(28 days)
The UltraTRAK PRO 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 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 UltraTRAK PRO Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.
Not Found
This FDA 510(k) summary does not contain the detailed information required to describe the acceptance criteria and the study proving the device meets them in the format requested. The document is a clearance letter for a medical device (UltraTRAK PRO Blood Glucose Monitoring System), stating that it has been found substantially equivalent to a predicate device. While it mentions regulatory numbers and product codes, it does not provide the specific performance data, study design, or ground truth establishment details.
Therefore, I cannot fulfill your request to create the table and provide the specific information about:
- A table of acceptance criteria and the reported device performance: This document does not include a table comparing acceptance criteria to performance data.
- Sample sizes used for the test set and the data provenance: Not mentioned in this document.
- Number of experts and their qualifications: Not mentioned in this document.
- Adjudication method: Not mentioned in this document.
- MRMC comparative effectiveness study: This is for a blood glucose monitor, not typically an AI-assisted diagnostic imaging device, so this type of study is unlikely to be relevant or present.
- Standalone performance: While the device performs standalone, the specific metrics of its standalone performance are not detailed here.
- Type of ground truth used: Not mentioned in this document. For a blood glucose monitor, ground truth would typically be a laboratory reference method (e.g., YSI analyzer), but this document doesn't specify.
- Sample size for the training set: Not mentioned in this document. (Blood glucose monitors usually don't have "training sets" in the AI sense; they are calibrated devices).
- How the ground truth for the training set was established: Not mentioned.
Summary of available information related to your request:
- Device Name: UltraTRAK PRO Blood Glucose Monitoring System
- Intended Use: Quantitative measurement of glucose in fresh capillary whole blood (finger, palm, upper-arm, calf, thigh) for healthcare professionals and people with diabetes mellitus at home. Not for diagnosis or screening, and not for neonates. Alternative site testing only during steady-state blood glucose conditions.
- Regulatory Class: Class II
- Regulation Number/Name: 21 CFR 862.1345, Glucose Test System.
- Product Codes: NBW, CGA
- FDA Determination: Substantially Equivalent to a legally marketed predicate device.
To obtain the information you requested, one would typically need to consult the full 510(k) submission, which is often more extensive than the clearance letter provided here.
§ 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.