(256 days)
Cutting and Shaping Bone.
Not Found
I am sorry, but the provided text is a 510(k) clearance letter from the FDA, not a study report. It states that the device, "Anspach Black Max Shielded Attachment," is substantially equivalent to a predicate device and can be marketed.
Therefore, the document does not contain any information about acceptance criteria or a study proving the device meets those criteria. It lacks details on:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, expert qualifications, or adjudication methods for a test set.
- Whether MRMC or standalone studies were performed, or any associated effect sizes.
- The type of ground truth used.
- Sample size for a training set or how its ground truth was established.
I cannot fulfill your request to describe the acceptance criteria and study based on this document.
§ 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.