(158 days)
The U-RIGHT TD-4116 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the finger and alternative sites (palm, forearm and upper arm). This blood glucose monitoring system is intended to be used by a single person and should not be shared. The U-RIGHT TD-4116 Blood Glucose Monitoring System 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. This system should not be used for the diagnosis of or screening for diabetes, nor for use on neonates. The alternative site testing in this system can be used only during steady-state blood glucose conditions (when glucose is not changing rapidly).
The U-RIGHT TD-4116 Pro Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the finger and alternative sites (palm, forearm and upper arm). This blood glucose monitoring system is intended to be used by professionals testing with capillary whole blood samples. The U-RIGHT TD-4116 Pro Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by health care professionals in clinical settings as an aid to monitor the effectiveness of diabetes control. This system should not be used for the diagnosis of or screening for use on neonates. The system is only used with single-use, auto-disabling lancing devices. The alternative site testing in this system can be used only during steady-state blood glucose conditions (when glucose is not changing rapidly).
The system consists of blood glucose meter and test strips. These products have been designed, tested, and proven to work together as a system to produce accurate blood glucose test results. And, use only U-RIGHT TD-4116 test strips with the U-RIGHT TD-4116 Blood Glucose Monitoring System. Use only U-RIGHT TD-4116 Pro test strips with the U-RIGHT TD-4116 Pro Blood Glucose Monitoring System.
The provided text describes information relevant to the submission of the U-RIGHT TD-4116 Blood Glucose Monitoring System and U-RIGHT TD-4116 Pro Blood Glucose Monitoring System to the FDA. However, it does not contain a detailed study report that proves the device meets specific acceptance criteria with all the requested information. The document is a 510(k) summary, which typically provides an overview of the device and its performance but not the full study details.
Based only on the provided text, here's what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance:
The document mentions that "Clinical and Non-clinical studies were conducted to evaluate the performance of the modified device. The data from these studies demonstrates that the proposed device is substantially equivalent to the predicate device." However, it does not explicitly state the acceptance criteria (e.g., ISO 15197 requirements for accuracy) or provide a table of reported device performance against those criteria. It only states that the device was compared to a YSI 2300 Glucose Analyzer.
Missing:
- Specific quantitative acceptance criteria (e.g., ISO 15197 accuracy percentages).
- Detailed reported device performance data (e.g., bias, % accuracy within certain ranges) against those criteria.
2. Sample size used for the test set and the data provenance:
The document states that "Clinical and Non-clinical studies were conducted," but it does not specify the sample size used for the test set in either study. It also does not mention the data provenance (e.g., country of origin, retrospective or prospective nature of the studies).
Missing:
- Sample size for clinical and non-clinical test sets.
- Country of origin of the data.
- Whether the studies were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document mentions that the devices are compared to a "YSI 2300 Glucose Analyzer" which is "calibrated with NIST (SRM) 917A reference material" for "Traceability." This indicates that the YSI 2300, a laboratory reference method, served as the ground truth. This type of ground truth typically relies on instrumental accuracy and calibration standards, not on human experts adjudicating results.
Missing / Not Applicable:
- This question is largely not applicable as the ground truth is an instrumental reference method (YSI 2300) rather than expert interpretation. Therefore, there are no "experts" in the traditional sense involved in establishing the ground truth for a glucose test system.
4. Adjudication method for the test set:
As mentioned above, the ground truth is established by a reference instrument (YSI 2300 Glucose Analyzer). Therefore, no human adjudication method (like 2+1 or 3+1) would be applicable or described for this type of device performance evaluation.
Missing / Not Applicable:
- Human adjudication methods are not applicable here.
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:
This is a blood glucose monitoring system, which is a diagnostic device for quantitative measurement of glucose. It is not an imaging device or an AI-assisted diagnostic tool that involves human "readers" or "cases" in the MRMC sense. Therefore, this type of study is not applicable to the device described.
Not Applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The performance evaluation described is for the device (meter + test strips) operating as a standalone system to measure glucose. While not explicitly termed "standalone algorithm performance," the comparison to the YSI 2300 inherently evaluates the device's accuracy without human interpretation influencing the measurement itself. The "human-in-the-loop" for this device would be the user performing the test, but the accuracy assessment itself focuses on the device's technical measurement capability.
Yes, implicitly. The clinical and non-clinical studies evaluate the device's ability to accurately measure blood glucose compared to a reference method, which is a standalone performance assessment of the device's measurement function.
7. The type of ground truth used:
The ground truth used is an instrumental reference method: the "YSI 2300 Glucose Analyzer," which is calibrated with "NIST (SRM) 917A reference material."
8. The sample size for the training set:
The document does not mention any training set or details about how the device's internal algorithms might have been developed or trained. This type of information is generally not included in a 510(k) summary for a blood glucose meter, as they are typically electrochemical systems rather than machine learning algorithms requiring a distinct "training set."
Missing / Not Applicable.
9. How the ground truth for the training set was established:
Since no training set information is provided or implied, there is no information on how its ground truth was established.
Missing / Not Applicable.
§ 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.