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LUMItest TRAK human is a luminescence receptor assay (LRA) for the quantitative determination of antibodies against the human thyrotropin (TSH) receptor. The measurement of TSH receptor autoantibodies is used in the assessment of patients with suspect Graves' disease (autoimmune hyperthyroidism).

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The provided document is a 510(k) premarket notification letter from the FDA to BRAHMS Diagnostica, LLC., concerning the device "LUMItest TRAK human". This document primarily focuses on regulatory approval and does not contain the detailed study information required to fully answer your request.

Specifically, the document states:

• Device Name: LUMItest TRAK human
• Regulation Number: 21 CFR 866.5870
• Regulation Name: Thyroid autoantibody immunological test system
• Indications for Use: LUMItest TRAK human is a luminescence receptor assay (LRA) for the quantitative determination of antibodies against the human thyrotropin (TSH) receptor. The measurement of TSH receptor autoantibodies is used in the assessment of patients with suspect Graves' disease (autoimmune hyperthyroidism).

However, it does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Information on experts used to establish ground truth or their qualifications.
4. Adjudication methods.
5. Details of a multi-reader multi-case (MRMC) comparative effectiveness study, nor effect sizes.
6. Results of a standalone algorithm performance study.
7. The specific type of ground truth used (beyond implying a clinical diagnostic context for "TSH receptor autoantibodies").
8. The sample size for the training set.
9. How ground truth for the training set was established.

Without access to the full 510(k) submission or associated study reports, it's impossible to provide the requested information. The letter merely confirms that the FDA reviewed the submission and found the device substantially equivalent to a legally marketed predicate device.

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DYNOtest Tg-pluS is a immunoradiometric assay (IRMA) for the quantitative determination of thyroglobulin in human serum. It is intended to aid in the monitoring for the presence of local or metastatic thyroid tissue in patients who have had thyroid gland ablation (by surgery with or without radioiodine therapy). DYNOtest Tg-pluS is also indicated for detecting the presence of thyroid tissue in patients with differentiated thyroid cancer when used with radioiodine whole body scans after recombinant thyrotropin (TSH) stimulation or thyroid hormone withdrawal. DYNOtest Tg-pluS includes a recovery test to aid in the detection of interfering anti-thyroglobulin antibodies or other substances.

DYNOtest Tg-pluS is a two-step immunoradiometric assay for the quantitative determination of thyroglobulin in human serum using a coated tube technique. Two antigen specific antibodies that recognize different binding sites on the antigen (thyroglobulin) are used in excess. In the first step, thyroglobulin in the sample, standard or control binds to rabbit anti-human Tg polyclonal antibodies attached to the solid phase. Following incubation, unbound thyroglobulin and serum components are washed from the tube. In the second step, the radioactive tracer (mouse antihuman thyroglobulin monoclonal antibody) reacts with the bound antigen forming a sandwich complex fixed to the side of the tube. Following a second incubation, unreacted tracer is washed from the tube and remaining radioactivity in the tubes is measured. The measured radioactivity is directly proportional to the quantity of thyroglobulin in the sample, standard or control. The standard curve is used to derive the thyroglobulin concentration in the patients samples.

Recovery Test: Because non-specific interferents and anti-thyroglobulin antibodies can result in falsely low thyroglobulin values, DYNOtest Tg-pluS includes a recovery test, the purpose of which is to aid in the detection of such interferences. In the recovery test, recovery buffer containing a known quantity of thyroglobulin, is added to the patient sample. In parallel, the recovery buffer is added to a recovery reference sample (thyroglobulin free serum). The patient sample, recovery sample and recovery reference sample are all run using DYNOtest Tg-pluS. The percentage recovery is determined by subtracting the patient Tg value from the patient recovery sample and dividing this result by the recovery reference Tg value:

Recovery Tg - Patient Tg x 100 = % Recovery Recovery reference Tg

Recovery values between 70% and 130% are considered valid. Values 130% are due to interferences; these patient results should be considered invalid.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study used to evaluate the DYNOtest Tg-pluS device:

Acceptance Criteria and Device Performance for DYNOtest Tg-pluS

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria with specific threshold values for the clinical study. Instead, it presents the results of a clinical performance study and a comparison to a predicate device. The effective acceptance criteria can be inferred from the reported performance characteristics.

