(168 days)
The Servotronic EC 100 System is intended to be used for high speed cutting, sawing, drilling, and manipulation of soft tissue and bone in microsurgical procedures including maxillofacial surgery, ENT surgery, orthopedic surgery, plastic surgery, dental surgery and neurosurgery.
The Servotronic EC 100 System's primary components are: (1) a control unit with irrigation pump; (2) a micromotor; (3) a foot switch for remote control; and (4) various hand pieces and tools. The hand pieces to be used with the Servotronic EC 100 System include the following: (1) Sachse Micro Oscillating Saw; (2) Sachse Micro Osseoscalpel Saw; (3) Micro Compass Saw; (4) Steinhauser Mucotome; (5) Micro Sagittal Saw; and (6) Hauenstein Angular Screwing Instrument.
The Servotronic EC 100 requires an AC current of 110V or 230/240V. An electrical cord, which is intended to be plugged into a standard electrical outlet, is connected to the back of the control unit. The Servotronic EC 100 has integrated safety and monitoring functions for excess temperature, current limitations within the main supply circuit and within the motor electronics, and a speed-dependent stop used during a change of direction.
This 510(k) submission for the Servotronic EC 100 provides a summary of its characteristics and states its substantial equivalence to a predicate device, but it does not include any acceptance criteria or the results of a study designed to prove the device meets such criteria.
The document is a premarket notification (510(k)) which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than presenting a performance study against predefined acceptance criteria.
Therefore, I cannot extract the requested information regarding acceptance criteria and performance study details from this document. The sections you asked for, such as sample size, ground truth, expert qualifications, and specific study types (MRMC, standalone), are typically found in clinical or performance testing reports, which are not part of this 510(k) summary.
§ 882.4360 Electric cranial drill motor.
(a)
Identification. An electric cranial drill motor is an electrically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.(b)
Classification. Class II (performance standards).