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MPO Flex® reagent cartridge: The MPO method is an in vitro diagnostic test for the quantitative measurement of myeloperoxidase (MPO) in human plasma on the Dimension® clinical chemistry system with the heterogeneous immunoassay module. Myeloperoxidase measurements may be used in conjunction with clinical history, ECG, and cardiac biomarkers to evaluate patients presenting with chest pain that are at risk for major adverse cardiac events, including myocardial infarction, need for revascularization, or death.

MPO Calibrator: The MPO Calibrator is an in vitro diagnostic product intended to be used to calibrate the Myeloperoxidase (MPO) method on the Dimension® clinical chemistry system with the heterogeneous immunoassay module.

MPO Control: The myeloperoxidase control is an in vitro diagnostic product intended for use as an assayed quality control product to monitor the performance of the Myeloperoxidase (MPO) method on the Dimension® clinical chemistry system with the heterogeneous immunoassay module.

Device Description

The MPO method is a one-step enzyme immunoassay based on the "sandwich" principle. The sample is incubated with chromium dioxide particles coated with monoclonal antibodies specific for MPO, and conjugate reagent (13-galactosidase labeled monoclonal antibodies specific for MPO). A particle/MPO/conjugate sandwich forms during the incubation period. Unbound conjugate is removed by magnetic separation and washing. The sandwich bound fl-galactosidase is combined with the chromogenic substrate chlorophenol red-ß-D-galactopyranoside (CPRG). Hydrolysis of CPRG releases a chromophore (CPR). The concentration of MPO present in the patient sample is directly proportional to the rate of color change due to formation of CPR measured at 577 nm.

AI/ML Overview

The provided text describes the Siemens Healthcare Diagnostics Dimension MPO Flex® reagent cartridge and its associated calibrator and control. The information focuses on demonstrating substantial equivalence to a predicate device, the PrognostiX CardioMPO™ Enzyme Immunoassay. The study does not involve an AI device, therefore, some of the requested information such as MRMC study, and number of experts to establish ground truth is not applicable.

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

1. Table of Acceptance Criteria (from predicate device) and Reported Device Performance:

Feature	Predicate Device (PrognostiX MPO) Acceptance Criteria (as reported)	Dimension® MPO Flex® (Reported Performance)
Intended Use	Quantitative determination of myeloperoxidase in human plasma to evaluate patients at risk for major adverse cardiac events (MACE).	Quantitative measurement of myeloperoxidase (MPO) in human plasma on the Dimension® clinical chemistry system, for evaluating patients at risk for MACE.
Assay Type	Sandwich enzyme immunoassay	Sandwich enzyme immunoassay
Reportable Range	13 to 5000 pmol/L	20 to 5000 pmol/L
Hook Effect	No high dose effect up to 800,000 pmol/L	No high dose effect up to 800,000 pmol/L
Odds Ratio (Clinical)	Increases from 1.0 to a max. of 3.3 across 4 quartiles	Increases from 1.0 to a max. of 4.29 across 4 quartiles (30 days MACE)
Expected Values	≤ 539 pmol/L (presumably a reference range)	20 - 633 pmol/L (presumably a reference range)
Analytical Specificity	< 0.15% cross-reactivity for listed substances	< 0.15% cross-reactivity for most listed substances, < 0.4% for Eosinophil Peroxidase

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

Method Comparison (Split-sample):
- Sample Size: 139 patient samples.
- Data Provenance: Not explicitly stated, but the mention of "patient samples" and "lithium heparin patient sample" suggests a collection from clinical settings. The type of study design for this (e.g., retrospective vs. prospective) is not specified.
Plasma Study (Comparative Specimen):
- Sample Size: 59 samples for Lithium Heparin vs. EDTA, 49 samples for Lithium Heparin vs. Sodium Heparin.
- Data Provenance: Not explicitly stated, but implies patient samples as different plasma types are being compared.
Reproducibility: Not applicable for a test set in the same way as clinical validation.
Clinical Study Results:
- Sample Size: 400 patients.
- Data Provenance: EDTA plasma samples obtained from patients who presented to the Emergency Department or acutely to out-patient facilities with chest pain or equivalent symptoms suggestive of ACS. This appears to be a prospective collection tied to patient enrollment, followed by a retrospective analysis of MACE at 30 days and 6 months.
- Country of Origin: Not specified in the provided text.

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

Not Applicable. This is an in vitro diagnostic device measuring a biomarker (MPO). The "ground truth" for the clinical study is the occurrence of Major Adverse Cardiac Events (MACE), defined as myocardial infarction, revascularization, or death, which are objective clinical outcomes, not interpretations by experts.

4. Adjudication Method for the Test Set:

Not Applicable. As mentioned above, the "ground truth" (MACE occurrence) is based on objective clinical outcomes, not subjective interpretations 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 an in vitro diagnostic device, not an AI-assisted diagnostic tool that involves human readers interpreting images or data.

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

Not Applicable. The device itself is a standalone immunoassay for quantitative measurement of MPO. There is no "algorithm" in the sense of AI performing a diagnostic task. The clinical study evaluates the performance of the MPO measurement in predicting MACE, which is an inherent property of the biomarker itself, not an algorithmic interpretation.

7. The Type of Ground Truth Used:

Clinical Outcomes/Pathology:
- For the clinical study, the ground truth was defined by Major Adverse Cardiac Events (MACE) at 30 days and 6 months. MACE was specifically defined as:
  - Myocardial infarction
  - Revascularization (coronary artery bypass graft, percutaneous coronary intervention, or placement of cardiac stent)
  - Death
- These are objective, outcome-based clinical endpoints.

8. The Sample Size for the Training Set:

Not Applicable. This filing describes an in vitro diagnostic device based on an immunoassay. There is no concept of a "training set" in the context of an immunoassay, as there is with machine learning or AI models. The device's performance characteristics (e.g., reportable range, specificity, reproducibility) are established through analytical studies, and its clinical utility is demonstrated through a clinical study.

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

Not Applicable. As there is no training set for this type of device, ground truth establishment for a training set is not relevant.

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