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The Access Intact PTH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and plasma using the Access Immunoassay Systems. It is indicated to aid in the differential diagnosis of hyperparathyroidism, hypoparathyroidism, or hypercalcemia of malignancy and can be used intraoperatively. Assay results should be used in conjunction with other clinical data to assist the clinician in making individual patient management decisions.

The Access Intact PTH Calibrators are intended to calibrate the Access Intact PTH assay for the quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and plasma using the Access Immunoassay Systems.

The Access Intact PTH reagents, calibrators, and the Access Immunoassay Analyzers (Access, Access 2, Synchron LXi 725, UniCel DxC600i, and UniCel Dxl 800) comprise the Access Immunoassay Systems for the determination of intact parathyroid hormone (PTH) levels in human serum and plasma.

Here's a breakdown of the acceptance criteria and study information for the Access Intact PTH and Intact PTH Calibrators on the Access® Immunoassay Systems, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria are "implied" as specific thresholds were not explicitly stated in the 510(k) summary (e.g., "CV must be < X%"). The reported performance implicitly met the FDA's requirements for substantial equivalence.

2. Sample size used for the test set and the data provenance

• Imprecision: Not explicitly stated, but concentrations ranged from 12 to 1400 pg/mL, suggesting multiple samples tested at different levels.
• Dilution Recovery (Linearity): "Multiple dilutions of EDTA plasma samples" were analyzed. Specific number not provided.
• Methods Comparison:
  • Routine vs. Commercial Immunoassay: 500 values
  • Routine vs. Intraoperative: 493 values
  • Intraoperative vs. Commercial Immunoassay: 393 values
• Analytical Specificity: Not explicitly stated, but tested for potential contaminants (bilirubin, hemoglobin, human serum albumin, and triglycerides).
• Clinical Reference Range: 289 matched human EDTA plasma and serum samples.
• Data Provenance: The document does not explicitly state the country of origin.
  • For the clinical reference range, samples were collected during three time periods in two geographic latitudes, suggesting prospective collection for that specific study. Other analytical studies do not specify prospective or retrospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is an in vitro diagnostic (IVD) device for quantitative measurement of a biomarker. The "ground truth" for the test set is established by the analytical method itself (e.g., reference method for comparison, known concentrations for dilution linearity, established analytical techniques for specificity and imprecision). No human experts are used to establish ground truth in the way they would for image interpretation or disease diagnosis. For the reference range study, specific criteria (normal serum calcium, creatinine, 25-hydroxyvitamin D) were used to select "apparently healthy" individuals, but the "ground truth" is the measured PTH level.

4. Adjudication method for the test set

Not applicable. As described above, this is an IVD device measuring a quantitative biomarker. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective interpretation, such as imaging.

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 an IVD assay. It does not involve human readers interpreting cases with or without AI assistance. The comparisons done were between the new device and predicate devices.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, the studies described are for the standalone performance of the Access Intact PTH assay on the Access Immunoassay Systems. The device produces a quantitative measurement of PTH levels. Human involvement is limited to operating the instrument and interpreting the numerical result in a clinical context, not in directly improving the "algorithm's" performance.

7. The type of ground truth used

• Imprecision & Dilution Recovery: The ground truth is the expected performance based on established analytical chemistry principles and the known characteristics of the samples (e.g., known concentrations, dilution factors).
• Methods Comparison: The ground truth is the measurement obtained from a commercially available, legally marketed immunoassay system (predicate device).
• Analytical Specificity: The ground truth is the known concentration of PTH in samples intentionally spiked with potential interferents.
• Clinical Reference Range: The "ground truth" is the distribution of PTH levels in a rigorously selected population of "apparently healthy" individuals, with exclusion criteria based on other clinical markers (serum calcium, creatinine, 25-hydroxyvitamin D).

8. The sample size for the training set

Not applicable in the context of typical AI/ML device development. This is an IVD device developed using traditional analytical chemistry and immunoassay principles, not a machine learning algorithm that requires a "training set" in the same way. The development and optimization of the assay would involve various experiments and reagent formulations, but these are not referred to as "training sets" in the ML sense.

9. How the ground truth for the training set was established

Not applicable for the reasons stated in point 8.

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