(90 days)
The Arthrex Synergy Vision 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, and procedures within the thoracic cavity. The device is also intended to be used as an accessory for microscopic surgery.
The Arthrex Synergy Vision 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 Synergy Vision 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 biliary duct visualization.
Upon interstitial administration and use of ICG consistent with its approved label, the Arthrex Synergy Vision 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 Vision Endoscopic Imaging System includes a non-sterile camera control unit (CCU) console, camera heads, a laser light source, and endoscope. The system integrates ultra-high-definition camera technology, light emitting diode (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 Vision Endoscopic Imaging System 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 describes the Arthrex Synergy Vision Endoscopic Imaging System. However, it does not contain specific acceptance criteria, performance metrics, or details of a study that would demonstrate the device meets such criteria in terms of clinical performance or diagnostic accuracy.
Instead, the document focuses on regulatory clearance for a medical device by demonstrating substantial equivalence to a predicate device. The "Performance Data" section details non-clinical testing related to safety and functionality, rather than clinical efficacy or accuracy.
Therefore, I cannot populate the requested table or answer most of the questions as the information is not present in the provided text.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Reported Device Performance (from non-clinical testing) |
|---|---|
| Biocompatibility | Device is biocompatible for its intended use (conforms to ISO 10993 standards) |
| Electrical Safety | Conforms with electrical safety standards (e.g., IEC 60601-1) |
| Electromagnetic Compatibility (EMC) | Conforms with EMC standards (e.g., IEC 60601-1-2) |
| Software Functionality | Arthrex software functions met product requirements and design specifications |
| Design Verification | Met Arthrex product requirements and design specifications for system and individual components (through inspection, engineering analysis, functional testing) |
| Clinical Performance/Accuracy | Not specified in the provided text. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable for clinical performance testing. The reported "testing" refers to non-clinical engineering and safety validations. No patient data or clinical test sets are mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. No expert review or ground truth establishment for clinical performance is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No adjudication method for clinical performance is mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No such study was done. The document explicitly states: "The Arthrex Synergy Endoscopic Imaging System did not require animal testing or human clinical studies to support the determination of substantial equivalence."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The device is an imaging system providing visible and near-infrared fluorescence imaging, not an AI-driven diagnostic algorithm that would typically have standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable for clinical performance. The "ground truth" for the non-clinical tests involved compliance with engineering standards and predefined design specifications.
8. The sample size for the training set
- Not applicable. The non-clinical testing does not involve training data in the context of machine learning.
9. How the ground truth for the training set was established
- Not applicable.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.