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The Access Thyroglobulin Antibody II 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 Hashimoto's disease, nontoxic goiter, and Graves' disease.

The Access Thyroqlobulin Antibody II 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 Hashimoto's disease, nontoxic goiter, and Graves' disease.

The Access Thyroglobulin Antibody II assay is a sequential two-step immunoenzymatic ("sandwich") assay. A sample is added to a reaction vessel with paramagnetic particles coated with the thyroglobulin protein. The TgAb in the sample binds to the thyroglobulin coated on the particles. After incubation, materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. The thyroglobulin-alkaline phosphatase conjugate is added and binds to the TgAb.

After second incubation, materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. Then, the chemiluminescent substrate is added to the vessel and light generated by the reaction is measured with a luminometer. The light production is directly proportional to the concentration of analyte in the sample. Analyte concentration is automatically determined from a stored calibration.

Here's a detailed breakdown of the acceptance criteria and study information for the Beckman Coulter Access Thyroglobulin Antibody II device, extracted from the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

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The Access Thyroglobulin Antibody II assay is a paramagnetic 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 Hashimoto's disease, nontoxic goiter, and Graves' disease.

The Access Thyroglobulin Antibody II reagents, Thyroglobulin Antibody II calibrators, and the Access Immunoassay analyzers comprise the Access lmmunoassay 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 II for use on the Access Immunoassay Systems, as extracted from the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the "Summary of Studies" section, which describes the performance characteristics that were measured and deemed acceptable for demonstrating substantial equivalence. Exact numerical acceptance thresholds for each test (e.g., "imprecision must be less than X%") are not explicitly stated as distinct criteria, but the reported performance values are presented as evidence of meeting acceptable levels.

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ImmunoCAP Thyrodlobulin is a device for the in vitro quantitative measurement of IgG antibodies specific for Thyroglobulin (TG) in human serum and plasma. ImmunoCAP Thyroglobulin is intended to be used with the ImmunoCAP 100° and ImmunoCAP 250 instruments. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of certain thyroid diseases, such as autoimmune thyroiditis and Graves' disease, and is to be used in clinical laboratories, as well as physicians office laboratories.

ImmunoCAP Thyroid Peroxidase is a device for the in vitro quantitative measurement of IgG antibodies specific for Thyroid Peroxidase (TPO) in human serum and plasma. ImmunoCAP Thyroid Peroxidase is intended to be used with the ImmunoCAP 100C and ImmunoCAP 250 instruments. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of certain thyroid diseases, such as autoimmune thyroiditis, Graves' disease and is to be used in clinical laboratories, as well as physicians office laboratories.

ImmunoCAP Thyroglobulin IgG Antibodies Controls NLH are intended for laboratory use in monitoring the performance of in vitro quantitative measurement of specific IgG Thyroglobulin antibodies in human serum. ImmunoCAP Thyroglobulin IgG Antibodies Controls are intended to be used with the instrument ImmunoCAP 100° and ImmunoCAP 250.

ImmunoCAP Thyroid Peroxidase IgG Antibodies Controls NLH are intended for laboratory use in monitoring the performance of in vitro quantitative measurement of specific IgG Thyroid Peroxidase antibodies in human serum. ImmunoCAP Thyroid Peroxidase IgG Antibodies Controls are intended to be used with the instrument ImmunoCAP 100€ and ImmunoCAP 250.

The modified devices belong to a fully integrated and automated system for immunodiagnostic testing. It comprises a Fluorescence-Immunoassay test system using ImmunoCAP single wells as the solid phase and is intended to be performed on the instruments ImmunoCAP 100 and ImmunoCAP 250. The conjugate for the ImmunoCAP IgG method is mouse anti-human IgG beta-galactosidase, which uses 4-Methylumbelliferyl-ßD-Galactoside as substrate. The total IgG calibration is based on a set of six WHO-standardized IgG Calibrators derived from human serum. They are used to establish an initial calibration curve, which may be used for up to 28 days on additional assays and can be stored by the instrument. Each additional assay includes calibrator (curve) controls that have to recover in defined ranges to ensure that the stored calibration curve is still valid. The Fluorescence-Immunoassay test system includes test-, method specific and general reagents that are packaged as separate units.

