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The IDEAL LIFE GlucoManager™ Blood Glucose Monitoring System, Model GMM0002 is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip or alternative sites (palm, forearm, upper arm, calf, and thigh). The system is intended to be used by a single patient and should not be shared.

The IDEAL LIFE GlucoManager™ Blood Glucose Monitoring System, Model GMM0002 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 system is not to be used for the diagnosis of or screening for diabetes or for neonatal use. Alternative site testing should only be done during steady state times when blood glucose is not changing rapidly.

The IDEAL LIFE Blood Glucose Test Strips, Model AGS-1112 are for use with the IDEAL LIFE GlucoManager™ to quantitatively measure glucose in fresh capillary whole blood drawn from the fingertips, palm, forearm, upper arm, calf, and thigh.

The IDEAL LIFE Control Solution, Model GCS-0104 is intended for use with IDEAL LIFE GlucoManager™ and IDEAL LIFE Blood Glucose Test Strips, Model AGS-1112. The control solution can be used to check that the qlucose meter and test strips are working properly and that the measurement is accurate.

The IDEAL LIFE GlucoManager™ can wirelessly communicate with a communication gateway such as the IDEAL LIFE Pod™ or the IDEAL LIFE Gateway Application™. The IDEAL LIFE Gateway Application receives data wirelessly from IDEAL LIFE devices to transmit over the Internet from the user's mobile device. The Gateway Application is intended to aid people at home and health care professionals to review and evaluate historical blood glucose results, to support effective health care management.

The IDEAL LIFE Gateway Application™ makes no interpretation, evaluation, medical iudgment or recommendations for treatment. This device is not intended as a substitute for medical care.

Device Description

The IDEAL LIFE Gluco-Manager™ Blood Glucose Monitoring System, Model GMM0002 consists of a blood glucose meter, single use test strips and control solution. The new device IDEAL LIFE Gluco-Manager™, Model GMM0002 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 IDEAL LIFE Gluco-Manager™ can be used alone to measure your blood glucose. If the user would like to transmit blood glucose information for display on a personal computer, the IDEAL LIFE Gluco-Manager™ can wirelessly communicate with a communication gateway (the optional IDEAL LIFE Pod™) or by using the Gateway Application, a mobile medical application.

AI/ML Overview

The IDEAL LIFE Gluco-Manager™ Blood Glucose Monitoring System, Model GMM0002, demonstrates its performance through compliance with ISO 15197: In vitro diagnostic test systems- Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus. While the document asserts compliance with this standard, it does not explicitly state specific acceptance criteria values or detailed performance results in the provided text.

Therefore, I cannot directly complete Table 1 with specific acceptance criteria and reported device performance values from the provided text. The document refers to the ISO standard as the basis for performance.

Here's what can be inferred and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria (from ISO 15197)	Reported Device Performance (from K132180)
System Accuracy	ISO 15197 (2003) Requirements: • For glucose concentrations < 75 mg/dL (4.2 mmol/L): ≥ 95% of results must be within ±15 mg/dL (±0.83 mmol/L) of the reference method. • For glucose concentrations ≥ 75 mg/dL (4.2 mmol/L): ≥ 95% of results must be within ±20% of the reference method.	Not explicitly stated with numerical values in the provided document, but "conforms to... ISO 15197." This implies the device met the ISO 15197 criteria through its studies.
Precision (Repeatability/Reproducibility)	ISO 15197 requirements (e.g., CV% or SD for different glucose levels)	Not explicitly stated with numerical values in the provided document.
Interferences (Hematocrit, temperature, known interfering substances)	ISO 15197 requirements for acceptable ranges and impact on results	Hematocrit Range: 20-60% (Stated as a characteristic, implying it meets the ISO standard for this range). Operating Temperature Range: 10°C to 40°C (50°-104°F) (Stated as a characteristic, implying it meets the ISO standard for this range). Other interferences not explicitly detailed.
Usability/User Performance	ISO 15197 requirements for user error rates and ease of use	Not explicitly stated with numerical values in the provided document.

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

Sample Size: Not explicitly stated for the test set or any performance study.
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The document mentions it's for self-testing at home and the submitter is in Toronto, ON, Canada, but this doesn't clarify the study's data origin.

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

Not stated. For blood glucose monitoring systems, ground truth is typically established using a laboratory reference method (e.g., YSI analyzer) rather than expert consensus.

4. Adjudication method for the test set:

Not applicable/Not stated. Given the nature of blood glucose measurements, an adjudication method like 2+1 or 3+1 for image interpretation is not relevant. The ground truth would be based on a laboratory reference method.

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:

Not applicable. This device is a standalone blood glucose monitoring system, not an AI-assisted diagnostic tool for human readers.

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

Yes. The document describes the IDEAL LIFE Gluco-Manager™ as a blood glucose monitoring system that measures glucose in fresh capillary whole blood and displays the result. It states it "can be used alone to measure your blood glucose." The wireless communication and Gateway Application are for transmitting and reviewing data, not for making interpretations, evaluations, or medical judgments. The core measurement is standalone.

7. The type of ground truth used:

Not explicitly stated, but for a blood glucose monitoring system claiming conformance to ISO 15197, the ground truth would invariably be established using a laboratory reference method (e.g., a YSI Glucose Analyzer) which is considered the gold standard for glucose measurement in blood.

8. The sample size for the training set:

Not applicable/Not stated. As a biosensor-based system, it likely does not involve a "training set" in the machine learning sense. Its performance is based on its electrochemical design and calibration, not a trained algorithm.

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

Not applicable. (See point 8).

In summary: The provided 510(k) summary for the IDEAL LIFE Gluco-Manager™ states that the device conforms to ISO 15197, which serves as the primary evidence of meeting acceptance criteria. However, explicit numerical performance data (e.g., accuracy percentages, precision metrics) and details about the study design, sample sizes, and ground truth methodology are not provided within this specific document, beyond the general statement of ISO compliance.

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