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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.

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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.

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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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