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The Arthrex SynergyID Endoscopic Imaging System is intended to be used as an endoscopic video camera in a variety of endoscopic surgical procedures, including but not limited to: orthopedic, laparoscopic, urologic, sinuscopic, and plastic surgical procedures. 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 near-infrared 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.

The Arthrex SynergyID Endoscopic Imaging System comprises a non-sterile camera control unit (CCU) console, camera head, and light engine source. The system integrates ultra-high-definition camera technology, LED lighting, and an image management system into a single console with a tablet interface in an identical manner as the Arthrex UHD4 System cleared under K153218.

The Arthrex SynergyID Endoscopic Imaging System camera control unit interacts with the near-infrared 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 the laparoscope with NIR excitation light from the external laser engine and the fluorescence response is then imaged with the camera, processed and displayed on an Arthrex UHD4 System monitor.

This document is a 510(k) summary for the Arthrex SynergyID Endoscopic Imaging System, which primarily focuses on establishing substantial equivalence to predicate devices rather than providing a detailed study proving performance against acceptance criteria. Therefore, much of the requested information regarding specific acceptance criteria, study methodologies, and performance metrics is not present in the provided text.

Based on the available information, here is a breakdown of what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria or a "reported device performance" table as would be found in a clinical study report. Instead, it focuses on demonstrating substantial equivalence to predicate devices based on design features, materials, intended use, principle of operation, and technical characteristics.

The "Performance Testing" section (not explicitly numbered as a table in the text, but a logical grouping of related information implicitly demonstrating performance through testing) outlines the types of tests conducted:

2. Sample Size for the Test Set and Data Provenance:

The document describes non-clinical testing. Therefore, there is no patient test set or human subject data provenance (country of origin, retrospective/prospective) mentioned. The tests were performed on the device and its components in a laboratory or simulated environment to verify its technical performance, safety, and functionality.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Given that the testing described is non-clinical, there is no concept of "ground truth" established by medical experts in the context of diagnostic accuracy or clinical decision-making. The "ground truth" for the engineering and performance tests would be defined by engineering specifications, international standards (e.g., ISO, IEC), and the expected performance of a functioning device. These are typically verified by qualified engineers and technicians. The document does not specify the number or qualifications of engineers/technicians involved in test verification.

4. Adjudication Method for the Test Set:

Not applicable, as this was non-clinical testing. Adjudication methods like 2+1 or 3+1 are used for clinical trials involving human interpretation of data, which is not the case here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was done as described in this document. The submission focuses on substantial equivalence based on technical specifications and non-clinical performance, not on direct comparison of human reader performance with and without AI assistance to quantifiably measure an effect size.

6. Standalone (Algorithm Only) Performance:

The device described is an "Endoscopic Imaging System" that provides real-time visible and near-infrared fluorescence imaging. It's a hardware and software system that enables visualization for human surgeons. The fluorescence imaging functions are integral to the system. While the "processing" of the fluorescence response is mentioned, it's not discussed as a standalone algorithm being evaluated for diagnostic performance independent of the human operator. Therefore, there is no standalone algorithm-only performance study described in this submission. The device is explicitly stated as "not intended for standalone use for biliary duct visualization" (implying human interpretation is always required).

7. Type of Ground Truth Used:

For the non-clinical performance testing, the "ground truth" is based on:

• Engineering specifications and design requirements: Whether the system produces images of required resolution, brightness, and color accuracy under white light.
• Physical principles of fluorescence: Whether the system correctly excites and detects fluorescence of Indocyanine Green (ICG) at appropriate wavelengths.
• Comparison to predicate device performance: The system's performance is deemed equivalent to the predicate devices, implying those predicates set the de facto performance standard.
• Compliance with international standards: Biocompatibility (ISO 10993-1), electrical safety (IEC 60601-1), and EMC (IEC 60601-1-2) standards serve as the "ground truth" for these aspects.

8. Sample Size for the Training Set:

This document describes a regulatory submission for a medical device that includes imaging capabilities. It does not describe the development of a machine learning or AI model in the sense of needing a "training set." Therefore, a sample size for a training set is not applicable and not mentioned.

9. How the Ground Truth for the Training Set Was Established:

As there is no mention of an AI/ML training set, this question is not applicable based on the provided text.

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