(53 days)
The Ascensia® CONTOUR®Blood Glucose Monitoring System is used for the measurement of glucose in whole blood. The Ascensia CONTOUR® Blood Glucose Monitoring System is an over-the-counter (OTC) device used by persons with diabetes and by healthcare professionals in home settings and in healthcare facilities.
The Ascensia CONTOUR® Blood Glucose Monitoring System is indicated for use with capillary, venous, and arterial whole blood samples and neonatal blood samples. Capillary samples may be drawn from the fingertip, palm, forearm, and in the case of neonates, the heel.
The frequent monitoring of blood glucose is an adjunct to the care of persons with diabetes.
The Ascensia® CONTOUR® Blood Glucose Monitoring System is used for the measurement of glucose in whole blood. The system contains a blood glucose meter, a bottle of strips, a bottle of normal control solution, a lancing device and lancets and instructions for use.
Here's a breakdown of the acceptance criteria and study information for the Ascensia CONTOUR® Blood Glucose Monitoring System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state numerical acceptance criteria in a table format for accuracy. Instead, it focuses on demonstrating "equivalent performance" to a predicate device. The performance assessment section describes the studies conducted.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalent performance to predicate device | Studies showed equivalent performance with the original Ascensia® CONTOUR® Blood Glucose Monitoring System |
| Substantially equivalent to predicate device | Demonstrated that the device produces blood glucose results that are substantially equivalent to results obtained on the predicate device. |
| (Specific accuracy criteria - e.g., % within +/- threshold) | Not specified in the provided text. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions that the device was "studied in the laboratory and in a clinical setting by persons with diabetes." However, it does not specify the sample size for the test set or the country of origin. It indicates that the clinical setting involved "persons with diabetes," suggesting a prospective clinical study component.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not provide information on the number of experts used or their qualifications for establishing ground truth specifically for the test set. It mentions comparison to "a laboratory method," which implies a reference method, but details about the personnel executing this reference method are absent.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. There is no information about human readers or the effect size of AI assistance. This type of study is typically relevant for interpretative devices (e.g., imaging) where expert readers provide interpretations. For a blood glucose meter, the primary comparison would be against a reference method rather than different human interpretations.
6. Standalone (Algorithm Only) Performance
The device itself is a standalone algorithm (blood glucose meter and its internal software). Its performance against the predicate and laboratory method is its standalone performance. There isn't a separate "algorithm only" study distinct from the device's overall performance.
7. Type of Ground Truth Used
The ground truth for evaluating the device's performance was established by:
- Comparison to the original Ascensia® CONTOUR® Blood Glucose Monitoring System (predicate device).
- Comparison to a "laboratory method." The specific type of laboratory method (e.g., YSI analyzer, enzymatic assay) is not detailed, but it serves as the reference standard.
8. Sample Size for the Training Set
The document does not provide information on the sample size for the training set. Blood glucose meters are typically calibrated during manufacturing and would have undergone extensive internal testing, but the specifics of a "training set" for algorithm development are not disclosed here.
9. How Ground Truth for the Training Set Was Established
The document does not describe how ground truth for any potential "training set" was established. Given the nature of a blood glucose meter, the "training" would likely involve robust manufacturing calibration and quality control procedures using known glucose concentrations.
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.