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Immunoassay for the in vitro quantitation of intact parathyroid hormone in human serum and plasma for the differential diagnosis of hypercalcemia and hypocalcemia. This assay can be used intraoperatively. The electrochemiluminescence immunoassay "ECLIA" is intended for use on cobas e immunoassay analyzers

Both the Elecsys PTH and Elecsys PTH STAT immunoassays make use of a sandwich test principle using a biotinylated monoclonal PTH-specific antibody labeled with a ruthenium complex. Both the Elecsys PTH and Elecsys PTH STAT immunoassays are intended for the in vitro quantitative determination of intact parathyroid hormone in human serum and plasma for the differential diagnosis of hypercalcemia and hypocalcemia. These assays can be used intraoperatively. They are intended for use on the cobas e immunoassay analyzers.

Results are determined via a calibration curve which is instrument-specifically generated by a two-point calibration and a master curve provided via the reagent barcode.

The reagent working solutions include: Rack Pack (kit placed on the analyzer)

• M Streptavidin coated microparticles (transparent cap), 1 bottle, 6.5 mL: Streptavidin . coated microparticles 0.72 mg/mL; preservative.
• . R1 Anti PTH Ab~biotin (gray cap), 1 bottle, 7 mL: Biotinylated monoclonal anti PTH antibody (mouse) 2.3 mg/L; phosphate buffer 100 mmol/L, pH 7.0; preservative.
• . R2 Anti PTH Ab~Ru(bpy) (black cap), 1 bottle, 7 mL: Monoclonal anti PTH antibody (mouse) labeled with ruthenium complex 2.0 mg/L; phosphate buffer 100 mmol/L, pH 7.0; preservative.

Unfortunately, the provided text does not describe a study involving an AI/Machine Learning powered medical device, nor does it contain information about typical acceptance criteria for such devices (e.g., sensitivity, specificity, AUC).

Instead, the document details a 510(k) premarket notification for Elecsys PTH and Elecsys PTH STAT, which are immunoassays for quantitative determination of intact parathyroid hormone. These are laboratory diagnostic tests, not AI-powered devices.

The document focuses on demonstrating substantial equivalence to a previously cleared predicate device (K070709) by:

• Comparing technological characteristics (Table 1 and Table 2).
• Providing non-clinical performance evaluations such as precision, analytical sensitivity (Limit of Blank, Limit of Detection, Limit of Quantitation), linearity, high dose hook effect, interference studies, and sample matrix comparison.
• Presenting a method comparison to the predicate devices.
• Reporting on stability and a reference range study.

Therefore, I cannot fulfill the request to describe the acceptance criteria and study that proves an AI device meets acceptance criteria based on this input. The information required for your questions (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone performance, training set details) are specific to AI/ML device evaluations and are not present in this document about an immunoassay.

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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 assay is a sandwich immunoenzymatic assay. The Access Intact PTH assay consists of the reagent pack and calibrators. Other items needed to run the assay include substrate and wash buffers. The Access intact PTH assay reagent pack, Access intact PTH assay calibrators, along with the Access wash buffer and substrate are designed for use on the Dxl 9000 Access Immunoassay Analyzers in a clinical laboratory setting.

The provided text describes the performance validation of the Beckman Coulter Access Intact PTH assay on the Dxl 9000 Access Immunoassay Analyzer. This is a biomedical measurement device, specifically an in vitro diagnostic (IVD) rather than an AI-powered system as might be initially implied by the format of the request. Therefore, some of the requested information regarding AI-specific criteria (like number of experts for ground truth, adjudication methods, MRMC studies, training set details) is not applicable to this type of device.

Here's an analysis of the acceptance criteria and study results, focusing on the relevant aspects for an IVD device:

Acceptance Criteria and Reported Device Performance

The study primarily focuses on demonstrating the performance characteristics of the Access Intact PTH assay run on the Dxl 9000 system, compared to its predicate device (Access Intact PTH on the Access 2 Immunoassay System). The "acceptance criteria" here are performance targets related to analytical precision, linearity, and detection/quantitation limits, based on standard laboratory guidelines (CLSI documents).

Table of Acceptance Criteria and Reported Device Performance:

Notes on Performance:

• For Imprecision, one sample in the "Intraoperative Mode" (Sample 1, 1.7 pg/mL) shows a %CV of 13.2%, which exceeds the general criteria of "≤ 8.0% CV at concentrations > 12 pg/mL (1.3 pmol/L)" and also "≤ 0.96 pg/mL (0.10 pmol/L) SD at concentrations ≤ 12 pg/mL (1.3 pmol/L)". However, given the actual concentration and the stated SD for this sample (0.23 pg/mL), it might be acceptable for very low concentrations where relative variability can be higher, or it might fall into a specific acceptance sub-criterion not fully detailed here. The SD of 0.23 pg/mL is still well below the 0.96 pg/mL SD target for concentrations ≤ 12 pg/mL.
• The correlation coefficients (R) of 1.00 and 0.99 for method comparison indicate excellent agreement with the predicate device. The slopes and intercepts also demonstrate good agreement, supporting the claim of substantial equivalence.

