(151 days)
The Clever Chek TD-3213 Blood Glucose and Blood Pressure Measurement System is intended for in vitro diagnostic use.
The system is intended to be used for the quantitative measurement of glucose in capillary whole blood from the fingertip. 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 not intended for use on neonates.
The system is also intended to be used to measure non-invasively the systolic and diastolic blood pressure and pulse rate of an adult individual, over age 16, at home by using a technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 5.25"~7.75".
The CLEVER CHEK TD-3213TM blood glucose and blood pressure measurement system consists of a meter with wrist cuff and test strips. The system utilizes an electrochemical method-based meter and dry reagent biosensor (test strips) for blood glucose testing. The size of the current is proportional to the amount of glucose present in the sample, providing a quantitative measurement of glucose in fresh whole blood and control solutions. Also, the system adopts the "oscillometric method" to as the measuring principle and provides the measurement of the systolic and diastolic blood pressure and heart rate of an individual by using a non-invasive technique in which as inflatable cuff is wrapped around the wrist. The pressure sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to determine the systolic and diastolic blood pressure and calculating pulse rate.
I am unable to provide a comprehensive response as the provided text only offers a high-level summary of the device and its intended use, rather than a detailed performance study. The document states "The performance of the CLEVER CHEK TD-3213™ system was studied in the laboratory and in clinical settings by healthcare professionals and lay users. The studies demonstrated that the CLEVER CHEK TD-3213TM system is suitable for its intended use" and "The CLEVER CHEK TD-3213™ system demonstrates satisfactory performance and is suitable for their intended uses," but it does not include any specific data, acceptance criteria, sample sizes, or methodologies of these studies.
Therefore, I cannot extract the following information to populate the table and answer your questions:
- A table of acceptance criteria and the reported device performance
- Sample sizes used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method for the test set
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human reader improvement with AI vs. without AI assistance. (This device is a blood glucose and blood pressure measurement system and does not mention any AI component, hence this question is likely not applicable).
- Whether a standalone (algorithm only) performance study was done. (Again, this device does not mention an algorithm in the context of interpretation beyond basic measurement).
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The sample size for the training set
- How the ground truth for the training set was established
To provide a complete answer to your request, the full performance study report (or at least a detailed summary of its findings, acceptance criteria, and methodology) would be required.
§ 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.