(14 days)
IMMULITE® Turbo Intact PTH is a solid-phase, two-site chemiluminescent enzyme immunometric assay for use with the IMMULITE Automated Analyzer and designed for the quantitative measurement of intact parathyroid hormone (parathyrin, PTH) in EDTA plasma or serum. It is intended strictly for in vitro use as an aid in the differential diagnosis of hypercalcemia and hypocalcemia.
IMMULITE® Turbo Intact PTH is a clinical device for use with the IMMULITE® Automated Immunoassay Analyzer, Reagent system for the determination of intact PTH in EDTA plasma or serum.
The provided text describes a 510(k) submission for the IMMULITE® Turbo Intact PTH device, an in vitro diagnostic assay. However, the document does not contain specific acceptance criteria or an explicit study that proves the device meets those criteria in the typical format of a device performance study with acceptance metrics such as sensitivity, specificity, accuracy, or correlation coefficients.
Instead, the document primarily focuses on establishing "substantial equivalence" to a legally marketed predicate device, as required for 510(k) clearances. This means that the FDA determined the new device is as safe and effective as a previously approved device. The "Conclusion" explicitly states: "The data presented in this summary of safety and effectiveness is the data that the Food and Drug Administration used in granting DPC substantial equivalence for IMMULITE® Turbo Intact PTH."
Therefore, based solely on the provided text, it's not possible to answer all aspects of your request as they relate to a direct performance study with defined acceptance criteria. I will address what can be inferred or stated about the device and the regulatory process.
Here's an analysis of the provided text in relation to your questions:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the provided documents. For an IVD like this, acceptance criteria would typically involve performance characteristics such as analytical sensitivity, specificity, precision (intra-assay, inter-assay), linearity, recovery, and correlation with a predicate device or a gold standard method. These are implied requirements for achieving "substantial equivalence" but not detailed in this summary.
- Reported Device Performance: Not explicitly enumerated in a table in the provided text. The submission itself contained data that demonstrated adequate performance for FDA to grant substantial equivalence, but the specific metrics are not included in this summary.
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 (Test Set): Not specified in the provided text.
- Data Provenance: Not specified in the provided text. However, since the manufacturer is Diagnostic Products Corporation in Los Angeles, California, and the submission is to the U.S. FDA, it is highly probable that the study data (if clinical samples were used) would primarily come from the United States. Whether it was retrospective or prospective is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts/Qualifications: Not applicable to this type of 510(k) summary for an immunoassay. The "ground truth" for an immunoassay like this would be established through analytical validation measures (e.g., comparison to a reference method, spiked samples, known concentrations) and clinical correlation, rather than expert consensus on diagnostic images or pathology.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies where human interpretation of medical images or other subjective data is being evaluated, often in the context of establishing ground truth through expert consensus. For an immunoassay, the "ground truth" is determined by reference methods or defined concentrations, not expert 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
- MRMC Study: No. This is an immunoassay for measuring a hormone concentration, not an AI-assisted diagnostic imaging device that involves human readers interpreting cases. Therefore, an MRMC study is not relevant here.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: For an immunoassay, the device itself provides the quantitative measurement. Its "standalone performance" refers to its analytical performance (accuracy, precision, linearity, etc.). While these studies were undoubtedly performed as part of the 510(k) submission to establish substantial equivalence, the specific details or results of these studies are not provided in this summary. The device operates automatically once the sample is loaded into the IMMULITE® Automated Analyzer.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: For an immunoassay like IMMULITE® Turbo Intact PTH, the "ground truth" for analytical performance would typically be established by:
- Reference Methods: Comparison against established, well-characterized reference methods for PTH measurement.
- Certified Reference Materials/Standards: Use of materials with known, accurately assigned concentrations of intact PTH.
- Expected Physiological Ranges: Correlation with expected PTH levels in healthy and diseased populations clinically, often in comparison to results from a predicate device.
- Recovery Experiments: Adding known amounts of intact PTH to samples and measuring how accurately the device recovers the added amount.
The specific methods used are not detailed in this summary.
8. The sample size for the training set
- Sample Size (Training Set): Not applicable in the context of this device as described. This is an immunoassay, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The "training" for such a device involves calibration with known standards, rather than training a model on a large dataset. While developmental and optimization work would have involved many samples, they wouldn't be referred to as a "training set" in the AI/ML context.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable for the reasons stated above (not an AI/ML device requiring a training set with established ground truth in that context). Calibration is performed using manufacturer-provided calibrators with assigned values based on reference methods and standardization procedures.
§ 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.