(273 days)
The Bioland Blood Glucose Monitoring System is comprised of Bioland Blood Glucose Meter and Bioland Blood Glucose Test Strips.
The Bioland 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 fingertip. The Bioland Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. It 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 Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. The Bioland Blood Glucose Monitoring System is not for use in neonates.
The Bioland Blood Glucose Monitoring System (hereafter as the System) is an in vitro diagnostic device intended for the measurement of glucose in capillary blood. The System consists of the Bioland Blood Glucose Meter, Bioland Blood Glucose Test Strips, lancing device / sterile lancet and Bioland Glucose Control Solution. The Bioland Glucose Control Solution is for use with the Bioland Blood Glucose Meter and Bioland Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results. These products have been designed and tested to work together as a system to produce accurate blood glucose test results. The measured result can be transferred to the appointed equipment that has been connected via the Bluetooth function.
The Bioland Blood Glucose Monitoring System is a device intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip. It is for self-testing by people with diabetes at home.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are based on the FDA Guideline "Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use" issued on October 11, 2016, and relevant CLSI and ISO standards. The studies evaluate various performance aspects of the system.
| Study/Test | Acceptance Criteria | Reported Device Performance and Compliance |
|---|---|---|
| Altitude Study | Individual bias 600 mg/dL. | Displays "Lo" for glucose 600 mg/dL. Meets acceptance criteria. |
| Hematocrit Interference Study | Mean differences 0.95. 100% of individual glucose results bias fall within ±10% or ±10 mg/dL (comparison to a reference method like YSI 2300). | Correlation coefficient r = 0.9998 (device G-427B and YSI 2300 highly correlated). 100% of individual bias within ±10% or ±10 mg/dL. Meets acceptance criteria. Linearity acceptable between 40 to 600 mg/dL. |
| Precision Testing | CV within 5% at glucose concentration ≥ 100 mg/dL. SD within 5 mg/dL at glucose concentration 75 mg/dL. | Meters normal after 3,650 cycles of cleaning/disinfection. Individual bias 75 mg/dL). Meets acceptance criteria. |
| Short Volume Detection Testing | Device detects insufficient blood volume and does not start measurement. | Device detects insufficient blood volume (blood volume 80 points. Indicates written materials provide sufficient understandable information for lay users. |
| Usability Engineering File | No usability problems when validated under normal and worst-case scenarios. | Evidence shows no usability problem when validated under normal conditions and worst-case scenarios. |
| Virucidal Efficacy (Disinfection) | Pass acceptance criteria for HBsAg efficacy on main housing materials (ABS), test slot (PMMA), and LCD display lens (PC). | Results passed acceptance criteria for all three parts of the subject device (ABS, PMMA, PC) using Clorox Germicidal Wipes. |
2. Sample Sizes Used for the Test Set and Data Provenance
The document details sample sizes for various tests:
- User Performance Study (Lay User Study): The test set included 351 individual glucose measurements.
- Precision Testing (Within-run and Within-day): Tables provided show data for 3 lots of test strips, with measurements across 5 glucose concentration intervals. Although exact number of samples for each interval isn't explicitly stated, these tables typically involve multiple replicates (e.g., 10-20 replicates per lot per glucose concentration level). For example, it lists means, SDs, and CVs implying multiple measurements were taken.
- Other tests (Altitude, Hematocrit, Linearity, Interference, etc.): The specific number of individual samples for these tests is generally not explicitly quantified in the provided summary. However, these are standard laboratory tests that involve a sufficient number of replicates and samples at various concentrations to ensure statistical validity, following guidelines such as CLSI EP7-A2, CLSI EP6-A, and FDA guidelines.
- Data Provenance: The document does not explicitly state the country of origin of the data for these studies or whether they were retrospective or prospective. Given that Bioland Technology Ltd. is located in Shenzhen, Guangdong, People's Republic of China, it is highly probable that the studies were conducted in China. The studies are described as "Pre-clinical data" and "Summary of performance testing," suggesting they were specifically conducted prospectively for this 510(k) submission to demonstrate device performance.
3. Number of Experts and Qualifications for Ground Truth
The document does not mention the number of experts or their specific qualifications for establishing ground truth. Instead, it relies on a reference method, the Glucose Analyzer YSI 2300, which is a widely accepted and highly accurate laboratory instrument for determining blood glucose concentration. This method inherently serves as the "ground truth" comparator for the device's measurements.
4. Adjudication Method for the Test Set
No adjudication method (e.g., 2+1, 3+1) is mentioned in the context of human expert review of results, as the studies primarily rely on direct comparison to a laboratory reference standard (YSI 2300) and quantitative statistical analysis. For the user performance study, the acceptance criteria are numerical (e.g., % of results within a certain bias), not subjective expert judgment that would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study was not conducted. This device is a self-monitoring blood glucose system, not an imaging AI system where human readers assist or benefit from AI. The user performance study evaluates the lay user's ability to operate the device correctly and obtain accurate results, which is a different type of assessment than an MRMC study.
6. Standalone Performance (Algorithm Only)
The device itself (Bioland Blood Glucose Monitoring System) is an "algorithm only" or "standalone" device in the sense that it provides a direct glucose measurement without human interpretation beyond reading the displayed number. The performance tests described (Precision, Linearity, Hematocrit, etc.) directly assess this standalone performance against a proven reference method (YSI 2300). The user performance study then adds the human-in-the-loop component, evaluating the system's performance when operated by lay users.
7. Type of Ground Truth Used
The primary ground truth used for the performance studies (e.g., Altitude, Hematocrit, Linearity, Precision) is comparison to a laboratory reference method, specifically the Glucose Analyzer YSI 2300. This is a highly accurate and precise instrument that measures glucose in blood samples. For the user performance study, the "ground truth" for the glucose values themselves would also be obtained from such a reference method, against which the lay user's device readings are compared.
8. Sample Size for the Training Set
This document describes a premarket notification (510(k)) for a medical device that measures blood glucose. It is not an AI/ML device that requires a "training set" in the sense of machine learning. The device's underlying "algorithm" is the electrochemical biosensor technology. Therefore, the concept of a "training set" for an algorithm, as seen in AI/ML, does not apply here. The data presented are from verification and validation studies for a traditional in vitro diagnostic device.
9. How the Ground Truth for the Training Set Was Established
As stated in point 8, the concept of a training set is not applicable to this type of device. The ground truth for the test and validation of the device's performance was established using a Glucose Analyzer YSI 2300 as the reference method.
§ 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.