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The device PNEUMOCLEAR™ is a CO2 insufflator intended for use during diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with CO2 gas. The Standard, High Flow/Bariatric, Pediatric and Advanced Flow operating mode of the device are indicated to fill and distend a perioneal cavity with gas during a laparoscopic procedure. The Pediatric operating mode is indicated for pediatic laparoscopic procedures. The Vessel Harvest operating mode is indicated for use during endoscopic vessel harvesting procedures to create a cavity along the saphenous vein or radial artery. The TAMIS operating mode is indicated to fill and distend the rectum and colon using CO2 gas during transanal minimally invasive surgery.

The PNEUMOCLEAR™ is a microprocessor controlled device that consists of the following major components and features: a casing, a world power supply, pressure reducers, pressure sensors, venting systems, various safety valves, a suction pump, a fluid sensor and a software controlled graphical user interface (GUI) touch screen with various setting keys and display elements. The proposed device offers six operating modes: Standard, High Flow/Bariatric, Pediatric, Advanced Flow, Vessel Harvest, and TAMIS. The PNEUMOCLEAR™is not intended to enter the sterile field and cannot be sterilized. It is to be used with one of the following specially designed, single-use, sterile insufflation tube sets: (1) insufflation tube set with integrated filter, (2) insufflation tube set with integrated filter and heating wire; (3) insufflation tube set with integrated filter, heating wire and humidification media; (4) insufflation and smoke evacuation tube set with integrated filter, heating wire. and humidification media; and (5) insufflation and smoke evacuation tube set with integrated filter. When a smoke evacuation tube set is connected, the PNEUMOCLEAR™ allows for removal and filtration of CO2 and surgical smoke from the abdomen. rectum or colon during laparoscopic and transanal minimally invasive procedures and at the end of a procedure.

The provided text is a 510(k) Premarket Notification for the PNEUMOCLEAR™ device. It describes the device, its intended use, and claims substantial equivalence to a previously cleared predicate device (K170784 PNEUMOCLEAR™).

However, the document does not contain the kind of detailed information about acceptance criteria and clinical study performance typically found for AI/ML-driven devices. This is because the PNEUMOCLEAR™ is a CO2 insufflator, which is a hardware device, not an AI/ML diagnostic or assistive tool that would undergo studies involving human readers, ground truth establishment by experts, or MRMC studies.

The "Performance Data" section in the document focuses on:

• Electrical Safety and Electromagnetic Compatibility: Adherence to AAMI ANSI ES60601-1 and IEC 60601-1-2 standards.
• Packaging and Shelf-Life Testing: Compliance with various ASTM and ISO standards for packaging integrity and shelf-life.
• Software/Bench Testing: Software developed and verified according to FDA guidance and IEC 62304. Modifications to sensor sealing and gas lines for tube sets ST297 and ST298 were confirmed through submerged testing and simulated use testing, respectively. All software changes were bench-tested.

This submission is a "catch-up 510(k) submission intended to update the PNEUMOCLEAR™ record at FDA with the changes that have been implemented for the device." The changes are primarily tweaks to optional features and routine developmental updates, not fundamental changes to the device's technological characteristics or intended use. Therefore, clinical performance studies involving patient data, expert review, or complex statistical analysis for diagnostic accuracy (common for AI/ML devices) are not relevant or present in this submission.

In summary, based on the provided text, it is not possible to describe acceptance criteria and study proving device meets them in the context of an AI/ML device. The document is for a hardware medical device (CO2 insufflator) and its substantial equivalence to a predicate, focusing on engineering, safety, and performance standards relevant to its mechanical and electrical functions, not diagnostic accuracy or human-in-the-loop performance of an AI system.

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