(29 days)
The OneTouch Ultra 2 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. The OneTouch Ultra 2 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 2 Blood Glucose Monitoring System is specifically indicated for use on the finger, forearm or palm.
The OneTouch Ultra 2 Blood Glucose Monitoring System consists of the OneTouch Ultra 2 Meter, OneTouch Ultra Test Strips (provided separately), OneTouch Ultra Control Solution, OneTouch UltraSoft Blood Sampler and OneTouch UltraSoft Sterile Lancets. The predicate OneTouch® Ultra® Meter has been modified to produce the OneTouch Ultra 2 Meter; there are no changes to other system testing components compared to the currently marketed product.
Here's a breakdown of the acceptance criteria and study information for the OneTouch® Ultra® 2 Blood Glucose Monitoring System, based on the provided document:
This 510(k) summary explains that the OneTouch® Ultra® 2 Blood Glucose Monitoring System is a modified version of an existing device (OneTouch® Ultra® Blood Glucose Monitoring System). The submission focuses on demonstrating substantial equivalence to the predicate device, rather than establishing entirely new performance criteria or conducting a comprehensive clinical trial from scratch.
Therefore, the acceptance criteria and performance data provided relate to demonstrating this equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device | A meter equivalence study demonstrated that the OneTouch® Ultra® 2 Blood Glucose Monitoring System and the currently marketed OneTouch® Ultra® Blood Glucose Monitoring System are substantially equivalent. |
| Performance, Safety, and Effectiveness (Design Verification) | Design verification (including software verification and validation testing) confirmed that the performance, safety and effectiveness of the OneTouch Ultra 2 Blood Glucose Monitoring System was equivalent with that of the predicate device. |
| Compliance with ISO 15197:2003(E) | The modified meter was tested in accordance with ISO 15197:2003(E). |
| Ease of Use (Human Factors and User Acceptance) | A consumer evaluation to assess ease of use (human factors and user acceptance) was conducted. |
| Labeling Comprehension | Reading level assessment of the product labeling was conducted and validated for comprehension. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample size for the "meter equivalence study" or the "consumer evaluation."
- Sample Size for Test Set: Not explicitly stated.
- Data Provenance: Not explicitly stated, but generally, such studies for medical devices seeking FDA clearance are conducted with data relevant to the target population (e.g., people with diabetes). It isn't specified whether the data was retrospective or prospective, or the country of origin.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the document. For a blood glucose monitoring system, "ground truth" typically refers to reference measurements from a laboratory analyzer, not expert consensus on interpretations.
4. Adjudication Method for the Test Set
Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving expert interpretation of medical images or complex diagnostic findings. For a blood glucose meter, where the output is a quantitative value, such adjudication methods are not applicable. The ground truth would usually be established by a reference laboratory method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study is not applicable to this device. This type of study assesses how human readers' performance changes with or without AI assistance, which is irrelevant for a standalone blood glucose meter. The document does not mention any human-in-the-loop AI assistance.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)
Since this is a blood glucose monitoring system, its primary function is to provide a direct quantitative reading of blood glucose. The performance described (substantial equivalence, ISO 15197 compliance, design verification) inherently relates to its standalone performance as a device measuring glucose levels without human-in-the-loop "interpretation" in the same way an imaging AI would.
7. The Type of Ground Truth Used
The document does not explicitly state the specific "ground truth" method used for the meter equivalence study or ISO 15197 compliance. However, for blood glucose meters, the ground truth is almost universally established by laboratory reference methods (e.g., YSI analyzer) known for their high accuracy and precision, when comparing a point-of-care device.
8. The Sample Size for the Training Set
The document does not mention any training set or machine learning model. The OneTouch® Ultra® 2 is presented as a modification of an existing device, with no indication of new algorithms requiring a separate training process.
9. How the Ground Truth for the Training Set Was Established
As no training set or machine learning model is mentioned, this information is 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.