(48 days)
The easy check TD-4209/Clever Chek TD-4222/Clever Chek TD-4225/Clever Chek TD-4226 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the palm, the forearm, the upper-arm, the calf and the thigh. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
The alternative site testing in the easy check TD-4209/Clever Chek TD-4222/Clever Chek TD-4225/Clever Chek TD-4226 Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.
Not Found
This FDA 510(k) clearance letter pertains to a Blood Glucose Monitoring System, not an AI-powered diagnostic device. Therefore, the requested information regarding AI-specific criteria (such as multi-reader multi-case studies, expert consensus on ground truth for AI, etc.) is not applicable to this document.
However, I can extract information related to the device's intended use and the regulatory approval process. There is no study data or acceptance criteria reported within this document itself, as it is solely the FDA's clearance letter. The letter refers to information provided in the 510(k) submission (which is not included here).
Here's an attempt to answer the applicable parts of your request based on the provided document and general understanding of medical device clearance:
1. A table of acceptance criteria and the reported device performance
- Not provided in the document. This document is a clearance letter, not the submission with the study results. For blood glucose monitoring systems, acceptance criteria typically relate to accuracy standards (e.g., ISO 15197 standards for analytical accuracy) comparing the device's measurements to a laboratory reference method. The "reported device performance" would be the results of the studies demonstrating compliance with these accuracy standards.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided in the document. This information would be in the 510(k) submission's study reports.
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 / Not provided. For a blood glucose meter, the "ground truth" is typically established by comparing the device's readings to highly accurate laboratory reference methods (e.g., using a YSI glucose analyzer), not through expert interpretation of images or other subjective assessments.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. Adjudication methods are typically used in studies involving subjective interpretation (e.g., radiology reads) where multiple experts review cases and resolve discrepancies. For a quantitative device like a blood glucose meter, the ground truth is a numerical value from a reference method.
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 device is a standalone blood glucose monitoring system, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, implicitly. A blood glucose meter operates as a standalone device. The "algorithm" here is the chemical reaction and electronic measurement process within the device. Its performance is evaluated independently against a reference method.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Likely a highly accurate laboratory reference method. For blood glucose meters, the ground truth is established by obtaining blood glucose measurements using a YSI glucose analyzer or a similar highly precise and accurate laboratory-based method.
8. The sample size for the training set
- Not applicable / Not provided. Blood glucose meters typically do not involve a "training set" in the context of machine learning algorithms. The device is calibrated during manufacturing and its performance validated through clinical studies.
9. How the ground truth for the training set was established
- Not applicable. 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.