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Immunoassay for the in vitro quantitative determination of antibodies to thyroglobulin in human serum and plasma. The anti-Tg autoantibodies determination is used as an aid in the detection of autoimmune thyroid diseases in conjunction with other laboratory and clinical findings.

The electrochemiluminescence immunoassay "ECLIA" is intended for use on the cobas e 411 immunoassay analyzer.

The Elecsys Anti-Tg immunoassay makes use of a competitive test principle using biotinylated human antigen and monoclonal human anti-Tg antibodies labeled with a ruthenium complex. The Elecsys Anti-Tg immunoassay is intended for the quantitative determination of antibodies to thyroglobulin in human serum and plasma. It is intended for use on the cobas e immunoassay analyzers.

Results are determined via a calibration curve which is instrument-specifically generated by 2 point calibration and a master curve provided via the reagent barcode or e barcode.

The provided text describes the performance evaluation of the Elecsys Anti-Tg immunoassay, a diagnostic device, and its acceptance criteria. Here's a breakdown of the requested information based on the text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a single table labeled "Acceptance Criteria" with corresponding "Reported Device Performance" in a direct side-by-side format. Instead, it describes various performance evaluations and states whether "All predefined acceptance criteria was met" for each. However, we can reconstruct a table based on the provided details for the non-clinical performance evaluation.

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set Sample Sizes:
  • Precision: Not explicitly stated, but includes "Human serum 1-5" and "PC THYRO1-2" (presumably replicates for each, as per CLSI EP05-A3 which requires sufficient replicates).
  • Lot-to-lot Reproducibility: "three reagent lots" (number of samples per lot not specified).
  • Analytical Sensitivity (LoB, LoD, LoQ): Not explicitly stated, determined according to CLSI EP17-A2 which has sample size recommendations.
  • Linearity: "Six dilution series" using "native human serum samples and sample pools" (number of samples/pools not specified).
  • Endogenous Interferences: Not explicitly stated per substance, but mentions "Six endogenous substances."
  • Analytical Specificity/Cross-Reactivity: Not explicitly stated (for anti-TPO).
  • Exogenous Interferences: "17 commonly and 14 specially used pharmaceutical compounds" (number of samples not stated).
  • Sample Matrix Comparison: "blood from 13 donors" (tested across serum, K2-EDTA, K3-EDTA plasma, and serum separation tubes from 3 manufacturers).
  • Method Comparison to Predicate: "total of 129 human serum samples."
• Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. It is a "510(k) Summary" for an FDA submission, reporting on laboratory performance studies. Given they are "non-clinical performance evaluation," these are typically controlled laboratory studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This device is an in-vitro diagnostic (IVD) immunoassay. The ground truth for such devices is established through analytical testing against reference materials, established methods, and clinical samples with known characteristics, not typically by expert consensus in the same way as an imaging AI. The "ground truth" here is the precise concentration or presence/absence of the analyte (thyroglobulin antibodies) as determined by the study's reference method or expected values for standards/controls.

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

Not applicable for this type of IVD analytical performance study. Adjudication methods like 2+1 or 3+1 are common in clinical trials or imaging studies where expert readers interpret results, but not for direct quantitative measurements from an immunoassay. The acceptance criteria are based on statistical analysis of quantitative results (e.g., precision, linearity, recovery, regression).

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 is an immunoassay for determining antibody levels, not an imaging device or an AI intended to assist human readers. Hence, no MRMC study was performed, and human reader improvement with AI assistance is not relevant to this device's evaluation.

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

This entire non-clinical performance evaluation section (4. NON-CLINICAL PERFORMANCE EVALUATION) describes the standalone performance of the Elecsys Anti-Tg immunoassay (a device, not an AI algorithm). The measurements are performed by the "cobas e 411 immunoassay analyzer," which acts as the "algorithm" or automated system. There's no human "in the loop" for the direct measurement results themselves, though human operators are involved in running the tests and interpreting the results in a clinical setting.

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

The ground truth for the analytical performance studies (precision, linearity, sensitivity, interferences, stability) is based on:

• CLSI guidelines: The studies adhere to specific Clinical and Laboratory Standards Institute (CLSI) guidelines (e.g., EP05-A3, EP17-A2, EP06-Ed2), which define how such analytical characteristics are determined using reference materials, spiked samples, and statistical methods.
• Reference Standards/Materials: Implied in sections like "Traceability/Standardization" against the NIBSC 65/93 Standard, and the use of calibrators (Anti-Tg CalSet) and controls (PreciControl ThyroAB).
• Known Sample Characteristics: For linearity, samples with varying known concentrations are typically used. For interference studies, samples spiked with known interferents are used.
• Predicate Device Comparison: For method comparison, the predicate device's results serve as a comparative reference.

