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The 1688 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/ sinuscope/ sinuscope is indicated for use. The 1688 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. Iaparoscopic appendectomy, laparoscopic pelvic lymph node detection, laparoscopically assisted hysterectomy. Iaparoscopic anterior spinal fusion, anterior cruciate ligament reconstruction, nnee 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 1688 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 and infrared spectrums. The optical image is transferred from the surgical site to the camera head by a variety of rigid and flexible endoscopes, which are amera head. The 1688 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.

The provided text is a 510(k) summary for the Stryker Endoscopy 1688 4K Camera System with Advanced Imaging Modality. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain information about acceptance criteria or a study proving the device meets those criteria, particularly in the context of clinical performance or AI-assisted improvements.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on equivalence to a previously approved device, primarily addressing mechanical and electrical safety, and performance as an endoscopic camera system, rather than AI-driven performance metrics or clinical study results.

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