(138 days)
The TD-4268 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 TD-4268 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 TD-4268 Blood Glucose Test Strips are for use with the TD-4268 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples.
The TD-4268 Multi Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary, venous and neonatal whole blood samples. The TD-4268 Multi Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple patient use in professional healthcare settings as an aid in monitoring the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus.
Professionals may test with capillary, venous and neonatal whole blood. Capillary samples may be drawn from the fingertip, and in the case of neonates, from the heel.
The system is only used with single-use, auto-disabling lancing devices.
The TD-4268 Multi Blood Glucose Test Strips are for use with the TD-4268 Multi Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary, venous and neonatal 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.
This 510(k) summary (K120042) for the TD-4268 Blood Glucose Monitoring System and TD-4268 Multi Blood Glucose Monitoring System does not contain detailed information about specific acceptance criteria or a dedicated study proving performance against those criteria beyond a statement of substantial equivalence to a predicate device.
Instead, the submission relies on demonstrating that the new device has "the same performance characteristics as the predicate device" (TD-4239 Blood Glucose Monitoring System and TD-4239 Multi Blood Glucose Monitoring System, K101635) and that software verification and validation confirmed its performance, safety, and effectiveness are equivalent to the predicate.
Therefore, many of the requested details about acceptance criteria, study specifics, sample sizes, expert involvement, and ground truth establishment are not explicitly provided in this document.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
As specific acceptance criteria are not detailed in this 510(k) summary, a table cannot be constructed with explicit criteria and reported performance. The document generally states:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Implied: Equivalent performance to predicate device (TD-4239 Blood Glucose Monitoring System) | "TD-4268 Blood Glucose Monitoring System/TD-4268 Multi Blood Glucose Monitoring System has the same performance characteristics as the predicate device." |
| "A comparison of system accuracy performance demonstrated that the TD-4268 Blood Glucose Monitoring System/TD-4268 Multi Blood Glucose Monitoring System and the TD-4239 Blood Glucose Monitoring System/TD-4239 Multi Blood Glucose Monitoring System are substantially equivalent." | |
| Implied: Performance, safety, and effectiveness | "Software verification and validation testing confirmed that the performance, safety and effectiveness of the TD-4268 Blood Glucose Monitoring System /TD-4268 Multi Blood Glucose Monitoring System are equivalent to the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in this document. The submission relies on demonstrating substantial equivalence to a predicate device rather than presenting a de novo performance study with a new sample size.
- Data Provenance: Not explicitly stated. Given that it's a submission from Taiwan, the data could originate from there, but this is not confirmed. The document does not specify if the data is retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable or not specified. Since the submission focuses on substantial equivalence and mentions "software verification and validation testing" rather than a clinical study with human interpretation of results, there's no indication of experts establishing a ground truth in this context.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable or not specified. There is no mention of a formal adjudication process for a test set in this summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- This is not applicable to this device. The TD-4268 is a blood glucose monitoring system, an in vitro diagnostic device that measures glucose levels. It is not an AI-assisted diagnostic imaging device requiring human reader interpretation, so an MRMC study comparing human readers with and without AI assistance would not be relevant.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- This is not applicable in the context of an AI algorithm. However, for a blood glucose meter, the "standalone" performance would typically refer to the device's accuracy in measuring glucose levels independently. The document states that the system's accuracy performance was compared to the predicate device to demonstrate substantial equivalence, implying its standalone measurement capability was assessed.
7. The Type of Ground Truth Used
- For blood glucose monitoring systems, the ground truth is typically established by reference laboratory methods (e.g., YSI analyzer) for glucose measurement. While not explicitly detailed in this summary, it's the standard practice for such devices to compare their readings against a highly accurate laboratory method. The document mentions "system accuracy performance," which would inherently involve comparison to a gold standard.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable or not specified. This document pertains to a blood glucose meter, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The "training" here would refer to the device's design and calibration, not an AI model.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable. As mentioned, this is not an AI algorithm requiring a training set in the machine learning context. The calibration and design of the blood glucose meter would rely on established chemical and electrical engineering principles, with accuracy validated against reference methods.
In summary, this 510(k) submission primarily demonstrates substantial equivalence to a previously cleared predicate device (K101635) by confirming similar operating principles, fundamental technology, circuit design, materials, shelf life, packaging, and manufacturing processes, along with confirmed performance characteristics through "software verification and validation testing." It does not present a detailed, de novo study with explicit acceptance criteria and corresponding performance data as might be expected for novel devices or AI algorithms.
§ 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.