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FUJIFILM Ultrasonic Endoscopes EG-580UT and EG-580UR are intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis, and endoscopic treatment. These products are intended to be used with a FUJIFILM ultrasonic processor. These products are not intended for use on children and infants.

FUJIFILM Ultrasonic Endoscopes EG-580UT and EG-580UR are comprised of three general sections: a control portion, an insertion and an umbilicus. The control portion controls the angulation of the endoscope. This portion also controls the flexibility of the distal end in the endoscope. The insertion contains glass fiber bundles, several channels and a chargecoupled device (CCD) image sensor in its distal end. The insertion portion assist in delivering air/suction as well as endoscope accessories, such as forceps. The glass fiber bundles allow light to travel through the endoscope and emit light from the tip of the insertion portion to illuminate the body cavity. This provides enough light to the CCD image sensor to capture an image and display it on the monitor. The umbilicus consists of electronic components needed to operate the endoscope when plugged into the video processor, light source, and ultrasonic processor. The endoscopes are used in combination with FUJIFILM's video processors, light sources, ultrasonic processors and peripheral devices such as monitor, printer, foot switch, and cart. All of these combinations were previously cleared in K181763.

The provided text is a 510(k) summary for the FUJIFILM Ultrasonic Endoscopes EG-580UT and EG-580UR. It describes the device, its intended use, and a comparison to predicate devices, focusing on the substantial equivalence argument.

However, the document does NOT contain information about an AI-powered device or an AI performance study. Instead, it describes a medical device undergoing a 510(k) submission, which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device through engineering performance, electrical safety, biocompatibility, and reprocessing validation.

Therefore, for the specific questions related to AI device acceptance criteria and performance study details (sample size for test set, data provenance, number of experts, adjudication, MRMC studies, standalone performance, ground truth, training set size), the provided text does not contain the information required to answer them.

The document primarily focuses on the physical and functional aspects of the endoscopes, such as control portion, insertion, umbilicus, and their compatibility with other FUJIFILM equipment. The performance data mentioned are related to:

• Electrical safety: evaluated using standards like ANSI/AAMI ES 60601-1:2012, IEC 60601-1-2:2007, etc.
• Biocompatibility: evaluated using standards like ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010.
• Endoscope specific testing: evaluated using standards like ISO 8600-1:2015, ISO 8600-3:1997, and ISO 8600-4:2014.
• Cleaning, high-level disinfection, and sterilization: evaluated according to AAMI TIR12:2010, AAMI TIR30:2011.
• Additional functional testing: including field of view, resolution, bending capability, working length, diameter of forceps channel, rates of suction, air supply, water supply, balloon water supply, balloon suction, viewing direction, LG output, axial resolution, lateral resolution, and penetration depth.

These are all standard tests for a physical medical device and do not involve AI or machine learning algorithms.

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