Study Details:

As this is a 510(k) submission for an in vitro diagnostic immunoassay system, the concept of AI-driven image analysis or clinical decision support is not applicable. Therefore, many of the questions related to AI-specific validation (e.g., number of experts, adjudication, MRMC studies, AI training sets) are not relevant to this document. The "ground truth" for an IVD refers to the true concentration of an analyte as measured by a reference method or established through rigorous characterization of control materials.

1. Sample sizes used for the test set and data provenance:

   • Imprecision Study:
     • Routine Mode: 86 replicates for most samples (one sample with 84 replicates).
     • Intraoperative Mode: 88 replicates for all samples.
     • Data Provenance: Not explicitly stated, but typically these studies are conducted in a controlled laboratory setting (prospective data collection from prepared samples/controls). No country of origin for the data is specified, but given the manufacturer (Beckman Coulter, Inc., Chaska, MN, USA), it's highly likely to be US-based or from their global R&D facilities.
   • Method Comparison Study:
     • Routine Mode: N=144 patient samples.
     • Intraoperative Mode: N=116 patient samples.
     • Data Provenance: Not explicitly stated regarding country of origin or retrospective/prospective. These are typically patient plasma/serum samples collected prospectively for the study or from biobanks.

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

   • Not Applicable. This is an immunoassay device for quantitative determination of a hormone. The "ground truth" for these tests is based on the chemical measurement itself, validated against reference materials or established methods, not subjective expert interpretation of images or clinical data.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not Applicable. See point 2.

4. 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 automated immunoassay system, not an AI-assisted diagnostic tool requiring human reader interpretation studies.

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

   • This entire validation represents the "standalone" performance of the analytical instrument and assay kit. The Dxl 9000 Access Immunoassay Analyzer functions largely as an automated "algorithm" in that it processes samples and produces quantitative results without direct human interpretive input during the measurement process. Human oversight and quality control are part of its real-world use.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for this immunoassay is likely established through:
     • Reference Materials/Calibrators: These are materials with precisely known concentrations of intact PTH, used to calibrate the instrument and verify accuracy.
     • Predicate Device Comparison: The "Method Comparison" study uses the results from the legally marketed predicate device (Access Intact PTH on the Access 2 Immunoassay System) as the comparative reference, implicitly relying on the established accuracy of that predicate.
     • Analytical Standards: Performance metrics (LoB, LoD, LoQ, linearity) are assessed against internationally recognized analytical standards, such as those from CLSI (Clinical and Laboratory Standards Institute), which define the statistical and experimental methods for confirming these basic analytical performance parameters.

7. The sample size for the training set:

   • Not Applicable. This is an immunoassay device, not an AI/machine learning model that requires a "training set" in the conventional sense. The "training" of the device involves calibration using specified calibrator materials and internal quality control procedures.

8. How the ground truth for the training set was established:

   • Not Applicable. See point 7.

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VITROS Immunodiagnostic Products Intact PTH II Reagent Pack quantitatively measures intact parathyroid hormone (iPTH) in human serum and plasma (K2-EDTA, lithium heparin) using the automated VITROS 3600 Immunodiagnostic System.

Intact PTH is indicated to aid in the diagnosis of hyperparathyroidism, differential diagnosis of hypocalcemia or hypercalcemia and for intraoperative measurement of iPTH levels.

The VITROS Immunodiagnostic Products Intact PTH II assay is performed using the VITROS Intact PTH II Reagent Pack and the VITROS Intact PTH II Calibrators on the VITROS 3600 Immunodiagnostic System.

VITROS Intact PTH II Reagent Pack contains:

1 reagent pack containing:

• 100 coated wells (biotinylated anti-PTH antibody, 2ug/ml). ●
• 7.4 mL assay reagent as buffer with bovine gamma globulin, bovine serum albumin, and antimicrobial agent.
• 7.4 mL conjugate reagent (HRP-mouse monoclonal anti-PTH, 6 ug/mL) in buffer with bovine serum albumin and antimicrobial agent).

The provided text is a 510(k) premarket notification for Ortho-Clinical Diagnostics' VITROS Immunodiagnostic Products Intact PTH II Reagent Pack, a device for quantitatively measuring intact parathyroid hormone (iPTH). While it details various performance characteristics, it does not describe an AI/ML-based device and therefore does not contain information on acceptance criteria for such a device, nor an AI/ML specific study.

The document focuses on the analytical and clinical performance of an in vitro diagnostic (IVD) assay, comparing it to a predicate device (Roche Elecsys PTH assay). The studies described are typical for IVD assays: precision, linearity, detection limits, analytical specificity (interference and cross-reactivity), and method comparison against a commercially available PTH assay and a clinical study for intra-operative use.

Therefore, I cannot extract the requested information regarding AI/ML device acceptance criteria and study details from the provided text. The questions below are specifically tailored for AI/ML device evaluations.

However, I can provide the available information relevant to the IVD device's performance studies:

Based on the provided document, here is the information available for the VITROS Immunodiagnostic Products Intact PTH II Reagent Pack, noting that it is an IVD assay, not an AI/ML device:

1. A table of acceptance criteria and the reported device performance

The document does not formally present a table of "acceptance criteria" against which performance is measured in the same way an AI/ML device would demonstrate specified accuracy metrics. Instead, it presents various performance characteristics and states that results "met the acceptance criteria" for certain comparisons without detailing those criteria explicitly in a table.

