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Immunoassay for the in vitro quantitative determination of antibodies to thyroglobulin in human serum and plasma. The anti-Tg determination is used as an aid in the detection of autoimmune thyroid disease.

The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys® 1010 / 2010 and Modular Analytics E170 (Elecsys module) Immunoassay Analyzers.

The ELECSYS® Anti-Tg Assay a two step sandwich immunoassay with streptavidin microparticles and electrochemiluminescence detection.
Results are determined using a calibration curve that is generated specifically on each instrument by a 2-point calibration and a master curve provided with the reagent bar code.

The provided text describes the ELECSYS® Anti-Tg Assay, an immunoassay for the in vitro quantitative determination of antibodies to thyroglobulin in human serum and plasma, used as an aid in detecting autoimmune thyroid diseases.

This submission is a 510(k) premarket notification, which aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. This type of submission generally relies on demonstrating comparable performance to an existing device rather than establishing new acceptance criteria based on a standalone clinical study. Therefore, the information typically requested for AI/ML device studies (e.g., sample size for test sets, number of experts for ground truth, MRMC studies) is not directly applicable in the same way to this conventional immunoassay submission.

Instead, the "acceptance criteria" here refer to the performance characteristics that demonstrate substantial equivalence to the predicate device. The "study" proving the device meets these criteria is the comparative performance testing against the predicate device.

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

Acceptance Criteria and Reported Device Performance

The "acceptance criteria" are implied by the performance characteristics of the predicate device, which the new device aims to be substantially equivalent to. The robust performance data from the predicate device serves as the benchmark.

Note on "Acceptance Criteria": For a 510(k) submission of an in vitro diagnostic (IVD) device, the primary "acceptance criterion" is almost always demonstrated substantial equivalence to a predicate device. This means the new device must perform comparably for its intended use, with any differences not raising new questions of safety or effectiveness. The data presented aims to show this comparability rather than meeting a pre-defined numerical performance target in isolation, as might be seen for a novel device undergoing a PMA.

Study Details

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: For reproducibility (precision) studies, the document states measurements were performed "five or six times daily for 10 days (n = 59 or 60); intra-assay precision on E170, n = 21." This refers to the number of replicates for specific samples, not the number of unique patient samples in a broad test set. The document does not specify a separate "test set" sample size for overall performance evaluation (e.g., comparing results across a range of patient samples from the new device vs. the predicate). This is typical for equivalence submissions where a full clinical trial with a defined test set and ground truth is not required.
   • Data Provenance: The document states "pooled human sera and commercial controls" were used for reproducibility testing. The country of origin is not specified, and the study is prospective in nature, as it involved actively collecting and analyzing samples with the new device and controls.

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

   • This question is not applicable in the context of this 510(k) submission for a quantitative immunoassay. The "ground truth" for an immunoassay like this is typically established by the quantitative measurement of antibodies to thyroglobulin, often calibrated against international standards (e.g., NIBSC 65/93 Standard, as stated for both devices). Expert consensus or human reader adjudication (as used in imaging studies) is not relevant for establishing the "ground truth" of an antibody concentration.

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

   • None. Adjudication methods like 2+1 refer to expert review processes, which are not relevant for establishing the "ground truth" of a quantitative immunoassay measurement.

4. 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:

   • No. This is an immunoassay device, not an AI/ML-driven diagnostic imaging device that involves human readers. Therefore, an MRMC study is not applicable.

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

   • Yes, by definition of the device. The ELECSYS® Anti-Tg Assay is a fully automated immunoassay performed on an analyzer. Its performance is entirely "standalone" in the sense that it provides a quantitative result without direct human intervention in the measurement process (though humans operate and interpret the analyzer). It is not an AI algorithm but a laboratory test.

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

   • The "ground truth" in this context is the quantitative concentration of antibodies to thyroglobulin as measured by a highly characterized method and calibrated against an international reference standard (NIBSC 65/93 Standard). It is not established by expert consensus, pathology, or outcomes data, as those are typically used for qualitative or diagnostic decision-making ground truth.

7. The sample size for the training set:

   • The document does not explicitly mention a "training set" in the context found in AI/ML algorithms. For immunoassay development, there are often various sets of samples used during assay optimization and verification (e.g., for linearity, accuracy, limits of detection). The specific sample numbers for these developmental phases are not detailed in this 510(k) summary, as the focus is on a comparison to the predicate.

8. How the ground truth for the training set was established:

   • As with point 7, the concept of a "training set" with an associated "ground truth" in the AI/ML sense is not directly applicable to this conventional immunoassay. The development process for an immunoassay involves rigorous analytical validation, with "ground truth" implicitly defined by the known characteristics of calibrators, controls, and reference methods used during development and validation.

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