The provided document is a 510(k) Summary for the ImmunoCAP™ Thyroglobulin and ImmunoCAP™ Thyroid Peroxidase immunological test systems. It focuses on demonstrating substantial equivalence to previously cleared devices rather than establishing novel acceptance criteria and proving performance against them from scratch. Therefore, many of the requested details about a study proving the device meets acceptance criteria are not explicitly stated in the document in the format one might expect for a de novo device submission.

However, based on the information provided, here's an attempt to answer the questions, highlighting what is present and what is not:

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

The document does not specify quantified acceptance criteria or reported device performance in a table format. Instead, it relies on demonstrating laboratory equivalence to previously cleared predicate devices (UniCAP TG Antibodies K981559 and UniCAP TPO Antibodies K981930). The "acceptance criteria" can be inferred as successful comparability and substantial equivalence to these predicates.

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

The document does not explicitly state the sample sizes used for the comparison studies or the provenance of the data (e.g., country of origin, retrospective/prospective). It mentions:

• "results obtained for clinically defined sera"
• "results obtained for samples from apparently healthy subjects (normal population)"

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 information is not provided. The ground truth for "clinically defined sera" and "apparently healthy subjects" is typically established through clinical diagnosis and standard laboratory tests, but the involvement of specific experts or their qualifications is not detailed in this 510(k) summary.

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

This information is not provided 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

A multi-reader multi-case (MRMC) comparative effectiveness study is not relevant to this type of in vitro diagnostic device, which is an automated immunoassay system measuring specific IgG antibodies. This is not an AI-assisted diagnostic tool for human interpretation.

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

This device is a standalone in vitro diagnostic system. The "algorithm" here refers to the immunoassay's reaction and instrument's software for evaluation. The document implicitly supports its standalone performance because the "instruments ImmunoCAP 100° and ImmunoCAP 250... include software for evaluation of test results." The equivalence studies described are effectively standalone performance assessments against predicate devices.

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

The document refers to "clinically defined sera" and "samples from apparently healthy subjects." This suggests the ground truth was based on clinical diagnoses (which could involve a combination of expert assessment, other laboratory tests, and potentially patient outcomes) rather than a single source like pathology for tissue samples.

8. The sample size for the training set

This information is not provided. As this is a modification of an existing device and focuses on demonstrating equivalence, detailed training set information is less likely to be presented than for a de novo AI/ML device. The "training" in this context would typically refer to the development and optimization of the immunoassay itself, not a machine learning model.

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

This information is not explicitly provided. Similar to the test set, the ground truth for developing and optimizing the assay (if considered a "training set") would likely involve clinically characterized samples, but the method of establishment is not detailed.

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The Access Thyroglobulin Antibody II (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 Hashimoto's disease, nontoxic goiter, and Graves' disease.

The Access Thryoglobulin Antibody II reagents, calibrators, and the Access Immunoassay Analyzers (Access, Access 2, Synchron LXi 725, UniCel DxC 600i, and UniCel DxI 800) comprise the Access Immunoassay Systems for the determination of thyroglobulin antibody (TgAb) levels in human serum and plasma.

Here's a breakdown of the acceptance criteria and study information for the Access Thyroglobulin Antibody II Assay, based on the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

Study Details:

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

   • Methods Comparison: 832 values were used for comparison. The document does not explicitly state the country of origin, but given the applicant is in the US and the clinical studies for expected values were in the US, it is highly likely this data is from the United States. The study appears to be retrospective as it compares the new device with a "commercially available enzyme immunoassay kit" which implies existing samples.
   • Imprecision, Dilution Recovery, Analytical Sensitivity, Analytical Specificity: Sample sizes are not explicitly given for each of these analytical studies, but details like "multiple dilutions," "20 replicates of the zero calibrator," and "sera samples obtained in the United States" are mentioned. For Expected Values, 137 screened samples and an additional 519 normal samples were collected in the United States. These appear to be prospective collections based on specific screening criteria.

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

   • This device is an immunoassay for quantitative determination of antibody levels. The "ground truth" for the analytical studies (imprecision, linearity, sensitivity, specificity) is based on the inherent properties of the assay and reference materials, not expert interpretation.
   • For the Methods Comparison, the "ground truth" was established by a "commercially available enzyme immunoassay kit." This implicitly means the established performance of that predicate device determined the reference. No human experts are mentioned for establishing ground truth in this context.
   • For Expected Values, the "ground truth" for "normal" was defined by specific clinical criteria (serum TSH levels, no personal/family history of thyroid disease, absence of non-thyroid autoimmune disease). This relies on clinical diagnosis and laboratory results rather than expert consensus on individual cases for the test set.

