(349 days)
The OneTouch® Reveal Diabetes Management Application is a software accessory to the OneTouch® Verio Sync Blood Glucose Monitoring System, and is intended for use in the home setting by people with diabetes. It is intended to aid in the review, analysis, and evaluation of patient data to support diabetes management. The OneTouch® Reveal Diabetes Management Application receives (from both manual entry and wireless transmission), stores, and sends patient data for display and reporting. The OneTouch® Reveal Diabetes Management Application also communicates with web-based applications. The OneTouch® Reveal Diabetes Management Application is available for use on commercially-available mobile devices and uses generally-available networks and communication protocols.
The OneTouch® Reveal Diabetes Management Application (App) is a diabetes management tool that can help you determine what your blood glucose test results mean. This allows you and your health care professional to better monitor and adjust your diabetes care plan. The App is designed to work in conjunction with the OneTouch® Verio™ Sync Meter. Using the Bluetooth® feature on your meter and Apple® device, blood sugar test results can be sent directly from your meter to the App. Once a blood sugar result is sent to the App you can: Tag the blood sugar result with a meal flag, Receive Low and High Pattern messages, Add carbs, activity, medication data and Notes about your activities, Manually enter other blood sugar test results, Review results on graphs, Share your blood sugar results with others for review and follow-up, and Set reminders to prompt you to complete certain tasks.
The OneTouch® Reveal Diabetes Management Application is a software accessory designed to aid in the review, analysis, and evaluation of patient data to support diabetes management. The device works in conjunction with the OneTouch® Verio™ Sync Meter, receiving blood sugar test results via Bluetooth, and allowing users to tag results, receive pattern messages, add data (carbs, activity, medication, notes), and review/share results.
Here's an analysis of its acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
The provided summary does not explicitly list quantitative acceptance criteria with corresponding performance metrics in a defined table format. Instead, it describes general validation activities and concludes with substantial equivalence. The "Summary of Performance Characteristics" section indicates:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Software functionality and compliance with FDA Guidance Document | "Full verification and validation testing of the OneTouch® Reveal™ Diabetes Management Application software was performed in accordance with the FDA Guidance Document 'General Principles of Software Validation (2002)'." This implies the software met all functional, performance, and safety requirements outlined in the validation plan derived from the guidance. |
| User performance and usability | "A user performance evaluation study was conducted to validate the OneTouch® Reveal Diabetes Management Application. Human Factors Formative Usability studies were also conducted to evaluate the usability of the OneTouch Reveal Diabetes Management Application and to inform final design of the product." This indicates the device was found usable and effective for its intended user group. |
| Equivalence to predicate device (DiabetesManager® System, K100066) | "The OneTouch Reveal Diabetes Management Application is substantially equivalent in its intended use, performance, safety, effectiveness and underlying scientific and operating principles used to the predicate..." |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not specify the sample size used for the user performance evaluation study or the human factors usability studies.
The data provenance is not explicitly stated. Given it's a submission for the US FDA, it's likely that at least some of the testing involved participants in a US-equivalent demographic or was overseen by US regulatory standards. However, the sponsor is LifeScan Europe, a Division of Cilag GmbH International (Switzerland), so testing could have occurred internationally. The summary does not indicate whether data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts to establish ground truth for the test set in the context of blood glucose pattern recognition or other analytical features. The validation focuses on software functionality and user interaction rather than diagnostic accuracy requiring expert consensus on specific cases.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method like 2+1 or 3+1. This type of adjudication is typically used for image-based diagnostics where multiple experts' opinions are combined to form a ground truth, which is not directly applicable to the described functionalities of this diabetes management application (e.g., displaying data, identifying patterns based on predefined algorithms).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No MRMC comparative effectiveness study was mentioned in the provided summary. The device's primary function is to process and display blood glucose data, not to perform interpretations that typically require multiple human readers. The summary focuses on comparing the device's functionality to a predicate device and validating its software and usability.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) was Done
Yes, a form of standalone evaluation was conducted as part of the "Full verification and validation testing of the OneTouch® Reveal™ Diabetes Management Application software." This validation would inherently involve testing the software's algorithms and functionalities (e.g., pattern recognition, data storage, display accuracy) in a standalone manner, separate from human-in-the-loop performance, to ensure they meet design specifications before user performance studies. The "user performance evaluation study" and "Human Factors Formative Usability studies" assessed the human-in-the-loop aspects.
7. The Type of Ground Truth Used
For the software validation, the "ground truth" would be established by the predefined software specifications and functional requirements. For example:
- Data Storage and Transmission: The ground truth would be that the data received, stored, and sent accurately matches the input data from the OneTouch® Verio™ Sync Meter or manual entry.
- Pattern Recognition: The ground truth would be the predefined rules or algorithms for identifying "Low patterns" and "Before-Meal High patterns." The algorithm's output (identification of a pattern) would be compared against the expected output based on these rules.
- Calculations/Display: The ground truth would be accurate mathematical calculations and correct display of data as per design.
No mention of pathology, outcomes data, or expert consensus specific to establishing the "correctness" of interpreted medical findings is made, as the device's main role is data management and simple pattern alerts based on pre-set thresholds.
8. The Sample Size for the Training Set
The document does not specify a sample size for a "training set." This type of application (diabetes management software) typically does not involve machine learning models that require explicit training data in the same way an AI diagnostic algorithm would. Its functionalities are rule-based and deterministic (e.g., displaying data, recognizing patterns based on pre-defined thresholds, calculating averages). Therefore, the concept of a "training set" is not applicable in the context usually addressed by such questions for AI/ML devices.
9. How the Ground Truth for the Training Set Was Established
As there's no mention of a traditional machine learning "training set," the concept of establishing ground truth for it is not applicable here. The "ground truth" for the device's functions (e.g., correct data processing, accurate pattern identification) would be established by its design specifications and the underlying mathematical or logical rules programmed into the 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.