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The Atellica IM Thyroglobulin (Tg) assay is for in vitro diagnostic use in the quantitative measurement of thyroglobulin in human serum and plasma (EDTA and lithium heparin) using the Atellica IM Analyzer.

Thyroglobulin measurements are used as an aid in monitoring differentiated thyroid cancer patients who have undergone thyroidectomy with or without radioiodine ablation.

The Atellica IM Thyroglobulin (Tg) assay includes:

• Tg ReadyPack primary reagent pack:
  • Lite Reagent: mouse monoclonal anti-human Tg antibody labeled with acridinium ester (~1.13 μg/mL); bovine serum albumin (BSA); mouse IgG; buffer; stabilizers; preservatives (7.5 mL/reagent pack).
  • Solid Phase: streptavidin-coated paramagnetic microparticles preformed with biotinylated mouse monoclonal antihuman Tg antibody (~267 μg/mL); BSA; mouse IgG; buffer; stabilizers; preservatives (15.0 mL/reagent pack).
• Ancillary Well Reagent: BSA; bovine gamma globulin; buffer; preservatives (6.0 mL/reagent pack).
• Tg CAL: After reconstitution, human thyroglobulin; BSA; buffer; stabilizers; preservatives (2.0 mL/vial).

The following devices are sold separately:

• Atellica IM Tg MCM:
  • MCM 1: After reconstitution, bovine serum albumin (BSA); buffer; stabilizers; preservatives (1.0 mL/vial).
  • MCM 2–5: After reconstitution, various levels of human thyroglobulin; BSA; buffer; stabilizers; preservatives (1.0 mL/vial).

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary for the Atellica IM Thyroglobulin (Tg) assay:

Device: Atellica IM Thyroglobulin (Tg) Assay
Purpose: Quantitative measurement of thyroglobulin in human serum and plasma as an aid in monitoring differentiated thyroid cancer patients who have undergone thyroidectomy with or without radioiodine ablation.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes various performance characteristics, which serve as acceptance criteria for the device. The reported performance is directly from the summary.

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

• Clinical Performance Test Set Sample Size: 291 serum samples collected from 189 subjects.
• Data Provenance:
  • The document states "A prospective, multi-center study was conducted." This indicates prospective data collection across multiple sites.
  • The country of origin is not explicitly stated in the provided text.
  • All samples were from subjects diagnosed with differentiated thyroid cancer, 6 or more weeks following thyroidectomy or radioiodine ablation.

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

• The document does not specify the number of experts or their qualifications for establishing the ground truth (structural disease). It simply states: "SD [Structural Disease] was established and classified as either positive or negative by cross-sectional or functional imaging results."
• This suggests that the ground truth was derived from standard clinical imaging reports rather than a consensus of independent expert readers specifically for this study.

4. Adjudication Method for the Test Set

• The document does not describe an adjudication method for the test set's ground truth (structural disease). It implies that the imaging results themselves provided the classification. This means there was no adjudication process as typically seen with multiple human readers reviewing images.

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

• No, an MRMC comparative effectiveness study was not done.
• This study is for an in vitro diagnostic (IVD) assay (a lab test), not an AI-assisted imaging or diagnostic tool where human readers work with or without AI. The performance metrics presented are for the analytical and clinical performance of the assay itself, comparing its results to a ground truth (structural disease status), not to human reader performance or improvement with AI.

6. If a Standalone Performance Study Was Done

• Yes, this is effectively a standalone (algorithm only) performance study.
• The Atellica IM Tg assay is an automated in vitro diagnostic device. Its performance characteristics (sensitivity, specificity, precision, linearity, etc.) are evaluated intrinsically, independent of human interpretation of the assay result values. The output is a quantitative measurement of thyroglobulin.

7. The Type of Ground Truth Used

• Ground truth for clinical performance: Structural disease (SD) status obtained from "cross-sectional or functional imaging results."
• Ground truth for analytical performance (LoB, LoD, LoQ, Precision, etc.): Established through laboratory protocols and reference materials (e.g., CLSI guidelines, certified reference materials like BCR CRM 457, spiked samples, control materials).

8. The Sample Size for the Training Set

• The document does not specify a separate training set or its sample size for the Atellica IM Tg assay.
• For IVD assays like this, the "training" is typically inherent in the assay's development and optimization process (e.g., reagent formulation, calibration curve development), which uses various known samples and standards, rather than a distinct, labeled "training dataset" as would be seen for a machine learning algorithm. The performance characteristics studies presented are akin to a "verification/validation set."

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

• As a traditional IVD assay, there isn't a "training set" in the sense of a machine learning model.
• Ground truth for assay development and calibration: This would have been established using reference materials (like BCR CRM 457), characterized control samples, and potentially a large panel of clinically characterized patient samples used during the assay's development and optimization phases. These activities are part of the broader product development lifecycle rather than a distinct "training set" with ground truth generated by experts in the context of a clinical study for submission. Standardization is explicitly noted as traceable to BCR CRM 457, which serves as a primary standard for establishing the quantitative accuracy of the assay.

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