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IMMULITE EPO is a solid-phase, two-site sequential chemiluminescent enzyme immunometric assay for use with the IMMULITE Automated Analyzer and designed for the quantitative measurement of erythropoietin (EPO) in serum or heparinized plasma. It is intended strictly for in vitro diagnostic use as an aid in the diagnosis of anemias and polycythemias.

IMMULITE® EPO is a solid-phase, two-site chemiluminescent sequential enzyme immunometric assay for use with the IMMULITE® Automated Immunoassay Analyzer

Here's a breakdown of the acceptance criteria and study information for the IMMULITE® EPO device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on demonstrating substantial equivalence through a method comparison, rather than pre-defined acceptance criteria with specific thresholds for accuracy, sensitivity, or specificity commonly seen with imaging devices. The acceptance criterion is implicit: the new device's performance must be comparable to the predicate device.

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

• Sample Size for Test Set: 130 endogenous serum samples.
• Data Provenance: Not explicitly stated (e.g., country of origin). The data is from "endogenous serum samples," implying human samples. It is retrospective in the sense that these were pre-existing samples used for comparison.

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

• This device measures a quantitative biomarker (EPO levels) in serum/plasma. Its "ground truth" is established by the measurements obtained from a legally marketed predicate device (Incstar's EPO-Trac 125I RIA), which is itself a laboratory assay.
• Therefore, there were no human "experts" in the sense of radiologists reviewing images to establish a ground truth. The predicate device's results served as the reference.

4. Adjudication Method for the Test Set

• Not applicable. This was a quantitative method comparison study against a predicate device, not a study involving human interpretation or adjudication of cases. The comparison was statistical.

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

• No. This is an in vitro diagnostic (IVD) device for quantitative measurement of a biomarker, not an imaging device with AI assistance for human readers. Therefore, an MRMC study is not relevant here.

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

• Yes, this was effectively a standalone performance study. The IMMULITE® EPO system operates as an automated immunoassay analyzer, and its output (EPO concentration) is compared directly to the output of the predicate device (Incstar's EPO-Trac 125I RIA). There is no "human-in-the-loop" performance in the measurement process itself, beyond the initial sample collection and loading.

7. The Type of Ground Truth Used

• Ground Truth: The quantitative EPO concentration values obtained from the predicate device, Incstar's EPO-Trac 125I RIA.

8. The Sample Size for the Training Set

• This document describes a 510(k) submission, which focuses on demonstrating substantial equivalence of a new device to a predicate device. For such devices, training set information for an "algorithm" as understood in AI/ML is typically not provided or relevant. The IMMULITE® EPO system is a chemiluminescent immunoassay, a chemical and biological measurement system, not a machine learning algorithm that requires a "training set" in the computational sense.
• The assay itself is developed and validated, but the term "training set" doesn't apply in the same way as it would for an AI-powered diagnostic.

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

• Not applicable for the reasons mentioned in point 8. The device's calibration and assay parameters would be established through a different set of internal validation experiments and reference materials, not a "training set" with ground truth in the AI sense.

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