Search Results

The EG-530UR and EG-530UT ultrasonic endoscopes are intended to be used with the SU-7000 ultrasound I ho system is used for the observation and diagnosis of the upper digestive tract (including the esophagus, stomach, duodenum, and underlying areas), as well as observation and diagnosis of submucosal and peripheral organs using ultrasonic images, and endoscopic treatment.

The EG-530UR and EG-530UT are medical ultrasonic gastrointestinal endoscopes. They are intended for the observation and diagnosis of the upper digestive tract (including the esophagus, stomach, duodenum, and underlying areas) using an Ultrasonic endoscope, observation and diagnosis of submucosal and perioheral organs using ultrasonic images, and endoscopic treatment at medical facilities under the management of physicians. These endoscopes are used in combination with a processor, light source, cart, ultrasonic processor (SU-7000), and video printer. The endoscopes are used with a single use balloon. The endoscopes have a groove on the tip to hold the balloon in place. The SU-7000 is an ultrasonic processor that is used with a medical ultrasonic endoscope (EG-530UR or EG-530UT). The processor connects to the ultrasonic endoscope, which emits ultrasound in a body cavity by driving an ultrasonic transducer of the endoscope. It also processes the reflection ultrasonic signal received by the transducer and coverts it to an ultrasonic image.

The provided document is a 510(k) summary for a medical device (Fujinon Ultrasonic Endoscope & Processor), which focuses on establishing substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a novel AI/software component.

Therefore, the document does not contain the information needed to fill out the requested table and answer the specific questions about acceptance criteria, study details, ground truth, and AI-related metrics.

The document states:

• "The subject device has been subjected to and passed electrical safety, thermal, and EMC testing requirements." This refers to general safety and operational standards, not performance in a clinical context for a specific AI function.
• "The materials in the endoscope are biocompatible and are identical to the materials used in the predicate device." This is a material safety claim.
• "We believe the changes are minor and conclude that the subject devices are as safe and effective as the predicate device." This is the core claim of a 510(k) based on substantial equivalence.

It does not describe a study that involves:

• Reporting device performance against quantifiable clinical acceptance criteria (e.g., sensitivity, specificity, accuracy).
• A test set with defined sample size, data provenance, ground truth established by experts, or adjudication methods.
• A multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm performance study.
• A training set with an established ground truth.

This document is a regulatory submission focused on demonstrating that the new device is "substantially equivalent" to existing, legally marketed devices. It does not provide the kind of performance data (e.g., for an AI algorithm) that would typically involve specific acceptance criteria and detailed study designs as requested in your prompt.

Ask a specific question about this device