However, key performance parameters and their reported values are listed below:

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

• Precision/Reproducibility: Patient pools tested with 80 observations (measurements) over 20 days for each concentration level. Data provenance not specified (country of origin, retrospective/prospective implied as prospective measurement in lab).
• Method Comparison: 206 patient (serum) samples. Data provenance not specified.
• Intra-operative Clinical Study: 32 subjects (sets of specimens) qualified for primary endpoints. Data provenance not specified (likely prospective for the study measurements, but subjects were undergoing surgery, so possibly a mix of retrospective patient selection and prospective sample collection).

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

• This device is an IVD assay, not an imaging/AI device requiring expert interpretation for ground truth. Ground truth for an IVD is established by standardized reference methods or the performance of a predicate device/comparator assay.
• For the intra-operative clinical study, the "success" criterion for surgery (50% or greater drop in PTH level) is based on the result from the comparator assay (hospital's assay) and the investigational device, rather than expert judgment on the device's output.

4. Adjudication method for the test set

• Not applicable as this is an IVD assay measuring a biomarker concentration, not an AI/ML device relying on human interpretation or adjudication of output.

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 as this is an IVD assay, not an AI/ML imaging device.

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

• The device is a standalone IVD assay. Its performance (precision, linearity, detection limits, analytical specificity, method comparison) is evaluated directly, without human interpretation of its output in the sense of an AI/ML diagnosis. The intra-operative study compares its quantitative results to another quantitative assay.

7. The type of ground truth used

• Analytical Performance (Precision, Linearity, Detection Limits): Established through laboratory testing using controlled samples (e.g., patient pools, dilutions, blanks) according to CLSI (Clinical and Laboratory Standards Institute) protocols (EP05, EP06, EP17). The "ground truth" here is the expected value of the controlled sample or the known characteristics of the samples used.
• Analytical Specificity (Interference, Cross-Reactivity): Known concentrations of interferents or cross-reactants added to samples with known PTH concentrations. Ground truth is the unbiased PTH value.
• Method Comparison: Comparison against a "commercially available PTH assay" (presumably the predicate device, although it's not explicitly named as such in this section, it's implied by "comparative method") as the reference.
• Intra-operative Clinical Study: The "success" criterion (50% or greater drop in PTH) was determined by comparing the device's results to the results from the hospital's (comparator) assay for the same patient samples. The "ground truth" for surgical success was defined by this 50% drop as measured by the comparator, and the study assessed concordance.

8. The sample size for the training set

• Not applicable. This is an IVD assay, not an AI/ML algorithm that requires a "training set." The system is a reagent pack and instrument system, not a learned model.

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

• Not applicable (no training set for an IVD assay).

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For in vitro diagnostic use.
Lumipulse G whole PTH is a Chemiluminescent Enzyme Immunoassay (CLEIA) for the quantitative measurement of PTH (1-84) in human serum and plasma on the LUMIPULSE G System. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia and hypocalcemia resulting from disorders of calcium metabolism.

The Lumipulse G whole PTH Immunoreaction Cartridges consists of 3 × 14 tests. Each kit contains the following:

1. Antibody-Coated Particle Solution (Liquid when used, 200 µL/Immunoreaction Cartridge) Contains 200 µg/mL anti-PTH polyclonal antibodies (goated ferrite particles, protein stabilizers (bovine and goat) and chemical stabilizers in MES buffer. This solution contains gelatin and turns into gel at 15 °C or lower. Preservative: ProClin 300
2. Enzyme-Labeled Antibody Solution (Liquid, 120 µL/Immunoreaction Cartridge) Contains 0.2 µq/mL alkaline phosphatase (ALP: calf)-labeled anti-PTH polyclonal antibody (qoat), protein stabilizers (bovine) and chemical stabilizers in MES buffer. Preservative: ProClin 300

Here's a breakdown of the acceptance criteria and the study details for the Lumipulse G whole PTH device, based on the provided FDA 510(k) summary:

Device: Lumipulse G whole PTH (Fujirebio Diagnostics, Inc.)
Intended Use: Quantitative measurement of PTH (1-84) in human serum and plasma on the LUMIPULSE G System for differential diagnosis of hypercalcemia and hypocalcemia.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes various analytical performance characteristics. For each characteristic, the reported performance is presented. Acceptance criteria are generally implied by the positive outcomes of the studies and their adherence to CLSI guidelines. For example, for precision, a certain percentage of Coefficient of Variation (%CV) is considered acceptable.

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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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The IDS-iSYS Intact PTH+ assay is an in vitro diagnostic device intended for the quantitative determination of intact PTH in human serum or plasma on the IDS-iSYS Multi-Discipline Automated System. Results are to be used in the differential diagnosis of hypercalcemia and hypocalcemia resulting from disorders of calcium metabolism.

The IDS-iSYS Intact PTH" assay is based on chemiluminescence technology. 100 uL of patient sample is incubated with a biotinylated polyclonal anti-PTH (39-84) antibody and an acridinium labelled PTH (13-34) antibody. Streptavidin labelled magnetic particles are added prior to a second incubation step. The magnetic particles are captured using a magnet and a wash step performed to remove any unbound analyte. Trigger reagents are added; the resulting light emitted by the acridinium label is directly proportional to the concentration of Intact PTH in the original sample.

