(90 days)
The CoPilot™ Health Management System is intended for use in the home and clinical settings by people with diabetes and healthcare professionals as an aid in the review, analysis and evaluation of historical glucose test results in support of an effective diabetes management program.
The CoPilot™ Health Management System is a PC-based software application that permits people with diabetes, their healthcare team, and caregivers to upload data from FreeStyle and Precision Blood Glucose Monitoring Systems into the CoPilot System. The CoPilot™ Health Management System is intended for use in home and clinical settings to upload data from these devices to a patient's or healthcare professional's computer where the data may be saved, displayed in a number of formats, printed, or exported to an authorized user.
The CoPilot Health Management System software is a data acquisition and storage application used for diabetes data management. The CoPilot software features three main data functions of data entry, reports, and synchronization.
CoPilot Health Management System software operates in a Microsoft Windows Operating System platform. The software allows the user to display a variety of graphs and statistics based on userselectable date intervals, time of day segments, and blood glucose target ranges.
The provided text describes a 510(k) summary for the CoPilot™ Health Management System, which is a data management software for diabetes. The document focuses on the regulatory submission and general conformity rather than a detailed scientific study with specific acceptance criteria and performance metrics.
Therefore, many of the requested details such as specific acceptance criteria values, reported device performance metrics against those criteria, sample sizes for test sets, data provenance, expert qualifications, adjudication methods, MRMC study results, standalone performance, and training set details are not explicitly mentioned in the provided text.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in terms of quantitative metrics or thresholds for performance. | "Software, Software QA, and System verification testing demonstrates that the CoPilot™ Health Management System meets the performance requirements for the intended use of the system." |
| "Results of non-clinical and clinical testing demonstrate that the performance of the CoPilot™ Health Management System is acceptable and comparable to the performance and safety characteristics of the predicate device when used according to its intended use." |
Explanation: The document states that the software "meets the performance requirements" and that its performance is "acceptable and comparable to the predicate device." However, it does not provide specific quantifiable acceptance criteria (e.g., accuracy percentages, error rates, time limits for data processing) or corresponding numeric results for the CoPilot™ system against those criteria. This section typically relies on specific metrics from validation studies.
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not specified.
- Data provenance: Not specified. The document mentions "non-clinical and clinical testing" but does not detail the source, country of origin, or whether the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Not specified.
- Qualifications of experts: Not specified.
4. Adjudication method for the test set
- Not specified. The document does not describe how ground truth was established or if an adjudication method was used for any testing.
5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done
- Not applicable. The CoPilot™ Health Management System is described as "PC-based software application that permits people with diabetes, their healthcare team, and caregivers to upload data... where the data may be saved, displayed in a number of formats, printed, or exported." It is a data management software, not an AI or diagnostic imaging device that would typically involve human readers interpreting cases. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this type of device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone performance: Yes, implicitly. The "Software, Software QA, and System verification testing" and "non-clinical testing" would primarily evaluate the software's functionality, data integrity, and reliability in a standalone manner (without continuous human intervention for each data processing step). However, specific metrics are not provided. The system's purpose is to manage and display data, so its "performance" is in its ability to correctly handle and present this data.
7. The type of ground truth used
- Type of ground truth: Not explicitly stated for specific performance validation. For a data management system, "ground truth" would generally relate to the accuracy of data storage, retrieval, display, and calculations compared to the input data and established logical rules. The document broadly refers to "performance requirements" but not how the "truth" of these requirements was established in a testing context (e.g., against manually verified data sets, or by comparing calculations to known correct results).
8. The sample size for the training set
- Not applicable. As a data management software, this device does not typically involve a "training set" in the context of machine learning, where algorithms are trained on data to learn patterns. Its development is based on software engineering principles and fulfilling functional requirements. Reference to a "training set" would usually be for AI/ML-driven devices.
9. How the ground truth for the training set was established
- Not applicable, as there is no mention of a training set for this type of software.
Summary of what is present and missing:
The document serves as a regulatory submission (510(k) summary) and confirms that standard software development and validation processes were followed. It asserts that the device meets performance requirements and is comparable to a predicate device. However, it lacks the detailed quantitative data and specific methodological descriptions of performance studies that would be expected to fully address the requested points, especially for a device involving complex algorithms or diagnostic interpretations.
§ 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.