(143 days)
The Bionime Diabetes Management System is an over-the-counter software system for use by Health Care Professionals and Patients with diabetes as an aid for managing diabetes. User(s) can transfer blood glucose readings from Rightest® Glucose meter(s) to a personal computer for the purpose of viewing, analyzing and printing the blood glucose readings, as well as to backup and to recover users' profile and data. Bionime Rightest™ GM550 and GM250 meters are compatible with Bionime Diabetes Management System.
The Bionime Diabetes Management System is not intended to provide treatment decisions, nor should it substitute professional opinion. All medical diagnoses and treatment plans should be performed by a licensed healthcare professional.
The Bionime Diabetes Management System allows the transfer of blood glucose readings from a compatible Bionime Rightest™ Glucose Meter to a PC via USB cable.
The Data analysis features enable the user(s) to view and analyze blood glucose readings from different meal times or time periods up to 90 days. Other features including data tables, trend charts, pie charts, and printed reports are available for viewing and analyzing these readings within the different time slots.
The system includes: 1) Installation CD with setup files for Bionime GP200 Diabetes Assistant Software and Rightest™ PC Link Adapter Driver, 2) GP550 PC Link Adapter.
Here's an analysis of the Bionime Diabetes Management System, detailing its acceptance criteria and the study that proves it, based on the provided 510(k) summary:
Analysis of Bionime Diabetes Management System Performance
The 510(k) summary for the Bionime Diabetes Management System (BDMS) provides limited details regarding specific, quantifiable acceptance criteria and the comprehensive study results to demonstrate performance. The primary focus of the performance section is on the user experience and the functionality of the software for managing glucose data.
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, the acceptance criteria are implicitly related to the usability and effectiveness of the software in displaying and analyzing blood glucose data.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| System allows transfer of blood glucose readings. | The Bionime Diabetes Management System allows the transfer of blood glucose readings from a compatible Bionime Rightest™ Glucose Meter to a PC via USB cable. |
| Data analysis features enable viewing and analysis of readings. | Data analysis features enable the user(s) to view and analyze blood glucose readings from different meal times or time periods up to 90 days. Other features including data tables, trend charts, pie charts, and printed reports are available for viewing and analyzing these readings within the different time slots. |
| System is easy to use. | "The results of these studies demonstrate satisfactory performance of Bionime Diabetes Management System (GP 200 Diabetes Assistant Software and GP550 PC Link Adaptor), and it is easy to use and the results are understandable by the users." |
| Results are understandable by users. | "The results of these studies demonstrate satisfactory performance of Bionime Diabetes Management System (GP 200 Diabetes Assistant Software and GP550 PC Link Adaptor), and it is easy to use and the results are understandable by the users." |
| Performance is satisfactory for its intended use (aid in managing diabetes). | "The results of the verification and validation studies of the Bionime Diabetes Management System demonstrated that the product is safe and effectiveness in the hands of lay users and health care professionals." "The product performance characteristics of Bionime Diabetes Management System were assessed through internal and external performance and validation studies, include a consumer study with 29 lay users. These studies demonstrate satisfactory performance..." |
| Substantial equivalence to predicate device. | The Bionime Diabetes Management System is substantially equivalent to the predicate device Glucofacts® Deluxe Diabetes Management Software (K091820). This is the overarching "acceptance" for 510(k) clearance. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: A consumer study was conducted with 29 lay users.
- Data Provenance: The document does not explicitly state the country of origin for the data or if it was retrospective or prospective. Given that the applicant is Bionime Corporation in Taiwan, it's possible the study was conducted there, but this is not confirmed. The study appears to be prospective in nature as it involved users interacting with the system, implying data was generated during the study.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not mention the use of experts to establish a "ground truth" for the test set in the traditional medical device sense (e.g., expert interpretation of medical images). The study primarily focused on user interaction, usability, and the system's ability to accurately display and analyze existing blood glucose readings. The "ground truth" in this context would be the accuracy of the glucose meter readings themselves (which is outside the scope of this software's performance validation) and the correctness of the software's data processing and display.
4. Adjudication Method for the Test Set
No adjudication method is described for the test set. Given the nature of the study (usability and display validation), an adjudication process among experts for diagnostic decisions would not be applicable here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices where multiple human readers interpret cases with and without AI assistance. The BDMS is a data management and analysis tool, not a diagnostic interpretation tool, and its evaluation focuses on its functionality and user experience.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done
Yes, in a sense, the core functionality of the software itself, in terms of its ability to transfer, store, and graphically represent data, would be evaluated in a "standalone" manner. The consumer study with lay users then validated the human-in-the-loop interaction from the user's perspective (usability and interpretability). The algorithm in this case is not making diagnostic decisions, but rather performing data processing and visualization. The evaluation of whether "data tables, trend charts, pie charts" are correctly generated based on the transferred data would be a standalone assessment of the algorithm's performance.
7. The Type of Ground Truth Used
The "ground truth" for the BDMS would be based on:
- Correctness of data transfer: Verifying that blood glucose readings are accurately transferred from the meter to the software.
- Accuracy of data processing and display: Ensuring that the software correctly calculates trends, averages, and generates accurate charts and tables based on the transferred data.
- User feedback on usability and understandability: Direct feedback from the 29 lay users.
This is fundamentally different from a ground truth established by pathology reports or clinical outcomes data, as the software is not making diagnostic calls.
8. The Sample Size for the Training Set
The document does not specify a training set sample size or even the use of a distinct "training set" in the context of machine learning. The BDMS, as described, appears to be a rule-based software for data management and visualization, rather than an AI/ML diagnostic algorithm that would require a vast training dataset for learning. The "internal and external performance and validation studies" (which include the consumer study) likely served as the testing/validation phase for the software's developed functions.
9. How the Ground Truth for the Training Set was Established
As no specific training set for a machine learning model is mentioned, there's no information on how the ground truth for such a set was established. The software's functionality would have been developed and tested against expected outcomes for data processing and display.
§ 862.2100 Calculator/data processing module for clinical use.
(a)
Identification. A calculator/data processing module for clinical use is an electronic device intended to process laboratory data.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.