3. Adjudication method for the test set:

   • Not applicable as this is an immunoassay device, and the "ground truth" in the analytical studies is based on established laboratory methods, reference ranges, or a comparator device's results, not on expert adjudication of individual case results.

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:

   • Not applicable. This device is an in vitro diagnostic (IVD) immunoassay for quantitative measurement, not an AI-assisted diagnostic imaging or interpretation device that would involve human readers.

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

   • Yes, the performance characteristics (imprecision, dilution recovery, analytical sensitivity, analytical specificity, methods comparison) reflect the standalone performance of the Access Thyroglobulin Antibody II Assay as an automated immunoassay system. There is no human-in-the-loop component described for its primary function of quantitative determination.

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

   • For analytical studies:
     • Imprecision, Dilution Recovery, Analytical Sensitivity, Analytical Specificity: Ground truth is based on the intrinsic properties of the assay system, known standards, and controlled experimental conditions typical for IVD assay validation.
     • Methods Comparison: Ground truth was established by the results from a commercially available enzyme immunoassay kit (the predicate device).
   • For clinical studies (Expected Values): Ground truth for "normal" was established by clinical criteria (TSH levels, medical history) rather than a single type of definitive outcome or pathology for each individual.

7. The sample size for the training set:

   • The document describes the validation of the device, not the development of an algorithm that requires a "training set." This is an immunoassay, not a machine learning model. Therefore, the concept of a training set in the AI/ML sense is not applicable. The studies described are for validation of the assay's performance.

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

   • Not applicable, as there is no "training set" in the context of this immunoassay.

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The quantitative determination of thyroid peroxidase (TPO) autoantibodies in human serum or plasma by a microplate enzymeimmunoassay. Measurements of TPO 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 thyroid peroxidase antigen, and a serum containing the autoantibody (anti-TPO), reaction results between the biotinylated theroid peroxidase 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 thyroid peroxidase antigen. After incubation is complete, decantation or aspiration separates the unbound components. The enzyme linked specific antibody (anti-h-lgG) is then added to the microwells. The anti-h-igG 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 an analysis of the provided text to extract information about the acceptance criteria and the study that proves the device meets them:

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

• Equation to a straight-line: y = 1.02(x) - 5.1
• Correlation coefficient: 0.989
• Mean values for reference method: 127.0 IU/ml (new device) and 122.9 IU/ml (predicate device). This indicates good method agreement. |
  | Linearity / Recovery | Average 101.2% recovery when specimens were diluted and compared to the dose response curve. |

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

• Sample Size for Test Set: 82 biological specimens.
• Data Provenance: The document does not explicitly state the country of origin or if the study was retrospective or prospective. It mentions the specimens were from "normal and disease states populations," including Hashimoto's thyroiditis, Graves Disease, thyroid nodules, and thyroid carcinoma.

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)

The document does not provide information on the number of experts or their qualifications. The ground truth for the comparison appears to be based on the results from the predicate device (Biomerica anti-thyroid peroxidase ELISA test) which is used as the "reference method."

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

Not applicable. The study compares the new device's quantitative measurements against a predicate device's quantitative measurements, not against expert interpretation requiring adjudication.

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 in-vitro diagnostic (IVD) device, not an imaging device or AI-assisted diagnostic tool that involves human readers.

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

Yes, this was a standalone performance study. The device (ELISA kit) directly produces a quantitative result; there is no human interpretation of an algorithm's output. The performance described is the device's measurement capability itself.

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

The ground truth for evaluating the new device's performance was the quantitative results obtained from the predicate device, the Biomerica anti-thyroid peroxidase ELISA test. The new device was compared to this "reference method."

8. The sample size for the training set

The document does not explicitly mention a "training set" in the context of device development or validation. This is an ELISA kit, which relies on chemical reactions rather than machine learning models that typically require training sets. The 82 specimens were used for the performance comparison.

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

As there's no mention of a traditional "training set" in the machine learning sense, this question is not applicable. The device's calibration involves "several different serum references of known antibody activity" to generate a reference curve, but this is part of the assay's operational setup rather than a training set for an algorithm. The "known antibody activity" in these calibrators would be established through a separate, highly controlled process, likely traceable to international standards (like WHO 66/387 mentioned for the calibrators).

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