(15 days)
The device is intended for use for urethral or intermittent catheterization. Device sizes are supplied for pediatric and adult male and female applications
The catheter consists of a single lumen catheter with two or four drainage eyes on the proximal tip. The catheter is available in a combination of French sizes and lengths to accommodate pediatric and adult male and female applications. Available catheter lengths range from 6.4 to 15.65 inches and French sizes from 6 to 26 French.
The provided text is a 510(k) summary for a medical device (Rochester Medical Corporation Personal Catheter™). It describes the device, its intended use, and comparisons to predicate devices. However, this document does not contain any information about acceptance criteria or a study proving device performance in the context of an AI/ML powered device.
The "Testing and Test Results" section refers to:
- Flow rates meeting ASTM 623-89 Standard for Foley Catheters.
- Biocompatibility testing (Cytotoxicity, Sensitization, Reactivity, Genotoxicity, Systemic Toxicity, Muscle Implant, and Bladder Irritation).
These are standard performance and safety tests for a physical medical catheter, not an AI/ML algorithm.
Therefore, I cannot provide the requested information as it is not present in the given input.
To answer your request, the input document would need to describe a study evaluating an AI/ML device, including details such as:
- Acceptance Criteria: Specific quantitative thresholds for metrics like accuracy, sensitivity, specificity, AUC, F1-score, etc.
- Reported Device Performance: The actual measured values of these metrics.
- Sample Size & Data Provenance: Details about the datasets used for testing and training.
- Ground Truth Establishment: How the true labels (e.g., presence/absence of disease) were determined.
- Adjudication Method: If human experts were used for ground truth, how disagreements were resolved.
- MRMC Study: If the AI was evaluated in a human-in-the-loop setting.
- Standalone Performance: If the AI's performance without human intervention was measured.
- Training Set Details: Information about the data used to train the AI model.
§ 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.