(311 days)
Rusch ureter stents are intended for use in temporary internal drainage from the kidney to the bladder or other external collecting location.
The Rusch DD Ureter Stent Set is an over the wire, coaxial, sterile, single use, radiopaque ureter stent that consists of a graduated open or cylindrical tip ureter stent with DD connector, optional hydrogel coating to aid in insertion, an introducer sheath with connector, a PTFE/Hydrogel coated guidewire with flexible core and marking, fixing clamp and an inner pouch that separates the stent from the guidewire during shipping and storage. These items are packaged in a paper and film pouch and sterilized with Ethylene Oxide.
The Rusch Integral Ureter Stent Set consists of a ureter stent that is completely radiopaque, coiled cylindrical or open tip with drainage holes at intervals of 5-20 mm, centimeter graduations, optional hydrogel coating, continuous black positioning line to indicate the direction in which the catheter tip coils, and black marking at the catheter end. The introducer sheath is approximately 45 cm long. The spiral stylet is made of stainless steel with optional PTFE/Hydrogel coating and a flexible safety tip and a marked rigid tip and is approximately 100 cm long. There are also plastic clips in the set.
For Ureterorenoscope applications the same features exist but the introducer sheath is approximately 90 cm long and the flexible stylet is approximately 150 cm long. One product configuration allows drainage of the renal system to external collection equipment (not supplied).
This is a 510(k) premarket notification for a medical device (Rüsch Ureter Stent), not an AI/ML medical device. Therefore, the requested information regarding acceptance criteria and a study proving device performance in the context of AI/ML is not applicable.
The document provided describes a traditional medical device and its substantial equivalence to legally marketed predicate devices, a common pathway for medical device clearance in the US, which does not involve performance studies of the sort relevant to AI/ML.
Here's why the requested information cannot be provided:
- No AI/ML Component: The device described, the Rüsch Ureter Stent, is a physical medical device (a stent and associated components) used for drainage. There is no mention of any artificial intelligence or machine learning component, software, or algorithm in its design, function, or intended use.
- Substantial Equivalence (510(k) Pathway): The 510(k) pathway for device clearance focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device (a device already legally on the market). This typically involves comparing design, materials, technological characteristics, and intended use to established devices, rather than conducting novel performance studies as would be required for an AI/ML diagnostic or assistive tool.
- No "Acceptance Criteria" for AI Performance: Since there's no AI/ML, there are no acceptance criteria related to metrics like sensitivity, specificity, AUC, or other performance characteristics typically associated with AI algorithms.
- No "Study Proving Device Meets Acceptance Criteria" (in the AI/ML sense): The "review" mentioned by the FDA is a regulatory review of the substantial equivalence claim, not a clinical trial or performance study designed to assess AI diagnostic accuracy or human performance with AI assistance.
Therefore, I cannot provide a table of acceptance criteria and reported device performance related to AI, nor information on sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, or training set details as these are specific to AI/ML device evaluations and are not present in this document.
§ 876.4620 Ureteral stent.
(a)
Identification. A ureteral stent is a tube-like implanted device that is inserted into the ureter to provide ureteral rigidity and allow the passage of urine. The device may have finger-like protrusions or hooked ends to keep the tube in place. It is used in the treatment of ureteral injuries and ureteral obstruction.(b)
Classification. Class II (performance standards).