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510(k) Data Aggregation
(430 days)
The A-CHECK DS-A Blood Glucose Monitoring System is used with DS-A Test Strips and 3-level Controls for the measurement of glucose in fresh capillary whole blood from the finger. Testing is done outside the body ( in vitro diagnostic use). It is indicated for use at home ( over the counter [OTC] ) by person with diabetes, or in clinical setting by health care professionals, as an aid to monitor the effectiveness of diabetes control. These are not intended for the diagnosis of or screening for diabetes mellitus, and are not intended for use on neonates.
The DS-A Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. DS-A Test Strips must be used with the A-CHECK DS-A Blood Glucose Monitoring System. Testing is done outside the body (In Vitro diagnostic use). Thev 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. These are not intended for the diagnosis of or screening for diabetes mellitus, and are not intended for use on neonates.
The Alliance Blood Glucose 3 levels Control Solution are for use with the A-CHECK DS-A Blood Glucose Monitoring System and DS-A Test Strips as a quality control check to verify the accuracy of blood glucose test results.
Based on an electrochemical biosensor technology and the principle of capillary action, DS-A Blood Glucose Monitoring System only needs a small amount of blood. Capillary action at the end of the test strip draws the blood into the action chamber and your blood glucose result is precisely and is displayed in 6 seconds.
The Draw-In blood glucose test strip is designed to provide an easy, accurate method for the determination of blood glucose in fingertip capillary whole blood. When the blood is applied to the edge of reaction zone, the blood is drawn into the reaction chamber and will display a reading on the meter. Only a small amount of blood is needed. The test strip for the quantitative measurement of blood glucose in the range is from 20-600 mg/dL (1.1-33.3 mmol/L).
This document describes the DS-A Blood Glucose Monitoring System and its adherence to acceptance criteria, supported by various studies.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for blood glucose monitoring systems typically involve accuracy compared to a laboratory reference method. The document presents results based on "lay user" (home user) and "professional" (clinical setting) studies, comparing the device to the YSI 2300 STAT Plus 1M glucose analyzer.
Acceptance Criteria (Commonly accepted for Blood Glucose Monitors):
- For Glucose Concentration < 75 mg/dL (4.2 mmol/L):
- ≥95% of results within ±15 mg/dL of the reference method.
- For Glucose Concentration ≥ 75 mg/dL (4.2 mmol/L):
- ≥95% of results within ±15% of the reference method.
Reported Device Performance (from the provided studies):
A. For Home Users (Lay User Study):
| Glucose Concentration | Acceptance Criteria (≥95% within range) | Reported Device Performance | Meets Criteria? |
|---|---|---|---|
| < 75 mg/dL | Within ± 15 mg/dL | 18/18 (100%) | Yes |
| Within ± 10 mg/dL | 18/18 (100%) | Yes | |
| Within ± 5 mg/dL | 15/18 (83.3%) | No | |
| ≥ 75 mg/dL | Within ± 15% | 131/132 (99.2%) | Yes |
| Within ± 10% | 129/132 (98%) | Yes | |
| Within ± 5% | 83/132 (62.9%) | No |
B. For Professionals (Accuracy Study):
| Glucose Concentration | Acceptance Criteria (≥95% within range) | Reported Device Performance | Meets Criteria? |
|---|---|---|---|
| < 75 mg/dL | Within ± 15 mg/dL | 32/32 (100%) | Yes |
| Within ± 10 mg/dL | 25/32 (78.1%) | No | |
| Within ± 5 mg/dL | 16/32 (50.0%) | No | |
| ≥ 75 mg/dL | Within ± 15% | 136/146 (93.2%) | No (slightly below) |
| Within ± 10% | 124/146 (84.9%) | No | |
| Within ± 5% | 102/146 (69.9%) | No | |
| Note: The "For Professionals" study shows the device did not meet the ≥95% within ±15% acceptance criteria for glucose concentrations ≥ 75 mg/dL. This might indicate a discrepancy or less stringent criteria were applied for approval. |
Precision (Repeatability) Study Results:
| Glucose Concentrations (mg/dL) | AVG (mg/dL) | S.D. (mg/dL) | C.V.% |
|---|---|---|---|
| 40 | 42 | 2.5 | 5.9% |
| 80 | 88 | 4.8 | 4.4% |
| 120 | 133 | 7.5 | 4.0% |
| 200 | 211 | 5.1 | 2.3% |
| 300 | 329 | 8.8 | 2.5% |
2. Sample Size and Data Provenance
- Test Set for Lay User Study: 150 patients.
- Test Set for Professional Accuracy Study: 178 patients.
- Test Set for Precision Study: 40 tests per glucose concentration level (40, 80, 120, 200, 300 mg/dL), using oxygenated Heparin-venous blood.
- Data Provenance: The document does not explicitly state the country of origin for the patient data for the lay user and professional accuracy studies, but the manufacturer is from Taiwan, ROC. The studies appear to be prospective clinical studies where human blood samples were tested.
3. Number of Experts and their Qualifications for Ground Truth
The document does not explicitly state the number of experts or their qualifications used to establish the ground truth. However, the reference method used for comparison is the YSI 2300 STAT Plus 1M glucose analyzer, which is a widely accepted laboratory reference instrument for measuring blood glucose. This implies that the 'ground truth' is established by a highly accurate laboratory method, overseen by laboratory professionals, rather than by human expert consensus (e.g., radiologists, pathologists).
4. Adjudication Method for the Test Set
Not applicable. The ground truth is established by a reference laboratory instrument (YSI 2300), not by human interpretation or consensus that would require an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not performed. This study focuses on the standalone performance of a medical device (blood glucose monitor) compared to a reference standard, not on the comparative effectiveness of human readers with or without AI assistance. Therefore, there is no effect size reported for human readers.
6. Standalone (Algorithm Only) Performance Study
Yes, a standalone study was performed. The device, the DS-A Blood Glucose Monitoring System, was tested on its own to measure blood glucose levels, and its readings were directly compared to the YSI 2300 reference analyzer. The "Lay User" and "Accuracy" sections provide these standalone performance metrics.
7. Type of Ground Truth Used
The ground truth used was laboratory reference method data, specifically readings from the YSI 2300 STAT Plus 1M glucose analyzer. This instrument is an established device for highly accurate glucose measurement in a controlled laboratory setting.
8. Sample Size for the Training Set
The document does not specify a separate "training set" or its sample size. This type of device (blood glucose monitor) likely does not involve machine learning algorithms that require a distinct training phase with labeled data in the same way an AI diagnostic tool would. The studies described are validation studies for the finished product.
9. How the Ground Truth for the Training Set Was Established
As there is no explicit training set mentioned for an AI/ML algorithm, this question is not directly applicable. If developmental testing was done, the ground truth would have similarly been established against a highly accurate laboratory reference method (like the YSI 2300) during the design and development phases of the device.
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