(30 days)
The EasyPlus mini MasterDriver SMBG Test System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
The EasyPlus mini MasterDriver Meter is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. EasyPlus mini MasterDriver Blood Glucose Test Strips must be used with the EasyPlus mini MasterDriver Meter. Testing is done outside the body (In Vitro diagnostic use). They are indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
The EasyPlus mini MasterDriver Blood Glucose Test Strips, are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. EasyPlus mini MasterDriver Blood Glucose Test Strips must be used with the EasyPlus mini MasterDriver Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). They are indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
EasyPlus mini MasterDriver Glucose Control Solutions: For use with the EasyPlus mini MasterDriver meter and EasyPlus mini MasterDriver Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results.
Not Found
I'm sorry, but I cannot fulfill your request to describe the acceptance criteria and study proving device performance based on the provided text. The document is an FDA 510(k) clearance letter for the "EasyPlus Mini MasterDriver SMBG System," which acknowledges the device is substantially equivalent to a predicate device.
This document does not contain the following information that you requested:
- A table of acceptance criteria and reported device performance: The letter states the device is "substantially equivalent," but does not provide specific performance metrics or acceptance criteria for the new device.
- Sample sizes used for the test set and data provenance: This information is not included in the clearance letter.
- Number of experts and their qualifications for ground truth: This detail is absent.
- Adjudication method for the test set: Not mentioned.
- Multi-reader multi-case (MRMC) comparative effectiveness study information: Not discussed.
- Standalone (algorithm only) performance: Not relevant for a glucose meter.
- Type of ground truth used: Not specified.
- Sample size for the training set: This is typically for algorithms; a glucose meter relies on physical calibration and validation, not a "training set" in the AI sense.
- How ground truth for the training set was established: Not applicable for this type of device in the context of AI.
The letter does provide:
- Device Name: EasyPlus Mini MasterDriver SMBG System
- Indications for Use: Quantitative measurement of glucose in fresh capillary whole blood samples from fingertips or forearm, for use at home (OTC) by persons with diabetes or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
To find the information you're looking for, you would typically need to review the 510(k) summary document or the full 510(k) submission, which are often publicly available on the FDA website for cleared devices. These documents would contain the detailed study protocols, results, and justification for the substantial equivalence determination.
§ 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.