(125 days)
The iglucose™ System collects and transmits stored data from a variety of FDA cleared blood glucose meters such as the LifeScan® OneTouch® and Home Diagnostics™ True™ monitoring systems to a secure database via wireless cellular technology. Subsequently, blood glucose data can then be reviewed through a web portal as an aid in supporting diabetes management. It is intended to be used in a home or health care facility settings.
The iglucose™ System does not measure, interpret or make decisions on the data that it conveys, nor is it intended to provide automated treatment decisions, or to be used as a substitute for professional healthcare judgment. All medical diagnosis and treatment are to be performed under the supervision and oversight of an appropriate healthcare professional.
The iglucose™ System is designed to assist individuals with diabetes with their record keeping management, by automatically tracking and storing historical blood glucose readings. It has been developed for home or health care facility settings as an aid in supporting diabetes management. iglucose™ is designed to connect to glucose meters and automatically transmit blood glucose reading(s) to a secure database. Users can then utilize the iglucoe™ diabetes management portal (web-based application) to view their blood glucose readings as well as to generate and display reports. At the user's discretion, authorized individuals can also view blood glucose readings and reports.
More specifically, the iglucose™ System is comprised of the following:
- · iglucose™ Device
- · Secure Database
- ·iglucose™ Diabetes Management Portal (web-based application)
The iglucose device is approximately the size of a cell phone and has a rechargeable battery. It connects to compatible FDA cleared glucose meters via a data cable and extracts data from a glucose meter. It then wirelessly (via the cellular network) transmits data (blood glucose readings, date and time) from a glucose meter to a secure database. Software used for the database enables the data to be viewable in an organized manner via the iglucose diabetes management portal (web-based application). At the user's discretion, the data can be communicated via email, SMS text message and/or fax.
Data can be displayed in a logbook form. In addition, data can be displayed and trended in reports that are in tabular and graphical formats such as line graphs, pie charts and histograms.
The iglucose™ System is a device designed to collect and transmit stored data from FDA-cleared blood glucose meters to a secure database via wireless cellular technology. This data can then be reviewed through a web portal to aid in diabetes management.
Acceptance Criteria and Reported Device Performance
The provided text details various testing performed on the iglucose™ System, including software, firmware, mechanical, and usability validation. The overarching acceptance criteria for these tests appear to be that "All tests passed" and that the device "performs as expected, and meets all its specification requirements," and "is easy to use and safe for its intended purpose."
Here's a summary of the testing and performance:
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Software Validation | All specified functions perform correctly. | "All tests passed" for examples like Home Page, Registration, Log-in, Administrative Area, device interfacing, and data transmission. |
| Firmware Validation | All specified functions perform correctly and interoperably. | "All tests passed" for examples like Power and initialization, network communication, glucose meters connection, battery testing, and integration testing. |
| Mechanical Testing | Durability meets requirements. | "All tests passed" for durability testing on the power cord and data cable. |
| Usability Study | Effectiveness of user manual, account creation, logging in, connections, viewing readings, and meeting validation success criteria. Device is easy to use and safe. | "Overall the usability test was successful, and demonstrated that the iglucose™ System is easy to use and safe for the purpose for which it is intended." |
Study Details:
The provided document describes various validation studies, but it does not detail a study specifically designed to prove acceptance criteria in the manner of a clinical trial for diagnostic accuracy or comparative effectiveness. Instead, the studies focus on functional validation and usability.
-
Sample Size used for the test set and the data provenance:
- Software Validation: Not specified.
- Firmware Validation: Not specified.
- Mechanical Testing: Not specified.
- Usability Study: Eighteen users with Type 1 or Type 2 diabetes participated.
- Data Provenance: Not explicitly stated for any of the tests, but implied to be internal testing conducted by PositiveID Corporation. The usability study was conducted in May 2011.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. The "ground truth" for these tests relates to the functional performance and usability of the device, which would typically be assessed against engineering specifications, user expectations, and safety standards, rather than requiring expert-established clinical ground truth in the traditional sense (e.g., for disease diagnosis).
-
Adjudication method for the test set:
- This information is not provided. Given the nature of the tests (software, firmware, mechanical, usability), adjudication methods like 2+1 or 3+1 typically used for subjective assessments (e.g., image interpretation) would not apply. Testing likely involved pass/fail criteria based on predefined specifications.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. The iglucose™ System is a data collection and transmission device, not an AI-assisted diagnostic tool that would involve "human readers" or AI assistance in clinical interpretation. It "does not measure, interpret or make decisions on the data that it conveys, nor is it intended to provide automated treatment decisions."
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The testing described (software, firmware, mechanical) represents testing of the device's standalone functionality. The device transmits data automatically. The usability study also assessed the device's interaction with users, but the core functionality is intended to be automated data transfer.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the various tests mentioned (software, firmware, mechanical) would be the predefined engineering specifications, functional requirements, and safety standards for the device. For the usability study, the ground truth was whether users could successfully perform tasks and perceive the device as easy to use and safe, against predetermined success criteria. There is no mention of clinical ground truth like pathology or outcomes data, as the device does not provide diagnostic information.
-
The sample size for the training set:
- The document does not mention a training set. The iglucose™ System is not described as utilizing machine learning or AI models that would typically require a training set. Its function is data transmission and presentation.
-
How the ground truth for the training set was established:
- Since no training set is mentioned or implied for this device, this question 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.