IDS-iSYS Intact PTH reagent kit consists of one (1) Immunoassay Cartridge, two (2) vials each of 2 concentration Calibrator levels and a mini-CD containing the Instructions For Use (IFU), CRY files and Certificate of Analysis.

IDS-iSYS Intact PTHN Cartridge, sufficient for 100 tests, consists of reagents provided in individual compartment within a plastic container called the Cartridge. The IDS-iSYS Intact PTHN Cartridge contains the following ready to use reagents:

• · Magnetic particles coated with streptavidin in a phosphate buffer containing sodium azide as preservative (1% (w/w%).
• · Calibrator B: Two vials of lyophilized porcine serum matrix buffer containing high level PTH and sodium azide as preservative >1% (w/w%).

The submission is due to a new source of antibody for the assay.

This document describes the performance characteristics of the IDS-iSYS Intact PTHN assay, an in vitro diagnostic device for quantitative determination of intact PTH.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as distinct numerical targets but are implicitly defined by the reported performance and the comparison to the predicate device. The information below summarizes the performance characteristics provided, which in a regulatory context, demonstrate the device meets its intended use and is substantially equivalent to the predicate.

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The DiaSorin LIAISON® 1-84 PTH assay is an in vitro chemiluminescent immunoassay (CLIA) intended for the quantitative determination of parathyroid hormone (1-84) in human serum and EDTA plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia resulting from disorders of calcium metabolism.

The test has to be performed on the LIAISON® Analyzer.

The DiaSorin LIAISON® 1-84 PTH Control Set is intended for in vitro diagnostic use as assayed quality control samples to monitor the accuracy and precision of the LIAISON® 1-84 PTH Assay.

The DiaSorin LIAISON® 1-84 PTH Calibration Verifiers are assayed quality control materials intended for in vitro diagnostic use in the quantitative verification of calibration and reportable range of the LIAISON® 1-84 PTH Assay.

The LIAISON® 1-84 PTH Assay is a modified two-step, two-site sandwich assay that uses two polyclonal antibodies for capture and detection of the 1-84 PTH molecule. Results are determined by a 2 point calibration conversion of the master curve to a working curve. The light signal is measured by a photomultiplier as relative light units (RLU) and is proportional to the concentration of 1-84 PTH present in the calibrators, controls or samples.

LIAISON® 1-84 PTH Control set contains;

• 2 levels controls containing human plasma spiked with 1-84 PTH, and preservatives: 4 vials each level; lyophilized
  The target concentration for control level 1 is 30 pg/mL. The target concentration for control Level 2 is 260 pg/mL.
  The range of concentrations of each control is reported on the certificate of analysis provided with each LIAISON® 1-84 PTH Control set.

LIAISON® 1-84 PTH Calibration Verifier set contains:

• 4 levels containing human plasma spiked with 1-84 PTH, with preservative, 1 vial each level, lyophilized.
  The target concentration for cal verifier A is 10 pg/mL. The target concentration for cal verifier B is 80 pg/mL. The target concentration for cal verifier C is 400 pg/mL. The target concentration for cal verifier D is 1450 pg/mL.
  The range of concentrations of each calibration verifier is reported on the certificate of analysis provided with each LIAISON® 1-84 PTH Calibration Verifier set.

This document describes the performance of the DiaSorin LIAISON® 1-84 PTH Assay, LIAISON® 1-84 PTH Control Set, and LIAISON® 1-84 PTH Calibration Verifiers, concluding they are substantially equivalent to their predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in the provided text as numerical targets for each performance characteristic. Instead, the study demonstrates performance by comparing the LIAISON® 1-84 PTH Assay with its predicate device and established CLSI guidelines. The performance characteristics for the LIAISON® 1-84 PTH Assay are summarized below:

