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CORI is indicated for use in surgical procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be determined.

These procedures include unicondylar knee replacement (UKR), total knee arthroplasty (TKA) and total hip arthroplasty (THA).

For Knee applications, CORI is indicated for use with cemented implants only.

CORI is a computer-assisted orthopedic surgical navigation and surgical burring system. CORI uses established technologies of navigation, via a passive infrared tracking camera.

For robotic knee applications, CORI software can control the cutting engagement of the surgical bur based on its proximity to the planned target surface. Alternatively, the surgeon can disable both controls and operate the robotic drill as a standard navigated surgical drill.

For the hip navigation application, CORI incorporates the Brainlab HIP7 software (K193307) which will be market by Smith & Nephew as RI.HIP NAVIGATION. It uses instruments and reference arrays, which are tracked by the IR camera, to determine pelvis and femur anatomical landmarks as well as implant orientation. RI.HIP NAVIGATION assists the orientation of prosthetic hip implants and enables measurement of leg length and offset when used intraoperatively in combination with CORI.

This document does not contain the requested information about acceptance criteria and a study proving device performance as it is a 510(k) summary for a medical device (REAL INTELLIGENCE CORI) seeking clearance for a new indication (Total Hip Arthroplasty - THA).

Here's why the requested information is not present in this document:

• 510(k) Summaries Focus on Substantial Equivalence: A 510(k) summary aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and similar technological characteristics, or different characteristics that do not raise new questions of safety or effectiveness.
• Performance Data is Summarized, Not Detailed: While the document mentions "Design verification and validation tests were performed on CORI to demonstrate that the changes presented in this submission meet all design input requirements and that CORI is as safe and effective as its predicate device," it does not provide the detailed acceptance criteria, specific study designs, sample sizes, expert qualifications, or ground truth methodologies that you've asked for. These details would typically be found in the full 510(k) submission, not in the publicly available summary.
• "No human clinical testing was required": The document explicitly states this, which means there wouldn't be studies involving human readers, comparative effectiveness, or certain types of ground truth (like pathology from live patients) that might be expected from a device requiring clinical trials. The focus here is on bench testing and software validation.
• Focus on Bench Testing and Software Validation: The section on "Non-Clinical Testing (Bench)" mentions software integration testing (adhering to IEC 62304 and FDA guidance) and usability engineering validation testing (for safe and effective use in a simulated environment). This indicates the type of testing performed, but not the specific quantitative performance metrics you've requested.

Therefore, I cannot extract the table of acceptance criteria, reported device performance, sample sizes, data provenance, expert details, adjudication methods, MRMC study results, standalone performance, type of ground truth, or training set information from the provided text. This document is a high-level summary for regulatory clearance, not a detailed technical report of performance studies.

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