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EndoAssist is indicated for use in general thoracoscopy, general cardiothoracic surgery, general laparoscopy, nasopharyngoscopy, ear endoscopy and sinuscopy, where a rigid laparoscope/endoscope is intended for use.

A few examples of the more common endoscopic surgeries are laparoscopic*

cholecystectomy hernia repair fundoplication splenectomy appendectomy hemicolectomy sympathectomy lymph node dissection hysterectomy gastric banding qastric by pass nephrectomy radical prostatectomy anterior spinal fusion, decompression fixation wedge resection lung biopsy pleural biopsy , internal mammary artery dissection for coronary artery bypass coronary artery bypass grafting where endoscopic visualization is indicated examination of the evacuated cardiac chamber during performance of valve replacement or repair.

• In this context "laparoscopic" is taken to embrace the use of a rigid endoscope in any part of the body

EndoAssist is a head-controlled Endoscopic camera manipulator. It is intended for use in minimally invasive laparoscopic, thoracoscopic, urological, gynecological and cardiac surgery and allows the surgeon directly to control movements of a rigid endoscope by head gestures.

I'm sorry, but without a dedicated study section detailing performance data, acceptance criteria, and ground truth establishment, I cannot fulfill your request for a table of acceptance criteria, device performance, and study information. The provided document is a 510(k) summary for the EndoAssist device, which primarily focuses on device description, intended use, and substantial equivalence to predicate devices, rather than detailed performance study results against specific acceptance criteria.

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Stereotaxic spatial positioning and orientation of an instrument holder or tool guide to be used by a surgeon manually to guide standard neurosurgical instruments.

A stereotaxic system with a computer-controlled mechanical arm for spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and utilises CCD camera registration based on fiducial markers. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments.

The provided documents do not contain the details required to complete your request. Specifically, the 510(k) summary for the "PathFinder Image Guided Surgical Localiser" (K041477) focuses on its equivalence to a predicate device, its intended use, and compliance with safety and EMC standards. It does not include information about:

• Acceptance criteria and reported device performance: There is no table or description of specific performance metrics or thresholds the device must meet. The document states "no substantive change in performance" compared to the predicate, but doesn't quantify it.
• Study details:
  • Sample size for test set.
  • Data provenance.
  • Number and qualifications of experts for ground truth.
  • Adjudication method.
  • MRMC comparative effectiveness study or its effect size.
  • Standalone algorithm performance.
  • Type of ground truth used.
  • Sample size for training set.
  • How ground truth for the training set was established.

The document primarily asserts equivalence based on technological characteristics and safe use, rather than presenting a performance study with detailed acceptance criteria and results.

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