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For the quantitative determination of free triiodothyronine (FT3) in serum using the Chiron Diagnostics ACS:180® Automated Chemiluminescence Systems.

Measurements obtained by this test are used in the diagnosis and treatment of thyroid diseases.

Trilodothyronine (3,5,3'-L-triiodothyronine, T3) is a hormone synthesized and secreted from the thyroid gland, and formed by peripheral deiodination of thyroxine (T4). T3 and T4 are secreted into the circulation in response to thyroid stimulating hormone (TSH) and play an important role in requlating metabolism

In the circulation, 99.7% of T3 is reversibly bound to transport proteins, primarily thyroxinebinding globulin (TBG) and to a lesser extent albumin and prealbumin. The remaining T3 does not bind to transport proteins, but is free in the circulation. This unbound fraction of the total T3 concentration is free triiodothyronine (free T3, FT3). Unbound T3 is metabolically active.

Free T3 levels correlate with T3 secretion and metabolism. In hypothyroidism and hyperthyroidism, free T3 levels parallel changes in total T3 levels. However, measuring free T3 is useful when altered levels of total T3 occur due to changes in T3 binding proteins, especially TBG. TBG levels remain relatively constant in healthy individuals, but certain conditions such as normal pregnancy and steroid therapy can alter these levels. In these conditions, free T3 levels are unchanged, while total T3 levels parallel the changes in TBG.

The Chiron Diagnostics ACS:180 FT3 assay is a competitive immunoassay using direct, chemiluminescent technology. FT3 in the sample competes with a T3 analog, which is covalently coupled to paramagnetic particles in the Solid Phase, for a limited amount of a combination of acridinium ester-labeled monoclonal mouse anti-T3 antibodies in the Lite Reagent.

The system automatically performs the following steps:

• dispenses 50 µL of sample into a cuvette ●
• dispenses 100 µL of Lite Reagent and incubates for 5.0 minutes at 37 C ●
• dispenses 450 µL of Solid Phase and incubates for 2.5 minutes at 37 C .
• separates, aspirates, and washes the cuvettes with reagent water ●
• dispenses 300 µL each of Reagent 1 and Reagent 2 to initiate the chemiluminescent . reaction
• . reports the results according to the selected option, as described in the system operating instructions or in the online help system

An inverse relationship exists between the amount of FT3 present in the patient sample and the amount of relative light units (RLUs) detected by the system.

The provided text describes the Chiron Diagnostics ACS:180 FT3 assay, a device for quantifying free triiodothyronine (FT3) in serum. The information is extracted from a 510(k) Summary for regulatory submission.

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

Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined "acceptance criteria" in the form of thresholds for performance metrics. Instead, it presents the results of performance studies. The table below summarizes the reported performance characteristics.

Study Details

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

• Expected Results/Reference Range Study:

  • Sample Size: 594 apparently healthy adult individuals for the primary range determination, and an additional 185 apparently healthy individuals for a confirmatory study.
  • Data Provenance: Not specified (e.g., country of origin). The studies appear to be prospective for establishing the reference range, as they studied "apparently healthy adult individuals."

• Method Comparison Study:

  • Sample Size: 359 samples.
  • Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

• Precision Study:

  • Sample Size: 3 samples (each assayed 6 times in each of 12 runs, on 4 systems). This describes a robust internal validation, rather than a "test set" of patient samples in the same way as the method comparison.
  • Data Provenance: Not specified.

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

This information is not provided in the document. For an in vitro diagnostic device measuring a quantitative analyte like FT3, "ground truth" is typically established by reference methods or validated laboratory measurements rather than expert consensus on images or clinical assessments. The studies appear to compare the device's measurements against themselves (precision) or against an "alternate method" (method comparison), where the "alternate method" would serve as the reference for comparison, not necessarily a human expert consensus.

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

This concept of "adjudication" is generally applicable to qualitative assessments (e.g., image interpretation) where there might be disagreement among human readers. For a quantitative immunoassay, adjudication as described (e.g., 2+1 consensus) is not applicable and therefore not mentioned. The method comparison study directly compared numerical results.

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 device is an automated immunoassay, not an AI-assisted diagnostic imaging system that would involve human readers interpreting cases. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and none was performed or described.

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

The device described is inherently a standalone automated system. The performance characteristics (sensitivity, reportable range, precision, method comparison) are all measurements of the algorithm's and system's performance without human intervention in the result generation or calculation process. Therefore, the presented studies are standalone performance assessments of the device.

