(144 days)
The IDEAL LIFE Gluco-Manager™ GMM 0001 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the palm, the forearm, the upper-arm, the calf and the thigh. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus.
The alternative site testing in this system can be used only during steady-state blood glucose conditions.
This system offers Bluetooth wireless communication function which is able to transfer historical data in the memory to other devices, such as PC or IDEAL LIFE POD™
IDEAL LIFE Gluco-Manager™ GMM 0001 Blood Glucose Monitoring System consists of a meter and test strips. The system utilizes an electrochemical method-based meter and dry reagent biosensor (test strips) for blood glucose testing. The size of the current is proportional to the amount of glucose present in the sample, providing a quantitative measurement of glucose in fresh whole blood and control solutions.
The provided document is a 510(k) summary for the IDEAL LIFE Gluco-Manager™ GMM 0001 Blood Glucose Monitoring System. It describes the device, its intended use, comparison to a predicate device, and concludes that it demonstrates satisfactory performance. However, it does not contain the detailed performance study results, acceptance criteria, or ground truth establishment methods that would be required to fully answer your questions.
Therefore, I cannot provide a complete answer based solely on the provided text. I can, however, extract the information that is present and highlight what is missing.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the provided text. Blood glucose monitoring systems typically have specific accuracy criteria (e.g., ISO 15197 standards), but these are not listed.
- Reported Device Performance: The document only states, "The studies demonstrated that the performance of this system meets its intended use" and "IDEAL LIFE Gluco-Manager ™ GMM 0001 Blood Glucose Monitoring System demonstrates satisfactory performance and is suitable for its intended use." No quantitative performance data (e.g., accuracy, precision, bias, MARD) is provided.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for any test set.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The studies were conducted "in the laboratory and in clinical settings by healthcare professionals and lay users."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Ground Truth Experts: The document states "clinical settings by healthcare professionals and lay users," but it does not specify how many healthcare professionals were involved or their qualifications for establishing ground truth, nor does it explicitly mention ground truth methods for lay user data. For blood glucose monitoring, ground truth is typically established by laboratory reference methods, not by expert consensus on visual inspection or interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not specified. This concept (e.g., 2+1, 3+1) is more relevant to human interpretation of images or other subjective data, not typically for objective measurements like blood glucose where a reference method serves as the ground truth.
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
- MRMC Study: Not applicable or mentioned. This is a blood glucose monitoring system, not an AI-powered diagnostic imaging device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Yes, implicitly. The "Performance Studies" section refers to the system's performance, which measures the accuracy of the device itself (meter + test strips) against reference methods. While users operate the device, the core performance measured is the algorithm's ability to accurately quantify glucose from the provided sample. The document does not detail these studies.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not explicitly stated, but for blood glucose monitoring systems, the ground truth is overwhelmingly a highly accurate laboratory reference method (e.g., YSI analyzer, hexokinase method). The document mentions "in the laboratory," which implies such reference methods would have been used.
8. The sample size for the training set
- Training Set Sample Size: Not applicable/not mentioned. This device is an electrochemical blood glucose meter, not a machine learning or AI algorithm that undergoes a "training" phase in the conventional sense with a distinct training set. Its "training" is in its design and calibration, which would be validated through the performance studies.
9. How the ground truth for the training set was established
- Training Set Ground Truth Establishment: Not applicable, as there's no explicitly defined "training set" in the context of an AI/ML algorithm. Calibration and validation data would have been compared against laboratory reference methods.
In summary, the provided document serves as a high-level summary for regulatory submission, confirming the device's technical characteristics and intended use. It does not contain the detailed technical data or study methodologies needed to answer specific questions regarding acceptance criteria, performance metrics, sample sizes, or ground truth establishment in a quantitative manner. Such information would typically be found in the full 510(k) submission, not the public summary document.
§ 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.