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510(k) Data Aggregation
K Number
K243292Device Name
brAIn Shoulder Positioning
Manufacturer
Date Cleared
2025-03-20
(153 days)
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Avatar Medical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
brAIn™ Shoulder Positioning is intended to be used as an information tool to assist in the preoperative surgical planning and visualization of a primary total shoulder replacement.
Device Description
The brAIn™ Shoulder Positioning software is a cloud-based application intended for shoulder surgeons. It is used to plan primary anatomic and reverse total shoulder replacement surgeries using FX Shoulder Solutions implants. The software is a webbased 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 are used for planning, which includes an interactive 3D viewer that allows for soft tissue visualization. Implants for the glenoid and humerus are positioned using this same 3D interface through 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. 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 postimplantation).
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K Number
K222035Device Name
Avatar Medical Software V1
Manufacturer
Date Cleared
2023-05-24
(317 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Avatar Medical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
AVATAR MEDICAL Software V1 is intended as a medical imaging system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from CT or MR imaging devices. It is also intended as software for preoperative surgical planning, and as software for the intraoperative display of the aforementioned multi-dimensional digital images. AVATAR MEDICAL Software V1 is designed for use by health care professionals and is intended to assist the clinician who is responsible for making all final patient management decisions.
Device Description
The Avatar Medical Software V1 (AMS V1) is a software-only device that allows trained medical professionals to review CT and MR image data in three-dimensional (3D) format and/or in virtual reality (VR) interface. The 3D and VR images are accessible through the software desktop application and, if desired, through compatible VR headsets which are used by users for preoperative surgical planning and for display during intervention/surgery.
The AMS V1 product is to be used to assist in medical image review. Intended users are trained medical professionals, including imaging technicians, clinicians and surgeons.
AMS V1 includes two main software-based user interface components, the Desktop Interface and the VR Interface. The Desktop Interface runs on a compatible off-the-shelf (OTS) workstation provided by the hospital and only accessed by authorized personnel. The Desktop Interface contains a graphical user interface where a user can retrieve DICOM-compatible medical images locally or on a Picture Archiving Communication System (PACS). Retrieved CT and MR images can be viewed in 2D and 3D formats. Users are able to make measurements, annotations, and apply fixed and manual image filters.
The VR Interface is accessible via a compatible OTS headset to allow users to review the medical images in a VR format. VR formats can be viewed only when the user connects a compatible VR headset directly to the workstation being used to view the Desktop Interface. Additionally. AMS V1 enables the intended users to remotely stream the Desktop Interface to another workstation on the same local area network (LAN).
The 3D images generated using AMS V1 are intended to be used in relation to surgical procedures in which CT or MR images are used for preoperative planning and/or during intervention/surgery.
The intraoperative use of the AMS V1 solely corresponds to the two following cases:
- Display of the AMS V1 Desktop Interface on existing monitors/screens in the operating room
- Use in a non-sterile image review room accessible from the operating room during the procedure (AMS V1 operates on VR headsets which are not approved to be used in the sterile environment of the operating room)
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