(186 days)
The Freestyle Auto-Assist Software Version 2.0 is intended for use by people with diabetes to aid in the review, analysis and evaluation of information such as blood glucose results. blood ketone test results and other data uploaded from a compatible meter. such as insulin doses and exercise data from the Freestyle Insulinx meter, in support of an effective diabetes health management program.
Freestyle Auto-Assist software is not intended for the diagnosis of or screening for diabetes mellitus.
Freestyle Auto-Assist Software Version 2.0 is a software application that allows people with diabetes to upload data from Freestyle Insulinx, Precision Xtra™, Freestyle Freedom. Freestyle 5. Freestyle Flash. Freestyle Lite and Freestyle Freedom Lite Blood Glucose Monitoring Systems into FreeStyle Auto-Assist Software Version 2.0, where users may review blood glucose and other data in a number of different graphical presentations.
It is a stand-alone software program available for download to a home user's computer via download from an Abbott Diabetes Care (ADC) website or if a previous version of Auto-Assist software is installed on the computer, through a notification from the ADC Informatics Upgrade Server. The software will also be available to users via a CD-ROM.
FreeStyle Auto-Assist Software Version 2.0 is intended for use in home settings by lay users to upload data from compatible meters to a patient's computer. Users can use FreeStyle Auto-Assist Software Version 2.0 to upload glucose data and other information (user entered notes, sound notifications, reminders) from their glucose meter and manually enter personal notes, such as insulin, meals, and exercise data. The software provides graphs and other software tools to help organize and present glucose readings. insulin dosage, and other diabetes-related factors that have been uploaded from devices or manually entered.
FreeStyle Auto-Assist Software Version 2.0 organizes the data in a presentable manner that is easy to view and interact with (save, generate reports and print reports). Communication with the devices is achieved through a serial cable or serial/USB adapter cable.
The provided text describes the Abbott Diabetes Care Inc. FreeStyle Auto-Assist Software Version 2.0 (K123089) and its accompanying verification and validation testing. The acceptance criteria are implicitly defined by the successful performance of the software in these tests in accordance with FDA guidance.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally implied by the successful completion of the studies and the statement that the software performed "according to the specifications and the intended use." The primary reported performance metric is related to the accuracy of report generation and data representation.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Software installation by typical users | All participants were able to install the software. |
| Successful upload of meter data by typical users | All participants were able to upload meter data. |
| Successful creation and printing of reports by typical users | 32 out of 35 subjects (approx. 91.4%) were able to successfully create and view reports. |
| Successful saving of reports by typical users | All participants were able to save reports to their desktop (implied from successful task completion). |
| Data in generated reports matches stored data | The data in these reports matched the stored data in 100% of cases. |
| Performance according to specifications and intended use | Studies "demonstrated that the FreeStyle Auto-Assist Software Version 2.0 performed according to the specifications and the intended use." (General statement). |
| Conformance to FDA Guidance for Software in Medical Devices | Software developed in accordance with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005) and General Principles of Software Validation 1/11/2002: Final Guidance for Industry and FDA Staff. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 35 participants.
- 16 were tested using FreeStyle Freedom Lite meters.
- 18 were tested using Precision Xtra meters.
- Data Provenance: Not explicitly stated regarding country of origin, but the study was a Human Factors study meaning it involved human participants interacting with the software. It involved preloaded data in the meters, which users then uploaded. Given the context of an FDA submission for a US market, it's reasonable to infer the data provenance is likely related to the US, but this is not explicitly stated. The study appears to be prospective in terms of user interaction and performance assessment, as users were actively performing tasks with the software. The meter data itself was "preloaded" implying simulated or previously collected data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The concept of "ground truth" for the test set in this context is primarily related to the accuracy of the software's functionality (e.g., does it correctly upload data, does the generated report match the preloaded data). The document states, "The data in these reports matched the stored data in 100% of cases." This suggests that the ground truth for the data accuracy was the preloaded data itself, and the software's output was compared against that.
There is no mention of external experts/clinicians establishing a "ground truth" for interpretations or clinical decisions, as this software is for data review and analysis, not diagnosis. The "experts" in validating the software's function would be the software testers/engineers responsible for verifying the output against expected results, but their number and qualifications are not provided in this summary.
4. Adjudication Method for the Test Set
Not applicable. This was a Human Factors study evaluating user interaction and software functionality, not a clinical assessment requiring adjudication of diagnostic findings. The assessment was based on participants' ability to complete tasks and the software's accurate representation of preloaded data.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No. This document does not describe an MRMC comparative effectiveness study. The study focused on the usability and functional performance of the FreeStyle Auto-Assist Software Version 2.0 by individual users, not a comparison of human readers with and without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
The primary study described is a Human Factors study, which does involve human-in-the-loop performance. However, the statement "Software evaluation consisted of functional testing and code inspections which was performed on FreeStyle Auto-Assist Software Version 2.0's design verification" implies that standalone algorithm testing (without human-in-the-loop) was performed as part of the overall software verification and validation process. The specific details of this standalone testing are not provided in this summary, but it would be a standard part of software development and validation.
7. The Type of Ground Truth Used
The ground truth used for the data accuracy assessment was the "stored data" that was preloaded into the meters. The "ground truth" for successful task completion was the pre-defined steps required for installation, data upload, report generation/printing, and saving.
8. The Sample Size for the Training Set
Not applicable. This document describes the validation of a software application that processes and presents data from blood glucose meters. It is not an AI/ML algorithm that requires a "training set" in the traditional sense. The software's logic is rule-based and deterministic for data handling and report generation, rather than learned from a large dataset.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" for this type of software.
§ 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.