(21 days)
The Ascensia ELITE™ Blood Glucose Meter is used with Ascensia ELITE™ Blood Glucose Test Strips, and Ascensia ELITE™ Controls for the measurement of glucose in whole blood from specimens taken from the fingers or an alternate puncture site within certain conditions. The Ascensia ELITE™ Diabetes Care 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 frequent monitoring of blood glucose is an adjunct to the care of persons with diabetes.
The Ascensia ELITE™ Diabetes Care System consists of an electrochemical methodbased meter and dry reagent sensor (test strips) designed for testing glucose by persons with diabetes or by healthcare professionals in the home or in healthcare facilities.
Here's an analysis of the provided text regarding the Ascensia ELITE™ Blood Glucose Meter, structured according to your requested information.
Please note that the provided 510(k) summary is very high-level and does not contain the detailed performance data or study methodology that would typically be required to fully answer all your questions. The document explicitly states: "An evaluation of the Ascensia ELITE™ Care System was studied to verify and validate that the microprocessor change did not adversely affect or change the performance characteristics of the system." This suggests the primary goal of the submission was to demonstrate that a change to an existing device did not degrade performance, and thus much of the detailed original performance data might be referenced from the predicate device submissions (K020208/K964630) which are not included here. Therefore, many sections will indicate "Not Specified in the document."
Acceptance Criteria and Device Performance for Ascensia ELITE™ Blood Glucose Meter
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Linear response to glucose (range) | 20-600 mg/dL |
| Result display time | 30 seconds |
| Substantial equivalence to current methods for blood glucose (predicate device K020208/K964630) | "demonstrated that users can obtain blood glucose results that are substantially equivalent to current methods for blood glucose." |
| Performance not adversely affected by microprocessor change | "demonstrated that the microprocessor change did not adversely affect or change the performance characteristics of the system." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the document.
- Data Provenance: Not specified in the document (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Not specified in the document. The general nature of blood glucose meter evaluations typically involves comparison to a laboratory reference method, not individual expert assessment of each reading.
4. Adjudication Method for the Test Set
- Not specified in the document. Given the nature of blood glucose measurement, a consensus-based adjudication method for individual readings is unlikely to be applicable. The "ground truth" would generally be a precise laboratory measurement.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size (AI vs. Without AI Assistance)
- Not applicable. This device is a standalone blood glucose meter and does not involve AI assistance or human reader interpretation for diagnostic purposes in the way an imaging AI system would.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, this is an inherent aspect of the device. The "algorithm" (the meter's electrochemical measurement and calculation) generates a result directly. The performance evaluation would be of this standalone measurement capability against a reference method. The document states: "An evaluation of the Ascensia ELITE™ Care System was studied to verify and validate that the microprocessor change did not adversely affect or change the performance characteristics of the system." This refers to the standalone performance of the device.
7. The Type of Ground Truth Used
- The document states that "Blood glucose results are referenced to plasma glucose." This strongly implies that the ground truth for performance evaluation was established using a laboratory reference method for plasma glucose. This is the standard for blood glucose meter validation.
8. The Sample Size for the Training Set
- Not applicable/Not specified. Blood glucose meters are not typically "trained" in the machine learning sense with a distinct training set. Their performance is based on the underlying chemical and electrical engineering principles, validated against reference measurements.
9. How the Ground Truth for the Training Set Was Established
- Not applicable/Not specified for the reasons stated in point 8.
§ 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.