(117 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),
- · revision knee arthroplasty, 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.
This document describes the Real Intelligence CORI surgical navigation and burring system. The current submission (K220958) is an update to a previously cleared device (K220255), specifically updating the Indications for Use to include revision knee arthroplasty procedures.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state specific numerical acceptance criteria for performance metrics like accuracy or precision. Instead, it relies on demonstrating that the device's performance is not negatively impacted by the expanded indications and is "as safe and effective" as the predicate device.
The reported device performance primarily focuses on the successful completion of a simulated revision knee arthroplasty procedure and confirmation that existing accuracy is maintained.
| Acceptance Criteria (Implied/General) | Reported Device Performance |
|---|---|
| Safe and effective use for revision knee arthroplasty procedures. | Summative usability testing demonstrated that participating surgeons were able to use the subject device safely and effectively to complete a revision knee arthroplasty procedure in a simulated use environment. The usability testing also validated the instructions for use. |
| Maintenance of implant and cut guide position accuracy. | Analysis confirmed implant position and cut guide position accuracy is not impacted by the addition of revision knee arthroplasty to the CORI indications for use statement since no modifications have been made to the CORI system, reusable or disposable components, software, implant/cut guide database, functional or performance requirements, or bone preparation methods. |
| Compliance with design input requirements. | Verification testing demonstrated that the system meets required design inputs. |
| Substantial equivalence to predicate device (K220255). | The submission concludes that CORI is as safe and effective as the predicate CORI system (K220255) and is substantially equivalent. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Usability Testing: Not explicitly stated as a number. The document mentions "participating surgeons" and "representative users."
- Sample Size for Accuracy Analysis: Not explicitly stated. The analysis focused on confirming non-impact rather than new testing on a specific sample size.
- Data Provenance: The usability testing was performed in a "simulated use environment," implying a lab or controlled setting. The document does not specify a country of origin, but Blue Belt Technologies, Inc. is based in Plymouth, Minnesota, USA. The testing appears to be prospective as it was conducted for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Usability Testing: The document mentions "participating surgeons" and "representative users." The specific number is not provided, nor are their detailed qualifications (e.g., years of experience, specific orthopedic specialties). However, it implies they were qualified surgeons capable of performing revision knee arthroplasty procedures.
- Accuracy Analysis: For the accuracy analysis, no experts are explicitly mentioned as establishing ground truth in the context of a test set, as the analysis primarily confirmed that no changes were made that would impact the existing accuracy parameters, which would have been established during the predicate device's clearance.
4. Adjudication Method for the Test Set
Not applicable/not specified. The studies described are usability testing and an analysis of impact on accuracy. There is no mention of an adjudication process typically associated with diagnostic performance studies involving multiple readers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a surgical navigation and burring system, not an AI-assisted diagnostic imaging device for "human readers." The evaluation focused on usability and maintenance of surgical accuracy.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device itself is inherently "human-in-the-loop" as it assists a surgeon. The system controls bur engagement based on proximity to a planned target surface, but the surgeon operates the bur and plans the surgical implant location. No "standalone" algorithm-only performance is described, as it's an intraoperative assistance system.
7. The Type of Ground Truth Used
- Usability Testing: The "ground truth" for usability was the ability of surgeons to "safely and effectively" complete a revision knee arthroplasty procedure in the simulated environment, and validation of the instructions for use. This can be considered a form of expert observation and task completion verification against defined procedural steps and safety metrics.
- Accuracy Analysis: For accuracy, the ground truth would be the established accuracy parameters of the predicate device. The analysis confirmed that the updated indications did not alter the physical system or software in a way that would modify these established accuracy limits.
8. The Sample Size for the Training Set
Not applicable. This document describes a surgical navigation system, not a machine learning model that requires a training set in the conventional sense. The "training" of the system would imply its design, development, and validation based on engineering principles and previous surgical data, but not a distinct "training set" of patient data for an AI algorithm. The device uses "intraoperatively-defined bone landmarks and known geometry of the surgical implant" but this is real-time operation, not a pre-trained model on a dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no traditional "training set" for a machine learning algorithm described in this submission. The system's functionality is based on established engineering principles, navigation technologies, and predefined anatomical and implant geometries.
§ 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).