(72 days)
The Easy Talk Blood Glucose Monitoring System, is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the forearm. It is intended for use by healthcare professionals and people with diabetes mellitus at home and as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis or screening for diabetes mellitus, nor for use with neonates.
The alternative site testing (forearm) in this system can only be used during steady-state blood glucose conditions.
This system contains a speaking function that provides audible test results for users with low vision.
The Easy Talk Blood Glucose Monitoring System, consists of a blood glucose meter, test strips, control solutions, lancing device, and commercially available lancets. The meter has a bilingual speaking feature that provides audible test results for users with low vision. The forearm may be used as an alternate site for capillary blood.
The provided text describes a 510(k) submission for the "Easy Talk Blood Glucose Monitoring System". While it mentions "clinical performance study" and "test results showed substantial equivalence", it does not provide specific acceptance criteria or detailed results of a study that proves the device meets those criteria in a quantitative manner that would allow for the tables and specific details requested.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance:
- No specific quantitative acceptance criteria are provided in the document. Blood glucose monitoring systems typically have accuracy criteria based on ISO standards (e.g., ISO 15197) or FDA guidance, which define acceptable percentages of readings within certain deviation limits from a reference method. These are not present in this summary.
- No reported device performance metrics (e.g., accuracy percentages, bias, precision) are provided. The document only states "The test results showed substantial equivalence."
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 for Test Set: Not specified.
- Data Provenance: Not specified, other than the submitter's address being in Taiwan. It's unclear if the study was conducted there or elsewhere. It is implied to be prospective as it's a "clinical performance study" for validation purposes.
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):
- Not Applicable. For blood glucose monitors, the ground truth is typically established by laboratory reference methods (e.g., YSI analyzer) rather than expert consensus on images or interpretations. The document does not mention how ground truth was established, but it would almost certainly be a chemical laboratory method.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used in studies where human interpretation of medical images or data is involved and discrepancies need to be resolved. This is not relevant for a blood glucose monitoring system where ground truth is established by an objective chemical measurement.
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:
- No MRMC study was done. This type of study is for evaluating human performance (e.g., radiologists) with or without AI assistance, typically for image interpretation. This device is a standalone blood glucose meter and does not involve AI for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance study was done. The entire "Clinical Tests" section refers to the performance of the device itself ("Easy Talk Blood Glucose Monitoring System") in terms of usability and accuracy, without human-in-the-loop interaction beyond operating the device. The device is designed to provide a direct measurement; it's not an AI assisting a human.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Inferred Ground Truth: While not explicitly stated, for blood glucose monitoring systems, the ground truth for accuracy studies is typically established by comparing the device's readings to those obtained from a central laboratory reference method (e.g., a YSI analyzer or similar highly accurate laboratory instrument) using venous blood samples.
8. The sample size for the training set:
- Not applicable / Not specified. Blood glucose monitoring systems, especially of this generation, do not typically use "training sets" in the machine learning sense. Their algorithms are based on established electrochemical principles, requiring calibration and validation, but not a "training set" of patient data for a machine learning model. If any internal calibration or algorithm refinement occurred using data, it's not described as a "training set".
9. How the ground truth for the training set was established:
- Not applicable. As explained in point 8, the concept of a "training set" with established ground truth in the context of machine learning is not described or indicated for this device.
In summary: The provided 510(k) summary is very high-level regarding performance studies. It asserts that "extensive verification, validation and testing activities" were performed and the device "passed all of the tests based on pre-determined Pass/Fail criteria," and "The test results showed substantial equivalence" to a predicate device. However, it lacks the specific quantitative data, acceptance criteria, sample sizes, and methodological details required to fully address your request in a structured scientific manner. Such detailed information would typically be found in the full submission, not in the 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.