(33 days)
The ACE System is primarily intended for the controlled incision or removal of bone in the ear, nose, throat and other areas of the head and neck. It also has applications in neurosurgery (e.g. cervical laminectomies), hand surgery, and plastic surgery (e.g. facial and mandibular reconstruction)
The ACE System is made up of a console, electric motor handpiece, foot pedal and various accessories. The Console is designed to mount onto an IV pole or to set on a cart and provides control of various functions such as handpiece speed and direction and irrigation. It has the ability to operate one or two handpieces (one selected at a time), angled and straight, and incorporates irrigation capability.
This 510(k) summary for the ACE System does not contain information regarding acceptance criteria, study design, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details.
The document focuses on:
- Device Description: What the ACE System is (console, handpiece, foot pedal, accessories).
- Intended Use: Controlled incision or removal of bone in ENT, neurosurgery, hand, and plastic surgery.
- Substantial Equivalence: Comparison to other predicate devices, primarily noting that the ACE System has enhanced speed and torque, making its performance equivalent to pneumatic drills but with the controls of electrical systems.
Therefore, I cannot provide the requested information based on the provided text. The document is a regulatory submission for substantial equivalence rather than a detailed performance study report.
§ 874.4140 Ear, nose, and throat bur.
(a)
Identification. An ear, nose, and throat bur is a device consisting of an interchangeable drill bit that is intended for use in an ear, nose, and throat electric or pneumatic surgical drill (§ 874.4250) for incising or removing bone in the ear, nose, or throat area. The bur consists of a carbide cutting tip on a metal shank or a coating of diamond on a metal shank. The device is used in mastoid surgery, frontal sinus surgery, and surgery of the facial nerves.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.