Search Results

SpeediCath Compact Set is indicated for use by patients with chronic urine retention and patients with a post void residual volume (PVR) due to neurogenic and nonneurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain. The device is intended for females only.

The SpeediCath Compact Set (Female) is a sterile, single use, disposable polyurethane catheter for females with a pre-attached urine collection bag. The catheter is pre-lubricated with a hydrophilic coating and immersed in saline solution. In use, the cover is removed, the bag is unfolded and the catheter is pulled out of the packaging. The catheter with attached bag is then ready to use allowing easy drainage and collection of urine.

This document appears to be a 510(k) summary for a medical device called "SpeediCath Compact Set." It describes the device, its intended use, and claims substantial equivalence to a previously cleared device. However, it does not contain the detailed acceptance criteria and study results typically found in an AI/ML device submission.

The "Summary of Testing" section is very brief and only mentions compliance with general standards for medical devices and biological evaluations. It does not provide specific performance metrics, sample sizes, ground truth establishment, or details about comparative effectiveness studies that would be relevant to an AI/ML device.

Therefore, based on the provided text, I cannot extract the information you've requested about acceptance criteria and a study that proves the device meets them, especially in the context of an AI/ML device. The SpeediCath Compact Set appears to be a physical medical device (a urinary catheter), not an AI/ML algorithm.

If you have a document pertaining to an AI/ML medical device, please provide that.

Ask a specific question about this device