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510(k) Data Aggregation
(260 days)
The PC care Blood Glucose Data Management Software is PC-based software intended for use in the home and professional settings to help people with diabetes and their healthcare professionals in the review, analysis and evaluation of glucose test results for an effective diabetes management program. The PC care™ Blood Glucose Data Management Software connects to an i-SENS blood glucose meter, which comes with a PC care USB cable. The PC care " Blood Glucose Data Management Software allows the user to download Blood glucose readings automatically from the meter to the PC.
The PC care™ Blood Glucose Data Management Software is an optional data management software for use only with the i-SENS Blood Glucose Meters. The PC care™ Blood Glucose Data Management Software allows the transfer of data from the i-SENS Blood Glucose Meters to a personal computer for enhanced data management using graphic displays and analysis tools of the device. Various graphic analysis tools in this software help users of i-SENS BGM system easily analyze the trends and changes in their blood glucose.
The provided text describes the i-SENS PC care™ Blood Glucose Data Management Software, which is an accessory application for glucose meters. The submission is a 510(k) for substantial equivalence to a predicate device, the Zero-Click™ Data Management System. The document focuses on comparing the new device to the predicate rather than presenting a standalone study with detailed acceptance criteria and performance metrics for the PC care™ software itself.
Therefore, much of the requested information (like specific acceptance criteria values, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC study details, ground truth types for original studies, etc.) is not directly available within the provided text. The document primarily details the software's features and its similarities and differences to the predicate device.
However, based on the information provided, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't list specific quantitative acceptance criteria with numerical performance targets for the PC care™ software. Instead, it compares features and functionalities to a predicate device to demonstrate substantial equivalence. The "performance" assessment is implied through the successful completion of validation activities and the belief in substantial equivalence.
| Acceptance Criteria Category | Device Performance (PC care™ Blood Glucose Data Management Software) |
|---|---|
| Intended Use | Meets the intended use to help people with diabetes and their healthcare professionals in the review, analysis, and evaluation of glucose test results for effective diabetes management, by connecting to an i-SENS blood glucose meter and allowing automatic download of readings. (Similar to Predicate Device) |
| System Compatibility | Compatible with specified Windows OS versions (95, 98, ME, 2000, XP, Vista 32-bit, 7 32-bit), minimum CPU (300MHz Pentium 2), RAM (128 MB), hard disk space (60 MB), USB port, PC care™ USB cable, mouse/keyboard, 1024x768 monitor resolution, CD-ROM drive. (Similar to Predicate; some differences in minimum CPU and OS range, but deemed substantially equivalent) |
| Installation | Installed using CD and has the ability to uninstall. (Similar to Predicate) |
| Data Transmission/Download | Capable of uploading data from various devices by installing a software driver on PC, uses a USB cable, and auto-detects COM port. Includes a function that monitors communication status. Allows automatic download of blood glucose readings from the meter to the PC. (Similar to Predicate, with an added feature of communication status monitoring) |
| Operation and Features | Ability to access the program via icon/explorer, view owner's manual (via Help menu or CD file), email reports, personalize target ranges, set default target ranges, enter hypoglycemic range, set default favorite report, print reports. Allows manual data entry. Downloaded results cannot be edited or deleted; only manual entry results may be deleted. Input of additional information on patient and downloaded results (Health Profile, comment) is possible. Provides various report types (Trend Graph, Average Analysis, Histogram, Target Analysis, Logbook, Statistics, Period Comparison Graph) with color/black and white printing options. Includes capabilities for specifying complications and medications/insulin, and managing doctor, insurance, hospital, and diabetes educator information. (Many similar features to Predicate, with several enhanced features like communication monitoring, specific report types, and more detailed patient/therapy management capabilities). |
| Safety and Controls | Complies with general controls provisions of the Act (registration, listing, GMP, labeling, misbranding/adulteration prohibitions). Labeling is sufficient per 21 CFR Part 809.10. |
| Software Validation | Software Validation Report (SV-05-Q, SV-05-A) and specific test reports (TR-EI series for starting up, printing, email, downloading, manual entry, user profile, reports, install, communication protocol). (All these validation activities were included in the submission to demonstrate performance, implying they met internal acceptance criteria for these functionalities, but specific performance metrics are not listed.) |
2. Sample Size for the Test Set and Data Provenance:
- Sample Size for Test Set: Not specified in the provided text. The document lists software validation test reports (TR-EI-0xx), but does not detail the number of test cases, data points, or scenarios used in these tests.
- Data Provenance: The company is i-SENS, Inc. located in Seoul, Republic of Korea. The study (software validation activities) would have been conducted to support the 510(k) submission, and likely uses data generated internally or in controlled test environments related to the i-SENS blood glucose meters. It is considered a regulatory submission for a software accessory, so the "data" being evaluated refers to the software's functionality and performance, not clinical data from patients. The study is prospective in the sense that the validation tests were conducted specifically for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts:
This information is not provided in the document. Software validation typically involves internal software testers or quality assurance personnel, but their number and specific qualifications are not detailed here. Given this is a software accessory for a glucose meter, the "ground truth" would relate to the software performing its intended functions correctly (e.g., accurately downloading data, generating correct graphs and statistics).
4. Adjudication Method for the Test Set:
This information is not provided. Software validation typically involves confirming expected outputs against actual outputs, and discrepancies would be resolved through debugging and re-testing. There's no mention of a formal expert adjudication method like 2+1 or 3+1 typically seen in diagnostic accuracy studies for image analysis.
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:
This is not applicable and not performed. The PC care™ Blood Glucose Data Management Software is a data management tool for blood glucose meters, not an AI-assisted diagnostic device for human readers. It does not involve human "readers" interpreting medical images or data with or without AI assistance in the way an MRMC study evaluates. Its function is to organize, display, and analyze existing glucose data.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, the software validation tests listed (TR-EI-0xx) represent a standalone assessment of the software's functionality. These tests evaluate if the software performs its intended functions (e.g., starting, printing, downloading, emailing, displaying reports) correctly, without continuous human intervention in its core computational and data handling processes. The "human-in-the-loop" here is the user who operates the software, but the validation is about the software's inherent capability.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this software validation would be based on the expected functional behavior and accuracy specifications of the software. For example:
- For data download: The ground truth would be the actual blood glucose readings and associated timestamps stored in the i-SENS blood glucose meter. The software should accurately download and represent these.
- For report generation: The ground truth would be the mathematically correct calculations (averages, statistics) and graphically accurate representations (trends, histograms) based on the downloaded data.
- For user interface elements: The ground truth would be the specified design and functionality of buttons, menus, and data entry fields.
This is a form of functional and performance verification against design specifications and known correct outputs, rather than a clinical ground truth like pathology or expert consensus on a medical diagnosis.
8. The Sample Size for the Training Set:
This information is not applicable and not provided. The PC care™ software is a rule-based data management system, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its development would involve coding and testing against functional requirements and specifications.
9. How the Ground Truth for the Training Set was Established:
This is not applicable, as there is no "training set" for this type of software. The software's "ground truth" during development and testing would be established through its functional and technical specifications, which define how it should process data, generate reports, and interact with the user and the glucose meter.
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