(55 days)
The device is intended to indicate the applied torque according to the set target torque value. This device is intended for use in surgical procedures on bone and tissue by a surgeon trained in its intended use.
Not Found
I apologize, but the provided text focuses on an FDA 510(k) clearance letter for a device called "Intellitorq." This document confirms the device's substantial equivalence to a predicate device and outlines regulatory compliance requirements.
However, the text does not contain any information regarding acceptance criteria, specific study details, sample sizes, ground truth establishment, or expert qualifications related to the device's performance.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. The document is solely an administrative FDA communication, not a performance study report.
§ 888.4540 Orthopedic manual surgical instrument.
(a)
Identification. An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.(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 the limitations in § 888.9.