(693 days)
The Bioland G-425-2V Blood Glucose Monitoring System is comprised of Bioland G-425-2V blood glucose meter and Bioland Blood Glucose Test Strips.
The Bioland G-425-2V 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 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 G-425-2V Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. The Bioland G-425-2V Blood Glucose Monitoring System is not for use in neonates.
The Bioland G-425-2 Blood Glucose Monitoring System is comprised of Bioland G-425-2 blood glucose meter and Bioland Blood Glucose Test Strips.
The Bioland G-425-2 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 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 G-425-2 Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. The Bioland G-425-2 Blood Glucose Monitoring System is not for use in neonates.
The Bioland G-425-2V Blood Glucose Monitoring System consists of three main components: the meter (with voice feature , no Bluetooth features), test strip and control solutions. Bioland Blood Glucose Test Strips (Test strips are the same as K191657) and Bioland Glucose Control Solution (Control solution are the same as K191657) can be used with the Bioand G-425-2V Blood Glucose Monitoring System.
The Bioland G-425-2 Blood Glucose Monitoring System consists of three main components: the meter (No voice feature, no Bluetooth features), test strip and control solutions. Bioland Blood Glucose Test Strips (Test strips are the same as K191657) and Bioland Control Solution (Control solution are the same as K191657) can be used with the Bioland G-425-2 Blood Glucose Monitoring System.
The Bioland G-425-2V / G-425-2 Blood Glucose Monitoring System consists of:
- a) Bioland G-425-2V / G-425-2 Blood Glucose Meter;
- Bioland Blood Glucose Test Strips; b)
- C) Bioland Glucose Control Solution;
The provided text describes a 510(k) premarket notification for a Blood Glucose Monitoring System, which is a medical device, not an AI/ML algorithm. Therefore, the information required to answer the prompt regarding AI/ML acceptance criteria and study details (like sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, etc.) is not present in the document.
The document focuses on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway for medical devices that are not novel and are similar in intended use, technology, and performance to devices already on the market.
However, I can extract the acceptance criteria related to the device's performance as a blood glucose monitoring system, based on the inherent requirements for such devices, and the general claims of equivalence.
Extracted Information (based on typical blood glucose monitor requirements and general claims):
- Device Name: Bioland G-425-2V Blood Glucose Monitoring System and Bioland G-45-2 Blood Glucose Monitoring System
- Intended Use: Quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip for self-testing by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. Not for diagnosis or screening, and not for use in neonates.
- Measurement Range: 40~600 mg/dL
- Specimen Type: Capillary whole blood from fingertip
- Enzyme: Glucose oxidase (indicating an electrochemical detection method)
- Test Principle: Amperometric glucose biosensor
- Measurement Unit: mg/dL
- Hematocrit Range: 20%~60%
- Sample Volume: ≥0.7uL
- Test strip calibration: No code function, no need to calibrate the meter
- Operating Range: 50
104°F (1040°C), 15~85%RH - Measuring Time: 6s
Regarding "Acceptance Criteria" for this type of device:
For blood glucose monitors, acceptance criteria are typically defined by accuracy standards (e.g., ISO 15197:2013). While the exact numerical criteria from such standards are not explicitly stated in this document, the submission claims that "All test results met acceptance criteria" in reference to verification and validation activities. The core of the substantial equivalence claim relies on the subject device performing equivalently to the predicate device, which itself would have met relevant performance standards.
Table of Acceptance Criteria and Reported Device Performance:
Since the document does not explicitly list the specific numerical acceptance criteria (e.g., X% of results must be within +/- Y mg/dL of a reference method) nor detailed efficacy performance data, I can only populate the table with the claimed functional equivalence to the predicate device and the general performance specifications provided.
