(190 days)
For in vitro quantitative determination Hemoglobin A1c in anticoagulated whole blood.
For the quantitative determination of Hemoglobin A1c.
For monitoring of long term blood glucose control in individuals with diabetes mellitus.
The device is an immunoturbidimetric test for the quantitative determination of per cent Hemoglobin A1c in anticoagulated venous or capillary whole blood for use on the INTEGRA family of analyzers.
The provided text describes a 510(k) premarket notification for a medical device, the INTEGRA Reagent Cassette for Hemoglobin A1c. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets acceptance criteria in the way this term is typically used for AI/ML devices (e.g., performance thresholds of sensitivity/specificity).
Therefore, the following response will interpret "acceptance criteria" as the performance characteristics reported for the device, and the "study" as the information provided to support the claim of substantial equivalence, which includes comparisons of performance characteristics.
Here is the information based on the provided text:
1. A table of acceptance criteria and the reported device performance
For a traditional IVD device like this, the "acceptance criteria" are generally implied to be that the device's performance characteristics are equivalent to a legally marketed predicate device. The document presents performance characteristics for the modified device and compares them to those of the predicate (implicitly arguing for equivalence).
| Feature | Acceptance Criteria (Implied: Equivalent to Predicate Device) | Reported Device Performance (Modified Device) |
|---|---|---|
| Precision | Within-run CV comparable to predicate device. | Whole Blood Application: |
| Within-run CV: 2.3% at 4.7%, 2.2% at 10.3% | ||
| Total CV: 2.4% at 4.7%, 2.4% at 10.3% | ||
| Total CV comparable to predicate device. | Hemolysate Application: | |
| Within-run CV: 1.5% at 4.8%, 1.8% at 12.1% | ||
| Total CV: 2.8% at 4.8%, 2.4% at 12.1% | ||
| **Analytical | ||
| Sensitivity** | Hb sensitivity comparable to predicate device. | Hb: 1.5 mg/dL |
| HbA1c sensitivity comparable to predicate device. | HbA1c: 0.4 mg/dL | |
| **Interfering | ||
| Substances** | No significant interference from common substances. | No significant interference from unconjugated bilirubin (60 mg/dL), lipemia (2000 mg/dL), or glycemia (1000 mg/dL), acetylated Hb, carbamylated Hb, and labile HbA1c. (For both applications) |
| **Calibration | ||
| Stability** | Calibration stability comparable to predicate device. | Whole Blood Application: Each lot and every 57 days |
| Hemolysate Application: Each lot and every 43 days |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample size for any test set or the data provenance (country of origin, retrospective/prospective). The presented data are performance characteristics like precision, analytical sensitivity, and interference, which are typically derived from laboratory studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. For an in vitro diagnostic (IVD) device measuring Hemoglobin A1c, the ground truth is established by the analytical method itself and its accuracy against a reference method or standard, not by expert consensus on interpretations of images or clinical cases.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective interpretation (e.g., imaging); this is an objective quantitative assay.
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 is an in vitro diagnostic device, not an AI/ML device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the device (INTEGRA Reagent Cassette for Hemoglobin A1c on an INTEGRA analyzer) performs as a standalone diagnostic assay to quantitatively determine Hemoglobin A1c. Its performance characteristics are reported directly.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for an IVD such as this would typically be established by established reference methods for Hemoglobin A1c or validated laboratory standards. The document does not explicitly state the specific reference method used for comparison, but it is implied that the stated performance characteristics (precision, sensitivity) are validated against such methods.
8. The sample size for the training set
Not applicable. This is a traditional IVD device, not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established
Not applicable. This is a traditional IVD device, not an AI/ML algorithm that requires a "training set."
§ 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).