(54 days)
Indications for use of the surgical bur and surgical drill bit devices are situations in surgical procedures where bone, hard tissue, or soft tissue is drilled, reamed, sculpted, augmented, reduced, replaced, or removed.
The subject devices (surgical burs and surgical drill bits) are stainless steel and/or tungsten carbide devices which may be coated with abrasion resistant coatings in order to increase cutting efficiency. They will be supplied as both sterile and non-sterile devices and will be labeled for single use.
The provided text is a 510(k) summary for surgical burs and surgical drill bits. It discusses the device's description, intended use, and substantial equivalence to legally marketed predicate devices. However, the document does not contain any information regarding acceptance criteria, device performance metrics, or study details such as sample sizes, expert qualifications, adjudication methods, or ground truth establishment.
Specifically, the document states: "Safety and Effectiveness Testing: All materials used in the surgical bur and surgical drill bit devices conform with industry specifications for medical device use. Material specifications are tested on a design basis." This indicates that safety and effectiveness were assessed through material specification conformity and design-based testing, but it does not provide any quantitative results, specific acceptance criteria, or details of a study that would allow for the completion of the requested table and sections.
Therefore, I cannot provide the requested information from the given text.
§ 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.