(88 days)
The ARVIS Surgical Navigation System is indicated for assisting the surgeon in the positioning and alignment of implants relative to reference alignment axes and landmarks in stereotactic orthopedic surgery.
The system aids the surgeon in making intraoperative measurements such as changes in leg length in Hip Arthroplasty. The system is compatible with straight acetabular impactors and with specific offset impactors, identified in the instructions for use, for which an adapter has been validated.
Example orthopedic surgical procedures include but are not limited to:
- Total Knee Arthroplasty
- · Unicompartrnental Knee Arthroplasty: Tibial Transverse Resection
- · Hip Arthroplasty
The ARVIS head mounted display is for displaying augmented reality visualization and information to the user intraoperatively. The augmented/ virtual displayed information should not be relied upon solely for absolute positional/alignment information and should always be used in conjunction with the displayed stereotaxic information.
ARVIS® Surgical Navigation System is a computer-controlled surgical navigation system intended to provide intra-operative measurements to the surgeon to aid in selection and positioning of orthopedic implant components.
The subject device is the fundamentally unchanged predicate ARVIS® Surgical Navigation System. It is indicated for use in knee and hip arthroplasties. ARVIS® Surgical Navigation System combines software, electronic hardware and surgical instruments to intraoperatively track tools and locate anatomical structures based on the patient's preoperative imaging.
The navigation platform is identical to the predicate and uses the same electronic hardware, mounted on the surgeon's head and waist.
The subject device adds the capability to remotely activate graphical user interface (GUI) buttons and check boxes for the surgeon, who optionally can use this to work in conjunction with the current methods of gaze and voice control. The added capability is intended to provide a third alternate option for the surgeon to interact with the software.
ARVIS® Surqical Navigation System displays measurements as described in Performance Claims.
The provided text does not contain information about the acceptance criteria or a study proving that a new device meets such criteria. Instead, it describes a medical device submission (K243980) for the ARVIS Surgical Navigation System, which is stated to be "the fundamentally unchanged predicate ARVIS® Surgical Navigation System."
The key takeaway is that this submission is for a device that is essentially the same as a previously cleared device (K203115), with only a minor technological difference: the addition of a remote activation capability for GUI buttons and checkboxes via a tablet device.
Therefore, the document explicitly states:
- "Clinical testing was not required to demonstrate substantial equivalence."
- "The performance data provided in this submission demonstrate that ARVIS® Surgical Navigation System is as safe, effective, and performs as well as the predicate device."
Since this is a submission for a device that is largely identical to a predicate device, the typical extensive studies to establish acceptance criteria and prove performance for a new device are not detailed here. The submission relies on the established safety and effectiveness of the predicate device and verification/validation for the minor change.
Consequently, I cannot fill out the requested information regarding acceptance criteria, sample size, expert ground truth establishment, MRMC studies, or standalone performance for a new device's proving study, as such studies are not described in this document for K243980.
The document only mentions:
- Non-Clinical Tests: Software Verification and Validation.
- Conclusion: The device changes were verified and validated with existing well-established methods, demonstrating substantial equivalence to the previously cleared ARVIS Surgical Navigation System (K203115).
§ 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).