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510(k) Data Aggregation
(67 days)
AxSYM® Intact PTH is a Microparticle Enzyme Immunoassay (MEIA) for the in vitro quantitative determination of intact human parathyroid hormone (I PTH) in human serum or plasma on the AxSYM® system. The AxSYM® I PTH assay is intended for use as an aid in the differential diagnosis of hypercalcemia and hypocalcemia.
AxSYM® I PTH is based on the Microparticle Enzyme Immunoassay (MEIA) technology. The AxSYM® I PTH assay uses paired monoclonal and polyclonal antibodies, each reactive with epitopes in the N-terminal portion of intact human PTH (1-84). The polyclonal antibody is biotin labeled. I PTH in the sample serves to bridge the two antibodies.
The provided text does not contain a study that proves the acceptance criteria of the device. Instead, it details the substantial equivalence of the "AxSYM Intact PTH" device to a predicate device, the "DSL-8000 ACTIVE™ Intact PTH IRMA," through method correlation and comparison of various performance characteristics.
Therefore, the following points address the questions based on the information available regarding the substantial equivalence study, rather than a study specifically proving acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria in this context are not explicitly stated numerical targets for device performance, but rather the demonstration of "substantial equivalence" to a predicate device. This is primarily shown through method correlation and comparable performance characteristics.
| Feature | Acceptance Criteria (Implied by Predicate Performance / Substantial Equivalence Goal) | Reported AxSYM® I PTH Performance |
|---|---|---|
| Method Correlation | Very high correlation (r value close to 1) between AxSYM® I PTH and predicate device. | r = 0.97 (p < 0.0001) |
| Regression Slope | Slope close to 1.0 (95% CI covering 1.0) | 0.99 (95% CI: 0.95, 1.05) |
| Regression Intercept | Intercept not statistically significant | Intercept not statistically significant (p < 0.35) |
| Precision (Within Run) | Comparable to predicate device. | Level I: 5.9 % CV; Level II: 6.2 % CV; Level III: 6.5 % CV |
| Precision (Inter) | Comparable to predicate device. | Level I: 9.4 % CV; Level II: 8.1 % CV; Level III: 8.8 % CV |
| Linearity | Comparable to predicate device. | 93.8 ± 8.9 % |
| Recovery | Comparable to predicate device. | 95.3 ± 8.9 % |
| Analytical Sensitivity | Equal to or better than predicate device. | ≤ 2.0 pg/mL I PTH |
| Specificity | No detection of human PTH fragments 53-84, 44-68 and 39-84. | No detection of human PTH fragments 53-84, 44-68 and 39-84 |
| Interference | Acceptable interference levels across various substances. | Bilirubin (20 mg/dL): < 10 %; Triglycerides (1500 mg/dL): < 10 %; Total Protein (3 mg/dL): < 10 %; Hemoglobin (1000 mg/dL): < 10 %; Red Blood Cells (0.2 % v/v): < 10 % |
| Dynamic Range | 0 - 2000 pg/mL | 0 - 2000 pg/mL |
| Expected Values | 8 - 57.8 pg/mL or comparable to predicate. | 8 - 57.8 pg/mL |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 120 samples were used for the method correlation study.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). However, given that it's a comparison for regulatory submission, it is likely data collected specifically for this purpose. The samples were "serum and plasma samples."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not relevant or provided for a chemical assay. The "ground truth" for a quantitative diagnostic assay like this is typically established by measurements from a reference method or a predicate device, as seen here. There are no "experts" in the sense of human adjudicators for establishing ground truth values of PTH in samples.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this involves a comparison to a predicate device, not subjective interpretation requiring 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
Not applicable. This is a quantitative diagnostic immunoassay, not an AI-driven imaging or diagnostic system that involves human readers or AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Yes, the performance characteristics and method correlation described are for the "AxSYM® Intact PTH" device operating in a standalone capacity (i.e., algorithm/device only). The device provides quantitative results directly from the sample. It is stated that "The I PTH assay is not used as a stand-alone test. Clinical interpretation requires simultaneous measurement of serum calcium levels." This refers to clinical utility, not device performance. The device itself performs its measurement independently.
7. The Type of Ground Truth Used
The "ground truth" for the performance evaluation, in this context of a substantial equivalence claim, is the performance and measurements obtained from the predicate device, DSL-8000 ACTIVE™ Intact PTH IRMA. The study compared the AxSYM I PTH results to those of the predicate device.
8. The Sample Size for the Training Set
Not applicable. This is a chemical immunoassay, not an AI/machine learning device that typically requires a "training set" in the computational sense. The device's calibration and internal parameters are set through manufacturing processes and control procedures, not through training on a dataset of clinical cases.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of this device technology.
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