(104 days)
The Ascensia BREEZE®2 Blood Glucose Monitoring System consisting of the Ascensia "BREEZE"2 Blood Glucose Meter, Ascensia" BREEZE® Reagent Strips and Ascensia BREEZE®2 Control Solution is for the measurement of glucose in whole blood. The Ascensia BREEZE® 2 Gonton Solution in of the measurement of glucose in whole blood. The Ascensia® BREEZE® 2 Blood Glucose Monitoring System allows the user an option to use the palm and forearm in addition to the fingertip (testing) to collect capillary blood for self-monitoring of blood glucose within certain conditions as explained in the labeling. Ascensia BREEZE®2 Blood Glucose Monitoring System is an over-the-counter (OTC) device used by persons with diabetes. Ascensia BREEZE 2 Blood Glucose Monitoring System is not for use with neonatal blood specimens. The frequent monitoring of blood glucose is an adjunct to the care of persons with diabetes.
The Ascensia® BREEZE®2 Blood Glucose Monitoring System consists of:
- Ascensia® BREEZE®2 Blood Glucose Monitor
- Ascensia BREEZE®2 Blood Glucose Test Strips
- Ascensia BREEZE®2 Control Solution
The provided text describes the Ascensia® BREEZE®2 Blood Glucose Monitoring System. Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state numerical acceptance criteria in a table format with specific performance metrics (e.g., accuracy percentages, limits of agreement). Instead, it makes a general statement about performance.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device | "The results of the clinical evaluations of The Ascensia® BREEZE®2 Blood Glucose Monitoring System demonstrated that the device can produce blood glucose results that are substantially equivalent to results obtained on the predicate device." |
| Improved Performance over Original Ascensia® BREEZE® | "The studies showed improved performance compared with past clinical studies of the original Ascensia® BREEZE® Blood Glucose Monitoring System." |
| Linearity Range | "The system has a linearity response to glucose from 20-600 mg/dL." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "subject meter results for capillary blood samples" and "a validation... performed in a clinical setting by persons with diabetes." However, the exact number of participants or samples is not provided.
- Data Provenance: Prospective and clinical. The study was "performed in a clinical setting by persons with diabetes," suggesting a prospective clinical trial. The country of origin is not specified but given the submitter's address (Mishawaka, IN, USA) and FDA submission, it likely involved data from the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: The ground truth was established by "results of a laboratory glucose analyzer" and "BREEZE®2 results obtained by a healthcare professional." The specific qualifications of the healthcare professional are not detailed, nor are the specific details of the laboratory glucose analyzer.
4. Adjudication Method for the Test Set
Not specified. The document states that "subject meter results for capillary blood samples were compared with BREEZE®2 results obtained by a healthcare professional and results of a laboratory glucose analyzer." This implies a comparison against these two reference methods, but no adjudication process for discrepancies is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This device is a blood glucose monitoring system, not an imaging device that would typically involve multiple human readers interpreting cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, a standalone performance assessment was effectively done. The device's results (from the Ascensia® BREEZE®2 Blood Glucose Monitor used by subjects) were compared directly against reference methods ("BREEZE®2 results obtained by a healthcare professional and results of a laboratory glucose analyzer"). This evaluates the device's performance independently.
7. The Type of Ground Truth Used
The ground truth for the test set was established by:
- Comparison with laboratory glucose analyzer results. This is considered a high-fidelity reference standard for blood glucose measurement.
- Comparison with BREEZE®2 results obtained by a healthcare professional. This serves as another point of comparison, likely using the device itself but operated by a trained professional.
8. The Sample Size for the Training Set
Not applicable/Not provided. The text describes a validation study, but there is no mention of a separate "training set" in the context of an AI/ML algorithm development, as this device predates widespread regulatory submissions for such technologies in medical devices. This is a traditional medical device submission for a blood glucose monitor.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As noted above, this device predates the typical AI/ML development paradigms involving distinct training sets requiring ground truth establishment in that context.
§ 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.