| Acceptance Criteria (based on device specifications and implicit equivalence) | Reported Device Performance (as stated in the document, implying compliance) |
|---|---|
| Intended Use: Quantitative measurement of glucose in fresh capillary whole blood samples from fingertip for self-testing by people with diabetes. Aid to monitor effectiveness of diabetes control. Not for diagnosis/screening, not for neonates. | Met: Bioland G-425-2V Blood Glucose Monitoring System and Bioland G-425-2 Blood Glucose Monitoring System are intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip. Intended for self-testing by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. Not for diagnosis or screening, not for neonates. Claims substantial equivalence to predicate device (K191657) with identical intended use. |
| Glucose Measuring Range: 40~600 mg/dL | Met: Detecting Range: 40~600 mg/dL (Identical to predicate device). |
| Specimen Type: Capillary whole blood from fingertip | Met: Specimen Type: Capillary whole blood from fingertip (Identical to predicate device). |
| Enzyme: Glucose oxidase | Met: Enzyme: Glucose oxidase (Identical to predicate device). |
| Test Principle: Amperometric glucose biosensor | Met: Test Principle: Amperometric glucose biosensor (Identical to predicate device). The test is based on the measurement of electrical current generated by the reaction of capillary whole blood glucose oxidase and a mediator on the test strip. |
| Hematocrit Range: 20%~60% | Met: Hematocrit Range: 20%~60% (Identical to predicate device). |
| Sample Volume: ≥0.7uL | Met: Sample Volume: ≥0.7uL (Identical to predicate device). |
| Measuring Time: 6s | Met: Measuring Time: 6s (Identical to predicate device). |
| Operating Range (Temperature/Humidity): 10 | Met: Operating Range: 50 |
| Accuracy / Clinical Performance: The document states "All test results met acceptance criteria" and "The Bioland G-425-2V Blood Glucose Monitoring System and Bioland G-425-2 Blood Glucose Monitoring System are substantially equivalent to the predicate device (K191657)." This implies that the device successfully passed the required accuracy and clinical performance tests to demonstrate equivalence, which typically involves comparing device readings to a laboratory reference method. Specific numerical accuracy data (e.g., % of results within certain error margins as per ISO 15197) is not provided in this summary document. | Met: The summary states "All test results met acceptance criteria and are included in the software validation report." and "The Bioland G-425-2V Blood Glucose Monitoring System and Bioland G-425-2 Blood Glucose Monitoring System are substantially equivalent to the predicate device (K191657), Bioland Blood Glucose Monitoring System." The modifications (removal of Bluetooth, addition/removal of voice) are stated to not have changed the glucose algorithm or other core software functions related to measurement accuracy. |
Regarding the AI/ML specific questions (for which the document provides NO information):
- Sample size used for the test set and the data provenance: Not applicable/Not provided. This is a hardware device with an algorithm, not an AI/ML model being assessed in an independent test set in the way the prompt implies. The testing would be clinical (human subject studies) and analytical (bench testing).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided. Ground truth for a blood glucose monitor is typically established by comparing its readings to a highly accurate laboratory reference method (e.g., YSI analyzer), not by human expert consensus or radiologists.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/Not provided. See point 3.
- 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/Not provided. This is not an AI-assisted diagnostic tool for human readers. It's a direct measurement device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/Not provided. The device is the standalone measurement system for the user.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): The ground truth for blood glucose monitoring systems is established by comparison to a laboratory reference method (e.g., YSI Glucose Analyzer) which provides highly accurate and precise glucose concentration measurements. This is intrinsic to the analytical accuracy assessment of blood glucose meters.
- The sample size for the training set: Not applicable/Not provided. Blood glucose meters use fixed algorithms based on electrochemistry, not AI/ML models that require training sets in the conventional sense. The "training" would be the initial development and calibration of the chemical and electrical components and the non-AI algorithm.
- How the ground truth for the training set was established: Not applicable/Not provided. The ground truth in the development/calibration phase would also be established using highly accurate laboratory reference methods.
In summary: The provided document is a 510(k) summary for a conventional medical device (blood glucose monitor) demonstrating substantial equivalence. It does not pertain to an AI/ML algorithm requiring the specific types of studies and acceptance criteria outlined in the prompt for AI/ML performance. The "study that proves the device meets the acceptance criteria" in this context refers to standard analytical and clinical performance studies required for blood glucose meters, which are implicitly stated to have been successfully completed as part of the overall "verification and validation activities" that showed "All test results met acceptance criteria."
§ 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.