brAIn Shoulder Positioning
Basic Information
- Brand Name
- brAIn Shoulder Positioning
- Primary DI
- 03770026095034
- Version / Model
- BSP001
- Company Name
- AVATAR MEDICAL
- Labeler DUNS
- 274654951
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-04-14
- Public Version
- 2
- Public Version Date
- 2025-11-28
- Public Version Status
- Update
- Public Device Record Key
- 3b4e9f75-f717-4c62-b739-d71e10270538
Device Description
The brAIn™ Shoulder Positioning software is a cloud-based application intended for shoulder surgeons. The software does not perform surgical planning but provides tools to assist the surgeon with planning primary anatomic and reverse total shoulder replacement surgeries using FX Shoulder Solutions implants. The software is accessible via a web-based interface, where the user is prompted to upload their patient's shoulder CT-scan (DICOM series) accompanied with their information in a dedicated interface. The software automatically segments (using machine learning) and performs measurements on the scapula and humerus anatomy contained in the DICOM series. These segmentations serve as a foundation for the surgeon’s manual planning, which is performed using an interactive 3D viewer that allows for soft tissue visualization. The surgeon positions the glenoid and humerus implants manually within this same 3D interface using a dedicated manipulation panel. The changes in shoulder anatomy resultant from the implants are relayed in a post-position interface that displays information related to distalization and lateralization. The software outputs a planning multimodal summary that includes textual information (patient information, pre- and post-op measurements) and visual information (screen captures of the shoulder pre- and post-implantation).
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QIH | Automated Radiological Image Processing Software | Radiology | 892.2050 | 2 |
| LLZ | System, Image Processing, Radiological | Radiology | 892.2050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46470 | Orthopaedic/craniofacial implantation planning software | A software program intended to add specific computer-assisted display, processing, and/or analysis capabilities to prepare for the implantation of an orthopaedic and/or craniomaxillofacial (CMF) prosthesis. Using digitized x-rays or imported computed tomography (CT) images, it provides implant-site anatomical images, and using computerized files representing implant patterns, provides the surgeon with images that help determine the appropriate size and placement of the implant. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03770026095034 | GS1 |