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The VereSee Optical Veres Needle System is intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars during laparoscopic surgery.

The VereSee Optical Veres Needle System is comprised two components: 1) Optical Veres Needle, and 2) Camera Control Unit. The Optical Veres Needle consists of a series of three concentric, stainless steel cannulas with a handle and an umbilical cable to connect it to the VereSee Camera Control Unit. The device is provided sterile for single-patient use. The Outer Cannula provides a luer fitting for connection of insufflation tubing with an integral flow control stopcock and a set of seals to prevent leakage of insufflation gas. The Central Cannula consists of a stainless steel hypo tube with a clear, point tip for penetration and visualization during abdomen penetration. The Inner Cannula is composed of a stainless steel hypo tube with a CMOS camera surrounded by light fibers at its tip. The light fibers carry the light from an integral LED which is mounted to a heat sink to distribute heat from the LED. The VereSee Camera Control Unit connects the CMOS camera in the Optical Veres Needle to HDMI compatible monitors to provide an image for laparoscopic procedures. The VereSee Camera Control Unit (CCU) includes an LED driver to power the LED. The CCU connects to the Optical Veres Needle via an umbilical cable. The VereSee Camera Control Unit converts signals from the CMOS camera in the Optical Veres Needle to a format compatible with HDMI display input requirements.

The provided text is a 510(k) summary for the VereSee Optical Veres Needle System and does not contain information about the acceptance criteria or a specific study proving the device meets those criteria in the context of an AI/human comparative effectiveness study or standalone algorithm performance.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (LaproLight Veress Needle) by comparing its intended use, technological characteristics, and performance data related to:

• Sterilization
• Transit Simulation and Shelf-Life
• Biocompatibility
• Electrical Safety and EMC Testing
• Bench and Functional Performance Testing (including optical performance, physical characteristics, mechanical testing like flow and leakage, spring obturator, and needle penetration tip force).

The "510(k) summary" confirms that the VereSee Optical Veres Needle Optical System had comparable performance to the legally marketed veres needles in mechanical testing. However, it does not provide details of acceptance criteria in a table format with reported performance for device safety or effectiveness (e.g., specific thresholds for flow rate, leakage, or optical clarity). It also does not discuss any AI components or their performance.

Therefore, I cannot extract the requested information (points 1-9) as it is not present in the provided text.

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