| Device |
arthroscopic or orthopedic endoscopic intraoperative augmented reality video see-through display system |
| Definition |
This device consists of augmented reality software on a head-mounted display that displays arthroscopic or endoscopic video and medical imaging during orthopedic surgery. The device is intended to intraoperatively augment visualization with contextually relevant information and data, including that received from other devices. |
| Physical State |
The device consists of a software application installed in a head-mounted display and computer console (medical device data system, for streaming in video). |
| Technical Method |
The software application is installed on a head-mounted display, which, when logged in, allows the user to access visualization of arthroscopic/endoscopic video and medical imaging. The user can perform the arthroscopic/endoscopic procedures by viewing through the augmented reality video see-through head-mounted display by accessing several screens displayed in front of the user through the installed software. |
| Target Area |
Intraoperative visualization of bone and/or soft tissue structures which are targeted in orthopedic surgical procedures. |
| Regulation Medical Specialty |
Orthopedic |
| Review Panel |
Orthopedic |
|---|
| Product Code | SIT |
|---|
| Premarket Review |
Office of Orthopedic Devices
(OHT6)
Restorative, Repair and Trauma Devices
(DHT6C)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
888.1150
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
