(32 days)
CORUS Spinal System is a set of instruments to be used to perform posterior cervical fusion in patients with cervical degenerative disc disease.
The CORUS™ Spinal System is a set of surgical instruments indicated for performing posterior cervical fusion. The instruments will be supplied sterile and single use only. The system consists of Access Chisel, Access Chisel Handle, Decortication Trephine, Guide Tube, Decortication Rasp, Decortication Burr, Bone Graft Tamp and a Fork Mallet. In combination, these instruments allow the user to access the posterior cervical spine to perform posterior cervical fusion by decortication of bone surfaces, including the posterior lateral mass and facet joints, combined with application of autograft or allograft.
The provided text is related to an FDA 510(k) premarket notification for a medical device called the CORUS Spinal System. This document does not describe an AI medical device or a study involving AI.
The 510(k) submission states specifically:
- "The purpose of this Special 510(k) submission is to modify the device trade name and device Instructions for Use. The intended use, indications for use, and contraindications of the modified device, as described in the Instructions for Use, have not changed as a result of this modification."
- "Furthermore, there have been no changes in design, intended use, indications for use statement, contraindications, operating principle, component materials, manufacturing processes, packaging, or sterilization method since FDA's clearance of K180876."
- "Therefore, no verification or validation activities were required."
This means the submission is for a minor administrative change (trade name and IFU modifications) to an existing, already cleared device (K180876). It is not for a new device, a device with modified technology, or an AI/software as a medical device (SaMD). Therefore, there are no acceptance criteria, performance studies, sample sizes, expert ground truth establishment, MRMC studies, or standalone algorithm performance data to report based on this document, as these elements are typically required for the initial clearance of a device, especially one involving AI or novel technology.
In summary, the request for information regarding acceptance criteria and study proving device meets criteria is not applicable to this specific FDA document, as it describes a special 510(k) for minor non-technological changes to an already cleared device, not the initial clearance or an AI-enabled device.
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.