(70 days)
The M6-C Artificial Cervical Disc Surgical Instruments are intended for the placement and positioning of the M6-C Artificial Cervical Disc.
The surgical implantation of the M6-C Artificial Cervical Disc requires specific surgical instruments including: a footprint template and a trial to determine the appropriate size and position of the implant; a fin cutter to create tracks in the superior and inferior vertebral endplates; and an implant inserter to place the disc into the desired position to aid in and ensure correct placement within the intervertebral space. Additionally, there is a tamp to independently adjust the posterior position of the M6-C endplates, a removal tool to remove the disc from the disc space, and general surgical instruments to assist in the distraction and mobilization of the disc space. The instruments are composed primarily of surgical stainless steel coated with ME-92 coating to increase corrosion resistance, with some instrument handles also featuring aluminum and Radel materials. Surgical instruments are provided nonsterile and are intended to be reusable. The instruments provided in the kit include Footprint Templates. Trials, Inserters, Fin Cutters, a Tamp, Removal Tools, an Intervertebral Distractor, a Paddle Distractor, a Distractor Spacer, a Slide Hammer, a Retainer, Retainer Pins and Locking Nuts. The M6-C Instrument Tray is multi-layered with various inserts to hold surgical instrumentation in place during handling and storage. The instrument tray is perforated to allow steam to penetrate which will allow sterilization of the contents to occur in a steam autoclave.
This document is a 510(k) submission for surgical instruments, not an AI/ML medical device. Therefore, it does not contain the information requested about acceptance criteria, study details, and AI performance metrics.
The document describes surgical instruments for the placement and positioning of an artificial cervical disc, not an AI-powered device. The performance testing summarized in the document (Impact testing, Bend/Functional testing, Transit testing, Sterilization validation) are typical for physical surgical tools and do not involve AI algorithms or data analysis.
Therefore, the requested information regarding AI device performance, sample sizes for test/training sets, expert ground truth, MRMC studies, or standalone algorithm performance cannot be extracted from this submission.
§ 888.4515 Orthopedic manual surgical instrumentation for use with total disc replacement devices.
(a)
Identification. Orthopedic manual surgical instrumentation for use with total disc replacement devices are non-powered hand-held devices designed specifically for use with a total disc replacement device and interface with the associated implant for the purpose of insertion, removal, placement, or repositioning, or to cut, rasp, or create a defect specific to the features of the associated implant. This type of device includes instruments specific to the geometry of the implant.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Technical specifications regarding geometry of the instruments must be specified and validated to demonstrate that the instruments can safely position, place, or remove the implant.
(2) The patient contacting components of the device must be demonstrated to be biocompatible.
(3) Performance data must demonstrate that reprocessing of reusable devices that are provided non-sterile, or sterilization of devices provided sterile, is validated.
(4) Labeling must include:
(i) Identification of implant(s) and instruments which have been validated for use together; and
(ii) Validated methods and instructions for reprocessing any reusable parts.