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The 1688 Video Camera 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 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.

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 spectrum. The optical image is transferred from the surgical site to the camera head by a variety of rigid and flexible scopes, which are attached to the camera 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 (integrated or standard); and (3) a coupler for attaching an endoscope to the camera head.

The provided text is a 510(k) summary for a medical device (Stryker 1688 4K Camera System) and does not contain the kind of information typically found in a study proving a device meets acceptance criteria for an AI/ML-based diagnostic or assistive system.

Specifically, this document describes a traditional medical device (an endoscopic camera system) and its substantial equivalence to a predicate device. The performance data presented are for standard engineering and safety tests (e.g., torque, electrical safety, EMC, software verification, cleaning/disinfection, sterilization), not for diagnostic accuracy or human-AI interaction.

Therefore, I cannot extract the information required by your prompt, as the prompt's questions are geared towards the evaluation of an AI-powered medical device, which this document does not describe.

To answer your prompt, there would need to be a section explicitly detailing:

• Acceptance Criteria for an AI-powered Diagnostic/Assistive System: This would specify metrics like sensitivity, specificity, AUC, or agreement rates for an AI in identifying conditions or assisting human performance.
• A "Study" with a Test Set: This would involve a clinical or simulated clinical study using a dataset of medical images/data, with rigorously established ground truth, to evaluate the AI's performance.
• Sample Size and Data Provenance for AI Evaluation: Details on the number of cases, patient demographics, and how the data was collected (retrospective/prospective, country).
• Ground Truth Establishment for AI: Information on how experts reviewed the cases, their qualifications, and adjudication methods.
• MRMC Study Design and Results: If human readers were part of the evaluation, showing how AI assistance impacted their performance.
• Standalone AI Performance: Metrics for the algorithm operating independently.
• Training Set Details: Information on the data used to train the AI, including its size and how ground truth was obtained for it.

The provided document explicitly states:

NOTE: The 1688 4K Camera System does not require clinical studies to support the determination of substantial equivalence.

This confirms that the evaluation performed for this device is not a clinical study involving human or AI evaluation of diagnostic performance.

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