(266 days)
Camera System: The Camera System is indicated for use in general laparoscopy, ear endoscopy, ear endoscopy, sinuscopy, and plastic surgery whenever a laparoscope/ endoscope/ arthroscope is indicated for use. A few examples of the more common endoscope surgeries are Laparoscopic cholecystectomy, Laparoscopic hernia repair, Laparoscopic appendectomy, Laparoscopic pelvic lymph node detection, Laparoscopically assisted hysterectomy, Laparoscopic and thorascopic anterior spinal fusion, Anterior cruciate ligament reconstruction, Knee arthroscopy, Decompression fixation, Wedge resection, Lung biopsy, Pleural biopsy, Dorsal sympathectomy, Pleurodesis, Internal mammary artery dissection for coronary artery bypass grafting where endoscopic visualization is indicated and Examination of the evacuated cardiac chamber during performance of valve replacement. The users of the Camera System are general surgeons, gynecologists, cardiac surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.
NIR FI Light Source: The NIR FI Light Source and NIR FI Light Guide are indicated for use to provide real-time endoscopic visible and nearinfrared fluorescence imaging. The NIR FI Light Source and NIR FI Light Guide enable surgeons to perform minimally invasive surgery using standard endoscope visual light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile duct, common bile duct and common hepatic duct), using near-infrared imaging.
Fluorescence imaging of biliary ducts with the NIR FI Light Source and NIR FI Light Guide is intended for use with standard-of-care white light and, when indicated, intraoperative cholangiography. The devices are not intended for standalone use for biliary duct visualization.
The individual components of the subject device, SCHOELL Y's NIR FI System, form a system to provide real-time endoscopic visible imaging (wight light imaging, WLI) and near-infrared (NIR) illumination and imaging (fluorescence imaging, FI) using indocyanine green (ICG):
- Camera System suitable for processing and recordings visible light images as well as NIR images. The Camera System consists of a Camera Control Unit (CCU) and a Camera Head for connection to a fiberoptic scope;
- . Light Source and Light Guide for use with a fiberoptic scope for emitting light within the visible spectrum as well as in the NIR spectrum to cause fluorescence;
- . Fiberoptic Laparoscope suitable for visible light and NIR light illumination and imaging;
The imaging agent (ICG) is not provided by SCHOELLY as part of the subject system.
The submitted information does not contain a study that proves the device meets the acceptance criteria in the format requested. The document primarily focuses on establishing substantial equivalence to a predicate device for regulatory clearance. It describes general performance testing conducted, but not in the context of specific acceptance criteria and detailed study results as typically found in clinical trials or dedicated performance studies for AI/ML devices.
However, based on the provided text, I can extract information related to the device and the types of testing performed to support its regulatory clearance.
Here's an attempt to structure the available information, noting where specific details (like acceptance criteria, sample sizes, ground truth establishment, or expert involvement for performance scores) are not explicitly present in the provided document:
Device Name: Near-Infrared (NIR) Fluorescence Imaging (FI) System: Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for device performance (e.g., specific sensitivity, specificity, accuracy targets). Instead, it relies on demonstrating compliance with recognized standards and substantial equivalence to a predicate device.
| Performance Aspect | Acceptance Criteria (Implicit from regulatory context) | Reported Device Performance |
|---|---|---|
| Reprocessing Validation | Compliance with FDA 2015 guidance, AAMI TIR12:2010, AAMI TIR30:2011(R)2016, ANSI/AAMI/ISO 17665-1:2006 (R)2013, ISO 17664:2017. | "These tests demonstrated that the device successfully passed cleaning, drying and sterilization validations according to the instructions in the user manual." |
| Software Documentation | Compliance with FDA's 2005 Guidance for Software, IEC 62304:2006/A1:2016 (MODERATE Level of Concern). | "Software documentation for a MODERATE Level of Concern device is provided in support of the proposed device... The software lifecycle, including software documentation and validation, is managed in accordance with IEC 62304:2006/A1:2016..." (Implies compliance). |
| Electrical Safety Testing | Compliance with IEC 60601-1:2005 + CORR. 1:2006 + CORR. 2:2007 + AM1:2012 and IEC 60601-2-18:2009. | "The NIR FI System was assessed for conformity with, and was found to comply with, the relevant requirements of IEC 60601-1:2005... and IEC 60601-2-18:2009..." |
| Electromagnetic Compatibility | Compliance with IEC 60601-1-2:2014. | "The NIR FI System was assessed for conformity with, and was found to comply with, the relevant requirements of IEC 60601-1-2:2014..." |
| Non-Clinical Performance | Substantial equivalence to predicate device (Stryker AIM System) and meeting design input requirements for endoscopic white light and NIR fluorescence imaging. | "Non-Clinical performance test data demonstrate that the proposed NIR FI System performs substantially equivalent to the Stryker predicate AIM System and that the design output meets the design input requirements for endoscopic white light and near-infrared fluorescence imaging." (No specific quantitative metrics for imaging performance are disclosed in this summary). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of evaluating a dataset for AI performance. The performance data mentioned refers to engineering and quality system validation tests. No information is provided regarding the origin (country, retrospective/prospective) of specific data sets used for validating imaging performance beyond general statements about "non-clinical performance test data."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable based on the provided text. The document does not describe a study involving expert readers establishing ground truth for a test set to assess AI performance. The focus is on the device's technical specifications and safety/effectiveness in a comparative context to a predicate device.
4. Adjudication Method for the Test Set
Not applicable. As no human expert evaluation of a test set for AI performance is described, no adjudication method is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No MRMC study is mentioned. The document primarily focuses on demonstrating substantial equivalence to a predicate device through technical comparisons and compliance with standards, rather than a study comparing human readers with and without AI assistance.
6. If a Standalone (Algorithm Only) Performance Study Was Done
The device described is a medical imaging system (hardware and integrated functionality for visible and NIR fluorescence imaging), not a standalone AI algorithm. Therefore, a standalone algorithm performance study as typically understood for AI/ML software is not applicable here. The "Non-Clinical Performance Testing" refers to the system as a whole.
7. The Type of Ground Truth Used
For the "Non-Clinical Performance Testing," the "ground truth" implicitly refers to the expected performance characteristics based on an existing predicate device and the design input requirements for endoscopic white light and near-infrared fluorescence imaging. The document does not specify an external "ground truth" like pathology, expert consensus on images, or outcomes data.
8. The Sample Size for the Training Set
Not applicable. The document does not describe the development or training of an AI algorithm with a training set. The device is an imaging system, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no mention of a training set or AI algorithm training, the establishment of ground truth for such a set is not discussed.
Summary of Non-Inclusion:
The provided document is a 510(k) summary for a medical device (an imaging system) seeking clearance based on substantial equivalence. It is not a report on a clinical or performance study evaluating an AI/ML algorithm against specific performance metrics with independent test sets and expert ground truth. Therefore, many of the requested details, particularly those related to AI/ML study design (sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies), are not present in the given text. The "Performance Data" section details compliance with recognized safety, software, and reprocessing standards, and general non-clinical performance demonstrations for substantial equivalence.
§ 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.