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The Scantibodies Laboratory, Inc. Total Intact Parathyroid Hormone (PTH) test system is a device intended to measure the levels of parathyroid hormone in serum and plasma. Measurements of parathyroid hormone 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 Immunoradiometric Assay (Coated Tube Version)

This document is a 510(k) premarket notification from the FDA for a medical device called "Total Intact PTH Immunoradiometric Assay (Coated Tube Version)". It primarily concerns the regulatory approval of the device and does not contain detailed information about acceptance criteria or specific study results as would be found in a clinical study report.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is what can be inferred or stated based on the document:

1. A table of acceptance criteria and the reported device performance:
This information is not provided in the document. The FDA letter states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices...". This implies that the device met certain criteria for substantial equivalence, but the specific acceptance criteria and the device's performance against them are not detailed.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided in the document.

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 in the document.

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:
This information is not provided in the document. This device is an in-vitro diagnostic assay, not an AI-assisted diagnostic tool, so an MRMC study with human readers improving with AI assistance would not be applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This device is a laboratory assay, which by its nature operates "standalone" in terms of generating a measurement. However, performance data for this "standalone" operation is not provided in this document.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For an in-vitro diagnostic device like this, the "ground truth" would typically refer to a reference method or a clinical diagnosis (e.g., confirmed hypercalcemia/hypocalcemia) against which the assay's measurements are compared. This specific information is not provided in the document.

8. The sample size for the training set:
This information is not provided in the document.

9. How the ground truth for the training set was established:
This information is not provided in the document.

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