(263 days)
iHealth BG3 Smart Gluco-Monitoring System is intended to be used for:
· quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf or thigh
· single person measurement only and should not be shared
• 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 iHealth BG3 Smart Gluco-Monitoring System should not be used for the diagnosis of or screening for diabetes, or for neonatal use.
Alternative Site Testing (AST) should be done only during steady state times when glucose levels are not changing rapidly.
The AGS10001 test strips are intended for use with the iHealth BG3 meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf or thigh using the iHealthBG3 meter
iHealth BG3 Smart Gluco-Monitoring System consist of blood glucose meter, single use test strips, sterile lancets, lancing device and the control solutions.
The new device iHealth BG3 Smart Gluco-Monitoring System is based on an electrochemical biosensor technology (electrochemical) and the principle of capillary action. Capillary action at the end of the test strip draws the blood into the action chamber and the blood glucose result is displayed in 5 seconds. The control solution available is used to test the performance of the device. It uses the same technological characteristics for testing with its predicate device.
The appearance of iHealth BG3 meter is different from the predicate device. More over, the new device iHealth BG3 Smart Gluco-Monitoring System can not display the test results itself, it has to connect an iPhone or iPod touch to complete its function.
The iHealth BG3 Smart Gluco-Monitoring System's acceptance criteria are based on ISO 15197 for in vitro diagnostic test systems, specifically for blood-glucose monitoring systems used for self-testing in managing diabetes mellitus. The information provided does not contain specific numerical acceptance criteria (e.g., accuracy percentages or error grids) or detailed study results to demonstrate compliance with these criteria beyond a general statement that "Non-clinical test and the clinical test are done according to the above standard."
Therefore, I cannot populate a table of acceptance criteria and reported device performance with specific numbers.
Here's what can be extracted and inferred from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Based on ISO 15197) | Reported Device Performance |
|---|---|
| Accuracy (specific metrics, e.g., % within ±X mg/dL or % within Y%) | Not explicitly detailed in the provided text. The document states "Non-clinical test and the clinical test are done according to the above standard [ISO 15197]," implying compliance but not providing specific performance data. |
| Precision | Not explicitly detailed in the provided text. |
| Measurement Range (20-600 mg/dL) | The device's measurement range is 20mg/dL-600mg/dL (1.1mmol/L~33.3mmol/L). This aligns with a common range for blood glucose meters. |
| Hematocrit Range (20-60%) | The device's hematocrit range is 20-60%. |
| Operating Temperature Range | The device's operating temperature range is 10℃~35℃(50°-95°F). |
| Test Time (5 seconds) | The device's test time is 5 seconds. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided text.
- Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It only states that "Non-clinical test and the clinical test are done according to the [ISO 15197] standard."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided in the given text.
4. Adjudication method for the test set
- This information is not provided in the given text.
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 device is a blood glucose monitoring system, not an AI-assisted diagnostic imaging or interpretation tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- The iHealth BG3 Smart Gluco-Monitoring System is an in-vitro diagnostic device that provides a direct numerical measurement of glucose. Its performance is inherently standalone in the sense that the device itself generates the glucose reading. It connects to an iPhone or iPod touch to display results, but the measurement itself is performed by the device and test strip. The performance evaluation would measure the accuracy of these readings against a reference method.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For blood glucose monitoring systems complying with ISO 15197, the "ground truth" (or reference method) typically involves laboratory-grade glucose analyzers, often using methods like hexokinase or glucose oxidase reactions, which are considered highly accurate for quantitative glucose measurement. While not explicitly stated, it's highly probable that a laboratory reference method was used for comparison in the clinical and non-clinical tests.
8. The sample size for the training set
- This information is not provided in the given text. Blood glucose meters do not typically have "training sets" in the same way machine learning algorithms do. Instead, their development involves calibration and characterization using a range of known glucose concentrations.
9. How the ground truth for the training set was established
- As mentioned above, the concept of a "training set" with ground truth in the context of machine learning isn't directly applicable here. The development and calibration of blood glucose meters involve rigorous testing against laboratory reference methods across the device's intended measurement range and various interfering substances to ensure accuracy.
§ 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.