(113 days)
The U-RIGHT TD-4280 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood samples from the finger. It is intended to be used by a single person and should not be shared.
The U-RIGHT TD-4280 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. It is not intended for the diagnosis of or screening for diabetes mellitus or be used on neonates. The meter contains speaking functions but is not intended for use by visually impaired users.
The U-RIGHT TD-4280 Blood Glucose Test Strips are for use with the U-RIGHT TD-4280 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples.
The system consists of three main products: the meter, test strips, and control solutions. These products have been designed, tested, and proven to work together as a system to produce accurate blood glucose test results.
Here's an analysis of the provided text regarding the U-RIGHT TD-4280 Blood Glucose Monitoring System:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document doesn't explicitly state specific numerical acceptance criteria for the U-RIGHT TD-4280 Blood Glucose Monitoring System. Instead, it relies on demonstrating substantial equivalence to a predicate device (TD-4277 Blood Glucose Monitoring System). The performance characteristic considered for equivalence is "system accuracy performance."
| Acceptance Criteria Category | Specific Criteria (Implicitly based on Predicate Equivalence) | Reported Device Performance |
|---|---|---|
| System Accuracy | Equivalent to TD-4277 Blood Glucose Monitoring System | Demonstrated equivalence to the predicate device. |
| Software Performance | Equivalent to TD-4277 Blood Glucose Monitoring System | Software verification and validation confirmed equivalent performance, safety, and effectiveness to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). This type of detail is typically found in the full study report, which is not included in this 510(k) summary. The summary only mentions "A comparison of system accuracy performance" and "Software verification and validation testing."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
This information is not provided in the given text. For a blood glucose monitoring system, the "ground truth" for accuracy studies is typically established by comparing the device's readings to laboratory reference methods (e.g., YSI analyzer) performed by trained clinical laboratory personnel, not by medical experts in the sense of radiologists or pathologists.
4. Adjudication Method for the Test Set
This information is not provided in the given text. Adjudication methods are typically relevant for studies where subjective expert review is involved. For a blood glucose meter, the comparison is usually against an objective reference laboratory method, making a traditional adjudication process (like 2+1) less applicable.
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
An MRMC comparative effectiveness study is not applicable to this device. This type of study is used for diagnostic imaging devices where human readers interpret images, often with and without AI assistance, to assess the AI's impact on human performance. The U-RIGHT TD-4280 is a blood glucose monitoring system, directly measuring glucose levels, not assisting human interpretation of complex data.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
The context of "standalone" performance (algorithm only) is usually discussed for AI/ML-driven diagnostic systems. For a blood glucose meter, the device itself provides the measurement, and its "standalone performance" is what is being evaluated (i.e., how accurately it measures glucose). The entire system (meter + strip) is designed to operate without continuous human-in-the-loop interpretation beyond the user taking the reading. The summary implies the device's accuracy was tested independently.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The exact type of ground truth is not explicitly stated, but for blood glucose monitoring systems, the ground truth is universally established through laboratory reference methods. This would involve comparing the glucose readings from the U-RIGHT TD-4280 system to results obtained from a highly accurate laboratory instrument, such as a YSI glucose analyzer, which is considered the gold standard for glucose measurement in blood samples.
8. The Sample Size for the Training Set
The concept of a "training set" is primarily relevant for machine learning algorithms. While the device contains software, the 510(k) summary does not indicate that it uses a machine learning algorithm that requires a separate "training set" in the conventional sense. The device's electrochemical biosensor technology likely relies on pre-defined algorithms and calibration, rather than a learned model from a large training dataset. Therefore, information about a training set sample size is not provided and likely not applicable in the AI/ML context.
9. How the Ground Truth for the Training Set was Established
As noted in point 8, the concept of a "training set" as it relates to AI/ML is likely not applicable here. If the device's internal algorithms required calibration, this would be done against laboratory reference methods to ensure accuracy across the measurement range, similar to how ground truth for performance evaluation is established. However, the document does not detail these developmental and calibration processes.
§ 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.