(28 days)
The EasyMax MU Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood from fingertip, palm, or forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can be only used during steady-state blood glucose conditions.
The EasyMax MU Pro Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in venous whole blood or fresh capillary whole blood from fingertip. Testing is done outside the body (In Vitro diagnostic use). It is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use lancing devices. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus.
The system consists of the EasyMax MU meter and the EasyMax MU test strips. The EasyMax MU meter only is used with the EasyMax MU test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip, palm, or forearm.
The system consists of the EasyMax MU Pro meter and the EasyMax MU Pro test strips. The EasyMax MU Pro meter only is used with the EasyMax MU Pro test strips to quantitatively measure glucose in venous whole blood or fresh capillary whole blood from fingertip.
The provided text from the 510(k) clearance letter and Indications for Use forms for the EasyMax MU and EasyMax MU Pro Self Monitoring Blood Glucose Systems does not contain the detailed information required to answer all parts of your request.
Specifically, the document focuses on regulatory clearance and intended use, but it does not include results from device performance studies, acceptance criteria, sample sizes for test sets, details on ground truth establishment, or information about AI assistance or human reader studies. It's common for these details to be in separate technical documentation submitted to the FDA, not typically summarized in the public-facing clearance letter.
Therefore, I can only address the parts of your request that can be inferred from the provided text.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document does not specify performance metrics (e.g., accuracy, precision) or acceptance criteria for those metrics.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. The document does not mention sample sizes for any test sets or data provenance.
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)
- Cannot be provided. The document does not describe how ground truth was established, nor does it mention any experts involved in such a process.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. The document does not describe any adjudication methods.
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
- Cannot be provided. The EasyMax MU and EasyMax MU Pro systems are Self Monitoring Blood Glucose Systems, meaning they are standalone devices for measuring glucose. They are not AI-assisted imaging devices or diagnostic tools that would involve "human readers" in the sense of interpreting images. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable to this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, by nature of the device. While not described as an "algorithm" in a software sense, the blood glucose measurement system inherently operates as a standalone device without human interpretation of the measurement result itself. The device provides a quantitative glucose reading directly. The "performance" being referred to would be the accuracy and precision of the device's quantitative glucose measurement against a reference method. The document implicitly confirms this is a standalone device through its description as "quantitative measurement of glucose."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Inferred: Reference laboratory method. For blood glucose monitoring systems, the "ground truth" or reference standard for comparison is typically a highly accurate laboratory-based glucose analyzer (e.g., hexokinase method). The document doesn't explicitly state this, but it's standard for this type of device.
8. The sample size for the training set
- Cannot be provided. The document does not mention any "training set" or its size. For a blood glucose meter, the "training" (calibration) is typically done during the manufacturing process and verified.
9. How the ground truth for the training set was established
- Cannot be provided. As above, no information on a training set or its ground truth establishment is present.
§ 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.