2. Sample Size and Data Provenance for the Test Set

• Sample Size for Test Set:
  • Clinical Performance Study: 133 patients diagnosed with thyroid cancer.
  • Predicate Device Comparison: 133 samples from patients diagnosed with thyroid cancer (likely the same cohort as the clinical performance study).
  • Interference from Tg auto-antibodies: 77 sera.
• Data Provenance: The clinical performance study was prospective in the sense that the device was evaluated on a specific set of categorized patients. The location of the test set is specified as occurring "at a single site," but the country of origin is not explicitly stated. Given the manufacturer is German (BRAHMS AG) and the distributor is US-based (BRAHMS Diagnostica LLC), it's possible the clinical site was in the US or Germany.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the number or qualifications of experts used to establish the ground truth for the test set.

4. Adjudication Method for the Test Set

The document does not describe a specific adjudication method (like 2+1 or 3+1). The "ground truth" (reference methodology) was established based on a combination of existing diagnostic results.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study focuses on the performance of the in-vitro diagnostic (IVD) device itself, not on how human readers' performance might change with or without AI assistance. The device is an assay, not an AI imaging interpretation tool.

6. Standalone Performance Study

Yes, the studies reported are for the standalone performance of the DYNOtest Tg-pluS device. The clinical performance section, including sensitivity, specificity, PPV, and NPV, directly evaluates the algorithm/assay without human-in-the-loop performance modifications.

7. Type of Ground Truth Used

The ground truth for the clinical performance study was established using a combination of existing clinical diagnostic results and reference methods:

• "Tg results from a reference method (immunochemiluminescent method)"
• "results from radioiodine whole body scans following TSH stimulation by administration of recombinant TSH or withdrawal of thyroid hormone therapy."
• Patients were categorized into three groups: (1) free of thyroid tissue, (2) active metastatic disease, and (3) residual thyroid/thyroglossal duct remnants.

For the auto-antibody interference study, the ground truth was based on samples that "tested positive for Tg auto antibodies using a radioimmunometric assay (DYNOtest anti-TGn)."

8. Sample Size for the Training Set

The document does not specify a separate training set or its sample size. This type of in-vitro diagnostic assay (IRMA) typically relies on extensive analytical validation and calibration to established standards (like CRM 457, in this case) rather than a "training set" in the machine learning sense. The "standards" and "controls" mentioned in the device description are used for calibration and quality control, not for training a predictive algorithm in the same way an AI model would be trained.

9. How Ground Truth for the Training Set Was Established

Since a distinct "training set" in the context of machine learning is not mentioned or applicable to this type of assay, the concept of establishing ground truth for it is also not applicable here. The assay is calibrated against a standard (CRM 457), which serves as a known reference for target values.

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DYNOtest anti-TPOn is a competitive radioimmunoassay for the quantitative determination of autoantibodies to thyroid peroxidase (TPO) in human serum using the coated tube technique. The DYNOtest anti-TPO, kit is used as an aid in the diagnosis of Hashimoto's thyroiditis and Graves' disease, autoimmune diseases affecting the thyroid gland.

DYNOtest anti-TPOn is a competitive radioimmunoassay intended for the quantitative determination of autoantibodies against thyroid peroxidase in human sera using a coated tube technique. Monoclonal antibodies against thyroid peroxidase bound to the solid phase compete with autoimmune anti-thyroid peroxidase antibodies in the sample for indirectly 12-1 labeled thyroid peroxidase. Following incubation, unreacted indirectly labeled thyroid peroxidase and unreacted 1251 labeled antibody against TPO is washed from the tube and radioactivity bound to the tube is counted. The measured radioactivity is inversely proportional to the quantity of anti-thyroid peroxidase antibody in the sample.

Here's an analysis of the provided text regarding the DYNOtest® anti-TPOn device, focusing on acceptance criteria and the supporting study:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than setting explicit quantifiable acceptance criteria for novel performance metrics. The 81.8% agreement is presented as sufficient to demonstrate substantial equivalence.

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

• Sample Size for Test Set: 77 serum samples
• Data Provenance: The document does not explicitly state the country of origin. It indicates the samples were "from patients with Graves' disease, Hashimoto's thyroiditis and non-autoimmune thyroid disease," implying they were clinical samples, likely retrospective given the nature of a 510(k) submission for an already developed product. The study is a "clinical comparison."

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

This information is not provided in the document. The "ground truth" for the test set is established by comparing the DYNOtest anti-TPOn results to those of the predicate device, the Orgentec Anti-TPO ELISA. The performance of the predicate device itself is the reference. There's no mention of independent expert review of the 77 samples to establish a separate ground truth.

