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IQ Endoscope's Gastroscope is intended to provide a live video stream in the upper gastrointestinal (GI) tract of adult patients to facilitate diagnosis of conditions in a clinical setting. The device channel which facilitates the capability to perform diagnostic/ therapeutic procedures of the upper GI tract. The device is sterile and single use and is not intended on being reprocessed.

IQ Endoscope's Q Base Q-100 Base Unit is designed to be used with IQ Endoscope's Q Vision G-100 Gastroscope and other ancillary equipment (e.g. medical grade video monitor) for endoscopic surgery within the upper digestive tract.

IQ Endoscope's Q Base Q-100 Unit is a reusable device intended to provide compressed air, power, and data connectivity to IQ Endoscope's Q Vision G-100 Gastroscope to facilitate diagnosis of conditions in a clinical setting.

The G-100 Gastroscope is only intended on being used with the Q-100 Base Unit. A description of the two devices and their functions can be found below:

IQ Endoscope's gastroscope is intended to provide a live video stream in the upper gastrointestinal (GI) tract of adult patients to facilitate diagnosis of conditions in a clinical setting. The device contains a working channel which facilitates the capability to perform diagnostic/ therapeutic procedures of the upper GI tract. The device is sterile and single use and is not intended on being reprocessed.

The G-100 Gastroscope is a flexible trans-orally introduced gastroscope which can be used to examine the oesophagus, stomach and the first and second parts of the duodenum using a live video feed from the Q-100 Base Unit. The device contains a working channel which facilities the capability to perform diagnostic and therapeutic procedures where indicated. Additionally, the device features water, air and suction channels to provide water, insufflate with air, and removal of debris as required during the endoscopy procedure. A water jet also allows the clinician to clear the distal tip lens of debris to ensure continued visualisation of the gastrointestinal tract throughout the procedure.

IQ Endoscope's Q Base Q-100 Base Unit is designed to be used with IQ Endoscope's Q Vision G-100 Gastroscope and other ancillary equipment (e.g. medical grade video monitor) for endoscopy and endoscopic surgery within the upper digestive tract.

IQ Endoscope's Q Base Q-100 Base Unit is a reusable device intended to provide compressed air, power, and data connectivity to IQ Endoscope's Q Vision G-100 Gastroscope to facilitate diagnosis of conditions in a clinical setting. The device connects air, power and data circuits to the G-100 gastroscope through a proprietary quick connector. The device connects to a 3rd party sterile water for irrigation and a visual display through an HDMI or BNC connection. The device may connect to a 3rd party data capture and storage accessory through an BNC connection for video and programmable on/off momentary button inputs.

The provided text is a 510(k) summary update for the IQ Endoscopes Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100) and Q Base Reusable Base Unit (Q-100). This document outlines the device's technical characteristics, intended use, and the non-clinical testing performed to establish substantial equivalence to predicate devices.

However, it does not include information about a study proving the device meets acceptance criteria related to a software-based diagnostic or AI-assisted component. The testing described focuses on:

• Electrical safety: Compliance with IEC 60601 series standards.
• Biocompatibility: Compliance with ISO 10993 series standards.
• Endoscope-specific performance: Compliance with ISO 8600 series standards for aspects like field of view, bending capability, rate of suction, working length, diameter of forceps channel, and viewing direction.

The document explicitly states: "Clinical testing is not applicable for this submission." (Page 10)

Furthermore, it explicitly details that the IQ Endoscopes Ltd. 'Q-100' base unit does not incorporate software and therefore does not have user menus or image processing enhancement features like the predicate device (BLI, LCI). This strongly indicates that the device itself, the Gastroscope (G-100) and Base Unit (Q-100), does not contain AI or advanced diagnostic software that would necessitate the kind of study described in the prompt (e.g., assessing AI performance, human reader improvement with AI assistance, MRMC studies, or establishing ground truth based on expert consensus for image analysis).

Therefore, I cannot provide the requested information for a study that proves the device meets acceptance criteria related to AI or a software-based diagnostic component because such a study is not described or implied in this 510(k) summary. The provided text describes a traditional medical device submission focused on hardware functionality, safety, and performance against established engineering and biocompatibility standards.

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