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The ADVIA Centaur® Intact Parathyroid Hormone (PTH) assay is for in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (PTH) in human serum and plasma using the ADVIA Centaur XP system. This assay is intended to be used to aid in the differential diagnosis of hyperparathyroidism, or disorders of calcium metabolism. This assay can be used intra-operatively.

The ADVIA Centaur® Intact Parathyroid Hormone (PTH) assay is a chemiluminescence sandwich immunoassay. It consists of a Lite Reagent containing acridinium ester-labeled mouse monoclonal anti-human PTH antibody and a Solid Phase Reagent containing biotinylated mouse monoclonal anti-human PTH antibody bound to streptavidin-coated paramagnetic particles. The assay also includes Low and High Calibrators which are reconstituted synthetic peptide in buffered saline with human EDTA plasma, surfactants, and preservatives.

Here's a breakdown of the acceptance criteria and study information for the ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally not explicitly stated as quantitative thresholds in this type of 510(k) summary for all tests (e.g., "must achieve X% recovery"). Instead, the document demonstrates that the device meets performance expectations through studies that align with recognized standards. Where explicit criteria or comparative results are given, they are listed below.

2. Sample Size Used for the Test Set and Data Provenance

• Precision: Six EDTA plasma samples and three levels of controls.
• Linearity: 11 serially diluted samples.
• Dilution Recovery: 3 spiked samples (low sample pool spiked to ~3,000, ~6,000, and ~9,000 pg/mL).
• Method Comparison: 349 EDTA plasma patient samples.
• Matrix Comparison: 56 matched specimens drawn in different tube types (serum red top, SST, EDTA, lithium heparin, and sodium heparin).
• Reference Intervals: 142 paired serum and EDTA plasma samples from apparently healthy donors.
• Detection Limit: Not explicitly stated beyond "CLSI protocol EP17-A2," which typically involves multiple replicates of blank and low-concentration samples.
• Interference: Two EDTA sample pools (at ~75 pg/mL and ~600 pg/mL PTH) for endogenous substances/drugs. Six human plasma samples for HAMA.
• Cross-Reactivity: One normal human EDTA plasma sample and blank assay diluent for each test compound.
• High-Dose Hook Effect: Patient samples as high as 100,000 pg/mL.
• Intra-Operative Clinical Study: Sets of specimens from 30 subjects.

Data Provenance (Country of origin / Retrospective or Prospective):
The document does not explicitly state the country of origin for the samples used in the performance or clinical studies. The method comparison and clinical study are likely prospective in nature (collecting new data for the device evaluation), given the testing against a predicate or a comparator device. The reference interval study is explicitly from "apparently healthy donors," implying a prospective collection or at least a specific selection criteria. The other studies typically involve controlled laboratory conditions or spiked samples rather than broad patient cohorts for provenance purposes.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

For this type of in vitro diagnostic (IVD) assay, "ground truth" is typically established by reference methods, established predicate devices, or pathology results, rather than by individual human experts evaluating diagnostic images or clinical cases.

• For the analytical performance studies (Precision, Linearity, etc.): Ground truth is established by the known concentrations of calibrators, controls, spiked samples, or by comparison to a legally marketed predicate device (ADVIA Centaur iPTH assay) which is itself a validated IVD. No specific number or qualification of experts is mentioned for establishing these analytical "ground truths."
• For the Clinical Study (Intra-operative use): The "ground truth" for surgical success was defined by the Miami Criterion (50% or greater drop in PTH level). The comparison was made against "the assays used by participating surgeons/sites (comparator devices)." This implies that the 'truth' was the outcome determined by the established clinical practice and the results of a clinically used (FDA-cleared) PTH assay at the sites. No external experts were used to establish this ground truth, but rather comparison to existing clinical standards.

4. Adjudication Method for the Test Set

Not applicable in the conventional sense of image or case adjudication. For the clinical study, the "Miami Criterion" served as the objective rule for determining surgical success, which was then compared between the investigational and comparator devices. There was no explicit adjudication process by multiple human readers for a single "ground truth" determination.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study, as typically understood for imaging devices involving multiple human readers, was not conducted. This is an IVD assay, not an imaging device. The clinical study focused on the agreement of the device's quantitative output with existing clinical practice based on a well-defined criterion (Miami Criterion), not on how human readers' diagnostic accuracy improves with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, this entire submission revolves around the standalone performance of the ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay. It's an automated in vitro diagnostic device, designed to produce quantitative results independently for clinical interpretation. The clinical study for intra-operative use also evaluated the device's ability to meet the Miami Criterion, comparing its raw output to that of other clinical devices, not its assistance to a human in a diagnostic workflow.

7. The Type of Ground Truth Used

• Analytical Studies (Precision, Linearity, Dilution Recovery, Detection Limit): Ground truth is based on known concentrations of standards and controls, or scientifically established principles of measurement procedure performance.
• Method Comparison & Matrix Comparison: Ground truth is the results obtained from a legally marketed predicate device (ADVIA Centaur Intact Parathyroid Hormone (iPTH) assay) or a comparison against a "gold standard" or accepted methodology.
• Reference Intervals: Ground truth is derived from results obtained from apparently healthy donors which define a normal range.
• Clinical Study (Intra-operative): Ground truth for surgical success was the Miami Criterion (a predefined clinical outcome threshold based on PTH levels), as determined by a separate, FDA-cleared clinical PTH test device used at the sites.

8. The Sample Size for the Training Set

This document does not specify a "training set" in the context of an AI/ML algorithm. This is a traditional IVD immunoassay. Therefore, there's no machine learning model that requires a distinct training dataset for its development that would be reported in this manner. The development and optimization of the assay reagents and parameters would be internal to the manufacturer's R&D process.

9. How the Ground Truth for the Training Set Was Established

As explained above, there is no "training set" or "ground truth for the training set" in the context of AI/ML for this device. The development of the assay's reagents and methodologies would be based on biochemical principles, antigen-antibody interactions, and optimization studies performed by the manufacturer, rather than by training a model on labeled data.

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