(25 days)
The OneTouch® Select™ Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood. The OneTouch® Select™ System is intended for self-testing outside the body (in vitro diagnostic use) by pcople with diabetes at home and/or by healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. The OneTouch® Select™ Blood Glucose Monitoring System is specifically indicated for use on the finger, forearm or palm.
The OneTouch® Select™ Blood Glucose Monitoring System consists of the OneTouch® Select™ Meter, OneTouch® Select™ Test Strips (provided separately), OneTouch® Select™ Control Solution (provided separately), OneTouch® Select™ High Control Solution (provided separately), either the OneTouch® UltraSoft® Adjustable Blood Sampler with OneTouch® UltraClear® Cap or the OneTouch® Lancing Device with Onc Touch® AST ClearCap and OneTouch® UltraSoft Sterile Lancets.
The OneTouch® Select™ meter, test strip and high control solution are modifications of the OneTouch Ultra 2® meter, test strip and normal control solution, respectively.
There are no changes to other system testing components compared to the currently marketed product.
The OneTouch® Select™ Blood Glucose Monitoring System was tested and found to be substantially equivalent to the predicate OneTouch Ultra 2 Blood Glucose Monitoring System.
Here's a breakdown of the requested information, although some details (like specific sample sizes for training sets and the exact number/qualifications of experts) are not explicitly provided in the summary:
1. Table of Acceptance Criteria and Reported Device Performance
The summary states that the modified blood glucose monitoring system was tested in accordance with ISO 15197:2003(E). This standard outlines acceptance criteria for the accuracy of blood glucose monitoring systems. While the exact numerical criteria from ISO 15197:2003(E) are not listed in this summary, the document asserts that the "System accuracy performance demonstrated that the OneTouch® Select™ Blood Glucose Monitoring System and the currently marketed OneTouch Ultra 2 Blood Glucose Monitoring System are substantially equivalent."
Therefore, the acceptance criteria would be those defined by ISO 15197:2003(E), and the performance reported is that it met these criteria as being substantially equivalent to the predicate device.
| Acceptance Criteria (based on ISO 15197:2003(E) - specific thresholds not stated in text) | Reported Device Performance (Relative to predicate device) |
|---|---|
| System Accuracy (e.g., % of results within specific ranges of reference method) | Demonstrated substantial equivalence in accuracy |
| Repeatability (Precision) | Tested and demonstrated |
| Intermediate Precision | Tested and demonstrated |
| User performance assessment (accuracy of results and usability) | Assessed and validated |
| Comprehension of product labeling | Validated |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not explicitly state the sample size used for the analytical performance testing (system accuracy, repeatability, intermediate precision) or the user performance evaluation.
- Data Provenance: Not explicitly stated, but the testing would typically be prospective for such performance studies. Given LifeScan's global presence, the data would likely be collected in a controlled clinical or laboratory setting as part of the design verification process.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: For ground truth in blood glucose measurements, this would typically involve laboratory reference methods and highly trained medical laboratory professionals rather than "experts" in the sense of radiologists. The "User performance evaluation" would assess accuracy by intended users (people with diabetes and healthcare professionals), but the ground truth for glucose values would be established by a reference laboratory method.
4. Adjudication Method for the Test Set
- Not applicable as the ground truth for blood glucose measurements is typically established by precisely calibrated and traceable laboratory reference methods, not subjective interpretation requiring adjudication among multiple human readers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No, an MRMC study was not done. This type of study is relevant for medical imaging where human readers interpret cases. For a blood glucose monitoring system, the primary evaluation is the accuracy of the device's measurement compared to a reference method, rather than human interpretation of device output.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, a standalone performance study was done. "Analytical performance testing included system accuracy, repeatability and intermediate precision testing." This refers to the device's inherent ability to measure glucose values accurately and precisely, independently of user interaction for the measurement itself (though user interaction is a separate usability test).
7. The Type of Ground Truth Used
- The ground truth for blood glucose measurement studies is typically established by laboratory reference methods. These are highly accurate and precise methods (e.g., hexokinase method) performed in a clinical laboratory to determine the true blood glucose concentration against which the device's readings are compared.
8. The Sample Size for the Training Set
- The document does not provide information regarding a specific "training set" or its size. For a blood glucose meter, the "training" (calibration) is inherent in its design and manufacturing. Any iterative development might involve internal testing, but a distinct "training set" like in machine learning is not typically detailed in 510(k) summaries for these devices.
9. How the Ground Truth for the Training Set Was Established
- As a "training set" is not explicitly mentioned in the context of this device's regulatory submission, the method for establishing its ground truth is not provided. The ground truth for the device's validation (test set) is established using laboratory reference methods.
§ 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.