. Its performance is based on its chemical and biological reactions, and its calibration is typically established through internal laboratory procedures using known standards, rather than a data-driven training set.

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

Not applicable, as there is no "training set" in the context of an immunoassay. The device is calibrated using internal standards and controls as per standard laboratory assay development practices, not through a ground-truthed training dataset for an AI model.

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