(12 days)
The Scantibodies Laboratory, inc. Whole Parathyroid Hormone (PTH) test system is a device intended to measure parathyroid hormone in plasma. PTH measurements 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.
Whole PTH (1-84) ImmunoChemiluminoMetric (ICMA) Assay
This is an FDA 510(k) clearance letter for an in vitro diagnostic (IVD) device, not an AI/ML medical device. Therefore, many of the requested criteria (like sample size for test set, number of experts, adjudication methods, MRMC study, standalone performance, training set details) are not applicable or typically not included in such submissions for IVD assays.
However, I can extract the relevant information regarding the device and its intended use. Here's a breakdown based on the provided text:
Device: Whole PTH (1-84) ImmunoChemiluminoMetric (ICMA) Assay
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document is a 510(k) clearance letter, which means the device was found substantially equivalent to a predicate device. Specific performance characteristics and acceptance criteria are usually detailed in the 510(k) summary document itself, which is not fully included here. The clearance letter only verifies that the FDA has reviewed the submission and determined substantial equivalence.
Therefore, a table of specific quantitative acceptance criteria (e.g., precision, accuracy ranges) and reported device performance (e.g., observed precision, accuracy) cannot be extracted directly from this clearance letter. These details would be found within the full 510(k) submission.
What can be inferred from the clearance: The device met the acceptance criteria required for substantial equivalence to a legally marketed predicate device. This implies that its performance (e.g., analytical sensitivity, specificity, precision, accuracy, linearity) was demonstrated to be comparable enough to the predicate to be considered safe and effective for its intended use.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not explicitly stated in this clearance letter.
- Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not explicitly stated in this clearance letter.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable for an IVD assay where performance is primarily analytical (chemical/biological), not based on expert interpretation of images or clinical findings.
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable for an IVD assay. Ground truth would be established through reference methods or clinical diagnosis, not expert adjudication of subjective results.
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:
- MRMC Study: Not applicable. This is an IVD assay, not an AI-assisted diagnostic imaging or interpretation device that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: For an IVD, standalone performance refers to its analytical performance (e.g., accuracy, precision, linearity) when run as specified by the manufacturer. This would have been assessed as part of the 510(k) submission to demonstrate substantial equivalence, but the specific metrics are not detailed in this clearance letter. The device itself is "algorithm only" in the sense that it's an automated chemical assay.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: For an IVD like this, ground truth would typically be established through:
- Reference analytical methods: Comparing the device's results to a recognized gold standard method for measuring PTH.
- Clinical diagnosis: Correlating PTH levels with patient diagnoses of hypercalcemia or hypocalcemia established through other clinical findings, lab tests, and expert opinion (though not "expert consensus" on the device's reading, but rather the patient's overall condition).
8. The sample size for the training set:
- Sample Size for Training Set: Not applicable in the context of an IVD assay. IVDs are developed and validated through analytical studies and clinical studies, but generally don't involve "training sets" in the machine learning sense. Assay parameters are optimized and calibrated during development.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable for an IVD assay. Calibration and optimization during development would use characterized samples, but not a "training set" with ground truth in the AI/ML context.
Summary for this specific device:
- This is an ImmunoChemiluminoMetric Assay (ICMA) for measuring Whole PTH (1-84) in plasma.
- It's classified as an In Vitro Diagnostic (IVD) device.
- The FDA clearance confirms substantial equivalence to a predicate device, meaning its performance for the stated indications is considered comparable to existing legally marketed devices.
- The Indications for Use: "The Scantibodies Laboratory, inc. Whole Parathyroid Hormone (PTH) test system is a device intended to measure parathyroid hormone in plasma. PTH measurements 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."
- Details on specific performance metrics, sample sizes, and ground truth establishment methods (which would be analytical validation data) are not part of this 510(k) clearance letter but would have been part of the full submission.
§ 862.1545 Parathyroid hormone test system.
(a)
Identification. A parathyroid hormone 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.(b)
Classification. Class II.