• Passing & Bablok Regression (R): 0.9812 (indicates strong correlation).
• Slope: 0.9810 (95% CI: 0.9497 to 1.0204) (close to 1).
• Intercept: -2.23 pg/mL (95% CI: -5.29 to -0.61) (close to 0). |
  | Sample Matrix Comparison | - n: 188 matched patient sets of EDTA plasma and serum samples.
• Passing & Bablok Regression (R²): 0.9981 (between serum and EDTA plasma).
• Slope: 1.0481 (95% CI: 1.03 – 1.08).
• Intercept: 0.14 pg/mL (95% CI: -0.48 – 0.69). Comparisons indicate good agreement between sample types. |
  | Reference Range | - EDTA Plasma: 5.72 - 45.4 pg/mL (Median: 25.0 pg/mL, N=125).
• Serum: 5.68 - 47.8 pg/mL (Median: 25.2 pg/mL, N=124).
• Established from healthy adults (21-70 years) from mixed ethnic backgrounds in the U.S. with normal relevant health markers. |
  | Precision | - Kit Control 1 (Mean 30.2 pg/mL): Total %CV 5.0% (N=160 replicates).
• Kit Control 2 (Mean 305.6 pg/mL): Total %CV 4.6% (N=160 replicates).
• EDTA PTH-S1 (Mean 11.8 pg/mL): Total %CV 10.4% (N=160 replicates).
• EDTA PTH-S7 (Mean 1743.9 pg/mL): Total %CV 5.8% (N=160 replicates).
• Calibration Verifier A (Mean 13.0 pg/mL): TOTAL (Within-lot) %CV 8.2% (N=80 replicate results).
• Calibration Verifier D (Mean 1487 pg/mL): TOTAL (Within-lot) %CV 5.7% (N=80 replicate results). |
  | Linearity | - Serum: Observed 1-84 PTH = 0.9992x + 0.0835; R² = 0.9976.
• EDTA plasma: Observed 1-84 PTH = 0.9679x - 3.328; R² = 0.9971. (Very high R² values indicate strong linearity across the tested range). If an AI component is involved, please describe what the AI is (e.g. classification, segmentation) and what it is trying to predict |
  | High Dose Hook Effect | No high dose hook effect observed for 1-84 PTH concentrations measured up to 60,000 pg/mL. |
  | Recovery | Mean Recovery across various spiked EDTA plasma samples was 95%. |
  | Analytical Specificity | - Very low % Cross Reactivity for all tested PTH fragments (e.g., 7-84 PTH: 0.00105%, 1-34 PTH: 0.00005%) and structurally similar proteins. |
  | Interference | No significant interference (≥ ±10%) observed for a wide range of endogenous substances (e.g., Hemoglobin up to 500 mg/dL, Bilirubin up to 40 mg/dL, Triglycerides up to 3,000 mg/dL) and exogenous substances (e.g., Acetaminophen up to 20 mg/dL, Vitamin D2/D3 up to 240 ng/mL, Biotin up to 1 ug/mL) at two PTH levels (40 and 70 pg/mL). |
  | Limit of Blank (LOB) | ≤ 0.5 pg/mL |
  | Limit of Detection (LOD) | 1.0 pg/mL |
  | Limit of Quantitation (LOQ) | 4.0 pg/mL |
  | Stability | Reagent Integral: 28 days (open vial on system/at 2-8°C). Calibrators/Controls: 8 weeks (open vial reconstituted and frozen at -20°C). Calibration curve: 7 days. Calibration Verifiers: 2 weeks (open vial reconstituted and frozen at -20°C). |
  | Measuring Range | 4 - 1800 pg/mL |
  | Traceability | Calibrators, Controls, and Calibration Verifiers referenced to an in-house standard preparation containing synthetic human PTH (1-84). |

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

• Method Comparison: 193 patient samples. The provenance is implied to be from patient samples used for laboratory testing, but specific country of origin or whether they were retrospective/prospective is not stated.
• Sample Matrix Comparison: 188 matched patient sets of EDTA plasma and serum samples. Data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin.
• Reference Range: 125 EDTA plasma samples (91 females, 34 males) and 124 serum samples (90 females, 34 males) collected from "apparently healthy adults; 21 - 70 years of age, from mixed ethnic backgrounds (32.0% dark-skinned, 67.2% lightskinned and 0.8% unknown) with normal 25 OH Vitamin D, TSH, Total Calcium, Phosphorus, Magnesium, Creatinine and Alkaline Phosphatase levels from the northern and southern regions of the U.S." This indicates the data is from the United States and is prospective in nature, as samples were collected from healthy individuals to establish ranges.
• Precision:
  • Coded panel (7 frozen EDTA plasma samples): 160 replicate results per sample (2 replicates per run, 2 runs per day for 20 operating days).
  • Kit Controls (2 levels): 160 replicate results per control (2 replicates per run, 2 runs per day for 20 operating days).
  • Calibration Verifiers (4 levels): 80 replicate results per calibration verifier (2 replicates per run, 2 runs per day for 20 operating days).
  • Data provenance not specified beyond "prepared by DiaSorin Inc."
• Linearity: Not explicitly stated, but "one sample pool of each type: serum and EDTA plasma were diluted and analyzed."
• High Dose Hook Effect: Three serum and three EDTA plasma samples were used, spiked with 1-84 PTH. Measured in triplicate.
• Recovery Study: Five high concentration EDTA plasma samples and five low concentration EDTA plasma samples were analyzed.
• Analytical Specificity Cross-Reactivity Studies: Not specified, but involved spiking LIAISON® 1-84 PTH Specimen Diluent with various substances.
• Interference Studies: Not specified, but involved spiking EDTA plasma at two PTH levels (40 and 70 pg/mL) with various substances.
• Limit of Blank, Limit of Detection, Limit of Quantitation: Not specified, but determined using CLSI EP17-A2.

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

For in vitro diagnostic (IVD) assays, the "ground truth" for patient samples is typically established by the reference method (either a validated predicate device or a clinical reference standard) and the inherent biological characteristics of the samples. This is not a study involving human readers or interpretation of images. Therefore:

• Number of Experts: Not applicable in the context of interpretation, as the device measures a quantitative analyte. The analytical performance is compared against a predicate device and established clinical guidelines.
• Qualifications of Experts: Not applicable in the context of interpretation. However, the studies were conducted according to CLSI guidelines, implying professionals with expertise in clinical laboratory testing and assay validation.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring adjudication of interpretations (e.g., 2+1, 3+1). The performance is based on quantitative measurements.

