(88 days)
1688 4K Camera System with Advance Imaging Modality:
The 1688 Video Camera is indicated for use in general laparoscopy, ear endoscopy, ear endoscopy, 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 hysterectorny, 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, 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 1688 Video Camera are general surgeons, gynecologists, cardiac surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.
L11 LED Light Source with Advanced Imaging Modality:
The L11 AIM Light Source and SafeLightTM Cable are indicated for use to provide real-time endoscopic visible and near-infrared fluorescence imaging. The L11 AIM Light Source and SafeLight Cable 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 ducts (cystic duct, common bile duct and common hepatic duct), using near-infrared imaging.
Fluorescence imaging of biliary ducts with the L1 AIM Light Source and SafeLight Cable 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 L11 AIM Light Source is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.
The AIM (Advanced Imaging Modality) System is an endoscopic real-time 4K visible white light and near-infrared light illumination and imaging system. Near-infrared illumination is used for both fluorescence imaging using indocyanine green (ICG) and transillumination of the ureters during minimally invasive and open surgical procedures, respectively. The AIM (Advanced Imaging Modality) System includes the following components: (1) A Camera System for processing near-infrared and visible light images; (2) A Light Source and SafeLight Cable for emitting light within the visible light as well as near-infrared light spectrum; (3) A Laparoscope for visible light and near-infrared light illumination and imaging; (4) The IRIS Ureteral Kit for transillumination of the ureters; and, (5) Imaging Agent Kits containing ICG used for fluorescence imaging.
The provided text describes the Stryker AIM (Advanced Imaging Modality) System, which includes the 1688 4K Camera System and the L11 LED Light Source. The document is a 510(k) summary of safety and effectiveness information, which aims to demonstrate substantial equivalence to legally marketed predicate devices, rather than establishing acceptance criteria and conducting studies to prove the device meets these criteria in the rigorous sense of a de novo device or a groundbreaking new technology.
Therefore, the document does not report specific acceptance criteria and detailed study results as one might expect for a new performance claim or a standalone performance study. Instead, it focuses on demonstrating that the device is as safe and effective as existing predicate devices based on various testing and comparison.
Here's a breakdown of the information that can be extracted, and what is not present based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists performance tests conducted, but it does not explicitly state specific quantitative acceptance criteria or numerical performance metrics for the device. The results are simply reported as "PASS," indicating that the device met internal specifications or regulatory standards.
| Test | Method | Reported Device Performance |
|---|---|---|
| Electrical Safety | ANSI IEC 60601-1:2005 + A1:2012; IEC 60601-2-18:2009; IEC 60601-1-6:2013 | PASS |
| EMC Testing | IEC 60601-1-2:2010 | PASS |
| Laser Safety | IEC 60825-1:2014 | PASS |
| Sterilization | ISO 14937:2009 | PASS |
| Software Validation & Verification | IEC 62304:2006 | PASS |
| Usability | IEC 62366-1:2015 | PASS |
| Performance - Bench | In accordance with device performance specifications | PASS |
| Performance - Animal | In accordance with user needs; Comparative testing to currently legally marketed device in compliance | PASS |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Performance - Animal" testing, but does not specify the sample size used for this animal study. It also does not specify the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since structured ground truth assessment by experts for a test set (like in a diagnostic AI study) is not described, this information is not provided. The "Performance - Animal" test mentions "user needs" and "comparative testing to currently legally marketed device," implying a functional assessment rather than expert-labeled ground truth.
4. Adjudication Method
Given the lack of expert-labeled ground truth, no adjudication method is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document states, "The AIM (Advanced Imaging Modality) System does not require clinical studies to support the determination of substantial equivalence." This indicates that an MRMC comparative effectiveness study was NOT done. The focus was on demonstrating substantial equivalence through technical performance tests and comparison to predicates, not on quantifying human reader improvement with or without AI assistance.
6. Standalone Performance Study
The document describes various performance tests (electrical, EMC, laser safety, sterilization, software validation, usability, bench, and animal performance). These can be considered standalone performance tests in that they evaluate the device's technical functionality and compliance with standards. However, it's important to note that for the L11 AIM Light Source with SafeLight Cable for biliary duct visualization, the indications for use explicitly state: "The devices are not intended for standalone use for biliary duct visualization," implying it is an assistive technology that complements standard-of-care white light and intraoperative cholangiography. Therefore, while technical standalone tests were performed, a standalone clinical performance study (e.g., measuring diagnostic accuracy without human intervention) was not conducted or required for this 510(k).
7. Type of Ground Truth Used
For the Performance - Animal test, the ground truth is implicitly tied to "user needs" and "comparative testing to currently legally marketed device in compliance." This suggests functional equivalence and safety against established benchmarks rather than a specific type of clinical ground truth like pathology or outcomes data. For other tests like electrical safety or software validation, the "ground truth" is defined by the relevant standards and specifications.
8. Sample Size for the Training Set
The document is for a medical device (camera system and light source), not an AI/machine learning algorithm that requires a "training set" in the conventional sense. While the device may incorporate some level of advanced image processing, it's not a standalone AI diagnostic software. Therefore, the concept of a "training set" and its sample size is not applicable or discussed in this document.
9. How Ground Truth for the Training Set Was Established
As above, this information is not applicable because the device is not described as an AI/ML algorithm requiring a training set.
§ 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.