(15 days)
The OneTouch Ultra Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. The OneTouch Ultra System is intended for use outside the body (in vitro diagnostic use) by people 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 Ultra Blood Glucose Monitoring System is specifically indicated for use on the finger, forearm or palm.
The OneTouch Ultra Blood Glucose Monitoring System consists of the OneTouch Ultra Meter, OneTouch Ultra Test Strips (provided separately), OneTouch Ultra Control Solution, OneTouch UltraSoft Blood Sampler with OneTouch ClearCap and OneTouch UltraSoft Sterile Lancets. The predicate OneTouch® Ultra® meter hardware and software has been modified. There are no changes to other system testing components compared to the currently marketed product.
This document describes the OneTouch® Ultra® Blood Glucose Monitoring System, which measures glucose in fresh capillary whole blood. The system is intended for use by people with diabetes at home and/or by healthcare professionals in a clinical setting to monitor diabetes control. It is specifically indicated for use on the finger, forearm, or palm.
Here's an analysis of the provided information regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state numerical acceptance criteria for glucose measurement accuracy. Instead, it refers to compliance with the ISO 15197:2003(E) standard. For blood glucose monitoring systems, ISO 15197:2003(E) typically sets accuracy criteria, often related to the percentage of results falling within specific ranges compared to a reference method (e.g., within ±15% or ±20%).
Since specific numerical criteria are not provided, we can only state the overall performance claim made in the document.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with ISO 15197:2003(E) for system accuracy and electrical safety. | A system accuracy study demonstrated that the modified OneTouch Ultra Blood Glucose Monitoring System and the currently marketed OneTouch Ultra Blood Glucose Monitoring System are substantially equivalent, and the modified meter was tested in accordance with ISO 15197:2003(E) including system accuracy. |
| Performance, safety, and effectiveness equivalent to the predicate device. | Design Verification (including software verification and validation testing) confirmed that the performance, safety and effectiveness of the modified OneTouch Ultra Blood Glucose Monitoring System were equivalent with that of the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide details on:
- The sample size used for the test set in the system accuracy study.
- The country of origin for the data.
- Whether the study was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
The document does not provide information on:
- The number of experts used to establish ground truth.
- The qualifications of those experts.
Given that this is a blood glucose monitoring system, the "ground truth" would typically be established by a laboratory reference method, not by an expert consensus on interpreting images or clinical data.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method. This is understandable as the "ground truth" in this context would likely be a precise numerical measurement from a laboratory reference instrument, not a subjective interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are typically used for diagnostic imaging devices where human readers interpret medical images. This device is a blood glucose monitor, not an imaging device.
6. If a Standalone Performance Study Was Done
Yes, a standalone performance assessment (algorithm only without human-in-the-loop performance) was done. The "system accuracy study" and "Design Verification (including software verification and validation testing)" are examples of standalone performance evaluations for a medical device. The device's performance is measured directly against a reference.
7. The Type of Ground Truth Used
The document implies that the ground truth used for the system accuracy study would be a laboratory reference method for glucose measurement. While not explicitly stated, this is standard practice for blood glucose meters to ensure accuracy. The ISO 15197:2003(E) standard inherently requires comparison to a highly accurate reference method.
8. The Sample Size for the Training Set
The document does not provide information on the sample size for a training set. For in vitro diagnostic devices like blood glucose meters, the development often involves analytical studies, calibration, and verification rather than "training sets" in the machine learning sense, although internal data is used during development.
9. How the Ground Truth for the Training Set Was Established
The document does not provide information on how ground truth for a training set was established. As mentioned above, the concept of a "training set" with established ground truth, as used in machine learning, is not explicitly discussed for this type of device. The development process would rely on precise chemical and analytical methods to calibrate and verify the device's measurement capabilities.
§ 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.