(374 days)
The BGM009 Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). The device includes speaking functions but is not intended for use in visually impaired users. It is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control and should only be used by a single patient and it should not be shared. It is not indicated for the diagnosis or screening of diabetes or for neonatal use.
The BGM009 Blood Glucose Test Strips are to be used with the BGM009 Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm.
The BGM009 blood glucose meter and BGM009 test strips are used for testing of blood glucose.
The provided text focuses on the FDA 510(k) premarket notification for the BGM009 Blood Glucose Monitoring System. It describes the device's intended use, classification, and comparison to a predicate device. While it mentions "clinical testing" and "accuracy study," it does not provide specific acceptance criteria or detailed results of a study proving the device meets those criteria.
Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, expert qualifications, and multi-reader studies are not available in the provided document.
Here's a summary of what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document. The document states "Results demonstrate substantial equivalence to the predicate system" for non-clinical and clinical testing, but it does not specify the quantitative acceptance criteria (e.g., accuracy percentages within certain glucose ranges) or the numerical performance results against those criteria.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document mentions "an accuracy study was conducted with home users" and "disinfection testing with recommended disinfectant wipes was done using an animal virus test model," but it does not specify the sample sizes for either.
- Data Provenance: The study on home users is implied to be prospective (a clinical study). The location of the home users (country) is not specified.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided. The document does not describe how the "ground truth" (reference glucose values) was established for the accuracy study.
4. Adjudication Method
This information is not provided. This concept is typically more relevant for subjective diagnoses from image-based medical devices, which is not the case for a blood glucose monitor.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not provided and is not applicable to a blood glucose monitoring system, which provides a numerical output rather than an interpretation requiring multiple readers. The "accuracy study" mentioned is likely comparing device readings to a reference method, not human interpretations.
6. Standalone Performance Study
Yes, a standalone study (algorithm only without human-in-the-loop performance) was effectively done. The "accuracy study" and "precision testing" described for the blood glucose monitoring system are inherently standalone performance evaluations of the device itself against a reference method.
7. Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for the accuracy study. For blood glucose monitors, the ground truth is typically established by laboratory reference methods (e.g., YSI glucose analyzer) performed on the same blood samples. This is a common practice in such studies, but not explicitly stated here.
8. Sample Size for the Training Set
This information is not provided. The document makes no mention of a "training set" as it would for a machine learning model. For a device like a blood glucose monitor, the "training" typically refers to the device's calibration and algorithm development, which would use internal data, not a formally defined "training set" in the context of FDA submissions for machine learning.
9. How the Ground Truth for the Training Set Was Established
This information is not provided and is not applicable in the same way it would be for AI/ML devices.
In summary, the provided text provides high-level information about the regulatory submission of a blood glucose monitoring system, but it lacks the detailed technical and clinical study results that would allow for a comprehensive answer to the requested questions regarding specific acceptance criteria and study data.
§ 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.