(205 days)
Luja Coudé is indicated for use by patients with urine retention and patients with 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.
The product is indicated for male patients only (adults and pediatric above the age of 1 years).
Luja Coude is a single-use, sterile, hydrophilic coated catheter for intermittent urinary catheterization. The catheter has a flexible tip which contains several small holes (micro holes) by the tip creating a drainage zone which allows the urine to flow from the bladder through the catheter. The drainage end of the device has an outlet to which a urine bag with a suitable connector can be connected. The catheter also contains a hydrophilic-coating and is sterilized by irradiation.
The primary packaging provides the sterile barrier and contains a proof of seal for identification of opened products.
Luja Coude is available in one length (33cm) with a flexible tip and diameters of 8 Fr, 10 Fr, 12 Fr, 14 Fr, 16 Fr, and 18 Fr.
The provided text is a 510(k) summary for a medical device (Luja Coude catheter) and outlines its substantial equivalence to a predicate device. However, it does not contain information about a study that proves the device meets specific acceptance criteria based on AI/ML performance metrics. The document focuses on non-clinical performance testing (bench testing, biocompatibility, packaging, aging) and usability testing relevant to catheter functionality and safety.
Therefore, I cannot extract the information required for your request, as the document does not describe:
- AI/ML performance metrics (e.g., accuracy, sensitivity, specificity).
- A test set or training set for an AI/ML model.
- Ground truth experts or adjudication methods for AI/ML performance.
- MRMC studies comparing human readers with and without AI assistance.
- Standalone algorithm performance.
The document states: "Bench performance testing and usability testing were conducted to verify the proposed subject devices met the pre-determined acceptance criteria per specified requirements. Testing was performed on final, finished, and sterilized devices as described in the applicable submission sessions." This refers to standard medical device performance and safety testing, not AI/ML model validation.
In summary, the provided text does not contain the type of study and data required to answer your prompt about an AI/ML device's acceptance criteria and performance.
§ 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.