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1. For the quantitative detection of IqG antibodies to thyroglobulin in human serum by enzyme immunoassay.
2. The SeraQuest Anti-thyroglobulin test can be used with other serological tests and clinical findings, to aid in the diagnosis of thyroid diseases such as Autoimmune Thyroiditis and Graves' disease.
3. For in vitro diagnostic use only.

The SeraQuest Anti-Thyroglobulin test is a solid-phase enzyme immunoassay (EIA), which is performed in microwells, at room temperature, in three thirty minute incubations. It has been developed to detect IqG antibodies which are directed against thyroglobulin, in human serum.

The Calibrators in the SeraQuest Anti-Thyroglobulin test kit have been assigned values based on the NIBSC standard. Test results are reported as international units per milliliter (IU/mL).

This document describes the validation study for the SeraQuest Anti-Thyroglobulin test.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set Sample Size: 144 serum specimens.
• Data Provenance: The study was conducted at Quest International, Inc., and the specimens were "serum specimens," implying human origin. The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the nature of a 510(k) submission for device clearance, it is generally assumed to be a prospective or at least properly collected retrospective dataset for regulatory purposes.

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

• This study did not use human experts to establish ground truth. Instead, it used a predicate device (Pharmacia Varelisa TG Antibodies test) as the reference standard. The performance of the SeraQuest Anti-Thyroglobulin test was compared directly to this established and legally marketed device.

4. Adjudication Method for the Test Set:

• No adjudication method by human experts was used for the test set. The comparison was directly against the results of the predicate device. When a discordant result occurred between the SeraQuest and Varelisa tests (1 specimen), it was further tested by a second legally marketed device, the Scimedix Anti-Thyroglobulin Test. This serves as a form of secondary verification rather than adjudication by expert consensus.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is an in-vitro diagnostic device comparison, not an imaging or clinical diagnostic aid that typically involves human readers.

6. Standalone (Algorithm Only) Performance Study:

• Yes, a standalone performance study was done. The SeraQuest Anti-Thyroglobulin test (the algorithm/device) was run independently on the 144 serum specimens, and its results were then compared to the results obtained from the predicate device (Pharmacia Varelisa TG Antibodies test), which also operated in a "standalone" fashion.

7. Type of Ground Truth Used:

• The "ground truth" used in this study was the results obtained from a legally marketed predicate device (Pharmacia Varelisa TG Antibodies test). This is a common approach for demonstrating substantial equivalence for in-vitro diagnostic devices. For the one discordant specimen, a second legally marketed device (Scimedix Anti-Thyroglobulin Test) was used for further verification, which gave an equivocal result.

8. Sample Size for the Training Set:

• The document does not explicitly state the sample size used for a "training set." This type of in-vitro diagnostic device likely undergoes development and internal validation and optimization with various samples, but the FDA submission focuses on the validation against a predicate device using a specific test set. The 144 specimens were for the performance study, not explicitly described as a training set.

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

• As a training set is not explicitly described or quantified, the method for establishing its ground truth is not provided. However, for the development and optimization of such an assay, ground truth would typically be established through a combination of well-characterized clinical samples (e.g., from patients with confirmed autoimmune thyroiditis or Graves' disease, and healthy controls), using reference methods or established clinical diagnoses.

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The Access® Thyroglobulin Antibody (TgAb) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thyroglobulin antibody levels in human serum and plasma using the Access® Immunoassay Systems. The measurement of thyroid autoantibodies may aid in the diagnosis of certain thyroid disorders, such as Hashimoto's disease, nontoxic goiter, and Graves' disease.

The Access Thyroglobulin Antibody reagents, Thyroglobulin Antibody calibrators, and the Access Immunoassay Analyzer comprise the Access Immunoassay System for the quantitative determination of thyroglobulin antibody in human serum and plasma.

