(212 days)
The EasyPlus mini R2N Self Monitoring Blood Glucose 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 R2N Meter is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. EasyPlus mini R2N Blood Glucose Test Strips must be used with the EasyPlus mini R2N Meter. 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 R2N 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 R2N Blood Glucose Test Strips must be used with the EasyPlus mini R2N 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.
The EasyPlus mini R2N Glucose Normal/High Control Solution For use with the EasyPlus mini R2N meter and EasyPlus mini R2N Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results.
Special conditions for use statement(s):
For Over-the-Counter use. Not for use with newborns.
Alternate site testing (AST) can only be used during steady-state blood glucose conditions. AST (forearm) should only be performed under the following conditions:
Testing before a meal
In a fasting state
Two hours or more after a meal
Two hours or more after insulin dosing
Two hours after physical activity
Special instrument requirements:
EasyPlus mini R2N Blood Glucose Meter
The EasyPlus mini R2N Self-Monitoring Blood Glucose System consists of the EasyPlus mini R2N Blood Glucose Meter, EasyPlus mini R2N Glucose Test Strips, Auto-Lancet Device, Check Strip and Control Solution (Please refer to the IFU for the product picture).
Here's a breakdown of the acceptance criteria and study details for the EasyPlus mini R2N Self Monitoring Glucose Test System, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance:
The primary acceptance criteria are based on ISO 15197:2003 for In Vitro Diagnostic Test Systems — Requirements for Blood Glucose Monitoring Test Systems for Self-Managing Diabetes Mellitus. This standard specifies acceptable limits for accuracy when comparing the device's readings to a reference method (YSI 2300D analyzer).
| Acceptance Criteria (ISO 15197) | Reported Device Performance (EasyPlus mini R2N) |
|---|---|
| 95% of individual glucose results falling within ±15 mg/dL of the reference method for glucose concentrations 75 mg/dL | Max bias for 20-60% hematocrit range generally falls within these limits. (E.g., Lot 012072901: -1.18% to -4.61% for 20-50% Hct, -0.47% for 60% Hct. Lot 012072701: -0.45% to -3.97% for 20-50% Hct, -0.59% for 60% Hct. Note: 0% and 70% hematocrit show higher biases but are outside the claimed range.) |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size (Clinical/Method Comparison): 165 total samples (156 diabetes patients + 9 spiked/glycolyzed samples) were used for the accuracy/method comparison studies across 3 sites.
- Data Provenance: The document implies the study was conducted in Taiwan, R.O.C. (submitter's address). The study appears to be prospective, as it involved participants performing finger-stick and forearm blood draws for testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- The ground truth for the test set was established using a YSI 2300D analyzer. This is a laboratory reference method, implying that the "experts" are the lab technicians operating and validating the YSI instrument, rather than medical experts interpreting images or clinical data. Their qualification would be in operating and calibrating such laboratory equipment. The document states: "Calibrate YSI 2300D analyzer before its use and the calibrators are manufactured gravimetrically and provided from the instrument supplier. Execute the validation of YSI 2300D analyzer by using this international standard reference material (NIST 965a) every year."
4. Adjudication Method for the Test Set:
- None specified in the traditional sense of expert adjudication for diagnostic opinions. The "ground truth" is a quantitative measurement from a reference laboratory instrument (YSI 2300D). Discrepancies would be handled through statistical comparison rather than an adjudication process between experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What Was the Effect Size?
- No, an MRMC comparative effectiveness study was not done. This device is a blood glucose meter, not an imaging device or a system requiring human interpretation of complex data. The study compares the device's measurements to a reference instrument and examines performance by lay users vs. professionals.
- However, the study did compare professional vs. lay users for various sample collection sites. For example:
- Finger vs YSI: Lay users (Y=1.0307X-2.8876, R2=0.9471) vs. Professionals (Y=1.0470X-3.9092, R2=0.9540).
- Forearm vs Finger: Lay users (Y=0.9410X+15.266, R2=0.9163) vs. Professionals (Y=0.9144X+16.121, R2=0.9448).
- While not an MRMC study in the imaging sense, these comparisons explore the effectiveness of the device with different types of users. There isn't an "effect size of how much human readers improve with AI vs without AI assistance" as it's not an AI-assisted interpretation task.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- Yes, a standalone study was done. The core performance evaluation (accuracy against YSI) directly assesses the device's (meter + strip) ability to measure glucose concentrations accurately. While human users collect the sample and operate the device, the "performance" itself relates to the analytical output of the system compared to the reference.
- The "Within-run" and "Day-to-Day Precision" studies, "Linearity/assay reportable range," "Traceability," and "Detection limit" are all analytical performance studies of the device itself (standalone).
7. The Type of Ground Truth Used:
- Expert Reference Method: The ground truth for the clinical accuracy studies (method comparison) was obtained using a YSI 2300D analyzer, which is a laboratory-grade glucose reference method.
- For the precision and linearity studies, the ground truth was venous blood samples with glucose added to achieve specific target concentrations, implying a gravimetrically prepared or precisely measured reference.
8. The Sample Size for the Training Set:
- The document describes performance studies, not the development or training of an AI algorithm. Therefore, there is no "training set" in the context of machine learning provided in this 510(k) summary. The device is an electrochemical biosensor, not an AI/ML-based diagnostic.
9. How the Ground Truth for the Training Set Was Established:
- As there is no AI/ML training set, this question is not applicable.
§ 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.