7. The type of ground truth used:

• For Expected Results/Reference Range: The "ground truth" was derived from the measured FT3 values in a large cohort of "apparently healthy adult individuals," establishing a statistical range for a healthy population.
• For Analytical Sensitivity/Reportable Range: The ground truth for these metrics is inherent to the assay's ability to detect and quantify the analyte against zero standards or known concentrations.
• For Method Comparison: The "ground truth" was established by an "alternate method." The specific nature or gold standard status of this alternate method is not detailed, but it serves as the reference for comparison.
• For Precision: The ground truth is the inherent variability of the assay itself, measured through repeated assessments of the same samples.

8. The sample size for the training set:

The document does not specify a "training set" sample size. This is typical for a traditional immunoassay, which does not employ machine learning algorithms that require a distinct training phase with labeled data in the same way AI algorithms do. The assay is based on chemical reactions and optical detection, with internal calibration curves determining its performance characteristics.

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

As there is no mention of a "training set" in the context of machine learning, this question is not applicable to the described device. The assay's operational parameters and calibration are established through laboratory R&D and validation processes, not through a 'training set' for an algorithm.

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The BioCheck Total T3 EIA is intended for the quantitative determination of triiodothyronine (T3) in human serum. This test is useful in the diagnosis and treatment of thyroid diseases such as hyperthyroidism.

Not Found

The provided document is a 510(k) premarket notification letter from the FDA for a medical device called the "BioCheck Total T3 Enzyme Immunoassay Test Kit." It concerns the regulatory approval process and does not contain detailed information about acceptance criteria or specific study results that prove the device meets those criteria.

Therefore, I cannot extract the requested information from the provided text. The document confirms that the FDA reviewed the device and found it substantially equivalent to a legally marketed predicate device, allowing it to proceed to market subject to general controls. However, it does not include the technical performance data, study design, or ground truth establishment details that would be required to answer your questions.

To elaborate on why each specific question cannot be answered:

1. A table of acceptance criteria and the reported device performance: This information is typically found in the submission's performance data section, which is not included in this FDA determination letter.
2. Sample size used for the test set and the data provenance: Not present in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present in the document.
4. Adjudication method: Not present in the document.
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 device is an "Enzyme Immunoassay Test Kit" for determining T3 levels, not an AI-assisted imaging device. Therefore, an MRMC study with human readers and AI assistance would not be relevant and is not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a laboratory test kit, not an algorithm. Its performance is inherent to the kit's reagents and methodology. So, this question is not applicable in the context of this device.
7. The type of ground truth used: Not present in the document. For an immunoassay, the "ground truth" would typically refer to a reference method or validated gold standard for T3 measurement.
8. The sample size for the training set: Not present in the document. For an immunoassay, there wouldn't typically be a "training set" in the sense of machine learning; rather, there would be validation studies performed during development.
9. How the ground truth for the training set was established: Not present in the document.

In summary, the provided document is a regulatory approval letter and does not contain the detailed technical and scientific study information required to answer your questions.

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AIA-PACK FT3 is intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of Free Triiodothyronine in human serum on TOSOH AIA System analyzers. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.

Not Found

This document is a 510(k) clearance letter from the FDA for a medical device called "AIA-PACK FT3 Assay." It does not contain the detailed information necessary to complete the requested table and study description regarding acceptance criteria and performance.

The letter explicitly states that the FDA has "reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices."

This means the clearance is based on substantial equivalence to a predicate device, and the letter itself does not describe new performance studies or acceptance criteria for this specific device. Such information would typically be found in the 510(k) submission itself, not in the clearance letter.

Therefore, I cannot provide the requested information from the given text.

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A total triiodothyronine test system is a device intended to measure the hormone triiodothyronine in serum. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases such as hyperthyroidism.

Not Found

This document is an FDA 510(k) clearance letter for the OptiCoat™ T3 EIA Kit, dated December 22, 1998. It primarily addresses the regulatory approval of the device and does not contain detailed information about the acceptance criteria or the specific study that proves the device meets those criteria.

Therefore, I cannot provide the requested information based on the provided text. The document confirms that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its market clearance, but it does not include the performance data of the device itself.

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The ARCHITECT™ Total T3 (TT) assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of total triiodothyronine (total T3) in human serum and plasma. The ARCHITECT Total T, assay is to be used as an aid in the assessment of thyroid status.

ARCHITECT Total T2 is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of total T, in human serum and plasma (lithium heparin, sodium heparin or potassium EDTA). ARCHITECT Total T, is calibrated with ARCHITECT Total T. Calibrators. ARCHITECT Total T2 Controls are assayed for verification of the accuracy and precision of the Abbott ARCHITECT i System.