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 document describes an in vitro diagnostic assay, not a medical imaging or AI-assisted diagnostic device that involves human readers.

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

Yes, the studies presented are for the standalone performance of the LIAISON® 1-84 PTH Assay on the LIAISON® Analyzer. This is a fully automated immunoassay system; there is no "human-in-the-loop" once the samples are loaded and the assay is initiated. The reported performance characteristics (e.g., precision, linearity, accuracy against predicate) represent the algorithm's performance.

7. The Type of Ground Truth Used

The ground truth for the performance studies was established through:

• Reference Method Comparison: Comparison against the Scantibodies Laboratory, Inc. Whole PTH™ (1-84) Specific immunoradiometric (IRMA) assay (predicate device) for patient sample results.
• Spiked Samples: For linearity, high-dose hook effect, recovery, analytical specificity, and interference studies, known concentrations of PTH or interfering substances were added to samples, with the expectation that the assay would accurately measure these known concentrations.
• Healthy Donor Population: For reference range establishment, samples from apparently healthy individuals with normal levels of related biomarkers formed the basis for defined reference intervals.
• Internal Standards: The calibrators, controls, and calibration verifiers are traceable to "an in-house standard preparation containing synthetic human PTH (1-84)," serving as an internal ground truth for the assay's measurements.

8. The Sample Size for the Training Set

This document describes the validation of an IVD assay, not an AI/ML device that requires a distinct "training set" in the machine learning sense. The assay works based on established biochemical principles and does not learn from data in the same way an AI algorithm does. Therefore, a "training set" in that context is not applicable.

However, if one were to consider the data used to develop and optimize the assay parameters (prior to the validation studies reported here), that would be considered the equivalent of a "training set." The document does not specify the sample size for this developmental phase.

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

As noted in point 8, the concept of a "training set" for this type of IVD, where performance is based on chemical-immunological reactions rather than machine learning, is not directly applicable. The "ground truth" during the development and optimization of such an assay would typically be established through:

• Reference materials: Highly characterized synthetic PTH or purified natural PTH standards with known concentrations.
• Validated methods: Existing, well-established reference methods for PTH measurement.
• Clinical samples: Use of patient samples with confirmed clinical states (e.g., hyperparathyroidism, hypoparathyroidism) to ensure the assay's output correlates with physiological conditions.
• Protocols following good laboratory practices and quality system regulations to ensure the accuracy and reliability of these references.

The document implicitly refers to these by stating the LIAISON® 1-84 PTH Calibrators, Controls, and Calibration Verifiers are "referenced to an in-house standard preparation containing synthetic human PTH (1-84)." This "in-house standard" would be the foundational "ground truth" for the assay's quantitative measurements.

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The ADVIA® Centaur Intact Parathyroid (iPTH) assay is for in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH) in EDTA plasma or serum using the ADVIA Centaur and ADVIA Centaur XP systems. This assay is intended to be used to aid in the differential diagnosis of hyperparathyroidism and hypoparathyroidism.

The ADVIA Centaur iPTH assay is a two-site sandwich immunoassay using direct chemiluminometric technology, which uses constant amounts of an antihuman PTH antibody in the Lite Reagent and an antihuman PTH antibody in the Solid Phase Reagent. The first antibody is a polyclonal goat antihuman PTH (N-terminal 1-34) antibody labeled with acridinium ester. The second antibody is a biotinylated polyclonal goat antihuman PTH (39-84 region) antibody that is preformed to streptavidin coated paramagnetic latex particles in the Solid Phase reagent.

The provided text describes the ADVIA® Centaur Intact Parathyroid Hormone (iPTH) Assay, a device intended for the quantitative determination of iPTH in EDTA plasma or serum to aid in the differential diagnosis of hyperparathyroidism and hypoparathyroidism. The document focuses on demonstrating the substantial equivalence of a modified version of this assay to its predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list "acceptance criteria" in a separate table for each performance characteristic with pass/fail outcomes. Instead, it describes various performance studies and presents their results, implying that these results met internal criteria for demonstrating substantial equivalence. Based on the described tests, here's a reconstructed table of implicit acceptance criteria and the reported performance:

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

• Precision: 7 samples (4 EDTA plasma pools, 3 commercial control materials). No specific provenance (country of origin) mentioned, but likely clinical samples and commercial controls from within Siemens' testing facilities or sourced according to industry standards.
• Detection Limits (LoB, LoD, LoQ): A single blank (Multi-Diluent 11) and 5 test samples (spiked/diluted plasma samples). Each sample tested n=6 x 2 instruments x 5 days (total n=60 per reagent lot for 2 reagent lots). Provenance not specified.
• Linearity / Assay Range: 12 test concentrations (pools). Provenance not specified.
• High Dose Hook Effect: One hook sample. Provenance not specified.
• Interfering Substances: Two patient plasma pools. Provenance not specified.
• Cross-reacting Substances: A plasma sample with endogenous iPTH and an assay-specific diluent. Provenance not specified.
• Method Comparison: 106 unaltered native matched serum and plasma samples. No specific provenance (country of origin) or retrospective/prospective status explicitly stated. Clinical samples are typically retrospective or prospectively collected for validation studies.
• Expected Values (Reference Range Verification): 40 plasma and 40 serum samples. Obtained from "apparently healthy individuals" (implying human clinical samples). Provenance not specified.

