Search Results
Found 1 results
510(k) Data Aggregation
(119 days)
microdot Blood Glucose Monitoring System is intended for self testing of glucose in capillary whole blood by persons with diabetes or by health care professionals in home settings or healthcare facilities. It is intended for monitoring of blood glucose levels only.
microdot Blood Glucose Meter The microdot Blood Glucose Meter is intended for the quantitative measurement r fromlers in fresh capillary whole blood from a fingerstick. It is intended for use by persons with diabetes or by health care professionals in home settings or healthcare facilities. It is intended for monitoring of blood glucose levels only.
microdot Test Strips The microdot Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood from a fingerstick. It is intended for use by o grassowith diabetes or by health care professionals in home settings or healthcare facilities. It is intended for monitoring of blood glucose levels only.
microdot Control solutions miorodot oontrol solutions are intended for use with microdot Blood Glucose Meter and microdot Test Strips as a quality control check to verify the accuracy of the blood glucose test results.
The microdot® Blood Glucose System is comprised of the microdot® Meter, Test Strips, & three controls. The test strip is inserted into the device, a drop of blood is added to the strip, and a glucose result is presented in 10 seconds.
The test principle is based on electrochemical biosensor technology. Glucose dehydrogenase converts to glucose to gluconolactone, with reduction of NAD to NADH. Re-oxidation of the mediator by the meter induces a micro current to flow, and the size of the micro current is directly proportional to the amount of glucose in the blood. The micro current is detected in of the blood glucose concentration.
The provided document describes the microdot® Blood Glucose Monitoring System and its performance studies. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" for accuracy in the same way modern regulatory submissions do (e.g., ISO 15197:2013). However, it reports on several performance metrics that demonstrate its equivalence to a predicate device and its overall functionality. Given the context of the comparison to the predicate device and the non-clinical and clinical study results, the implied acceptance criterion for accuracy is a strong correlation with a reference method and acceptable bias within a specified hematocrit range.
| Performance Metric | Acceptance Criteria (Implied/Direct) | Reported Device Performance |
|---|---|---|
| Accuracy (Clinical Study) | Strong correlation with YSI reference method and similar performance to predicate device. | Regression equation for microdot® vs. YSI: y = 1.0055x + 0.7776, r = 0.982 (when tests carried out by healthcare professionals).Predicate (One Touch® Ultra™) vs. YSI: y = 0.9705x - 1.3727, r = 0.988. |
| Linearity | High correlation coefficient (r > 0.99) across the measuring range. | Venous blood spiked with glucose (20 to 520 mg/dL):- Lot 1: slope = 0.93, r = 0.996- Lot 2: slope = 0.94, r = 0.996 |
| Precision (Within-run CV%) | Low coefficient of variation (CV%) at various glucose concentrations. Specific criteria not defined, but generally <5% at higher concentrations and acceptable at lower concentrations to demonstrate reliability. | 20 readings with glucose spiked venous blood (one day study):- 5.48 % at 43 mg/dL- 4.01% at 81 mg/dL- 3.31% at 124 mg/dl- 2.91% at 197 mg/dL- 2.9% at 296 mg/dL |
| Hematocrit Effects (Bias) | ≤± 15 mg/dL for samples below 75 mg/dL and ≤±20% for samples above 75 mg/dL. | Tested over 30% to 50% hematocrit range at nominal glucose concentrations of 60, 150, 250, and 400 mg/dL.The results shown that in the range 30-50%, the bias criteria of ≤± 15 mg/dL for samples below 75 mg/dL and ≤±20% for samples above 75 mg/dL is met. (There is a positive bias at low hematocrit and a negative bias at high hematocrit, but still within criteria). |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions 121 diabetic patients for the clinical study.
The provenance of the data is not explicitly stated in terms of country of origin. The study is described as a "clinical study," implying a prospective design, but it's not explicitly labeled as prospective or retrospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The ground truth for the test set in the clinical study was established using the YSI reference method. This is an automated laboratory analyzer for measuring glucose and does not involve human experts in establishing the ground truth directly for each measurement. The measurements were "carried out by healthcare professionals," but their role was in performing the glucose tests, not in establishing the ground truth itself.
4. Adjudication Method for the Test Set
Not applicable. Ground truth was established by an automated reference method (YSI), not through expert consensus 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 blood glucose monitoring system, not an AI-assisted diagnostic imaging or analysis tool that typically involves human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the performance data presented (linearity, precision, hematocrit effects, and the YSI comparison in the clinical study) represents the standalone performance of the microdot® Blood Glucose Monitoring System. While "healthcare professionals" performed the tests in the clinical study, they were operating the device as intended, not providing an interpretation that the algorithm then validated or assisted with. The system itself provides the glucose reading.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The type of ground truth used was a reference laboratory method, specifically the YSI reference method, which is a highly accurate and standardized method for glucose measurement.
8. The Sample Size for the Training Set
The document refers to performance studies and a clinical study, but does not explicitly mention a "training set" or "validation set" in the context of machine learning. Blood glucose meters are typically calibrated during manufacturing, and their performance is then validated through studies like those described. The data from the linearity, precision, and hematocrit studies contribute to understanding the device's inherent performance.
9. How the Ground Truth for the Training Set Was Established
As no "training set" in the machine learning sense is explicitly described, this question is not fully applicable. However, the ground truth for establishing the device's fundamental performance characteristics (like linearity and precision) would have been based on controlled samples with known glucose concentrations, likely verified by reference laboratory methods.
Ask a specific question about this device
Page 1 of 1