(26 days)
The ASCENSIA™ DEX®2 Blood Glucose Meter is used with ASCENSIA™AUTODISC™ Blood Glucose Test Strips GLUCOMETER® DEX® Test Sensor and Controls for the measurement of glucose in whole blood. The ASCENSIA™ DEX®2 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™ DEX®2 Diabetes Care System consists of an electrochemical method-based 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.
The provided text is a 510(k) summary for the ASCENSIA™ DEX® 2 Diabetes Care System, a blood glucose meter. It describes the device, its intended use, technological characteristics, and notes that performance data was collected. However, it does not provide specific acceptance criteria or detailed results of a study that proves the device meets those criteria, nor does it contain information about sample sizes for test or training sets, expert qualifications, or adjudication methods.
The document makes general statements about performance but lacks the quantitative data and study design details requested in the prompt.
Therefore, many sections of your request cannot be fulfilled based on the
provided text.
Here is what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the document.
- Reported Device Performance:
- "The studies demonstrated that users can obtain blood glucose results that are substantially equivalent to current methods for blood glucose."
- "The System has a linear response to glucose from 10-600 mg/dL."
- "The results of in-house and clinical evaluations of the ASCENSIA™ DEX® 2 Diabetes Care System demonstrate that the device is equivalent in performance to the predicate devices and suitable of its intended use."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified.
- Data Provenance: "in-house and in clinical settings" - no country of origin is mentioned. The description "An evaluation...was studied..." suggests prospective data collection.
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 specified. The text mentions studies "by healthcare professionals and by persons with diabetes," but does not detail the role of experts in establishing ground truth or their qualifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified.
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 a blood glucose meter, not an AI-assisted diagnostic imaging device that uses "human readers." No MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The device itself is a standalone blood glucose meter. Its performance would be inherently "standalone" in the context of its direct measurement capabilities. The text states: "The ASCENSIA™ DEX® 2 Diabetes Care System consists of an electrochemical method-based meter and dry reagent sensor (test strips) designed for testing glucose..." The performance evaluation appears to be of the device's accuracy in measuring glucose values, which is its standalone function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The text states, "Blood glucose results are referenced to plasma glucose." This implies that a laboratory reference method for plasma glucose was used as the ground truth.
8. The sample size for the training set
- Not specified. (The document doesn't explicitly refer to "training sets" as it's not a machine learning device in the modern sense, but rather a traditional medical device.)
9. How the ground truth for the training set was established
- Not specified. (See 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.