(102 days)
The 1788 4K Camera System with Advanced Imaging Modality is indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, neurosurgery and plastic surgery whenever a laparoscope/ endoscope/ arthroscope/ sinuscope is indicated for use. The 1788 4K Camera System with Advanced Imaging Modality is indicated for use in adults and pediatric patients.
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, Small joint 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 1788 4K Camera System with Advanced Imaging Modality are general and pediatric surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT/neurosurgeons and urologists.
The 1788 4K Camera System with Advanced Imaging Modality is an endoscopic camera system that produces live video in the surgical field during surgical endoscopic procedures. The system is sensitive in the visible, infrared spectrums. The optical image is transferred from the surgical site to the camera head by a variety of rigid and flexible to the camera head. The 1788 4K Camera System consists of three main components: (1) a camera control unit (CCU); (2) a camera head with an integral cable that connects to the CCU; and (3) a coupler for attaching an endoscope to the camera head.
I am sorry, but the provided text does not contain any information about acceptance criteria or a specific study proving the device meets acceptance criteria. The document is an FDA 510(k) clearance letter for the Stryker Endoscopy 1788 4K Camera System with Advanced Imaging Modality.
It primarily focuses on:
- Regulatory Clearance: Affirming that the device is substantially equivalent to legally marketed predicate devices.
- Device Description: A brief overview of the camera system and its components.
- Indications for Use: The specific medical procedures and patient populations for which the device is intended.
- Technological Comparison: Stating that the subject device has similar technological characteristics to its predicate, with the addition of an optical shutter.
- Non-Clinical Testing Summary: Listing various non-clinical bench, software, EMC, and electrical safety tests performed to standards like IEC 62304, IEC 60601, and ANSI AAMI ES 60601. It concludes that these tests successfully completed to conform with recognized safety standards and design specifications.
- Absence of Clinical Studies: Explicitly stating, "The subject devices do not require clinical studies to support the determination of substantial equivalence."
Therefore, I cannot extract the requested information such as:
- A table of acceptance criteria and reported device performance.
- Sample size and data provenance for a test set.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study results.
- Standalone (algorithm only) performance.
- Type of ground truth used.
- Training set sample size.
- How ground truth for the training set was established.
This document indicates that substantial equivalence was determined based on non-clinical testing against recognized safety standards and a comparison of technologies, rather than through a clinical study with detailed performance metrics and ground truth establishment against an AI algorithm.
§ 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.