(94 days)
Indications for use:
CORI is indicated for use in unicondylar knee replacement (UKR) surgical knee procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be determined.
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, to aid the surgeon in establishing a bone surface model for the target surgery and in planning the surgical implant location. Based on intraoperatively-defined bone landmarks and known geometry of the surgical implant, CORI aids the surgeon in establishing a bone surface model for the target surgery and planning the surgical implant location.
CORI 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 drill motor controller 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.
The provided text is a 510(k) Summary for the "REAL INTELLIGENCE CORI (CORI)" device. It details the device's intended use, indications for use, technological characteristics, and comparison to a predicate device (NAVIO Surgical System).
However, the document does not contain the specific information required to answer the prompt regarding acceptance criteria and the study proving the device meets these criteria. The text mentions "Design verification and validation testing was performed to demonstrate that CORI meets all design requirements" and "Comprehensive performance testing demonstrated that the system meets required design inputs," but it does not provide details of:
- A table of specific acceptance criteria values (e.g., accuracy thresholds, precision targets).
- Reported device performance values for these criteria.
- Sample sizes used for the test set.
- Data provenance (country, retrospective/prospective).
- Number/qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study details (effect size, human improvement).
- Standalone performance details.
- Type of ground truth used (expert consensus, pathology, outcomes).
- Training set sample size and ground truth establishment for training set.
The document primarily focuses on demonstrating substantial equivalence to a predicate device through shared intended use, indications, and technological characteristics, along with various general performance tests (biocompatibility, EMC, software verification, usability). It states, "No human clinical testing was required to determine the safety and effectiveness of CORI."
The closest the document comes to specific performance data is: "The comparative results of the cut-to-plan accuracy indicate that CORI implant placement accuracy data is acceptable and equivalent to the UKR implant placement accuracy data for the NAVIO system." However, it does not provide the numerical accuracy data itself or the acceptance criteria for "acceptable."
Therefore, based solely on the provided text, I cannot fulfill the request for detailed information about acceptance criteria and the study proving the device meets them. The document indicates that such testing was done ("Design verification and validation testing was performed to demonstrate that CORI meets all design requirements"), but it does not disclose the specific criteria or the quantitative results.
§ 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).