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The autosuture™ Modified VERSAPORT™ trocar with fixation sleeve is intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.

The autosuture™ Modified VERSAPORT™ trocar with fixation sleeve is available in 5 mm short length, 5 mm regular length, 11 mm regular length, 12 mm regular length, and 12 mm long length sizes. The autosuture™ Modified VERSAPORT™ trocar with fixation sleeve has a sharp linear blade with a spring- loaded locking shield. Upon entry into a free space the shield advances to cover the blade, reducing the potential for injury to internal structures. The trocar sleeve contains an internal seal to prevent loss of pneumoperitoneum when instruments are inserted or withdrawn. The VERSASEAL™ self-adjusting seal accommodates instruments ranging from 5 mm to 12 mm and is designed to effectively reduce the seal diameter to allow insertion of smaller instruments. There is a stopcock valve for insufflation and rapid desufflation.

The provided text is a 510(k) summary for a medical device (autosuture™ Modified VERSAPORT™ trocar with fixation sleeve). It primarily focuses on demonstrating substantial equivalence to predicate devices and does not contain detailed information about acceptance criteria, efficacy studies, or AI performance metrics as typically found in studies for AI-based medical devices.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, or AI specific performance details (MRMC studies, standalone performance, etc.) because these details are not present in the provided document.

The "PERFORMANCE DATA" section states: "In-vitro and in-vivo tests were performed to verify that the autosuture™ Modified VERSAPORT™ trocar with fixation sleeve is substantially equivalent to the predicate devices in creation and maintaining a port of entry and to validate that the creation and maintaining a port of entry of a trocar with fixation sleeve will perform as intended."

This statement indicates that performance data exists to show substantial equivalence for mechanical/functional aspects (creating and maintaining a port of entry), but it does not provide the specific acceptance criteria or the results of these tests. It also does not mention any AI components or related performance metrics.

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