(88 days)
The prodisc® L Instruments are intended for the placement, positioning, and removal of the prodisc® L implants.
The prodisc® L Instruments enable the Centinel prodisc® L disc to be implanted into the disc space. The purpose of this Traditional 510(k) is to seek marketing clearance for the prodisc® L Instruments.
This document is a 510(k) premarket notification for the prodisc® L Instruments. It does not present a study or acceptance criteria for device performance related to diagnostic accuracy or AI/algorithm performance.
Instead, this document is a regulatory submission demonstrating the substantial equivalence of surgical instruments (prodisc® L Instruments) to previously cleared predicate devices. The focus is on the instruments' design, materials, manufacturing, and intended use for placing, positioning, and removing prodisc® L implants.
Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, as these concepts are not applicable to the content of this 510(k) summary for surgical instruments.
§ 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.