Search Results
Found 1 results
510(k) Data Aggregation
(306 days)
The EasyMax T1 Pro Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. Testing is done outside the body (In Vitro diagnostic use). It is indicated for multiple-patient use in a professional healthcare setting, as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use lancing devices. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can be only used during steady-state blood qlucose conditions.
The system consists of the EasyMax T1 Pro Meter and the EasyMax T1 Pro Blood Glucose Test Strips. The EasyMax T1 Pro Meter is only used with the EasyMax T1 Pro Blood Glucose Test Strips to quantitatively measure glucose in fresh capillary whole blood samples drawn from fingertips.
The EasyMax T1 Self Monitoring Blood Glucose 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 a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can be only used during steady-state blood glucose conditions.
The system consists of the EasyMax T1 Meter and the EasyMax T1 Blood Glucose Test Strips. The EasyMax T1 Meter is only used with the EasyMax T1 test strips to quantitatively measure glucose in fresh capillary whole blood samples drawn from fingertips or forearm.
The system consists of the EasyMax T1 Pro Meter and the EasyMax T1 Pro Blood Glucose Test Strips. The EasyMax T1 Pro Meter is only used with the EasyMax T1 Pro Blood Glucose Test Strips to quantitatively measure glucose in fresh capillary whole blood samples drawn from fingertips.
The system consists of the EasyMax T1 Meter and the EasyMax T1 Blood Glucose Test Strips. The EasyMax T1 Meter is only used with the EasyMax T1 test strips to quantitatively measure glucose in fresh capillary whole blood samples drawn from fingertips or forearm.
Acceptance Criteria and Study for EasyMax TI Self Monitoring Blood Glucose System
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (CliniLabs Guidelines) | Reported Device Performance (EasyMax TI System) |
|---|---|
| ≥ 95% of results within ± 15 mg/dL or ± 15% of reference for glucose concentrations < 75 mg/dL or ≥ 75 mg/dL, respectively. | 97.4% of results within ± 15 mg/dL or ± 15% across all sites. |
| ≥ 98% of results within ± 20 mg/dL or ± 20% of reference for glucose concentrations < 75 mg/dL or ≥ 75 mg/dL, respectively. | 100% of results within ± 20 mg/dL or ± 20% across all sites. |
2. Sample Size and Data Provenance for Test Set
The document provided does not explicitly state the sample size of the test set for the clinical study. It also does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. However, it does mention "all sites," suggesting a multi-center study.
3. Number of Experts and Qualifications for Ground Truth
The document provided does not specify the number of experts used to establish the ground truth for the test set or their qualifications. Given that the ground truth is established by a "reference method," it implies the use of a highly accurate, laboratory-based glucose measurement technique, which would inherently be overseen by qualified laboratory personnel.
4. Adjudication Method for the Test Set
The document provided does not specify an adjudication method for the test set beyond comparing device results to a "reference method." This implies a direct comparison rather than an expert consensus or multi-reader adjudication process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study was mentioned. The study focuses on the standalone performance of the blood glucose monitoring system against a reference method.
6. Standalone Performance Study
Yes, a standalone study was performed. The study evaluates the EasyMax TI Self Monitoring Blood Glucose System's accuracy by comparing its results directly to a reference method, without human readers "in the loop" to interpret or intervene with the device's output.
7. Type of Ground Truth Used
The ground truth used was a reference method. The document states that the EasyMax TI system's results were compared against an "enzymatic (YSI) reference method" to establish accuracy.
8. Sample Size for the Training Set
The document provided does not mention details about a training set or its sample size. This is common for studies evaluating the accuracy of a medical device against a reference standard, as these devices typically operate based on established chemical or enzymatic reactions rather than machine learning models that require extensive training data.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned or implied for this type of device, the method for establishing its ground truth is not applicable in this context.
Ask a specific question about this device
Page 1 of 1