Search Results
Found 1 results
510(k) Data Aggregation
(157 days)
The Easy Pain Supreme Self-Monitoring Blood Glucose System is used by individuals with diabetes. It is for the quantitative measurement of glucose levels in fresh capillary whole blood, as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings.
The Easy Pain Supreme Self-Monitoring Blood Glucose System consists of the Easy Pain Supreme meter, Easy Pain Supreme Glucose Test Strips, Auto-Lancet Device, Check Strip, Code Card, and Control Solution.
Here's a detailed breakdown of the acceptance criteria and the study proving the device meets them, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance:
The 510(k) summary does not explicitly state formal "acceptance criteria" in a separate section. Instead, the performance characteristics are presented as findings from analytical and comparison studies. The implicit acceptance criteria are that the device's performance should be comparable to or within acceptable limits relative to the predicate device and established analytical standards. Below is a summary of the key performance metrics reported:
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Analytical Performance | ||
| Precision (Within-Run) | Low CV% for various glucose concentration levels. (Generally, CV% < 5% is good for low concentrations, higher for higher concentrations) | Level 1 (40-50 mg/dL): CV 4.3% |
| Level 2 (51-110 mg/dL): CV 3.5% | ||
| Level 3 (111-150 mg/dL): CV 3.3% | ||
| Level 4 (151-250 mg/dL): CV 3.1% | ||
| Level 5 (251-400 mg/dL): CV 3.3% | ||
| Precision (Day-to-Day) | Low CV% for control solutions. | Low (56 mg/dL): CV 5.6% |
| Normal (129 mg/dL): CV 3.5% | ||
| High (388 mg/dL): CV 2.6% | ||
| Linearity/Reportable Range | Demonstration of linear relationship between measured and actual glucose concentrations over the claimed range. R² close to 1.0. | Range: 40-600 mg/dL (2.2-33.3 mmol/L) |
| Regression: Y=0.9589x + 6.1617 | ||
| R² = 0.9958 | ||
| Syx = 10.14 | ||
| Traceability | Referenced to recognized standards. | Referenced to NBS, NIST Standards (via CAS# and MDL# Glucose). |
| Detection Limit | Stated range of measurement. | 40-600 mg/dL (2.2-33.3 mmol/L) |
| Analytical Specificity | Minimal effect from tested interferents. | Interference testing conducted, results imply acceptable specificity (no specific values given to compare against for this summary). |
| Method Comparison with Predicate Device | High correlation with a reference method (YSI 2300 Analyzer), slope close to 1.0, y-intercept close to 0. | Slope = 0.967 |
| Y-intercept = 11.98 mg/dL | ||
| Correlation coefficient (r) = 0.972 | ||
| Range tested = 33-514 mg/dL |
2. Sample Size Used for the Test Set and Data Provenance:
- Analytical Performance (Precision/Reproducibility):
- Within-Run Precision: 5 different glucose concentration levels were tested. Each sample was measured 5 times. The table indicates "No. of Assay" as 200 for each level, suggesting that for each level, a concentration was prepared, and then multiple aliquots were tested (possibly 5 tests on each of 40 separate preparations or 40 tests on each of 5 preparations, or a combination).
- Day-to-Day Precision: 3 control solutions (Low, Normal, High) were measured twice a day for a month. The "No. of Assay" is 400 for each control solution, indicating a substantial number of measurements over time.
- Data provenance: Not explicitly stated, but implies laboratory-controlled experiments.
- Linearity/Assay Reportable Range:
- A total of 210 tests were performed using 5 meters across seven glucose ranges. The regression analysis (N=630) suggests that each test might have involved multiple data points contributing to the regression calculation, or that 'N' refers to the total number of individual measurements collected across all meters and ranges.
- Data provenance: Not explicitly stated, but implies laboratory-controlled experiments.
- Method Comparison with Predicate Device:
- Sample Size: 202 subjects with diabetes.
- Data Provenance: The study involved human subjects, implying prospective clinical data collection for this comparison. The statement "derived from a three independent capillary data versus YSI plasma data" suggests data was collected from patients, likely in a clinical setting. Country of origin not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- No information provided about "experts" to establish ground truth in the traditional sense.
- For the analytical and method comparison studies, the "ground truth" was established by:
- Carefully prepared glucose solutions with known concentrations (for precision and linearity).
- The YSI 2300 Analyzer a recognized laboratory reference method, served as the ground truth for the method comparison study. The qualifications of the operators of the YSI 2300 Analyzer are not specified, but it's presumed to be a standard laboratory procedure with qualified personnel.
4. Adjudication Method for the Test Set:
- Not applicable / not mentioned. Since this device is a quantitative blood glucose measuring system, ground truth (reference values) are obtained through precise laboratory methods (YSI 2300 Analyzer, known glucose concentrations) rather than expert interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a self-monitoring blood glucose system, not an AI-powered diagnostic imaging tool that would typically involve human "readers" or MRMC studies. Its function is to provide a numerical measurement, not an interpretation of complex data.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in essence, this is a standalone device. The performance characteristics (precision, linearity, method comparison) are evaluating the device's direct measurement capabilities. While it's used by individuals with diabetes (human-in-the-loop for using the device), the "performance" described relates solely to the accuracy and reliability of the device's output, independent of human interpretation beyond simply reading the displayed number. The YSI 2300 comparison directly assesses the algorithm/system's ability to match a reference.
7. The Type of Ground Truth Used:
- Analytical Ground Truth:
- Known glucose concentrations for precision and linearity studies (i.e., preparing solutions with specific, verifiable glucose levels).
- YSI 2300 Analyzer results for the method comparison study. The YSI 2300 is considered a laboratory reference method.
8. The Sample Size for the Training Set:
- Not applicable or Not explicitly stated as a separate "training set". This type of medical device (blood glucose meter) typically undergoes rigorous analytical testing and clinical comparison, but the internal algorithms (e.g., for converting electrochemical signal to glucose concentration) are often developed, calibrated, and validated through extensive in-house data and engineering processes rather than a distinct "training set" in the machine learning sense for submission. The provided summary focuses on validation data.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable or Not explicitly detailed. As mentioned above, the development and calibration of the device's internal algorithms would likely use established chemical principles and controlled experiments with known glucose concentrations, similar to how the analytical ground truth was established for the performance studies. However, the exact process for "training" or calibrating the device during its development phase is not outlined in this 510(k) summary.
Ask a specific question about this device
Page 1 of 1