(75 days)
The VersaOne™ Fascial Closure System Bladed Trocar with fixation cannula is intended for use in a variety of minimally invasive gynecologic, general, and urologic procedures to create and maintain a port of entry for laparoscopic instruments.
The VersaOne™ Fascial Closure System Bladeless Trocar with fixation cannula is intended for use in a variety of minimally invasive gynecologic, general, and urologic procedures to create and maintain a port of entry for laparoscopic instruments.
The VersaOne™ Fascial Closure System Optical Trocar with fixation cannula is intended for use in a variety of minimally invasive gynecologic, general, and urologic procedures to create and maintain a port of entry for laparoscopic instruments.
The VersaOne™ Fascial Closure System Bladed Trocar (12mm) is available in standard length (100mm) transparent cannula. The Bladed Trocar obturator has a dolphin nose (conical) shaped tip with a sharp linear blade and a spring-loaded locking shield. The blade is used to cut the tissues as the trocar is inserted into the body cavity. The shield advances to cover the blade upon entry into a free space. The cannula assembly is composed of a seal system, trocar housing, transparent cannula sleeve, and a stopcock. The trocar housing contains internal seals to prevent loss of pneumoperitoneum when instruments are inserted into a port or withdrawn completely from a port. The cannula seal system accommodates instruments ranging 5mm up to 12mm. The distal end of the trocar cannula has two windows, 180 degrees apart, covered by a pierce-able membrane. A guide is provided which fits inside the trocar cannula to guide a suture passer through the wall of the cannula and soft tissue to be approximated. The stopcock valve is for insufflation and desufflation. A reusable suture passer is provided, which delivers suture through the trocar cannula to aid in port site closure.
The VersaOne™ Fascial Closure System Bladeless Trocar (12mm) is available in standard length (100mm) transparent cannula. Bladeless Trocar obturator has a dolphin nose (conical) shaped bladeless tip. The conical shape is for smooth insertion into the body cavity by spreading the tissue layers during insertion. The cannula assembly is composed of a seal system, trocar housing, transparent cannula sleeve, and a stopcock. The trocar housing contains internal seals to prevent loss of pneumoperitoneum when instruments are inserted into a port or withdrawn completely from a port. The cannula seal system accommodates instruments ranging 5mm up to 12mm. The distal end of the trocar cannula has two windows, 180 degrees apart, covered by a pierce-able membrane. A guide is provided which fits inside the trocar cannula to guide a suture passer through the wall of the cannula and soft tissue to be approximated. The stopcock valve is for insufflation and desufflation. A reusable suture passer is provided, which delivers suture through the trocar cannula to aid in port site closure.
The VersaOne™ Fascial Closure System Optical Trocar (12mm) is available in standard length (100mm) transparent cannula. The Optical Trocar with transparent cannula and obturator allows for visualization of tissue layers during insertion. The obturator housing contains a scope retention mechanism. The cannula assembly is composed of a seal system, trocar housing, transparent cannula sleeve, and a stopcock. The trocar housing contains internal seals to prevent loss of pneumoperitoneum when instruments are inserted into a port or withdrawn completely from a port. The cannula seal system accommodates instruments ranging 5mm up to 12mm. The distal end of the trocar cannula has two windows. 180 degrees apart, covered by a pierce-able membrane. A guide is provided which fits inside the trocar cannula to guide a suture passer through the wall of the cannula and soft tissue to be approximated. The stopcock valve is for insufflation and desufflation. A reusable suture passer is provided, which delivers suture through the trocar cannula to aid in port site closure.
The provided document is a 510(k) premarket notification for a medical device (VersaOne Fascial Closure System Trocar). It describes the device, its intended use, and comparisons to predicate devices to demonstrate substantial equivalence. Crucially, this document does NOT describe the performance of an AI/ML-driven medical device. It details bench testing, in-vivo testing (on animals), biocompatibility, sterilization, and cleaning studies for a physical surgical instrument.
Therefore, I cannot provide the information requested in your prompt (Acceptance Criteria and Study for an AI/ML device) because the provided text is about a surgical trocar, not an AI/ML system.
The prompt specifically asks for details relevant to AI/ML device validation, such as:
- A table of acceptance criteria and reported device performance (for AI metrics like sensitivity, specificity, AUC).
- Sample size and data provenance for the test set (relevant for imaging datasets for AI).
- Number of experts and their qualifications for ground truth establishment.
- Adjudication methods.
- MRMC studies for human reader improvement with AI.
- Standalone AI performance.
- Type of ground truth (e.g., pathology, outcomes data).
- Training set sample size and ground truth establishment for AI.
None of this information is present or applicable to the conventional medical device described in the provided text.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.