(56 days)
The prodisc® C SK, prodisc® C Nova, and prodisc® C Vivo instruments are intended for the placement, positioning, and removal of the prodisc® C SK, prodisc® C Nova, and prodisc® C Vivo devices.
The prodisc® C SK, prodisc® C Nova, and prodisc® C Vivo Instruments enable the prodisc® C SK, prodisc® C Nova, and prodisc® C Vivo devices to be implanted as a single unit into the disc space. Additional instruments are included to allow for the removal of the prodisc® C SK, prodisc® C Nova, and prodisc® C Vivo. The purpose of this Traditional 510(k) is to seek marketing clearance for the prodisc® C SK, prodisc® C Nova, and prodisc® C Vivo Instruments.
The provided text describes a 510(k) premarket notification for surgical instruments used with total disc replacement devices. It does not contain any information about an AI/ML powered device, acceptance criteria related to AI/ML device performance, or details of a study proving such a device meets acceptance criteria.
Therefore, I cannot provide the requested information, including the table of acceptance criteria, sample sizes, expert qualifications, ground truth establishment, or any details about a multi-reader multi-case (MRMC) study or standalone algorithm performance.
The document focuses on demonstrating substantial equivalence of the surgical instruments to previously approved predicate devices based on indications, design, materials, function, manufacturing, and performance (which includes user testing with cadaver studies, European clinical use report, cleaning validation, and steam sterilization). It explicitly states: "All completed tests met the pre-determined acceptance criteria." However, these acceptance criteria are not specified in terms of quantitative performance metrics for a diagnostic or AI/ML device.
The document is a regulatory approval letter and summary for manual surgical instruments, not an AI/ML medical device.
§ 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.