(77 days)
The Advantage® Turbo Drive System functions as a powered instrument system consisting of handpieces and accessories to perform cutting of soft tissue and bone. The fields of application include Arthroscopic, Foot, Hand, Medial Sternotomy, Neurosurgical, Orthopedic, Otolaryngological, Oral/Maxillofacial, Plastic/Reconstructive and Spinal surgical procedures.
The Advantage® Turbo Drive System device description is identical to the original submission except for the modifications listed below. The modifications described in this Special 510(K) are listed below: 1. A new motor has been installed which provides additional torque and speed to the handpiece. 2. The software, Version 7.0, has been modified to allow Advantage@ Turbo Drive System to run at a maximum forward/reverse speed of 10.000 RMP or 12,000 RPM. This maximum speed is selectable using an appropriate code during the calibration request. All other software parameters used to run the Advantage@ Turbo Drive System operate in the same manner as all pre-existing software versions.
The provided text is a 510(k) premarket notification for the Advantage® Turbo Drive System, which is an electric cranial drill motor. The document describes modifications to an existing device, primarily a new motor and updated software to increase speed and torque.
However, the document is a regulatory submission for a medical device that performs cutting of soft tissue and bone and does not involve any AI/ML components or software for diagnostic or screening purposes.
Therefore, I cannot provide the requested information about acceptance criteria and study details related to AI/ML device performance (such as sample sizes, expert ground truth, MRMC studies, standalone performance, training data, etc.). The provided text does not contain any of that information because it describes a mechanical surgical tool, not an AI/ML algorithm.
§ 878.4820 Surgical instrument motors and accessories/attachments.
(a)
Identification. Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.(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 § 878.9.