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510(k) Data Aggregation
(51 days)
Endoscopic scissors and graspers are instruments that have a 5 to 10 mm diameter insulated shaft designed for use through surgical trocars. Endoscopic scissors and graspers, in conjunction with trocars, are used in a variety of minimally invasive procedures to facilitate grasping, mobilization, dissections and transection of tissue.
Endoscopic Surgical Scissors and Graspers are hand-manipulated devices, with and without electrocautery capability; and with and without rotation capability. They are designed for use during minimally invasive surgical procedures and are equipped with elongated shafts to fit through the surgical trocar cannula.
The provided document is a 510(k) summary for Adven Medical, Inc.'s reprocessed used disposable endoscopic scissors and graspers. It describes the device, its intended use, and its substantial equivalence to a legally marketed predicate device.
However, this document does not contain information regarding objective acceptance criteria, a detailed study proving the device meets said criteria, or specific performance metrics. It is a regulatory submission outlining the device's classification and substantial equivalence for market clearance, rather than a scientific study report with detailed performance data.
Therefore, I cannot extract the requested information such as acceptance criteria, reported device performance, sample sizes, ground truth establishment, expert qualifications, or MRMC study details from this document. The document focuses on regulatory compliance and substantial equivalence, not on a detailed performance study with specific quantitative acceptance criteria and results.
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