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The IRON method for the Dimension® clinical chemistry system is an in vitro diagnostic test intended to quantitatively measure iron in human serum and plasma. Iron measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia and other disorders of iron metabolism.

Device Description

The Dimension® IRON Flex® reagent cartridge (DF85) is an in vitro diagnostic device that consists of prepackaged reagents in a plastic eight well cartridge for use on the Dade Behring Dimension® clinical chemistry system for the quantitative determination of iron in serum and plasma.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Performance Characteristic	Acceptance Criteria (Implied/Direct)	Reported Device Performance
Precision/Reproducibility	Based on CLSI/NCCLS EP5-A2 guideline. Specific CV% targets are implied by showing results within acceptable clinical ranges.	Repeatability (%CV): Plasma pool: 0.5% Serum pool 1: 0.5% Serum pool 2: 0.5% Serum pool 3: 0.5% BioRad Lyphochek® control Level 1: 0.5% BioRad Lyphochek® control Level 2: 1.1% BioRad Lyphochek® Anemia control Level 1: 1.3% Reduced Sample Volume Serum pool 1: 0.6% Reduced Sample Volume Serum pool 2: 0.5% Reduced Sample Volume Serum pool 3: 0.5% Reduced Sample Volume BioRad Lyphochek® Anemia control Level 1: 1.3% Reduced Sample Volume BioRad Multiqual® control Level 3: 0.7% Within-lab Standard Deviation (%CV): Plasma pool: 0.7% Serum pool 1: 0.6% Serum pool 2: 1.1% Serum pool 3: 0.8% BioRad Lyphochek® control Level 1: 0.7% BioRad Lyphochek® control Level 2: 1.9% BioRad Lyphochek® Anemia control Level 1: 1.9% Reduced Sample Volume Serum pool 1: 0.9% Reduced Sample Volume Serum pool 2: 1.1% Reduced Sample Volume Serum pool 3: 0.8% Reduced Sample Volume BioRad Lyphochek® Anemia control Level 1: 1.9% Reduced Sample Volume BioRad Multiqual® control Level 3: 0.9%
Linearity/Assay Reportable Range	Correlation coefficient of 0.999, slope of 0.999, and intercept of 0.178. Assay range claim: 5.0 µg/dL to 1000 µg/dL.	Correlation Coefficient: 0.999 Slope: 0.999 Intercept: 0.178 Assay Range Claim: 5.0 µg/dL to 1000 µg/dL
Detection Limit (Analytical Sensitivity)	Ability to distinguish iron from zero.	Analytical Sensitivity: 5 µg/dL [0.9 µmol/L]
Analytical Specificity (Interference)	Systematic inaccuracies (bias) due to interfering substances < 10% within specified iron concentrations.	Inaccuracies < 10% at iron concentrations of 26-38 µg/dL and 118-136 µg/dL for tested substances. (Specific interfering substances and non-interfering substances are in the package insert, not detailed here.)
Method Comparison (vs. Predicate Device)	Linear regression relationship with predicate device (Dimension® IRN (DF49A)) indicating strong correlation. (Implied acceptability based on similarity to predicate)	Slope: 0.980 Intercept: -0.488 µg/dL Correlation Coefficient: 0.9996 Range of IRON values in study: 9 to 963 µg/dL
Matrix Comparison	Excellent agreement between serum, lithium heparin plasma, and sodium heparin plasma specimens; no clinically significant difference.	Sodium heparin plasma vs. serum: y = 0.988x + 0.804, r = 0.999 Lithium heparin plasma vs. serum: y = 0.985x + 1.42, r = 0.999 Lithium heparin plasma vs. sodium heparin plasma: y = 0.997x + 0.666, r = 0.999
Traceability	Standardization to NIST SRM 937 Iron Metal Clinical Standard.	The Dimension® IRON Calibrator is standardized to NIST SRM 937.

Study Details:

Sample sizes used for the test set and the data provenance:
- Precision/Reproducibility: Not explicitly stated as "test set," but specimens (commercial controls, serum, and plasma pools) were analyzed in duplicate twice a day for 20 days.
- Linearity: Solutions of NIST SRM 937 were prepared by sequential mixing. The exact number of samples is not given, but they ranged from 0 to 2000 µg/dL iron.
- Analytical Specificity: Not explicitly stated, but interference testing was performed according to CLSI/NCCLS Protocol EP-7A.
- Method Comparison: 147 samples (99 individual patient serum samples + 48 individual patient serum samples spiked with NIST-937 reference iron material).
- Matrix Comparison: 129 matched specimens of serum and heparinized plasma.
- Data Provenance: Not explicitly stated, but given the nature of the device (in vitro diagnostic for human serum/plasma) and the use of patient samples, the data is prospective clinical data from a medical setting. The location (country of origin) is not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is an in vitro diagnostic device for quantitative iron measurement, where "ground truth" is established through analytical reference methods or reference materials (like NIST SRM 937) rather than expert interpretation of images or clinical cases.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as the "test set" involves quantitative measurements on biological samples/controls against known values or reference methods, not subjective interpretation requiring adjudication.
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 IVD device for automated quantitative measurement, not an AI-assisted diagnostic imaging or interpretation system involving human readers.
If a standalone (i.e., algorithm only without human-in-the loop performance) was done:
- Yes, the performance characteristics described (precision, linearity, detection limit, analytical specificity, method comparison, matrix comparison) represent the standalone performance of the Dimension® IRON Flex® reagent cartridge on the Dimension® clinical chemistry system, without human "in-the-loop" interpretation beyond standard laboratory procedures.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Reference Materials/Reference Methods:
  - Linearity/Traceability: NIST SRM 937 Iron Metal Clinical Standard.
  - Method Comparison: The predicate device, Dimension® IRN (DF49A), serves as the comparator, with its own established performance likely tracing back to similar reference methods/materials.
  - Detection Limit: Based on statistical calculation (mean + 2 standard deviations) of a low-level calibrator.
The sample size for the training set:
- Not applicable/Not explicitly stated in the context of "training set" as it would be understood for an AI/machine learning model. For this type of IVD, the development process involves extensive R&D, formulation, and iterative testing, but not a distinct "training set" in the AI sense. The performance studies mentioned (precision, linearity, etc.) serve to validate the final reagent formulation and instrument integration.
How the ground truth for the training set was established:
- Not applicable, as there isn't a "training set" in the context of an AI/ML device. The ground truth for the validation studies mentioned (e.g., linearity, method comparison) relies on established analytical standards and reference methods as described in point 6.

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