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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 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.
iHealth Blood Glucose Test Strips(AGS-1000I) are intended for use with the iHealth Align Mini Glucose meter (BG1) to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf or thigh using the iHealth BG1 meter.

Device Description

The iHealth BG1 Align Mini Gluco-Monitoring System (BGMS) consists of blood glucose meter, single use test strips, sterile lancets, lancing device and the control solutions.
The new device iHealth BG1 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 BG1 is different from the predicate device. Both the iHealth BG1 and the predicate device BG3 need to connect to iOS device to display the rest results, however, iHealth BG1 connect to iOS device through the earphone kack, while BG3 connect to iOS device through the 30-pin dock interface.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the iHealth BG1 Align Mini Gluco-Monitoring System, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary states that the device conforms to ISO 15197: "In vitro diagnostic test systems- Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus."

Given that the document is a 510(k) summary, it does not explicitly detail the entire set of ISO 15197 acceptance criteria in a table format. However, it indicates compliance with the standard. For a Class II device like a blood glucose monitoring system, the key performance criteria from ISO 15197 (at the time this 510(k) was likely submitted) generally revolve around accuracy percentages relative to a reference method.

Based on the information provided, here's a representation of the acceptance criteria and implied performance:

Acceptance Criteria (Based on ISO 15197)	Reported Device Performance (Implied by compliance)
Accuracy (System Accuracy Evaluation):
- For glucose concentrations < 4.2 mmol/L (75 mg/dL), at least 95% of results shall fall within ±0.83 mmol/L (±15 mg/dL) of the reference measurement values.	The device would meet these criteria, as "Non-clinical test and the clinical test are done according to the above standard." Specific percentage agreement or bias values are not directly reported in this summary beyond the statement of conformity.
- For glucose concentrations ≥ 4.2 mmol/L (75 mg/dL), at least 95% of results shall fall within ±20% of the reference measurement values.	The device would meet these criteria.
Intermediate Precision (Repeatability): No explicit criteria or performance is given in the summary, but compliance with ISO 15197 implies that repeatability studies were conducted and met the standard's requirements for coefficient of variation (CV%) or standard deviation (SD) for various glucose concentration ranges, demonstrating consistent results under repeated testing.	Implied to meet ISO 15197 requirements.
Measurement Range: 20mg/dL-600mg/dL (1.1mmol/L~33.3mmol/L) (Typically, ISO 15197 requires that the system's claimed measurement range be verified and that the system performs accurately within this range).	Stated measurement range: 20mg/dL-600mg/dL (1.1mmol/L~33.3mmol/L). Implied to perform accurately within this range, as "Non-clinical test and the clinical test are done according to the above standard."
Hematocrit Range: 20-60% (ISO 15197 requires demonstration of accuracy across the claimed hematocrit range, as hematocrit can interfere with glucose measurements).	Stated hematocrit range: 20-60%. Implied to perform accurately within this range, as "Non-clinical test and the clinical test are done according to the above standard."
Interfering Substances: No explicit criteria or performance is given, but ISO 15197 requires testing for common interfering substances to ensure they do not significantly affect measurement accuracy.	Implied to meet ISO 15197 requirements.
Operating Temperature: $10℃~35℃(50°-95°F)$ (Systems must maintain accuracy within their specified operating temperature range).	Stated operating temperature: $10℃~35℃(50°-95°F)$. Implied to perform accurately within this range, as "Non-clinical test and the clinical test are done according to the above standard."
User Performance (Lay-user study): ISO 15197 typically includes criteria for lay-user performance, demonstrating that intended users can operate the device correctly and obtain accurate results. (e.g., specific percentages of readings within a defined accuracy range when performed by lay users).	Implied to meet ISO 15197 requirements for self-testing devices, as "Non-clinical test and the clinical test are done according to the above standard."

2. Sample Sizes and Data Provenance

Test Set Sample Size: The summary document explicitly states that "Non-clinical test and the clinical test are done according to the above standard [ISO 15197]". However, the specific sample sizes used for the clinical and non-clinical tests are not provided in this 510(k) summary. ISO 15197 outlines minimum sample sizes for system accuracy evaluation (e.g., at least 100 capillary blood samples for system accuracy, with specific distributions across the measuring range).
Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given the submitter's address in Tianjin, P.R. China, it's plausible the studies were conducted in China, but this is not stated. The studies would have been prospective to meet the requirements for clinical and non-clinical testing under ISO 15197.

3. Number of Experts and Qualifications

This information is not provided in the 510(k) summary. For blood glucose monitoring systems, "experts" typically refer to laboratory professionals or clinical staff who perform comparative reference measurements (e.g., using a YSI glucose analyzer). Their role is to establish the ground truth using a highly accurate laboratory method, not to interpret images or diagnose.

4. Adjudication Method

This information is not applicable/not provided for this type of device and study. Adjudication methods like 2+1 or 3+1 are typically used in studies involving expert review of medical images or complex diagnostic interpretations, where there might be disagreement in expert opinions. For a blood glucose meter, the "ground truth" is established by a highly accurate laboratory reference method, not by expert consensus on interpretation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not conducted (or at least not mentioned in this summary). MRMC studies are specific to evaluating the impact of AI on human reader performance, particularly in diagnostic imaging or similar fields where human interpretation is a key component. This device is a standalone measurement system, not an AI assistance tool for human readers.

6. Standalone Performance

Yes, a standalone performance study was done. The entire "Performance summary" section (section 8.0) and the statement that "Non-clinical test and the clinical test are done according to the above standard [ISO 15197]" refer to the performance of the algorithm/device itself. Blood glucose meters are inherently standalone devices that provide a measurement directly. The studies conducted would evaluate the meter's accuracy (agreement with a reference method), precision, and other analytical performance characteristics.

7. Type of Ground Truth Used

The ground truth used for performance evaluation of blood glucose monitoring systems is typically established by:

Reference Measurement System: This usually involves a highly accurate laboratory-based glucose analyzer (e.g., YSI 2300 STAT Plus Glucose & L-Lactate Analyzer, or similar enzymatic reference methods), which is regularly calibrated and subjected to stringent quality control. This is the standard "gold standard" for comparative studies for blood glucose meters.
Venous Plasma or Serum Samples: The reference measurements are usually performed on venous plasma or serum samples, which are then compared to the finger-prick capillary whole blood measurements from the device under evaluation, often after applying a conversion factor if comparing whole blood to plasma/serum.

8. Sample Size for the Training Set

This information is not provided and is largely not applicable in the context of this device. The iHealth BG1 Align Mini Gluco-Monitoring System likely uses a fixed algorithm based on electrochemical principles (amperometry with glucose oxidase). While there might be some calibration data used during manufacturing, it is not an AI/machine learning device that requires a "training set" in the sense of a deep learning model. Its performance is based on the inherent chemical and electrical properties of the test strip and meter design.

9. How the Ground Truth for the Training Set Was Established

Since this device does not appear to be an AI/machine learning product that requires a "training set" in the conventional sense, this question is not applicable. The ground truth for calibration during development and manufacturing would typically be established similarly to the ground truth for performance testing – using highly accurate laboratory reference methods.

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