(22 days)
The PBN Drainage Catheter Guidewires are intended for use in the placement of non-vascular percutaneous drainage catheters in abscesses, cysts, and other fluid collections, as well as for use in paracentesis, thoracentesis, and other fluid drainage.
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I am sorry, but I cannot fulfill your request because the provided document does not contain any information about acceptance criteria or a study proving that a device meets those criteria.
The document is a US FDA 510(k) clearance letter for a device called "PBN Drainage Catheter Guidewires." This letter confirms that the FDA has reviewed the device and found it to be substantially equivalent to legally marketed predicate devices.
While it mentions the "indications for use," it does not include any technical performance specifications, acceptance criteria, or details of a study with data about device performance against such criteria. The letter is a regulatory approval, not a technical performance report.
Therefore, I cannot extract the specific information you requested, such as:
- A table of acceptance criteria and reported device performance
- Sample size and data provenance for a test set
- Number and qualifications of experts for ground truth
- Adjudication method
- MRMC comparative effectiveness study details
- Standalone performance details
- Type of ground truth used
- Training set sample size and ground truth establishment details
§ 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.