(291 days)
The Bioland G-423 BLOOD GLUCOSE MONITORING SYSTEM is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. This system is intended to be used by a single person and should not be shared.
The Bioland G-423 Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Bioland G-423 Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use.
The Bioland G-423 Test Strips are for use with the Bioland G-423 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
The kit of BIOLAND G-423 BLOOD GLUCOSE MONITORING SYSTEM MODEL G-423 consist of: the meter with blood glucose measurement function and test strips. These products have been designed and tested to work together as a system to produce accurate blood glucose test results.
The provided 510(k) summary for the BIOLAND G-423 BLOOD GLUCOSE MONITORING SYSTEM, MODEL G-423, offers limited detail regarding specific acceptance criteria and the comprehensive study methodology. While it states that the device "met the performance requirements for its intended use" for various tests, it does not provide explicit tables of acceptance criteria nor detailed study designs, sample sizes, or ground truth establishment for the performance tests mentioned.
Here's a breakdown of the available information based on your request, along with what is not specified in the document:
1. A table of acceptance criteria and the reported device performance
The document broadly states that the device met "performance requirements" but does not provide a specific table of acceptance criteria or the numerical performance results for each criterion. It mentions "system accuracy, user study precision, interference, hematocrit, altitude, meter reliability, storage stability and in-use stability" as areas where performance tests were conducted.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the summary. The document does not specify the sample sizes used for any of the performance tests (system accuracy, precision, etc.), nor does it indicate the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable in the traditional sense for a blood glucose monitoring system, as the ground truth for glucose measurements is typically established by a laboratory reference method, not by expert consensus in the way a diagnostic imaging study would. The summary does not mention any expert involvement for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as there is no mention of expert review or adjudication in the context of establishing ground truth for blood glucose measurements.
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
This information is not applicable as the BIOLAND G-423 BLOOD GLUCOSE MONITORING SYSTEM is a standalone glucose meter and does not involve "human readers" interpreting results or "AI assistance" in the way a diagnostic imaging or AI-enabled system would.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This point is partially applicable. The device is inherently a "standalone" system in that it provides a numerical glucose reading without human interpretation or further input once the sample is applied. The performance tests ("system accuracy, user study precision, etc.") would effectively evaluate its standalone performance. However, the document doesn't explicitly label a study as "standalone performance" in the context of an algorithm's performance vs. human-in-the-loop.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For blood glucose monitoring systems, the ground truth is typically established by comparing the device's readings to a laboratory reference method (e.g., a YSI analyzer or similar highly accurate lab instrument). The summary does not explicitly state the specific reference method used, but this is the standard for such devices.
8. The sample size for the training set
This information is not applicable/not provided in the context of the device as described. Blood glucose meters do not typically employ "training sets" in the same way machine learning algorithms do. Their performance is based on the chemical and electrical design, and verification occurs through direct measurement comparisons against a reference.
9. How the ground truth for the training set was established
This information is not applicable/not provided for the same reasons as point 8.
In summary, the provided 510(k) document is a high-level summary that indicates performance tests were conducted and the device met its requirements. However, it lacks the detailed methodology, specific acceptance criteria data, sample sizes, and ground truth establishment details that you are requesting. For a medical device of this type, such detailed information would typically be found in the full submission to the FDA, not in the publicly available 510(k) summary.
§ 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.