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The Total Iron Binding Capacity (IBCT) Flex® reagent cartridge for the Dimension® clinical chemistry system is an in vitro diagnostic device intended to quantitatively measure total iron binding capacity in human serum and plasma. Measurements of total iron binding capacity are used in the diagnosis and treatment of iron deficiency anemia and chronic inflammatory disorders.

The IBCT method for the Dimension® clinical chemistry system is a fully automated assay in which serum or plasma is mixed with a ferric iron solution, to saturate all available iron-binding sites of transferrin in the sample. Under non-acidic conditions (pH 8.6), only unbound, excess saturating iron is available to be reduced to ferrous iron by ascorbic acid and to form a blue complex with Ferene®. Subsequent addition of acid (final pH of 4.5) releases the iron bound to transferrin; this additional iron is reduced to ferrous iron by ascorbic acid and forms an increased amount of blue complex with Ferene®. The increase in absorbance upon shifting from pH 8.6 to pH 4.5, measured using a bicromatic (600,700 nm) endpoint technique, is proportional to the concentration of transferrin-bound iron, and thus to the iron binding capacity (total) of the serum or plasma sample.

The provided document is a 510(k) summary for the "Total Iron Binding Capacity (IBCT) Flex® reagent cartridge". It describes a device that measures total iron binding capacity in human serum and plasma and compares its performance to a predicate device.

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Acceptance Criteria and Study Details

1. Table of Acceptance Criteria and the Reported Device Performance:

Note: The document does not explicitly state pre-defined acceptance criteria values for the correlation coefficient, slope, or intercept. However, for a device to be considered "substantially equivalent" to a predicate, these values would implicitly need to fall within an acceptable range, with 0.971 for correlation generally indicating strong agreement.

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

• Sample Size for Test Set: 137 clinical patient samples.
• Data Provenance: Not explicitly stated, but given it refers to "clinical patient samples," it is implied to be from patient populations. It does not mention country of origin or whether it's retrospective or prospective.

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

• Not applicable for this type of device and study. The "ground truth" in this context is the quantitative measurement provided by the predicate device (Dimension® Total Iron Binding Capacity (TIBC) Flex® reagent cartridge). Expert consensus is not used to establish the reference values for these types of clinical chemistry assays.

4. Adjudication method for the test set:

• Not applicable. This is a quantitative comparison study between two diagnostic devices, not a study involving human interpretation 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:

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This is a performance comparison of an in-vitro diagnostic device against a predicate device, not an AI-assisted human reader study.

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

• Yes, this study represents a standalone performance comparison. The IBCT Flex® reagent cartridge, when used with the Dimension® clinical chemistry system, operates as an automated assay without human intervention in the measurement process itself, similar to the predicate device. The performance data presented (correlation, slope, intercept) indicates its direct measurement capabilities.

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

• The "ground truth" was established by the predicate device, the Dimension® Total Iron Binding Capacity (TIBC) Flex® reagent cartridge (K864230). The study performed a split sample comparison, meaning both the investigational device and the predicate device measured the same clinical patient samples, and the predicate's results served as the reference for comparison.

8. The sample size for the training set:

• Not applicable. This is a comparison study for an in-vitro diagnostic reagent cartridge, not a machine learning or AI algorithm that requires a "training set." The device is a chemical reagent-based assay.

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

• Not applicable, as this device does not involve a training set.

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