Search Results

The Arthrex SynergyID Endoscopic Imaging System is intended to be used as an endoscopic video camera to provide visible light imaging in a variety of endoscopic diagnostic and surgical procedures, including but not limited to: orthopedic, spine, laparoscopic, urologic, sinuscopic, plastic surgical procedures within the thoracic cavity. The device is also intended to be used as an accessory for microscopic surgery.

The Arthrex SynergyID Endoscopic Imaging System is indicated for use to provide real time endoscopic visible and nearinfrared fluorescence imaging. Upon intravenous administration and use of ICG consistent with its approved label, the system enables surgeons to perform minimally invasive surgery using standard endoscope visible light as well as visualization of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct or common hepatic duct), using near-infrared imaging. Fluorescence imaging of biliary ducts with the Arthrex SynergyID Endoscopic Imaging System is intended for use with standard of care white light, and when indicated, intraoperative cholangiography. The device is not intended for standalone use for billary duct visualization.

Upon interstitial administration and use of ICG consistent with its approved label, the Arthrex SynergyID Endoscopic Imaging System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

The Arthrex Synergy® Endoscopic Imaging System includes a non-sterile camera control unit (CCU) console, camera heads, a laser light source, and laparoscopes. The system integrates ultra-high-definition camera technology, LED lighting, and an image management system into a single console with a tablet interface. The system provides real-time visible and near-infrared light illumination and imaging.

The Arthrex Synergy® Endoscopic Imaging System CCU interacts with the laser light source to be able to provide near-infrared (NIR) imaging to visualize the presence of Indocyanine Green (ICG). The ICG fluoresces when illuminated through a laparoscope with NIR excitation light from the laser light source and the fluorescence response is then imaged with the camera, processed and displayed on a monitor.

The provided text is a 510(k) summary for the Arthrex SynergyID Endoscopic Imaging System. It outlines the device's indications for use, technological characteristics, and comparison to predicate devices, along with performance data related to standards conformance. However, it does not contain information about studies involving acceptance criteria based on metrics like Accuracy, Sensitivity, Specificity, AUC, or studies involving human readers or ground truth established by experts/pathology for the purpose of proving device performance relative to clinical metrics.

The "Performance Data" section primarily addresses conformance to safety and electrical standards, and software validation. It states that "functional analysis were conducted to demonstrate the accessory spine endoscopes are compatible with the Arthrex Synergy/D Endoscopic Imaging System." but does not provide an acceptance criterion or specific performance metrics from such a functional analysis beyond stating that all verification activities were successful.

Therefore, for this specific document, I cannot provide the detailed information requested in your prompt regarding:

1. A table of acceptance criteria and reported device performance (in terms of clinical metrics).
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study results or effect size.
6. Standalone performance metrics.
7. Type of ground truth used (beyond system compatibility/functional verification).
8. Sample size for the training set.
9. How the ground truth for the training set was established.

This document focuses on demonstrating substantial equivalence to predicate devices primarily through technological comparison and adherence to standards for safety and software, rather than reporting on clinical performance studies with specific statistical acceptance criteria for diagnostic accuracy or efficacy.

Ask a specific question about this device