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This instrument is intended to be used with a PENTAX Video Processor (including light source), documentation equipment, Monitor, Endotherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the lower digestive tract including the anus, rectum, sigmoid colon, colon and ileocecal valve.

The subject device is identical to the predicate device. There are no changes to the design, specifications, or technological characteristics of the PENTAX Medical Video Colonoscopes as described in K131855. The PENTAX Medical Video Colonoscopes (EC Family) are used with Video Processors. They are composed of three main components: an Insertion Portion, Control Body, and PVE Connector. The Insertion Portion is inserted into the body cavity of the patient. The Insertion Portion includes the Distal End and Bending Section. The Objective Lens, Light Guide, and Instrument Channel are located on the Distal End of the Insertion Portion. The Distal End also contains an Air/Water Nozzle and Water Jet Nozzle. This Air/Water Feeding System is used to deliver the air and water to the Objective Lens. The Control Body is held by the user's hand. The Control Body includes the Angulation Control lever used to operate the endoscope angulation, a Suction Cylinder and Suction Nipple for suctioning fluid and air in the body cavity, Remote Buttons used to operate the function of video processor, and an Instrument Channel Inlet used to insert endotherapy devices, such as biopsy forceps, into the body cavity. The PVE Connector is connected to the Video Processor via an Electrical Contacts. The PVE Connector includes the Electrical Contacts and Light Guide Plug. The Light Guide Plug is connected to the Light Source inside the Video Processor. The Light Guide of the Distal End is used to illuminate the body cavity by light that is carried through the Light Carrying Bundle. The Light Carrying Bundle guides the light Guide Plug that is connected to the Light Source. The CCD built into the Distal End receives reflected light (image data) from the body cavity, and sends the image data to the Video Processor through the video cable. The image data are converted into the image signal by the Video Processor and the image inside the body cavity is displayed on the Monitor. The PENTAX Medical Video Colonoscopes are reusable semi-critical devices. Since they are packaged non-sterile, they must be high-level disinfected or sterilized before initial use. Prior to each subsequent procedure, they must be subjected to an appropriate cleaning and either high-level disinfection or sterilization processes.

I am sorry, but the provided text does not contain the information required to answer your request. The document is a 510(k) premarket notification for PENTAX Video Colonoscopes, focusing on a modification to their reprocessing instructions.

It specifically states: "There are no other changes to the reprocessing instructions for use, nor are there any changes to the design, intended use, or indications for use of the EC Family of endoscopes." and "The subject device is identical to the predicate device. There are no changes to the design, specifications, or technological characteristics of the PENTAX Medical Video Colonoscopes".

Therefore, this document does not describe a new device that requires acceptance criteria and a study to prove it meets them in the context of Artificial Intelligence (AI) or an algorithm's performance. The "performance data" mentioned refers to reprocessing validation data, specifically "soil accumulation and cleaning efficiency studies," not data related to clinical effectiveness or an AI algorithm's performance.

To answer your request, I would need a document describing a device that includes an AI component or an algorithm that requires clinical validation.

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