This 510(k) submission pertains to the Abbott ARCHITECT™ Total T3 assay, a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of total triiodothyronine (total T3) in human serum and plasma. The study conducted aimed to demonstrate substantial equivalence to a legally marketed predicate device, the AxSYM® Total T3 assay.

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

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state pre-defined acceptance criteria in terms of numerical thresholds for correlation, slope, or intercept. Instead, it presents the results of the comparison study to demonstrate substantial equivalence to the predicate device. The performance is reported in comparison to the AxSYM Total T3 assay.

Note: The acceptance criteria are implicitly derived from the objective of showing substantial equivalence to the predicate device, meaning the new device should perform very similarly to the predicate.

2. Sample Size for Test Set and Data Provenance

• Sample Size for Test Set: 1120 specimens
• Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth

This type of in vitro diagnostic device (IVD) submission typically relies on a comparator method (the predicate device) as the reference for "ground truth" or a well-established clinical assay. There is no mention of human experts being used to establish ground truth for individual test cases in the context of this 510(k) submission.

4. Adjudication Method for Test Set

Not applicable. The ground truth was established by comparison to a predicate device, not by expert interpretation requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically associated with imaging devices where human readers interpret medical images. This submission is for an in vitro diagnostic assay.

6. Standalone Performance Study

Yes, a standalone performance study was done for the ARCHITECT Total T3 assay in the sense that its performance was assessed independently by comparing its results against a predicate device. This is a common approach for IVDs to demonstrate performance for regulatory clearance. The "algorithm only" in this context refers to the assay's performance itself, independent of human interpretation of the results.

7. Type of Ground Truth Used

The "ground truth" for the test set was essentially the results obtained from the AxSYM® Total T3 assay, which is the legally marketed predicate device. The study aimed to show strong agreement between the new device and this established method.

8. Sample Size for Training Set

The document does not specify a separate "training set" or its sample size. For an IVD like this, the development and optimization of the assay would typically involve extensive internal testing during the R&D phase, but this information is usually not detailed in the 510(k) summary, which focuses on validation data. The 1120 specimens mentioned are for the comparison study, effectively acting as the validation or test set against the predicate.

9. How Ground Truth for Training Set Was Established

As there is no explicit mention of a separate training set in the context of the 510(k) summary, how its "ground truth" was established is not provided. If a training phase existed for the assay's development, it would likely involve comparisons to reference methods or clinically validated samples during the assay optimization process.

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The ARCHITECT™ Free Ts (FT2) assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of free triiodothyronine (free T3) in human serum and plasma. The ARCHITECT Free T3 assay is to be used as an aid in the assessment of thyroid status.

ARCHITECT Free T, is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of free T, in human serum and plasma (lithium heparin, sodium heparin or potassium EDTA). ARCHITECT Free T2 is calibrated with ARCHITECT Free T2 Calibrators. ARCHITECT Free T2 Controls are assayed for the verification of the accuracy and precision of the Abbott ARCHITECT i System.

This 510(k) summary describes a traditional device equivalence study rather than an AI/ML-based device study. Therefore, many of the requested categories are not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of Acceptance Criteria: The document directly states that "Substantial equivalence has been demonstrated between the ARCHITECT Free T3 assay and the AxSYM® Free T3 assay." This implies that the statistical metrics (correlation, slope, intercept) were compared against a pre-defined range of acceptable values (often based on clinical relevance or previous regulatory approvals for similar devices) to determine if the new device performed similarly enough to the predicate. The specific thresholds for these metrics (e.g., minimum correlation coefficient, acceptable range for slope and intercept) are not explicitly stated in this summary but would have been part of the full submission.

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

• Sample Size: 1101 specimens
• Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It only states "human serum and plasma."

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

• This is not applicable to this type of in vitro diagnostic device study. The "ground truth" for quantitative assays is typically established by the reference method (the predicate device in this case) and traceable standards, not by expert consensus.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication is typically for subjective assessments (e.g., image interpretation), not for quantitative chemical assays.

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

• No. This is an analytical performance study comparing two quantitative assays, not a diagnostic accuracy study involving human readers interpreting outputs.

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

• Yes, in a sense. The study assesses the performance of the ARCHITECT Free T3 assay (the "device" being evaluated) in comparison to the AxSYM® Free T3 (the "predicate device"). Both are automated or semi-automated assays, and their output is a quantitative value, not subject to human interpretation in the same way an AI output would be. The study focuses purely on the analytical performance of the device itself.

