(89 days)
Aesculap's HilLan Motor System is a high-speed pneumatic motor system intended for use in surgical procedures to drive handpieces which cut and shape bone. It is indicated for use in orthopedics, spine, and plastic/reconstructive (i.e. maxillofacial and craniofacial) procedures.
The Hillan Pneumatic Motor System consists of a small hand held motor, an air hose, a foot control, a pneumatic motor hose, and various handpieces. The system components connect to each other via a proprietary coupling system.
The provided document is a 510(k) summary for the Aesculap HiLan Motor System, a pneumatic motor system for surgical procedures. It details the device description, intended use, technological characteristics, and a substantial equivalence review by the FDA.
Based on the provided text, the document states there are no applicable performance standards for this device under Section 514 of the Food, Drug and Cosmetic Act. Instead, the motor system is manufactured in accordance with ISO and German DIN Standards, and Aesculap AG has received ISO 9001 certification.
Therefore, the document does not contain the information requested regarding acceptance criteria, a study proving the device meets those criteria, sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or the specific type of ground truth used for training or testing. The approval is based on "substantial equivalence" to predicate devices already on the market, rather than a detailed performance study against specific acceptance criteria.
§ 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.