(284 days)
Upon intravenous administration of TRADENAME (ICG drug product), System green is used with TRADENAME (ICG drug product) to perform intraoperative fluorescence angiography, and it is also indicated for use in fluorescence imaging of biliary ducts, and when indicated, during intraoperative cholangiography.
System green is indicated for use to provide real time endoscopic visible and near-infrared fluorescence imaging. System green enables surgeons to perform minimally invasive surgery using standard endoscope visible light as well as visual assessment 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 System green 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 of TRADENAME (ICG drug product), System green is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes
System green combines the camera head, the rigid endoscope, the light source including light cables and a foot switch and the camera controller. The camera head is connected via a standard camera cable while the connection between the camera controller and light source is possible via a LAN (Ethernet) connection cable. This is the precondition for the video in fluorescence mode.
The camera head is further connected to the rigid endoscope via a snap-on locking mechanism. The rigid endoscope is further coupled via the fiber light source, which can also be connected to an optional foot switch.
System green allows for fluorescence imaging by exciting indocyanine green (ICG), a dye (FDA approved drug, not included in this submission) that is applied intravenously or interstitially in the body. Fluorescence imaging and white light imaging is possible with the same system setup at the same time. The NIR images can only be displayed as overlay pictures with the NIR information added to the white light image. The white light image can also be displayed on its own.
The provided text is a 510(k) summary for the "System green" endoscopic fluorescence imaging system. It details the device's indications for use and a summary of performance testing. However, it does not contain the specific information required to describe acceptance criteria for an AI/ML-based device or a detailed study proving the device meets those criteria in human clinical trials.
The performance testing section (5.10 Summary of Performance Testing) primarily focuses on non-clinical performance (e.g., Electromagnetic Compatibility and Electrical Safety, Photobiological safety, Temperature safety, Tightness, Transport simulation) and animal testing. There is no mention of a human clinical study, an AI component, specific acceptance criteria for AI model performance (like sensitivity, specificity, AUC), or details about ground truth establishment, expert adjudication, or MRMC studies.
Therefore, most of the requested information cannot be extracted from this document. The device in question is an imaging system that enables fluorescence imaging by exciting indocyanine green (ICG), a dye, and displaying NIR images as overlays. It is not an AI/ML diagnostic or prognostic device that has specific performance metrics in terms of classification, detection, or segmentation, which would typically be evaluated in the manner requested.
Unable to Fulfill Request with Provided Information:
The provided document describes a medical device clearance submission (K212808) for "System green," an endoscopic fluorescence imaging system. The performance testing detailed in the document (Section 5.10) focuses on non-clinical tests (electromagnetic compatibility, electrical safety, photobiological safety, temperature safety, tightness, transport simulation) and animal testing.
There is no mention of any AI or machine learning component within the "System green" device, nor is there any description of a clinical study, acceptance criteria, or performance metrics typically associated with AI/ML device validation (e.g., sensitivity, specificity, AUC, human reader improvement).
Therefore, I cannot populate the requested table or answer the specific questions related to AI acceptance criteria, ground truth, sample sizes for training/test sets, expert adjudication methods, or MRMC studies based on the provided text. The document indicates that the device met "all specified acceptance criteria set out for the animal testing," but these are not the detailed AI/ML specific criteria requested.
Information that can be extracted, but does not directly address the AI/ML acceptance criteria or study details:
- Device Name: System green (includes Logic HD camera head green, Light Source LED Green, Fiber Light Cable, Logic HD Camera Controller, Logic 4K Camera Controller, PANOVIEW ULTRA Telescopes).
- Study Type (closest fit): Animal Testing (pre-clinical model).
- Device Performance (from animal testing): "The test results show that the subject device met all specified acceptance criteria set out for the animal testing, and that the performance of the device with respect to the risk of incorrect fluorescence has been confirmed. Animal testing verified the effectiveness as described in the indications for use."
- Ground Truth (for animal testing): Implied to be derived from the animal model itself, confirming effectiveness and risk of incorrect fluorescence.
All other requested information regarding AI acceptance criteria, sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, and how ground truth was established for the training set, is not present in the provided text.
§ 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.