8. The sample size for the training set

Not applicable in the context of an immunoassay. This device is an in-vitro diagnostic test kit (reagents) used on an existing analyzer. It does not involve a "training set" in the machine learning sense. The "development" or "training" of such a diagnostic involves optimizing the chemical and biological components of the assay (reagents, antibodies, detection method) and calibrating the system across a range of known concentrations.

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

As there is no "training set" in the AI/machine learning sense, this question is not applicable. The development process for an immunoassay involves extensive research and development to create reagents that accurately quantify the target analyte. Calibration is done using reference materials with assigned values, and the assay's performance characteristics (as detailed in section 4) are then rigorously validated.

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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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The Elecsys® Anti-Tg CalCheck is intended for use in the verification of the calibration established by the Elecsys® Anti-Tg reagent on Elecsys® 1010/2010/MODULAR ANALYTICS E170 immunoassay analyzers.

The Elecsys® Anti-Tg CalCheck is a lyophilized product manufactured using a human serum base, human Anti-Tg, and preservative. The analyte is appropriately spiked into the CalCheck matrix to the correct concentration.

The provided document is a 510(k) summary for the Elecsys® Anti-Tg CalCheck, a calibration verification material. This type of device is a control material used to verify the calibration of an immunoassay analyzer and does not typically involve traditional "device performance" in terms of diagnostic accuracy metrics like sensitivity or specificity. Instead, the performance characteristics relevant to this device are related to its value assignment and stability. Therefore, some of the requested information (e.g., MRMC studies, number of experts for ground truth, adjudication methods) is not applicable to this type of medical device's evaluation.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the Elecsys® Anti-Tg CalCheck was evaluated for "value assignment and stability." While specific numerical acceptance criteria (e.g., ±X% deviation from target value) and detailed reported performance metrics are not explicitly provided in this 510(k) summary, the FDA's clearance indicates that these criteria were met during the submission's review.

Note: For this type of device, the "performance" is about whether the control material provides the correct, stable values needed to verify the calibration of the primary diagnostic assay. The 510(k) summary confirms these evaluations were performed and found acceptable for clearance.

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

This information is not provided in the 510(k) summary. Given that it's a calibration verification material, the "test set" would likely refer to the number of lots or samples of the CalCheck material manufactured and tested. Data provenance (country of origin, retrospective/prospective) is also not detailed for this type of product.

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

This information is not applicable/not provided. For a calibration verification material, the "ground truth" would be established by reference methods or highly accurate analytical techniques to determine the true concentration of the analyte (Anti-Tg) in the control material. This is a characteristic determined by laboratory measurements, not human expert consensus.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. Adjudication methods (like 2+1, 3+1) are typically used in studies where human readers are interpreting images or clinical data to establish a ground truth, which is not relevant for the performance evaluation of a calibration verification material.

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

This information is not applicable. This device is a calibration verification material, not an AI-powered diagnostic tool for human interpretation. Therefore, MRMC studies and AI-assisted performance improvements are not relevant.

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

This information is not applicable. The Elecsys® Anti-Tg CalCheck is a physical control material, not an algorithm. Its "performance" is inherent to its physical and chemical properties and how accurately it can verify the calibration of an immunoassay system.

7. The Type of Ground Truth Used

For a calibration verification material, the "ground truth" is typically established by:

• Reference methods: Highly accurate and precise analytical methods used to determine the true concentration of the analyte (Anti-Tg) within the control material.
• Traceability to an international standard: Ensuring the assigned values are directly comparable to recognized international reference materials.

The 510(k) summary describes the device as a "lyophilized product manufactured using a human serum base, human Anti-Tg, and preservative. The analyte is appropriately spiked into the CalCheck matrix to the correct concentration," implying that the concentrations are scientifically determined and assigned during manufacturing.

8. The Sample Size for the Training Set

This information is not applicable/not provided. Calibration verification materials do not involve "training sets" in the context of machine learning or AI.

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

This information is not applicable/not provided. (See points 7 and 8.)

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