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The HbA1c assay used on the Dimension Vista® system is an in vitro diagnostic assay for the quantitative determination of per cent Hemoglobin A1c in human anticoagulated whole blood. Measurements of hemoglobin A1c are effective in monitoring long term glucose control in individuals with diabetes mellitus.

HbA 1c calibrator is intended for use in the calibration of the Hemoglobin A 1c (HbA 1c) method on the Dimension Vista® system.

The Dimension Vista® HbA1c kit contains Flex® reagent cartridges and calibrator. Each cartridge contains reagents used to measure total hemoglobin and hemoglobin A1c. the reagents are liquid and ready to use on the instrument. The calibrator in the kit is a five level lyophilized product. Each level is hydrated with 2.0mL of reagent grade water. The lot matched reagents and calibrator product are for use on the Dimension Vista Systems.

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 Reported Device Performance

The acceptance criteria for the Dimension Vista® HbA1c Kit are implicitly established through its substantial equivalence claim to the predicate device and comparison with a reference method. The primary studies focus on method comparison.

Here's the additional information requested, based on the provided text:

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

• Test Set 1 (vs. Predicate Device):
  • Sample Size: 124 fresh, EDTA-treated whole blood samples.
  • Data Provenance: Not explicitly stated, but "fresh, EDTA-treated whole blood samples" usually implies prospective collection from a clinical setting, likely within the country of the manufacturer's operation or study site. However, specific country of origin is not mentioned.
• Test Set 2 (vs. Tosoh HPLC):
  • Sample Size: 91 human whole blood samples preserved with EDTA.
  • Data Provenance: Not explicitly stated, but similar to Test Set 1, likely prospective collection. Specific country of origin is not mentioned.

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

• The ground truth for the test set was established by analytical methods (the predicate device and the Tosoh HPLC analyzer), not by human experts. Therefore, this question is not applicable in this context. The "experts" would be the manufacturers and certified laboratories maintaining the reference methods.

4. Adjudication Method for the Test Set

• No adjudication method is mentioned as the ground truth was established by analytical instruments. This is not applicable to an analytical device comparison.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for image-based diagnostic systems where human readers interpret medical images. This document describes an in vitro diagnostic assay for quantitative laboratory measurements.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

• Yes, the studies described are of the standalone performance of the Dimension Vista® HbA1c kit. The device performs the measurement quantitatively without direct human intervention in the result generation beyond sample loading and instrument operation. The reported performance metrics (Passing-Bablok regression, Bland-Altman bias) represent the algorithm's (or device's) direct analytical output compared to reference methods.

7. The Type of Ground Truth Used

• The ground truth was established by comparison with established analytical methods:
  • The legally marketed predicate device (Dimension Vista® HA1C kit) for the first comparison.
  • A recognized reference method, the Tosoh Ion Exchange HPLC analyzer, for the second comparison. This HPLC method is a standard for HbA1c measurement and is often considered a higher-level reference.

8. The Sample Size for the Training Set

• The document does not explicitly mention a "training set" or its size. For an in vitro diagnostic device like this, the development process would involve internal optimization and validation, but a defined "training set" in the context of machine learning (where this term is most common) is not typically described in 510(k) summaries for such devices. The method comparison studies serve as clinical validation.

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

• As a defined "training set" is not explicitly discussed, the method for establishing its ground truth is not provided. The development and calibration of such assays typically rely on certified reference materials and established laboratory protocols.

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