7. The Type of Ground Truth Used

• Predicate Device Comparison: The "ground truth" or reference for comparison was the AxSYM® Free T3 assay. This is a common approach for 510(k) submissions where a new device's performance is demonstrated to be substantially equivalent to an already legally marketed device with the same intended use.

8. The Sample Size for the Training Set

• Not applicable. This is an analytical validation of an in vitro diagnostic device, not an AI/ML model that requires a training set.

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

• Not applicable. (See point 8)

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The AuraFlex® FT3 assay is a fluorescent immunoassay for the quantitative determination of free triiodothyronine assay in human serum or plasma using the AuraFlex® System.

Fluorescent immunoassay reagents.

The provided text describes a 510(k) premarket notification for the Alfa Biotech (UK) Ltd AuraFlex® FT3, an immunoassay for free triiodothyronine. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 110 human serum samples.
• Data Provenance: Not explicitly stated, but the submission is from Alfa Biotech (UK) Ltd, suggesting the study may have been conducted in the UK or with UK-sourced samples. The data type is retrospective as it refers to a "comparison study" that was "conducted."

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

This information is not provided in the given text. The "ground truth" appears to be established by comparison to another existing FT3 assay, rather than expert consensus on individual samples.

4. Adjudication Method for the Test Set

This information is not provided in the given text.

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

No, an MRMC comparative effectiveness study was not done. The study conducted was a comparison of a new immunoassay against an existing one, not a study involving human readers or AI assistance.

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

Yes, this was a standalone study of the device (immunoassay) performance. There is no mention of human-in-the-loop performance or AI.

7. The Type of Ground Truth Used

The ground truth was established by comparison to the results of an "Other FT3 assay." This implies a reference method or legally marketed predicate device.

8. The Sample Size for the Training Set

This information is not provided in the given text. The text describes a "comparison study" of 110 samples, likely representing the test set for performance evaluation. There's no mention of a separate training set.

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

Since no training set information is provided, how its ground truth was established is not applicable/not provided.

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DPC's IMMULITE® Free T3 is a chemiluminescent assay for use with the IMMULITE® Automated Immunoassay Analyzer and is designed for the quantitative measurement of Free T3 in serum. It is intended strictly for in vitro diagnostic use as an aid in clinical assessment of thyroid status.

Free T3 is a solid-phase, IMMULITE® Chemiluminescent enzyme immunoassay for use with the IMMULITE® Automated Immunoassay Analyzer.

Here's a breakdown of the acceptance criteria and study information for the Diagnostic Products Corporation IMMULITE® Free T3 device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly state quantitative acceptance criteria in a pass/fail format for a primary outcome. Instead, it demonstrates performance by comparing the IMMULITE® Free T3 assay to a legally marketed predicate device (Chiron Diagnostics' ACS:180 Free T3) through a method comparison. The acceptance is implied by the "substantial equivalence" determination by the FDA.

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

• Sample Size: 237 patient samples.
• Data Provenance: Not explicitly stated (e.g., country of origin). The samples are referred to as "patient samples," which typically implies prospective or retrospective collection from a clinical setting, but it's not specified. It is a retrospective study since it compares the device to an existing predicate device.

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

This information is not provided in the document. The study is a method comparison against a predicate device, not a diagnostic accuracy study establishing ground truth based on expert consensus.

4. Adjudication Method for the Test Set

This information is not applicable as the study is a method comparison between two assays, not a diagnostic performance study requiring adjudication of expert interpretations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study focuses on the analytical performance of the new device compared to an existing one.

6. Standalone (Algorithm Only) Performance Study

This is an in vitro diagnostic (IVD) device, not an algorithm in the typical sense of AI. The performance reported is the standalone performance of the IMMULITE® Free T3 assay in direct comparison with the ACS:180 Free T3 assay. There is no human-in-the-loop component described for its operation or interpretation beyond the standard laboratory workflow.

7. Type of Ground Truth Used

The "ground truth" in this context is the results obtained from the predicate device (Chiron Diagnostics' ACS:180 Free T3 assay). The study aims to demonstrate that the new IMMULITE® Free T3 assay provides comparable results to an already legally marketed and established assay for free T3 measurement.

8. Sample Size for the Training Set

This information is not provided and is largely not applicable in the same way it would be for a machine learning algorithm. The IMMULITE® Free T3 device is a chemiluminescent immunoassay, and its "training" or optimization would involve laboratory development and calibration, not a traditional machine learning training set. The standard curve (mentioned as "stored" and "calibrated") is analogous to a training phase in a broader sense, but the specific sample size for its establishment is not detailed.

