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The IMMAGE® Immunochemistry System Ferritin (FER) Reagent, when used in conjunction with Beckman Coulter IMMAGE® Immunochemistry Systems and Beckman Coulter Ferritin Calibrator, is intended for the quantitative determination of ferritin in human serum by turbidimetric immunoassay.

Beckman Coulter Ferritin Calibrator, when used in conjunction with Ferritin reagent, is intended for use on IMMAGE® Immunochemistry Systems for the calibration of ferritin.

Device Description

The IMMAGE® Immunochemistry System Ferritin (FER) Reagent and Fentiin Calibrator are designed for optimal performance on the IMMAGE® Immunochemistry Systems. They are intended for the quantitative determination of Ferritin in serum.

AI/ML Overview

Here's an analysis of the acceptance criteria and study detailed in the provided text, formatted as requested:

Acceptance Criteria and Device Performance

The document describes the IMMAGE® Immunochemistry System Ferritin (FER) Reagent and Calibrator. The core of the study reported is a comparison to a predicate device and an evaluation of the device's imprecision. The acceptance criteria are implicitly defined by the reported performance and the finding of "substantial equivalence" to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance	Study Type
Method Comparison:
Slope close to 1	1.059	Comparison to Predicate (IMx Ferritin)
Intercept close to 0	-6.5 ng/mL	Comparison to Predicate (IMx Ferritin)
Correlation coefficient (r) ≥ 0.98	0.987	Comparison to Predicate (IMx Ferritin)
Imprecision (within-run):
Level 1: ≤ 4.4% C.V.	4.4% C.V. (S.D. 2.4 ng/mL at 53.5 ng/mL Mean)	Imprecision Study
Level 2: ≤ 3.0% C.V.	3.0% C.V. (S.D. 5.3 ng/mL at 172.0 ng/mL Mean)	Imprecision Study
Level 3: ≤ 2.6% C.V.	2.6% C.V. (S.D. 10.5 ng/mL at 397.0 ng/mL Mean)	Imprecision Study
Imprecision (total):
Level 1: ≤ 5.5% C.V.	5.5% C.V. (S.D. 2.9 ng/mL at 53.5 ng/mL Mean)	Imprecision Study
Level 2: ≤ 4.1% C.V.	4.1% C.V. (S.D. 7.1 ng/mL at 172.0 ng/mL Mean)	Imprecision Study
Level 3: ≤ 3.1% C.V.	3.1% C.V. (S.D. 12.4 ng/mL at 397.0 ng/mL Mean)	Imprecision Study

Note: The acceptance criteria are inferred from the reported "good" performance metrics that led to substantial equivalence.

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

Method Comparison Study:
- Sample Size (n): 116 serum samples
- Data Provenance: Not explicitly stated, but clinical samples (serum) would typically be from a patient population. It is not specified if they were retrospective or prospective, nor the country of origin.
Imprecision Study:
- Sample Size (N): 80 replicates for each of the three levels (240 total measurements).
- Data Provenance: Not explicitly stated, but these would be internal laboratory samples or controls.

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

This type of in-vitro diagnostic device does not typically rely on "experts" in the same way an imaging or pathology device would for establishing ground truth.

For the method comparison study, the "ground truth" for the test set was effectively the measurements obtained from the predicate device (Abbott IMx® Ferritin). Therefore, the "experts" were the established and validated methodology of the predicate device.
For the imprecision study, the "ground truth" refers to the true concentration of ferritin in the control samples used. This would be established through robust analytical methods, often by the control manufacturer, and not by individual human experts in a consensus manner.

4. Adjudication Method for the Test Set

Not applicable for this type of in-vitro diagnostic device study. The comparison is quantitative to an existing method or to established control values, not subject to human expert 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 device is an automated immunoassay system for quantitative determination of ferritin, not an AI-assisted diagnostic tool that involves human interpretation of varied cases.

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

Yes, the studies reported (method comparison and imprecision) represent standalone performance of the IMMAGE® Immunochemistry System Ferritin Reagent. The system performs the quantitative determination of ferritin automatically without human interpretive input for each measurement. Human involvement is in operating the system, loading samples, and interpreting the final quantitative results output by the machine.

7. The Type of Ground Truth Used

For the method comparison study: The ground truth was the quantitative results obtained from the predicate device, the Abbott IMx® Ferritin system. This is a form of "reference method" ground truth.
For the imprecision study: The ground truth was the known or assigned concentration values of control materials at different ferritin levels.

8. The Sample Size for the Training Set

The document does not provide information about a "training set" in the context of machine learning or AI. This is a traditional immunoassay system, not an AI-based device that undergoes a training phase with a specific dataset. The closest analogue would be the calibration process, which uses the IMMAGE® Immunochemistry System Ferritin Calibrator according to its instructions.

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

Not applicable, as there is no "training set" in the context of AI/machine learning for this device. For the calibrators, the "ground truth" (assigned values) would be established by the manufacturer through rigorous analytical methods, often traceable to an international reference standard (e.g., WHO Standard as mentioned for the IMMAGE System FER Calibrator).

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