(57 days)
For Cervical Fusion:
CORUSTM System-X is a set of instruments indicated to be used to perform posterior cervical fusion in patients with cervical degenerative disc disease.
For Lumbar Fusion:
CORUSTM Spinal System-X is a set of instruments indicated to be used to perform posterior lumbar fusion in patients with lumbar degenerative disc disease.
The CORUS™ Spinal System-X is a set of instruments indicated for performing posterior cervical or lumbar fusion. The instruments will be supplied sterile and single use only. The system consists of:
- Access Chisel
- Access Chisel Handle
- Trephine Decorticator
- Guide Tube
- Rasp Decorticator
- Rotary Decorticator
- Bone Graft Tamp
- Multi-Tool
- Guide Tube Adapter
These instruments allow the user to access the posterior cervical or lumbar spine to perform posterior fusion by decortication of bone surfaces, including the posterior lateral mass and facet joints, combined with application of autograft or allograft.
This document does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. The document is a 510(k) premarket notification clearance letter from the FDA for the CORUS™ Spinal System-X, which is an arthroscope regulated under 21 CFR 888.1100.
The content mainly focuses on:
- FDA Clearance: Stating that the device is substantially equivalent to legally marketed predicate devices.
- Indications for Use: Posterior cervical fusion in patients with cervical degenerative disc disease and posterior lumbar fusion in patients with lumbar degenerative disc disease.
- Device Description: A set of instruments for accessing the posterior cervical or lumbar spine to perform posterior fusion by decortication of bone surfaces, combined with application of autograft or allograft.
- Technological Characteristics: Emphasizing that the fundamental operational principles, surgical approach, design, materials, and performance are essentially the same as the predicate devices, raising no new safety and effectiveness questions.
- Summary of Performance Testing (Non-clinical):
- Simulated use cadaveric testing: Demonstrated instruments can be used for posterior cervical or lumbar fusion.
- Bench testing: Demonstrated safety, efficacy, strength, and integrity against impaction, insertion, removal, and rotational loads.
- Shelf life and package performance testing: Demonstrated safety and reliability for a two-year shelf life.
- Compliance with FDA consensus standards for sterilization, microbiological methods, packaging, biological evaluation, and metallic materials for surgical instruments.
- Basis of Substantial Equivalence: Comparing the CORUS™ Spinal System-X to predicate devices (Providence Medical Technology, Inc. CORUS™ Spinal System (K190201) and Vertos Medical, Inc. Vertos medical mild™ Device Kit (K093062)) based on similar technological characteristics, design features, materials, principles of operation, and performance data.
The 510(k) process for arthroscopes like this device typically involves demonstrating substantial equivalence to a predicate device, which usually relies on non-clinical performance testing and comparison of technological characteristics, rather than extensive clinical studies with specific acceptance criteria related to diagnostic performance metrics (e.g., sensitivity, specificity, AUC) that are common for AI/ML devices. Therefore, the requested information about acceptance criteria, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone performance is not present in this document, as it pertains to a different type of device (surgical instruments, not an AI/ML diagnostic or prognostic tool).
§ 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.