(75 days)
The Nichols Advantage QuiCk-IntraOperative™ Bio-Intact PTH (1-84) is intended for use with the Nichols Advantage® Specialty System to measure parathyroid hormone in EDTA plasma and human serum. This procedure is recommended for rapid intraoperative measurement of Intact PTH 1-84 using EDTA plasma or human serum. The reagent cartridge is designed for single use only.
The Nichols Advantage QuiCk-IntraOperative Bio-Intact PTH (1-84) assay contains sufficient reagents for 26 tests. The assay is a two-site chemiluminometric assay specific for hPTH 1-84.
Here's a summary of the acceptance criteria and the study that proves the Nichols Advantage QuiCk-IntraOperative™ Bio-Intact PTH (1-84) device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" as a set of pass/fail thresholds. Instead, it presents performance characteristics of the new device and compares them to a predicate device to demonstrate substantial equivalence. The implication is that performance comparable to the predicate device is considered acceptable.
| Feature | Acceptance Criteria (Implied: Comparable to Predicate) | QuiCk-IntraOperative PTH Performance | Predicate Device (Bio-Intact PTH (1-84)) Performance |
|---|---|---|---|
| Method Comparison | Y = 1.00X - 1.1; r = 0.99 (Passing Bablok) | Y = 1.00X - 1.1 (95% CI: 0.97-1.03 slope, -2.9 to +0.8 intercept) | N/A (predicate itself) |
| Pearson's Correlation (r) | r = 0.99 (Implicitly acceptable) | 0.99 | N/A |
| Range of values measured | Comparable to predicate | 12.3 to 792 pg/mL | 10.8 to 773 pg/mL |
| Functional Sensitivity | Comparable to predicate | 12 pg/mL | 4 pg/mL |
| Analytical Sensitivity | Comparable to predicate | 5 pg/mL | 1.5 pg/mL |
| Within-Run Precision (%CV) | Comparable to predicate | 3.9-16.1% | 2.2-3.6% |
| Total Precision (%CV) | Comparable to predicate | 5.8-22.6% | 5.6-8.3% |
| Recovery | Comparable to predicate | 94-117% | 94-103% |
| Linearity | Comparable to predicate | 99-111% | 92-109% |
Note: While the new device's functional and analytical sensitivity, and precision, are numerically different from the predicate, the conclusion states that the data demonstrates "safety and effectiveness" and "substantial equivalence." This implies that these differences were deemed acceptable within the context of the intended use, likely because the performance characteristics are still clinically appropriate for rapid intraoperative measurement.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: One hundred thirty (130) remnant serum samples.
- Data Provenance: The clinical diagnosis for these samples was "unknown," indicating they were likely de-identified samples from a clinical laboratory or biobank. The country of origin is not specified but is presumed to be the USA, given the manufacturer's location and the FDA submission. The study appears to be retrospective as it used "remnant serum samples."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. The study primarily focuses on comparing the new device's measurements to those of the predicate device, which serves as the reference or "ground truth" for the comparison. There's no indication that external experts were used to establish ground truth for the 130 samples beyond what the predicate device provided.
4. Adjudication Method for the Test Set:
This information is not provided. The comparison involved running each sample "in duplicate by both methods." There's no mention of an adjudication process for discrepancies beyond duplicate measurements.
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 immunoassay (laboratory test), not an imaging or diagnostic device that typically involves human "readers." The study evaluates the analytical performance of the assay itself.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This device is an in vitro diagnostic immunoassay, which by nature is a standalone (algorithm only/device only) test. Its performance is measured independently of human interpretation in the sense of a radiologist reading an image. The study assesses the device's ability to accurately measure PTH concentrations.
7. The Type of Ground Truth Used:
The "ground truth" for the comparative study was established by the predicate device, Nichols Advantage Bio-Intact PTH (1-84) assay. The study aims to show substantial equivalence to this already-cleared device. The clinical diagnosis of the samples was unknown, so it was not directly based on pathology or patient outcomes for this specific comparative study.
8. The Sample Size for the Training Set:
This information is not provided. The document describes a comparison study for regulatory submission of an already developed device. It does not detail the development or training of the assay itself.
9. How the Ground Truth for the Training Set Was Established:
This information is not provided. As explained above, the document focuses on the validation for regulatory submission, not the initial development or "training" of the assay.
§ 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.