(28 days)
The ONE Touch® Zoom™ Diabetes Management Program is intended for use in home and clinical settings to aid people with diabetes and healthcare professionals in the review, analysis, and evaluation of historical blood glucose test results to support effective diabetes management. It is intended for use as an accessory to LifeScan blood glucose monitoring systems with data management capabilities.
The OneTouch® Zoom™ Diabetes Management Program is a web-based application that is designed to retrieve blood glucose data from the Microsoft® HealthVault™ and provide trending and reports in order to assist people with diabetes management. The program also includes a stand-alone software driver, branded as OneTouch® Meter Drivers for use with Microsoft® HealthVault™ that downloads blood glucose data from Lifescan Brand blood glucose meters with data management capabilities to Microsoft® HealthVault™ Connection Center, which subsequently upload the data to the user's online Microsoft® HealthVault™ account. The OneTouch® Zoom™ Diabetes Management Program is a .NET based client/server application that runs on Windows 2003 server and supports Internet Explorer 6.0 and higher on the client side. The OneTouch® Meter Drivers for use with Microsoft® HealthVault™ run on Windows XP Service Pack 2 and Windows Vista platforms.
Here's an analysis of the provided text regarding the acceptance criteria and study for the OneTouch® Zoom™ Diabetes Management Program:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No explicit acceptance criteria mentioned. | "Design Verification testing (including software verification and validation testing) confirmed that the performance, safety, and effectiveness of the OneTouch® Zoom™ Diabetes Management Program was equivalent to that of the predicate device." |
| No change to the intended use. | Confirmed, as stated. |
| No change to the operating principle. | Confirmed, as stated. |
| No change to the functionality. | Confirmed, as stated. |
| No change to the material composition. | Confirmed, as stated. |
| No change to the fundamental scientific technology. | Confirmed, as stated. |
| No change to the performance characteristics. | Confirmed, as stated. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated in the provided text. The document refers to "Design Verification testing" but does not give specific numbers for test cases or datasets.
- Data Provenance: Not explicitly stated. The testing is described as design verification and software verification/validation, implying internal testing, but details on the origin of data used for this testing (e.g., country, retrospective/prospective) are absent.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The device is a software program for diabetes management data analysis; there is no mention of human expert-established ground truth in the context of diagnostic accuracy for the device itself. The "ground truth" would likely relate to the accuracy of data retrieval, processing, and display, rather than clinical diagnosis.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this type of adjudication is typically for diagnostic accuracy studies with human readers, which is not the nature of this device's testing.
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
No. An MRMC comparative effectiveness study was not performed. The device is a data management program, not an AI-assisted diagnostic tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, implicitly. The "Design Verification testing (including software verification and validation testing)" would assess the standalone performance of the software in its intended functions (data retrieval, trending, reporting). The focus is on the software's ability to accurately process and present the blood glucose data.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device would be established by:
- Conformance to requirements: Ensuring the software correctly implements its specified functions (e.g., retrieves data accurately, generates reports as defined, performs calculations correctly).
- Predicate device equivalence: The primary "ground truth" or benchmark is the predicate device. The testing aimed to confirm that the new device's performance characteristics were equivalent to the already approved predicate.
- The accuracy of the blood glucose data itself, which originates from LifeScan blood glucose meters, is assumed as established by the prior approval of those meters.
8. The Sample Size for the Training Set
Not applicable. This device is a data management program, not a machine learning model that undergoes a training phase.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of software device.
§ 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.