(111 days)
Synthes Sterile Drill Bits are intended to bore a hole into bone for insertion of a screw, wire, cable, plate, pin, bolt, etc.
Synthes Sterile Drill Bits are available in various sizes and lengths, have a fluted design, and are either solid or cannulated, and may be calibrated. The Synthes Sterile Drill Bits have various coupling mechanisms.
This document (K962913) is a Summary of Safety and Effectiveness Information for Synthes Sterile Drill Bits, submitted in July 1996. It is not a study that describes acceptance criteria and device performance in the context of advanced AI/ML models as typically requested for such questions.
Therefore, I cannot provide the requested information. The document focuses on the sterilization of an existing medical device, not on analytical or clinical performance metrics that would involve AI, expert consensus, ground truth, or statistical studies with sample sizes for performance evaluation.
The key points of the document are:
- Device: Synthes Sterile Drill Bits
- Purpose: To make commercially available Synthes Drill Bits available as sterile.
- Intended Use: To bore a hole into bone for insertion of a screw, wire, cable, plate, pin, bolt, etc.
- Sterilization Method: Gamma radiation will be used to sterilize the device.
- Date: July 1996
The document does not contain any of the information requested in the prompt, such as acceptance criteria for performance, a study proving performance, sample sizes, ground truth, expert qualifications, or AI-related metrics.
§ 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.