(62 days)
The Liberty™ Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (in vitro diagnostic use). It is indicated for use in the home by persons with diabetes as an aid to monitor the effectiveness of diabetes control.
The Liberty™ Blood Glucose Monitoring System consists of the following elements: test strips; a battery operated, portable, compact meter; and a control solution.
Instrument Operating Principle: photometric
Reagent Test Principle: glucose oxydase
The Liberty™ System is based on photometric biosensor technology. The test strip is first inserted into the meter and the meter is switched on by pressing the "ON" button. A code number will appear on the display that should match the code on the vial of strips. An icon showing a flashing drop near the end of a test strip will appear on the display to prompt the user to apply a drop of blood. When a drop of blood is applied to the top of the strip at the mesh-filled target area, it flows into the membrane and starts the measurement. This is indicated on the display by a moving bar. After approximately 30 seconds, a glucose reading is displayed on the meter. The reading is stored in the meter memory with a date and time.
The Liberty™ System uses a photometric test strip that includes glucose oxidase to generate a color reaction that is proportional to the concentration of glucose in the sample.
I am sorry, but the provided text does not contain sufficient detail to fully address all parts of your request regarding acceptance criteria and a study proving device performance as it pertains to AI/ML devices. The document seems to be a 510(k) summary for a blood glucose monitoring system, and the information provided is typical for such a submission for a non-AI/ML device.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides performance characteristics for the Liberty™ System and compares them to a predicate device (Accu-Chek Simplicity). Since this is not an AI/ML device, the acceptance criteria are not explicitly stated in terms of model performance metrics (like sensitivity, specificity, AUC). Instead, the performance is reported as correlation and precision data against a laboratory reference method.
| Characteristic | Acceptance Criteria (Implied by Predicate & Study Results) | Reported Liberty™ System Performance |
|---|---|---|
| Capillary Blood Study vs. YSI/HemoCue | Correlation coefficient, linear regression, and range comparable to predicate device. | Linear regression: Y = 0.930, Correlation coefficient = 0.941, Range = 35 - 470 mg/dL |
| Consumer Study vs. Lab Reference | Correlation coefficient, linear regression, and range comparable to predicate device. | Linear regression: y = 0.872, Correlation coefficient = 0.921, Range = 28 to 390 mg/dL |
| Precision (Within-run) | CV 99% in "A" region (likely Clarke Error Grid Zone A). | Control solution: Mean 163 mg/dl, sd 11.3, CV 99% in "A" region. |
Note: The "acceptance criteria" are implied by demonstrating substantial equivalence to the predicate device, which met FDA requirements. The specific numeric thresholds for acceptance are not explicitly listed but are demonstrated through the provided results being comparable to or better than the predicate for the given metrics.
2. Sample Size for the Test Set and Data Provenance:
- Capillary blood study: N = 116 patients
- Consumer study: N = 116 different patients
- Provenance: The document does not explicitly state the country of origin. It indicates it's a "clinical study" and "consumer study," which implies prospective data collection, but this is not explicitly stated. It does not mention retrospective data.
3. Number of Experts and Qualifications for Ground Truth:
This information is typically not relevant or included for blood glucose monitoring systems. The "ground truth" for glucose measurements is established by a highly accurate laboratory reference method (Yellow Springs Instrument (YSI) and HemoCue), not by human expert consensus or radiologists.
4. Adjudication Method for the Test Set:
Not applicable for this type of device. Glucose measurement is an objective quantitative biochemical reading, not a subjective interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is a standalone diagnostic device, not an AI-assisted interpretation system for human readers.
6. Standalone Performance Study:
Yes, a standalone study was conducted. The performance data presented in the table (Capillary blood study and Consumer study) represents the performance of the Liberty™ System (algorithm/device only) against a laboratory reference method.
7. Type of Ground Truth Used:
The ground truth used was a laboratory reference method, specifically the Yellow Springs Instrument (YSI) and HemoCue, which are highly accurate established methods for measuring glucose in blood.
8. Sample Size for the Training Set:
The document does not mention a "training set" in the context of machine learning. For traditional medical devices like this, the device's development involves engineering and calibration, not an AI training set. Performance is evaluated through analytical and clinical studies on defined sample sizes.
9. How Ground Truth for the Training Set Was Established:
As there is no mention of a "training set" in the AI/ML sense, this question is not applicable. The device relies on photometric biosensor technology and glucose oxidase chemistry, not a trained AI model.
§ 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.