All studies appear to be retrospective in nature, as they involve testing existing samples or prepared samples under controlled conditions to evaluate device performance characteristics.

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

For this type of in vitro diagnostic device (immunoassay), ground truth is not typically established by human expert review in the same way it would be for imaging diagnostics.

• Ground truth for quantitative assays like this one is generally established through:
  • Reference Methods: Highly accurate and precise laboratory methods (e.g., mass spectrometry). While not explicitly stated for all measurements, this is the gold standard for establishing true analyte concentrations.
  • Predicate Device: For method comparison, the predicate device's results serve as the comparison "truth" against which the modified device is evaluated.
  • Defined Concentrations: For studies like linearity, precision, and detection limits, samples are often prepared with known, spiked, or characterized concentrations.

There is no mention of human "experts" establishing ground truth for individual test samples. The "experts" involved are implied to be the laboratory personnel, scientists, and statisticians who designed and conducted the studies, and who interpret the results against established statistical and clinical criteria (e.g., CLSI guidelines).

4. Adjudication Method for the Test Set

Not applicable for this type of quantitative diagnostic assay. Adjudication methods like 2+1 or 3+1 are typically used in imaging studies where multiple human readers assess findings and resolve discrepancies. Here, the "truth" for evaluation is based on quantitative measurements.

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 laboratory immunoassay, not an AI-assisted diagnostic imaging device that involves human readers.

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

Yes, this is a standalone device. The performance characteristics (precision, linearity, detection limits, interference, cross-reactivity, method comparison) are all evaluations of the assay itself, demonstrating its analytical performance without any human intervention beyond standard laboratory procedures for running the test. It's a fully automated system for quantitative determination.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth used in these studies is primarily based on:

• Reference standards/known concentrations: For linearity, precision, and detection limit studies, samples are often prepared with known concentrations or characterized against highly accurate reference methods.
• Values from the predicate device: For method comparison, the results obtained from the predicate device serve as the comparative "ground truth."
• Clinical status for reference ranges: Normal healthy individuals are used to verify the expected reference range.

8. The Sample Size for the Training Set

Not applicable in the traditional sense of machine learning. This device is an immunoassay, not a machine learning algorithm that requires a "training set" to learn a model. Its performance is based on the chemical and immunological reactions of the assay components.

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

Not applicable for the reasons stated above (not an ML-based device requiring a training set). The assay's performance is driven by its reagent formulation and instrument design, which are developed and validated through iterative testing and process control during manufacturing.

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The LIAISON® N-TACT® PTH Gen II is an in vitro chemiluminescent immunoassay (CLIA) intended for the quantitative determination of intact human parathyroid hormone in serum, EDTA and Lithium Heparin plasma samples. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia and hypocalcemia resulting from disorders of calcium metabolism. The test is to be performed on the LIAISON® XL Analyzer.

The LIAISON® N-TACT® PTH Gen II Control Set is intended for use as assayed quality control samples to monitor the accuracy and precision of the DiaSorin LIAISON® N-TACT® PTH Gen II assay.

The LIAISON® N-TACT® PTH Gen II Calibration Verifiers are assayed quality control materials intended for the quantitative verification of calibration and reportable range of the LIAISON® N-TACT® PTH Gen II assay.

The LIAISON® N-TACT® PTH Gen II assay is a modified two-step, two-site sandwich assay that uses two goat polyclonal antibodies for capture and detection of intact PTH. Results are determined by a 2 point calibration conversion of the master curve to a working curve. The light signal is measured by a photomultiplier as relative light units (RLU) and is proportional to the concentration of intact PTH present in the calibrators, controls or samples.

LIAISON® N-TACT® PTH Gen II Control set contains:
2 levels controls containing 80% human plasma spiked with 1-84 PTH, and preservatives; 4 vials each level; lyophilized
The target concentration for control level 1 is 20 pg/mL. The target concentration for control Level 2 is 300 pg/mL.
The range of concentrations of each control is reported on the certificate of analysis provided with each LIAISON® N-TACT® PTH Gen II Control set.

LIAISON® N-TACT® PTH Gen II Calibration Verifier set contains:
4 levels containing 80% human plasma spiked with 1-84 PTH, with preservative, . 1 vial each level, lyophilized
The target concentration for cal verifier A is 10 pg/mL. The target concentration for cal verifier B is 150 pg/mL. The target concentration for cal verifier C is 650 pg/mL. The target concentration for cal verifier D is 1600 pg/mL.
The range of concentrations of each calibration verifier is reported on the certificate of analysis provided with each LIAISON® N-TACT® PTH Gen II Calibration Verifier set.

Here's an analysis of the acceptance criteria and study details for the LIAISON® N-TACT® PTH Gen II device based on the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

The 510(k) summary for the LIAISON® N-TACT® PTH Gen II primarily demonstrates substantial equivalence to a predicate device. As such, the "acceptance criteria" are generally implied by the performance of the predicate device and the demonstration that the new device performs comparably or better, meeting established clinical laboratory guidelines. Specific numeric acceptance criteria are not explicitly stated in a "PASS/FAIL" format for each performance characteristic, but rather the study results are presented to show satisfactory performance.

