(57 days)
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).
The subject of this Traditional 510(k) is REAL INTELLIGENCE CORI (CORI), a robotic-assisted orthopedic surgical navigation and burring system. CORI uses established technologies of navigation via a passive infrared tracking camera. Based on intraoperatively-defined bone landmarks and known geometry of the surgical implant, the system aids the surgeon in establishing a bone surface model for the target surgery and planning the surgical implant location. For knee applications, CORI then aids the surgeon in executing the surgical plan by controlling the cutting engagement of the surgical bur.
CORI knee application software controls the cutting engagement of the surgical bur based on its proximity to the planned target surface. The cutting control is achieved with two modes:
- Exposure control adjusts the bur's exposure with respect to a guard. If the surgeon encroaches on a portion of bone that is not to be cut, the robotic system retracts the bur inside the guard, disabling cutting.
- Speed control regulates the signal going to the tool control unit itself and limits the speed of the drill if the target surface is approached.
Alternatively, the surgeon can disable both controls and operate the robotic drill as a standard navigated surgical drill.
I am sorry, but the provided text does not contain the specific information required to answer your request.
Here's why:
- Acceptance Criteria and Reported Device Performance: The document states that "Verification and validation testing demonstrated the safety and efficacy of CORI when the system is used to place porous total knee implants intended for use without bone cement." and "Comprehensive verification testing demonstrated that the system meets required design inputs." However, it does not list the specific acceptance criteria (e.g., target accuracy, precision thresholds) or report the numerical performance results against these criteria.
- Sample Size and Data Provenance for Test Set: The document mentions "Verification and validation testing" and "Summative usability testing" but does not provide details on the sample size used for these tests (e.g., number of procedures, number of patients, number of simulated cases) or the provenance of the data (e.g., country of origin, retrospective/prospective).
- Experts for Ground Truth: There is no mention of experts used to establish a ground truth for a test set, nor their qualifications or number.
- Adjudication Method: No information regarding an adjudication method is provided.
- MRMC Comparative Effectiveness Study: The document does not describe any multi-reader multi-case (MRMC) comparative effectiveness study, nor does it mention any effect size for human reader improvement with AI assistance.
- Standalone Performance: While the document describes the device's functionality, it does not explicitly state or provide data for a standalone (algorithm only without human-in-the-loop) performance evaluation. The description focuses on its function as an assistant to the surgeon.
- Type of Ground Truth: The document does not specify the type of ground truth used (e.g., expert consensus, pathology, outcomes data) for any of its testing.
- Sample Size for Training Set & Ground Truth for Training Set: The document is a 510(k) summary for a premarket notification, which focuses on device modifications and substantial equivalence. It does not provide details about the training set used for the underlying AI/software components, including its size or how its ground truth was established.
The document primarily focuses on establishing substantial equivalence to a predicate device (K212537) by highlighting that the subject device (CORI) has the same intended use and technological characteristics, with the main difference being an updated indication for use to support porous total knee implants. It confirms that non-clinical testing and usability testing were performed but does not delve into the detailed results or methodologies that would be needed to answer your specific questions about acceptance criteria and study particulars.
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).