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Endo Assist positions a Laparescope, and is indicated for use laparoxopic, thoracoscopic and pelvic procedures. Laparoscopic: cholecystectory hernia repair Fundaplication Splenectomy appendectiony henicolectory synpathe ctony by oph node dissection hysterectory nysterectomy

EndoAssist is a microprocessor-driven robotic arm which holds a rigid laparoscope for the surgeon during laparoscopic surgical procedures. It stands separately from the operating table, and reaches up and over into the surgical field through a series of motorized mechanical linkages. These motors allow the microprocessor to change the configuration of the linkage.

The provided text does not contain information about acceptance criteria or a study proving the device meets said criteria.

It is a 510(k) summary for the EndoAssist device, which is a robotic arm for manipulating a laparoscope during surgery. The document focuses on:

• Device identification: Proprietary name (EndoAssist), common name, classification name.
• Substantial equivalence claim: Comparison to predicate devices (AESOP and Endex Endoscopy Positioning System).
• Device description: How it works, its components, and its unique technological characteristics compared to predicates.
• Intended use: Mechanical laparoscope holder and manipulator for laparoscopic and thoracoscopic surgery.
• Safety issues: Design features to ensure operational, electrical, and mechanical safety.
• FDA correspondence: The FDA's letter confirming substantial equivalence and allowing the device to be marketed.
• Indications for Use: A list of specific laparoscopic, thoracoscopic, and pelvic procedures for which the device is indicated.

While safety features are mentioned, there is no mention of specific acceptance criteria (e.g., performance metrics, thresholds) or a study that evaluates and reports on these criteria. The determination of substantial equivalence is explicitly stated as "not based on an assessment of clinical performance data."

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