(23 days)
The Clever Chek TD-4230/ SureChek 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 Clever Chek TD-4230/ SureChek Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.
Not Found
The provided document is an FDA 510(k) clearance letter for the Clever Chek TD-4230 Blood Glucose Monitoring System and SureChek Blood Glucose Monitoring System. It explicitly states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain the detailed study results, acceptance criteria, or performance data that would allow a complete answer to your request.
Specifically, the document lacks information regarding:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, and ground truth establishment for a test set.
- Information about expert involvement for ground truth or adjudication methods.
- MRMC studies, effect sizes, or standalone algorithm performance.
- Training set details.
Therefore, based solely on the provided text, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method for the test set
- 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
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
§ 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.