Here's a breakdown of the acceptance criteria and study information for the Access® Thyroglobulin Antibody assay, based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Information

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

   • Test Set Sample Size:
     • Relative Sensitivity and Specificity: 296 serum samples (99 with Graves' disease, 97 with Hashimoto's disease, and 100 normals).
     • Method Comparison: 276 samples (values ranging from approximately <2.2 to 284 IU/ml).
     • Analytical Specificity: Number of samples not specified, but involved samples from persons with autoimmune disease.
     • Dilution Recovery: "Various dilutions of serum samples and serum sample pools" - specific number not provided.
   • Data Provenance: Not explicitly stated, but assumed to be retrospective as patients with diagnosed conditions (Graves' disease, Hashimoto's disease, and normals) were used. No mention of geographical origin.

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

   • Not mentioned. The study compares the device to a predicate device (Kronus Thyroglobulin Antibody RIA Kit) and categorizes samples based on existing diagnoses (Graves' disease, Hashimoto's disease, normals). The "ground truth" seems to be based on the established clinical diagnoses of the patients and the results of the predicate device, rather than a new adjudication by experts for this study.

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

   • Not mentioned. The study relies on comparing results to a predicate device and established clinical diagnoses.

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 in-vitro diagnostic (IVD) assay looking at the quantitative determination of a biomarker. MRMC studies are not applicable as there are no "human readers" interpreting images or clinical data in the context of AI assistance. The device is for laboratory use for biomarker measurement.

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

   • Yes, the performance characteristics (analytical specificity, sensitivity, precision, etc.) and the comparison to the predicate device are standalone evaluations of the Access® Thyroglobulin Antibody assay. The assay is an automated chemiluminescent immunoassay, meaning its performance is evaluated as an algorithm/system without direct human-in-the-loop interpretation during the assay's operation.

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

   • For Relative Sensitivity and Specificity, the ground truth for sample classification appears to be based on pre-existing clinical diagnoses (Graves' disease, Hashimoto's disease, and normal status). The comparison itself is against a predicate device's results.
   • For Method Comparison, the "ground truth" is effectively the results obtained from the predicate device (Kronus Thyroglobulin Antibody immunoradiometric assay), against which the new device's measurements are correlated.
   • For other analytical performance studies (sensitivity, precision, etc.), the "ground truth" refers to established analytical standards and measurements.

7. The sample size for the training set:

   • Not specified. The document describes performance studies (similar to validation/test sets) but does not detail a separate "training set" or how it was used in the development of the assay. For an immunoassay, the "training" aspect often refers to assay development and optimization, rather than machine learning algorithm training with a distinct dataset.

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

   • Not specified, as a distinct training set in the AI/ML sense is not described. For an IVD, the ground truth during development would typically be established through rigorous analytical methods using reference materials, spiked samples, and comparison to established methods or clinical samples with known characteristics.

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The Zeus Scientific, Inc. TPO (thyroid peroxidase) IgG ELISA Test System is an enzyme linked immunosorbent assay (ELISA) for the qualitative and semiquantitative detection of IgG autoantibodies to human thyroid peroxidase in human serum. The results of this serological test together with other clinical findings may aid in the diagnosis of thyroid diseases. This test is for in vitro diagnostic use.

Not Found

This document is a 510(k) clearance letter from the FDA for a diagnostic device. It does not contain information about the acceptance criteria or a study proving the device meets those criteria. Therefore, I cannot address most of your request.

Here's what can be inferred from the provided text:

• Device Name: Zeus Scientific, Inc., TPO IgG ELISA Test System
• Indications for Use: "The Zeus Scientific, Inc. TPO (thyroid peroxidase) IgG ELISA Test System is an enzyme linked immunosorbent assay (ELISA) for the qualitative and semiquantitative detection of IgG autoantibodies to human thyroid peroxidase in human serum. The results of this serological test together with other clinical findings may aid in the diagnosis of thyroid diseases. This test is for in vitro diagnostic use."

The letter states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices, meaning it performs similarly to other devices already on the market. However, it does not provide the specific performance metrics, study design, or expert qualifications that would be detailed in a study report.

To answer your questions, the actual 510(k) submission document, which would include the study data and acceptance criteria, would be needed. This letter is simply the FDA's decision based on that submission.

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The Zeus Scientific, Inc. Thyroglobulin IgG ELISA Test System is an enzyme linked immunosorbent assay (ELISA) for the qualitative and semi-quantitative detection of IgG autoantibodies to human thyroglobulin in human serum. The results of this serological test together with other clinical findings may aid in the diagnosis of thyroid diseases. This test is for in vitro diagnostic use.