Here's a table summarizing the performance characteristics and their reported results, which implicitly serve as the demonstration of meeting acceptance:

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The ADVIA® Centaur Intact Parathyroid (iPTH) assay is for in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH) in EDTA plasma or serum using the ADVIA Centaur XP system. This assay is intended to be used to aid in the differential diagnosis of hyperparathyroidism and hypoparathyroidism.

The ADVIA Centaur iPTH assay is a two-site sandwich immunoassay using direct chemiluminometric technology, which uses constant amounts of an antihuman PTH antibody in the Lite Reagent and an antihuman PTH antibody in the Solid Phase Reagent. The first antibody is a polyclonal goat antihuman PTH (N-terminal 1-34) antibody labeled with acridinium ester. The second antibody is a biotinylated polyclonal goat antihuman PTH (39-84 region) antibody that is preformed to streptavidin coated paramagnetic latex particles in the Solid Phase reagent.

The ADVIA Centaur iPTH reagent kit contains the following:
. ReadyPack® primary reagent pack containing ADVIA Centaur Lite and Solid Phase Reagent)
ADVIA Centaur iPTH Master Curve card .

Materials Required but Not Provided
iPTH Calibrator .
Optional Reagents
ADVIA Centaur Multi-Diluent 11 .
iPTH 1, 2, 3 quality control material .
iPTH Master Curve Material .

The Siemens ADVIA® Centaur Intact Parathyroid (iPTH) Assay is a quantitative in vitro diagnostic device used to measure intact parathyroid hormone (iPTH) in EDTA plasma or serum to aid in the differential diagnosis of hyperparathyroidism and hypoparathyroidism. The device's performance was evaluated through studies on precision, interfering substances, cross-reactivity, and method comparison, demonstrating substantial equivalence to the predicate device, the Abbott Architect Intact PTH assay.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria were implicitly established by demonstrating comparability to the predicate device and meeting common analytical performance standards for in vitro diagnostic assays. The specific acceptance thresholds for each performance characteristic (e.g., %CV for precision, % bias for interference) are not explicitly stated as numbered criteria but are inferred from the reported results and the conclusion of substantial equivalence.

*   **Data Provenance:** Not explicitly stated, but typically involves collecting samples from a healthy population, likely prospective.

3. Number of Experts and Qualifications

This submission pertains to an in vitro diagnostic assay, which relies on quantitative measurements rather than expert interpretation of images or clinical findings. Therefore, the concept of "experts" to establish ground truth in the context of diagnostic imaging or clinical assessment is not applicable here. The ground truth is based on the chemical and immunological properties of the assay and comparison to a legally marketed predicate device.

4. Adjudication Method

Not applicable for an in vitro diagnostic assay like this. Adjudication methods are typically used in studies involving human interpretation or subjective assessments (e.g., by multiple readers).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is an in vitro diagnostic assay, not a device requiring human reader interpretation or assistance.

6. Standalone Performance

Yes, the studies described are for the standalone performance of the ADVIA Centaur iPTH assay (algorithm only, without human-in-the-loop performance in the sense of interpretative assistance). The performance metrics (precision, interference, cross-reactivity, method comparison) directly evaluate the assay's ability to accurately and reliably measure iPTH concentrations.

7. Type of Ground Truth Used

The ground truth for this device is established primarily by:

• Quantitative Chemical Measurement: The assay directly measures the concentration of intact parathyroid hormone using a chemiluminescent immunoassay. The "truth" is the actual concentration of iPTH in the samples.
• Comparison to a Predicate Device: For method comparison, the results from the legally marketed Abbott Architect Intact PTH assay (K063232) served as the reference or "ground truth" to establish substantial equivalence.
• Known Reference Standards/Spiked Samples: For precision and interference studies, the ground truth is often established by using clinically relevant pools with known or spiked analyte concentrations.
• Clinically Established Reference Ranges: Normal physiological ranges for iPTH from healthy donors are used to establish expected values.

8. Sample Size for the Training Set

The provided summary does not explicitly mention a "training set" in the context of machine learning or AI models. This device is a traditional immunoassay, which does not typically involve distinct training and test sets in the same way an AI/ML device would. The development (optimization and calibration) of the assay itself would involve numerous samples, but these are part of the assay's development and validation, not a formal "training set" as described in AI. The "testing" samples mentioned above are for performance validation for regulatory submission.

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

As noted above, the concept of a formal "training set" with established ground truth is not directly applicable to this traditional immunoassay. The development and optimization of such assays involve:

• Biochemical assays and calibration curves: These define the relationship between the signal detected (Relative Light Units) and the analyte concentration (iPTH). This is established using known iPTH standards.
• Cross-validation and optimization: During development, various reagents and parameters are tested and optimized using a wide range of samples to ensure robust and accurate performance across the assay's range.
• Reference materials and spiked samples: These are used to ensure the assay can accurately quantify iPTH across different concentrations and in the presence of potential interferences.

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