(467 days)
The SODEM HIGH SPEED SYSTEM (with associated accessories/attachments) is intended for use for neurosurgery (spine and craniotomy) and median sternotomy.
The SODEM HIGH SPEED SYSTEM is a modular, pneumatic, high speed instrument system consisting of a handpiece and accessories/attachments (including but not limited to adapter, spindles, and burrs).
The provided text is a 510(k) summary for a medical device (SODEM High Speed System) and does not contain information about acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the provided questions. This type of document focuses on demonstrating substantial equivalence to predicate devices based on intended use, materials, sterility, energy consumption, and operational principles, rather than presenting a performance study with detailed acceptance criteria and results as typically found in clinical trials or software validation studies.
Therefore, I cannot extract the requested information from the given text.
§ 882.4370 Pneumatic cranial drill motor.
(a)
Identification. A pneumatic cranial drill motor is a pneumatically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.(b)
Classification. Class II (performance standards).