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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trocar housing contains internal seals to prevent loss of pneumoperitoneum when instruments are inserted into a port or withdrawn completely from a port.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.

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