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The Scantibodies Laboratory, Inc. Total Intact Parathyroid Hormone (PTH) test system is a device intended to measure parathyroid hormone in plasma. Measurements of a crother incone levels are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism.

Total Intact PTH ImmunoChemiluminoMetric (ICMA) Assay

This is an FDA premarket notification (510(k)) letter for an in vitro diagnostic device, the Scantibodies Laboratory, Inc. Total Intact PTH ImmunoChemiluminoMetric (ICMA) Assay. This type of document, particularly from 2006, generally does not contain detailed study information, acceptance criteria, or performance data in the same way that a more recent AI/ML device approval would.

510(k) clearances typically establish substantial equivalence to a legally marketed predicate device, and the detailed performance data, acceptance criteria, and study methodologies are usually filed with the FDA and summarized in publicly available summaries if these were required as part of the 510(k) submission. However, the letter itself primarily focuses on the regulatory decision.

Based on the provided text, I can extract the following:

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

The provided document does not contain any acceptance criteria or reported device performance. The letter is a regulatory announcement of clearance, not a summary of the underlying validation studies.

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

The provided document does not specify the sample size for the test set or the data provenance.

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 provided document does not mention the number of experts or their qualifications for establishing ground truth. For an in vitro diagnostic assay, the "ground truth" would typically be established through reference methods or clinical diagnosis, not by experts reviewing images.

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

The provided document does not describe any adjudication method.

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 ImmunoChemiluminoMetric (ICMA) Assay, which is a laboratory test for measuring parathyroid hormone. It is not an AI-powered image analysis device or a device that involves human readers. Therefore, an MRMC comparative effectiveness study involving "human readers" and "AI assistance" is not applicable to this type of device.

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

This device is a standalone laboratory assay. Its performance is evaluated intrinsically, not in the context of human-in-the-loop performance. Its performance would be evaluated against established analytical performance metrics (e.g., precision, accuracy, limit of detection, linearity), which are not detailed in this clearance letter.

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

For this type of in vitro diagnostic assay measuring a biomarker (parathyroid hormone), the "ground truth" in validation studies would typically be established by:

• Correlation with a reference method or a legally marketed predicate device (as implied by the 510(k) process for substantial equivalence).
• Correlation with clinical diagnosis of hypercalcemia or hypocalcemia (e.g., from patient records, physician diagnosis).
• Pathology is not directly applicable here as it's not a tissue-based diagnostic. Outcomes data might be used to assess clinical utility but isn't typically the primary ground truth for an assay's analytical performance.

However, the provided document does not explicitly state the type of ground truth used for its studies.

8. The sample size for the training set:

The provided document does not specify the sample size for any training set. As this is not an AI/ML device, the concept of a "training set" in the machine learning sense is not applicable. For traditional IVD assays, there might be studies for method development and optimization, but they wouldn't be termed "training sets."

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

Not applicable, as this is not an AI/ML device with a "training set."

In summary: The provided document is a 510(k) clearance letter from the FDA for an immunoassay. It confirms regulatory approval based on substantial equivalence to a predicate device but does not contain the detailed study design, acceptance criteria, or performance results that would be submitted to the FDA as part of the application. Many of the requested details are specific to AI/ML device evaluations and are not relevant or present for a traditional immunoassay from 2006.

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