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

Similar to point 8, this information is not explicitly detailed in the document. For an immunoassay, the "ground truth" for calibration curves is typically established using a series of known concentration standards of free T3. These standards would be meticulously prepared and verified to ensure accurate calibration of the assay.

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The ACCESS® Total T3 Assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of triiodothyronine levels in human serum, using the ACCESS® Immunoassay System. The clinical importance of total serum T3 determination is in the diagnosis of thyroid disorders. Elevated concentrations of T3 can be found in Grave's disease, and most other classical causes of hyperthyroidism. Decreased concentrations occur in primary hypothyroid diseases such as Hashimoto's thyroiditis and neonatal hypothyroidism or secondary hypothyroidism due to defects at the hypothalamo-hypophyseal level.

The ACCESS® Total T3 reagents and the ACCESS® Immunoassay Analyzer comprise the ACCESS® Immunoassay System for the quantitative determination of triiodothyronine in human serum.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets them:

Acceptance Criteria and Device Performance for ACCESS® Total T3 Assay

This submission describes the ACCESS® Total T3 assay, an in vitro diagnostic device for the quantitative determination of triiodothyronine (T3) levels in human serum. The studies presented demonstrate analytical performance, proving substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The documentation does not explicitly state pre-defined acceptance criteria in terms of numerical thresholds for precision, accuracy, or correlation. Instead, it presents the results of studies and implies that these results are considered acceptable for demonstrating substantial equivalence to the predicate device. For the purpose of this analysis, the reported statistical results from the "Summary of Studies" section are presented as the "reported device performance." The implied acceptance is that these values demonstrate performance comparable to or adequate for the intended use and are similar to a legally marketed predicate device.

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

• Sample Size for Test Set:

  • Precision Studies: Not explicitly stated for each level (low, mid, high control), but typically involves replicates over several runs/days.
  • Accuracy (Recovery) Studies: "two patient samples" for dilution recovery and "two patient samples" for spiking recovery. This is a very small sample size for these studies.
  • Correlation Study: 153 samples.
  • Analytical Sensitivity: Not explicitly stated but usually involves multiple measurements of zero calibrator and low-level samples.

• Data Provenance: The document does not specify the country of origin for the patient samples. It also does not explicitly state whether the studies were retrospective or prospective, though performance studies for a 510(k) submission are typically prospective, conducted under controlled conditions to evaluate the new device's analytical capabilities.

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

N/A. This device is an in vitro diagnostic assay for a quantitative analyte (Total T3). The "ground truth" for the test set is established by the reference measurement method (the predicate device for correlation) or by the inherent properties of the controls and spiked/diluted samples. There are no human experts involved in establishing a "ground truth" in the way one would for image interpretation or disease diagnosis.

4. Adjudication Method for the Test Set

N/A. No adjudication method is applicable as this is not a subjective interpretation task requiring expert consensus.

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 diagnostic devices that involve human interpretation (e.g., radiologists reading images) and would assess the impact of an AI tool on reader performance. The ACCESS® Total T3 assay is an automated quantitative immunoassay.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the studies presented are essentially "standalone" performance evaluations. The device (ACCESS® Immunoassay System and reagents) outputs a quantitative T3 value, and the performance metrics (precision, accuracy, correlation, sensitivity) are evaluated based on these automated outputs. There is no human-in-the-loop component for interpreting the result itself, though human operators are involved in running the assay.

7. The Type of Ground Truth Used

• Precision: Statistical variability of repeated measurements on control materials or patient samples. The "ground truth" is the inherent stability and reproducibility of the assay.
• Accuracy:
  • Dilution/Spiking Recovery: The "ground truth" is the expected concentration based on the known dilution factor or amount spiked.
  • Correlation: The "ground truth" is the measurement obtained from the legally marketed predicate device (Ciba Corning ACS™ T3 assay).
• Analytical Sensitivity: The "ground truth" is typically defined by statistical methods (e.g., 95% confidence interval of zero calibrator measurements).

8. The Sample Size for the Training Set

N/A. The ACCESS® Total T3 assay is a biochemical immunoassay, not a machine learning or AI-based algorithm that requires a "training set" in the conventional sense. The assay's performance characteristics are inherent to its chemical and biological components and the instrument's design.

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

N/A. As there is no "training set" for this type of device, this question is not applicable.

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