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The iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+) consists of the iHealth Wireless Smart Glucose Meter (BG5S) and the iHealth Blood Glucose Test Strips (EGS-2003). The iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+) is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf, or thigh. The iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+) is intended to be used by a single person and should not be shared.

The iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+) 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 iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+) should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The iHealth Wireless Smart Gluco-Monitoring System ( iHealth Gluco+ ) consist of BG5S glucose meter, EGS-2003 test strip, iHealth® control solution(Level I, Level III), lancet and lancing device. The BG5S glucose meter can display test result on meter itself, and can also be connected to iOS device and Android device through bluetooth and display test result on iOS or Android device.

The provided text is a 510(k) summary for the iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+). This document describes the device, its intended use, and comparisons to a predicate device to demonstrate substantial equivalence.

However, it does not contain the detailed information required for a comprehensive answer to your questions regarding acceptance criteria and the study proving the device meets those criteria. Specifically, the document mentions:

• "Performance, functionality, and reliability of the proposed device has been evaluated. The performance evaluation include precision, altitude, temperature & humidity, linearity, interference, sample volume and hematocrit." This indicates that these tests were performed, but the acceptance criteria and the results of these tests (the actual reported device performance against those criteria) are not provided in this summary.
• "User Evaluation was completed for the iHealth Wireless Smart Gluco-Monitoring System(iHealth Gluco+)." This indicates a user study was done, but details about sample size, ground truth, expert involvement, or MRMC studies are missing.
• "The user accuracy and ease of use (via participant questionnaire scoring) confirmed the proposed device to be substantially equivalent to the predicate device." This states a conclusion but lacks the data to support it.

Therefore, I cannot populate the table or answer most of your detailed questions directly from the provided text. The document is a summary for regulatory clearance, not a full study report.

Here's what I can extract and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and data provenance:

• Test Set Sample Size: Not specified in the provided text.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The document is a regulatory submission, so likely encompasses data generated specifically for the submission, but the details are absent.

3. Number of experts used to establish the ground truth for the test set and their qualifications:

• Not specified in the provided text. The "User Evaluation" implies human interaction but does not detail the establishment of ground truth by experts for the performance metrics. Ground truth for blood glucose is typically based on a laboratory reference method.

4. Adjudication method for the test set:

• Not specified. This would typically be relevant for studies involving human readers or interpretation (e.g., imaging studies), which isn't explicitly detailed here for a glucose meter.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size:

• Not applicable / Not specified. MRMC studies are primarily for evaluating diagnostic imaging systems where multiple readers interpret cases. This device is a blood glucose meter. The "User Evaluation" mentioned might involve multiple users but is not an MRMC study in the traditional sense for diagnostic accuracy improvement.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• Implied for the meter's performance: The "Performance evaluation" (precision, linearity, etc.) implicitly assesses the device's standalone accuracy against a reference method. The results of these tests, however, are not provided. The phrase "user accuracy" refers to human operation of the device.

7. The type of ground truth used:

• For a blood glucose monitoring system, the ground truth for accuracy measurements (precision, linearity) would typically be established by a laboratory reference method (e.g., a YSI analyzer). This is not explicitly stated in the summary but is standard practice for these devices.
• For "user accuracy" and "ease of use," the ground truth would be based on the reference method for glucose levels and participant questionnaire scoring, respectively.

8. The sample size for the training set:

• Not applicable / Not specified. This refers to machine learning models. A blood glucose meter, operating on electrochemical biosensor principles, is not typically "trained" in the same way an AI/ML algorithm is. Its performance is determined by its physical and chemical design and calibration.

9. How the ground truth for the training set was established:

• Not applicable. See point 8.

In summary, the provided document is a 510(k) summary for a blood glucose meter, which focuses on demonstrating substantial equivalence to a predicate device. It lists the types of performance evaluations conducted but does not provide the quantitative acceptance criteria or the study results (device performance data) that would allow for a complete answer to your detailed questions. To get that level of detail, one would typically need to review the full 510(k) submission, not just the summary.

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