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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.

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