Not Found

I am sorry, but based on the provided text, I cannot provide a table of acceptance criteria and reported device performance or other details of a study. The document is an FDA 510(k) clearance letter for the "Zeus Scientific, Inc., Thyroglobulin IgG ELISA Test System".

This letter states that the device has been found substantially equivalent to legally marketed predicate devices, allowing it to be marketed. However, it does not include the detailed performance study results, acceptance criteria, sample sizes, ground truth establishment, or multi-reader multi-case study information that you requested. Such information would typically be found in the 510(k) submission itself, not in the clearance letter.

Therefore, I cannot fulfill your request with the input provided.

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The quantitative determination of thyroglobulin autoantibodies in human serum or plasma by a microplate enzymeimmunoassay. Measurements of Tg autoantibodies may aid in the diagnosis of certain thyroid diseases such as Hashimoto, Graves, and nontoxic goiter.

The Monobind method is based on ELISA technology utilizing the streptavidin-blotin reaction to effect separation. Upon mixing blotinylated thyroglobulin antigen, and a serum containing the autoantibody (anti-Tg), reaction results between the biotinylated thyroglobulin antigen and the antibodies to form an immune complex. Simultaneously, the complex is deposited to the well through the high affinity reaction of streptavidin, coated on the well, and biotinylated thyroglobulin antigen. After incubation is complete, decantation or aspiration separates the unbound components. The enzyme linked species specific antibody (anti-h-igG) is then added to the microwells. The anti-h-lgG enzyme conjugate that binds to the immobilized immune complex in a second incubation are separated from unreacted material by a wash step. The enzyme activity in this fraction Is directly proportional to the antibody concentration in the specimen. By utilizing several different serum references of known antibody activity, a reference curve can be generated from which the antibody activity of an unknown can be ascertained.

Here's a breakdown of the acceptance criteria and the study details for the Monobind Anti-Thyroglobulin (Tg) Microplate ELISA, based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Details

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

   • Sample Size: 82 biological specimens.
   • Data Provenance: The specimens were from "normal and disease states populations," including "Hashimoto's thyroiditis, Graves Disease, thyroid nodules as well as thyroid carcinoma." The text does not specify the country of origin, but it implies human serum or plasma samples. The study appears to be retrospective as it used existing biological specimens for comparison.

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

   • The document does not explicitly state the number of experts or their qualifications. The "ground truth" for the test set appears to be established by the "reference method" (the Biomerica anti-thyroglobulin ELISA test), which is itself a validated diagnostic method. The values for comparison were "known antibody activity," implying established measurements from the predicate device.

3. Adjudication method for the test set:

   • The document does not describe an adjudication method involving experts. The comparison was quantitative, based on linear regression between the new device's measurements and the predicate device's measurements.

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, an MRMC comparative effectiveness study was not done. This device is an ELISA kit, which is an in-vitro diagnostic test, not an AI-assisted imaging or diagnostic tool that would involve human readers in the classical sense.

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

   • Yes, this study represents a standalone performance evaluation of the ELISA kit. The "algorithm" here is the chemical reaction and measurement process of the ELISA kit itself, without direct human interpretation influencing the numerical result.

6. The type of ground truth used:

   • The primary ground truth used for performance comparison was the quantitative results obtained from a predicate device (Biomerica anti-thyroglobulin ELISA test), which is itself a legally marketed diagnostic method. This is a form of clinical comparison against an established method. The results were also tied to "known antibody activity" and specimens from "disease states," implying a correlation with clinical diagnoses.

7. The sample size for the training set:

   • The document does not specify a separate "training set" in the context of device development. For an ELISA kit, method development (e.g., optimizing reagent concentrations) would involve internal testing, but the 82 specimens discussed are for the validation/test set used to demonstrate substantial equivalence.

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

   • As there's no explicitly mentioned "training set" with ground truth establishment described for this type of device, this question is not directly applicable in the context of the provided information. Instead, the "ground truth" for calibrators (standards) used in the assay itself is established by preparing them from "diluted human serum" "standardized against the same international reference material 1st IRP 65/93." This ensures the traceability and accuracy of the calibration curve.

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