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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.

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