(59 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 four additional prodisc® L Instruments:
- IN1575, Hemi Chisel +3mm, 10mm
- IN1576, Hemi Chisel +3mm, 12mm
- IN1570, Superior Impactor, Medium
- IN1571, Superior Impactor, Large
These are new instruments, based on similar devices within the existing instrument set.
The provided text is a 510(k) clearance letter from the FDA for medical instruments. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies for an AI/software device.
The device in question, "prodisc® L Instruments," falls under the product code QLQ, which is for "Manual Instruments Designed For Use With Total Disc Replacement Devices." This indicates it is a set of physical surgical tools, not a software or AI-powered device.
Therefore, I cannot provide the requested information because the provided document does not pertain to the evaluation of an AI or software device. The questions you've asked are typically relevant to the validation of diagnostic or predictive AI tools.
§ 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.