(333 days)
The EasyPlus mini Self Monitoring Blood Glucose Monitoring System is intended for in vitro diagnostic use (outside of body). It is indicated to be used by professional healthcare personnel or diabetics at home to measure glucose concentration for aiding diabetes management. The glucose concentration is measured with quantitative capillary whole blood from the fingertip, and forearm by using Easy Plus mini Monitoring Blood Glucose Monitoring System. The device is not intended for testing neonate blood samples.
The EasyPlus mini Meter is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. EasyPlus mini Blood Glucose Test Strips must be used with the EasyPlus mini 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 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 Blood Glucose Test Strips must be used with the EasyPlus mini 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 Normal/High Control Solution is for use with the EasyPlus mini meter and EasyPlus mini Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results.
The EasyPlus mini Self Monitoring Blood Glucose System is comprised of the EasyPlus mini Meter, EasyPlus mini Blood Glucose Test Strips, Auto Lancet, Check strip, Code card and Normal/High Control solutions.
Here's a breakdown of the acceptance criteria and study information for the EasyPlus mini Self Monitoring Blood Glucose Test System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state the specific numerical acceptance criteria used (e.g., minimum accuracy percentages, specific bias limits). However, it broadly indicates that "A full array of in-house and clinical testing was done consistent with relevant FDA guidances for blood glucose monitoring systems." This implies that the device met the generally understood accuracy and performance requirements for a glucose meter at the time of submission.
Therefore, the table below reflects what is reported in the summary against the implied or general expectation of acceptance for such devices.
| Acceptance Criterion (Implied/General) | Reported Device Performance |
|---|---|
| Accuracy (Clinical Testing - Finger stick) | "Clinical testing included evaluation of accuracy for both finger stick..." (Implied: Met FDA guidance requirements for accuracy for capillary whole blood from the fingertip) |
| Accuracy (Clinical Testing - Alternate Site Testing) | "...and Alternate Site Testing." (Implied: Met FDA guidance requirements for accuracy for alternate site testing) |
| Interferences | "Bench testing included evaluation of interferences..." (Implied: Device demonstrated acceptable performance in the presence of common interfering substances or conditions as per FDA guidance.) |
| Sensitivity | "Bench testing included evaluation of ... sensitivity..." (Implied: Device was sufficiently sensitive to detect glucose within the relevant clinical range.) |
| Linearity | "Bench testing included evaluation of ... linearity..." (Implied: Device provided linear results across its intended measuring range.) |
| Reportable Range | "Bench testing included evaluation of ... reportable range..." (Implied: Device accurately measured glucose within its specified reportable range.) |
| Altitude Effects | "Bench testing included evaluation of ... altitude effects..." (Implied: Device maintained performance across tested altitude variations.) |
| Stability (Test Strips and System) | "Bench testing included evaluation of ... stability..." (Implied: Test strips and the overall system demonstrated acceptable stability over their shelf life and in-use period.) |
| Precision and Reproducibility | "Bench testing included evaluation of ... precision and reproducibility." (Implied: Device demonstrated acceptable levels of precision (repeatability) and reproducibility (between-device/operator variability) as per FDA guidance.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the exact sample size for the clinical test set. It only states that "Clinical testing included evaluation of accuracy for both finger stick and Alternate Site Testing."
- Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given the submitter's location (Taiwan), it's highly probable the studies were conducted there. The nature of clinical trials for blood glucose meters typically involves prospective data collection.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide details on the number of experts, their qualifications, or how they established ground truth for the clinical test set. For blood glucose meters, the ground truth is typically established by a laboratory reference method (e.g., spectrophotometric method like YSI 2300 STAT Plus Glucose & Lactate Analyzer) rather than expert consensus.
4. Adjudication Method for the Test Set
Not applicable. As ground truth for blood glucose meters is typically established by a reference laboratory method, there is no need for expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The provided text does not mention an MRMC comparative effectiveness study where human readers improve with or without AI assistance. This type of study is more common for diagnostic imaging AI devices, not for a self-monitoring blood glucose system.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, implicitly. The entire evaluation of the "EasyPlus mini Self Monitoring Blood Glucose Test System" as described (bench testing, clinical accuracy for finger stick and alternate site, etc.) represents the standalone performance of the device itself (meter + strips). There's no "human-in-the-loop" component in the sense of a diagnostic interpretation as there would be with an AI imaging tool. The device provides a quantitative measurement directly.
7. Type of Ground Truth Used
The document doesn't explicitly state the type of ground truth (e.g., YSI reference method) but for blood glucose meters, the ground truth is universally established by a laboratory reference method (e.g., an FDA-cleared laboratory analyzer known for high accuracy and precision, like a hexokinase reference method). It is not expert consensus, pathology, or outcomes data for accuracy evaluations.
8. Sample Size for the Training Set
Not applicable. This device is a measurement system (hardware + chemical strips), not an AI/machine learning algorithm requiring a "training set" in the computational sense. The device is calibrated during manufacturing and validated through rigorous testing.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of an AI algorithm for this device. The "ground truth" for calibration/development would be based on highly accurate reference solutions with known glucose concentrations.
§ 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.