(384 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 non-neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain. This device is intended for females only.
The SpeediCath Compact Set is a sterile, ready to use intermittent catheter for females. It is a single use catheter with an integrated urine bag. The catheter is a hollow polyurethane tube that facilitates drainage of urine from the bladder through the urethra to the collection bag. It is available in three sizes FR/CH 10, FR/CH 12 and FR/CH 14. The catheter is hydrophilic coated and placed in a sterile solution (swelling medium) inside a tube, which together with a cover and plug make up the primary packaging and the sterile barrier. The subject device is the same as the predicate device, apart from the swelling medium. The swelling medium resides between the catheter and the tube and lubricates the catheter. The swelling medium in the subject device contains polyethylene glycol (PEG), and the predicate contains polyvinylpyrrolidone (PVP).
The provided text is a 510(k) summary for a medical device (SpeediCath Compact Set), and it describes the performance testing conducted to demonstrate substantial equivalence to a predicate device. However, it does not detail the acceptance criteria and device performance in the context of an AI/ML device or a similar complex medical device that would necessitate the extensive requirements outlined in your prompt (e.g., number of experts, adjudication methods, MRMC studies, training set details).
This document is for a urological catheter, where the primary concern is the material (specifically, the swelling medium) and its physical and biological properties. The "performance testing" here refers to standard engineering and biocompatibility tests, not clinical performance in the sense of diagnostic accuracy or effect on human readers.
Therefore, I cannot directly answer your prompt using the provided text. The information requested (e.g., acceptance criteria for AI, sample sizes for AI test/training sets, expert consensus for ground truth in diagnostic accuracy, MRMC studies) is fundamentally different from the nature of the device and testing described in this 510(k) summary.
In summary, the provided document does not contain the information needed to address your prompt about acceptance criteria and study design for an AI/ML medical device.
§ 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.