4. Adjudication Method for the Test Set

This information is not applicable/provided as there's no mention of individual expert assessment and subsequent adjudication. The comparison is directly between the new device and the predicate device's results. The 2x2 table shows the direct agreement and disagreement.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic (IVD) assay; therefore, human interpretation/reading of the assay results is not the primary focus in the same way it would be for an imaging AI device. The comparison is between two automated assay results.

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

Yes, a standalone performance study was done. The "clinical comparison" directly compares the results of the DYNOtest anti-TPOn assay (the algorithm/device) to the results of the predicate Orgentec Anti-TPO ELISA. There is no human intervention or "human-in-the-loop" component in interpreting the quantitative results of either assay within this comparison.

7. The Type of Ground Truth Used

The "ground truth" for the comparison study is the results of the legally marketed predicate device, Orgentec Anti-TPO ELISA. The study evaluated whether the DYNOtest anti-TPOn agreed sufficiently with the established predicate device, which is a common approach for 510(k) submissions seeking substantial equivalence for IVD devices.

8. The Sample Size for the Training Set

This information is not provided and is generally not relevant for 510(k) submissions of traditional IVD assays like radioimmunoassays, as they are not "trained" in the typical machine learning sense. The device is a chemical/biological assay run on samples.

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

This information is not applicable/provided for the reasons mentioned above. There is no "training set" or "ground truth" establishment in the context of machine learning training for this type of device.

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DYNOtest anti-Tgn is a competitive radioimmunoassay (RIA) for the quantitative determination of autoantibodies against thyroglobulin (Tg) in human serum using the coated tube technique. The DYNOtest anti-Tg, kit is used as an aid in the diagnosis of Hashimoto's thyroiditis and Graves' disease, autoimmune diseases affecting the thyroid gland.

DYNOtest anti-Tg, is a competitive radioimmunoassay intended for the quantitative determination of autoantibodies against thyroglobulin in human sera using a coated tube technique. Human polyclonal antibodies against thyroglobulin bound to the solid phase compete with autoimmune antithyroglobulin antibodies in the sample for 1351 labeled thyroglobulin. Following incubation, unreacted labeled thyroglobulin is washed from the tube and radioactivity bound to the tube is counted. The measured radioactivity is inversely proportional to the quantity of anti-thyroglobulin antibody in the sample.

Here's an analysis of the provided text regarding the DYNOtest® anti-Tgn device, focusing on acceptance criteria and supporting study details:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly define acceptance criteria as a standalone quantitative metric (e.g., "sensitivity must be >X%"). Instead, it focuses on demonstrating substantial equivalence to a predicate device. The performance is assessed through a direct comparison where the agreement between the new device and the predicate device is the key metric.

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

• Sample Size for Test Set: 74 serum samples.
• Data Provenance: The document states the samples were "from patients with Graves' disease, Hashimoto's thyroiditis and non-autoimmune thyroid disease." The country of origin is not specified, nor is whether the data was retrospective or prospective.

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

The document explicitly states that the ground truth for this comparison study was the results obtained from the predicate device, the Orgentec Anti-Tg ELISA (K952130). Therefore, no human experts were directly involved in establishing the ground truth for this particular comparison. The predicate device's performance established the reference.

4. Adjudication Method for the Test Set

Not applicable. The "ground truth" was the result from the predicate device; therefore, no expert adjudication was required or performed.

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 device is an in vitro diagnostic (IVD) assay, not an AI-assisted diagnostic tool or an imaging device requiring human interpretation. The study is a comparative effectiveness study between two IVD kits.

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

Yes, in the context of an IVD, the comparison study against the predicate device effectively functions as a standalone performance evaluation of the DYNOtest® anti-Tgn assay. It evaluates the kit's performance independently without human interpretation influencing the final result beyond conducting the assay.

7. The Type of Ground Truth Used

The ground truth used for the comparison study was the results obtained from the legally marketed predicate device, the Orgentec Anti-Tg ELISA (K952130). This functions as a "reference standard" rather than a clinical ground truth like pathology or expert consensus. Patients were characterized by their diagnoses (Graves', Hashimoto's, non-autoimmune thyroid disease), but the direct comparison was against the predicate's output.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/Machine Learning device that requires a separate training set. The study describes the validation of an IVD kit.

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

Not applicable, as there is no training set for this type of device.

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