(139 days)
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.
§ 876.5130 Urological catheter and accessories.
(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.