(60 days)
REAL INTELLIGENCE 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. For knee applications, CORI aids the surgeon in planning the surgical implant location and in executing the surgical plan by controlling the cutting engagement of the surgical bur.
For knee applications, 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.
- o 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, K240139, describes a 510(k) premarket notification for a modification to the REAL INTELLIGENCE™ CORI™ device. The modification integrates an image-based planning option into the Total Knee Arthroplasty (TKA) and Unicondylar Knee Replacement (UKR) applications. The provided text, however, does not include detailed acceptance criteria or a specific study proving the device meets those criteria with performance data in the format requested.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (K231963) by outlining similarities in intended use, indications for use, technological characteristics, and environmental use. It mentions "Design verification and validation testing demonstrated that CORI meets all design requirements" and "Comprehensive testing demonstrated that the system meets required design inputs," but does not provide the specific quantitative acceptance criteria or performance results from these tests.
Therefore, the following points address the requested information based only on what is available in the provided text. Many points will be marked as "Not provided" or "Not applicable" due to the nature of the submission (a 510(k) for a modification focusing on substantial equivalence rather than a full de novo study with detailed performance metrics).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| System Meets Design Requirements | "CORI meets all design requirements." (No specific quantitative criteria or metrics provided) |
| Meets Required Design Inputs | "Comprehensive testing demonstrated that the system meets required design inputs." (No specific quantitative criteria or metrics provided) |
| Image-Based Planning Registration is Safe and Effective | "The key determining factor in establishing substantial equivalence is whether CORI can register the pre-operative plans safely and effectively." |
| "Comprehensive verification testing demonstrated that the system meets required design inputs." (No specific quantitative metrics for safety and effectiveness of registration, e.g., accuracy, precision, or success rates, are provided.) | |
| Usability (Safe & Effective Use in Simulated Environment) | "Summative usability validation testing demonstrating that representative users were able to use the subject device safely and effectively in a simulated use environment." |
| "The study demonstrated that the surgeon users were able to safely and effectively perform tasks necessary to execute TKA and UKA procedures using the CORI system." (No specific quantitative usability metrics, like task completion rates, error rates, or time to completion, are provided.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified for the software verification, design verification, or image-based planning registration testing. For the summative usability validation testing, it mentions "representative users," but the number is not provided.
- Data Provenance: Not specified. (e.g., country of origin, retrospective/prospective). This is a modification of an existing device, so the testing mainly focuses on the modified functionalities.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: Not specified.
- Qualifications of Experts: For the usability study, "surgeon users" are mentioned, implying qualified medical professionals, but specific qualifications (e.g., years of experience, specialty) are not detailed. For other testing, the method of establishing ground truth for technical performance (e.g., registration accuracy) is not explicitly described as relying on "experts" in the sense of clinical reviewers, but rather on engineering verification.
4. Adjudication Method for the Test Set
- Not applicable/Not specified. The document refers to "design verification and validation testing," "software verification testing," and "summative usability validation testing." There is no mention of an adjudication process typically associated with reviewer consensus on medical images or clinical outcomes.
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
- Not done/Not applicable. This submission is for a surgical navigation system, not an AI-assisted diagnostic tool that would typically involve a multi-reader, multi-case study to assess human reader performance improvement. The "image-based planning option" implies the import and use of pre-operative imaging data, but the device itself is not described as an AI intended to assist human readers in image interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable in the conventional sense of a diagnostic algorithm. The device, REAL INTELLIGENCE™ CORI™, is described as a "robotic-assisted orthopedic surgical navigation and burring system" with an integrated image-based planning option. Its function inherently involves human interaction (a surgeon) and mechanical components. The "standalone" performance would relate to the accuracy of its navigation and burring control, which is implied by "Comprehensive testing demonstrated that the system meets required design inputs," but specific standalone performance metrics are not given.
7. The Type of Ground Truth Used
- The type of ground truth for general "design requirements" and "design inputs" would typically be engineering specifications, physical measurements, and computational models. For the "image-based planning option," the ground truth for registration accuracy would likely be established metrologically against known anatomical landmarks or fiducials in the pre-operative image data. For usability, the ground truth is simply the ability of users to safely and effectively complete tasks, assessed through observation and user feedback. No mention of pathology or outcomes data in this context.
8. The Sample Size for the Training Set
- Not applicable/Not specified. The document does not describe the development of a machine learning or AI model with a distinct "training set." The modification is described as integrating an "image-based planning option," implying a capability to import and use image data, rather than a system trained on image data in an AI development pipeline.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As noted in point 8, no training set for an AI model is described.
§ 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).