(143 days)
The Electric Drill System is indicated for the incision / cutting, removal, drilling, and sawing of soft and hard tissue and biomaterials in Neurosurgical (Cranial, Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General Surgical Procedures.
The electric drill system consists of a power console, footswitches, connection cables, irrigation / cooling tubing sets, a remote irrigation control unit, and assorted handpieces to drive various burs, blades, drills, rasps, and saw blades. The system can also function as an endoscope lens cleaning system.
I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, or any studies proving the device meets acceptance criteria. The document is a 510(k) summary for an Electric Surgical Drill/Saw System, focusing on its classification, equivalence to predicate devices, and intended use for regulatory approval.
Therefore, I cannot provide the requested table or answer the specific questions about studies, sample sizes, ground truth, or adjudication methods.
§ 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.
(a)
Identification. Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.(b)
Classification. Class II (performance standards).