(156 days)
The HAIC assay used on the Dimension® clinical chemistry system is an in vitro diagnostic assay for the quantitative determination of percent hemoglobin Alc (HbAIc) in anticoagulated whole blood. Measurements of percent hemoglobin A1c are effective in monitoring long term glucose control in individuals with diabetes mellitus.
The Dimension® HA1C assay measures both HbA1c and hemoglobin. The HbA1c measurement is based on a turbidimetric inhibition immunoassay (TINIA) principle, and the measurement of total hemoglobin is based on a modification of the alkaline hematin reaction. Using the values obtained for each of these two analytes (in g/dL), the percentage of the total hemoglobin that is glycated is calculated and reported as %HbA1c. The final %HbAlc result has been standardized to the results obtained in the Diabetes Control and Complications Trial (DCCT). Pre-treatment to remove the labile fraction is not necessary as only the Amadori rearranged form of HbA1c is detected. All hemoglobin variants that are glycated at the beta-chain N-terminus and have epitopes identical to that of HbA lc, are measured by this assay.
The provided text does not contain information about an AI device or a study involving human readers or expert adjudication for a test set. This document describes the "Dimension® HA1C Assay," which is an in vitro diagnostic assay for measuring hemoglobin A1c. It's a chemical assay, not an AI-powered device. Therefore, many of the requested fields cannot be filled.
However, I can extract information related to the device's performance given the available text.
1. A table of acceptance criteria and the reported device performance
The primary "acceptance criteria" here is substantial equivalence to the predicate device. The performance is reported as a correlation between the two methods.
| Acceptance Criteria / Performance Metric | Reported Device Performance (Dimension® HA1C Assay) |
|---|---|
| Correlation Coefficient with Predicate Device (Roche Tina-quant® HBA1C II) | 0.994 |
| Slope of correlation with Predicate Device | 0.985 |
| Intercept of correlation with Predicate Device | 0.3% HbA1c |
2. Sample sized used for the test set and the data provenance
- Sample Size: 136 anticoagulated whole blood samples
- Data Provenance: The document doesn't explicitly state the country of origin. It indicates these were "anticoagulated whole blood samples" used for "method correlation" with a legally marketed predicate device, implying they were likely collected in a clinical setting in the region where the study was conducted (presumably the US, given the FDA submission). It is a retrospective comparison or split-sample study as existing samples were tested on both devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as this is a chemical assay comparison, not an imaging or diagnostic device requiring expert interpretation of ground truth. The "ground truth" for this device's performance is its correlation with a recognized predicate device.
4. Adjudication method for the test set
Not applicable.
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. No AI component or human reader study is described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in a sense, the device's performance was evaluated in a standalone manner by comparing its results to a predicate device. It's an automated chemical analysis, so human intervention in the result generation itself is minimal once the sample is prepared.
7. The type of ground truth used
The "ground truth" for proving substantial equivalence was the results obtained from a legally marketed and established predicate device, the Roche Tina-quant® HBA1C II assay. This is a form of comparative reference standard.
8. The sample size for the training set
Not applicable. This device is a chemical assay, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable.
§ 864.7470 Glycosylated hemoglobin assay.
(a)
Identification. A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a , A1b , and A1c ) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.(b)
Classification. Class II (performance standards).