(61 days)
To provide power to operate various accessories to cut hard tissue, bone, soft tissue.
Not Found
I am sorry, but the provided text does not contain the detailed study information required to answer your request. The document is a 510(k) clearance letter for a "Med'ext 1000 Surgical Drill," indicating it has been deemed substantially equivalent to a predicate device. However, it does not include:
- A table of acceptance criteria or reported device performance.
- Information on sample sizes, data provenance, number or qualifications of experts, or adjudication methods for a test set.
- Details about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
- The type of ground truth used or how it was established for either test or training sets.
- The sample size for the training set.
The document primarily focuses on the regulatory clearance of the device based on substantial equivalence, rather than a detailed performance study report.
§ 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.