(173 days)
The ACCU-CHEK Pocket Compass Diabetes Management Software is a single user system indicated for use as an accessory to compatible Disetronic insulin pumps and a number of commercially available Accu-Chek blood glucose meters to download data from these devices to a personal digital assistant (PDA) where it may be saved, displayed, reviewed, analyzed, and evaluated to support effective diabetes management. The Accu-Chek Pocket Compass Software is also indicated for the management of diabetes by calculating an insulin or carbohydrate dose based on user entered data. The device is indicated for over-the-counter sale.
An accessory software that enables the person with diabetes and their health care professionals in review, analysis and evaluation of historical blood glucose test results and insulin infusion pump data to support effective diabetes management, including calculating an insulin or carbohydrate dose based on user entered data. The device is not intended to provide any diagnosis based upon patient results.
The provided document is a 510(k) summary for the ACCU-CHEK® Pocket Compass Diabetes Management Software. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, device performance results, sample sizes for testing or training, ground truth establishment, or clinical studies.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance
- Sample sizes used for the test set and data provenance
- Number of experts used to establish ground truth and their qualifications
- Adjudication method
- MRMC comparative effectiveness study results or effect size
- Standalone performance results
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
This document is a regulatory submission summary that focuses on demonstrating substantial equivalence to an existing device, primarily based on features and intended use, rather than presenting detailed performance study data. For such data, one would typically look for a full clinical study report, a detailed V&V (Verification and Validation) report, or perhaps a more extensive technical file that would accompany this summary.
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).