Manufacturer
Brainlab AGSpine Planning (2.0), Elements Spine Planning, Elements Planning Spine
Country / Region:United States (US)Submission type:Traditional
Product code OLO· 21 CFR 882.4560
Product code
OLO
21 CFR 882.4560
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K223553
- Device name
- Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine
- Company
- Brainlab AG
- Country / Region
- United States(US)
- Product code
- OLO
- Device class
- Class 2
- Regulation number
- 21 CFR 882.4560
- Date received
- 2022-11-25
- Decision date
- 2023-08-02
- Submission type
- Traditional
Indications for Use
The planning part of the use case shall be done in an office or in the operating room. The device can be used in an office / team room or in the operating room.
Intended Use
The planning part of the use case shall be done in an office or in the operating room. The device can be used in an office / team room or in the operating room.
Device Description
The Spine Planning software allows the user to plan spinal surgery pre-operatively or intra-operatively. The software is able to display 2D X-Ray images and 3D datasets (e.g. CT or MR scans). The software consists of features for automated labelling of vertebrae and proposals for screw and rod implants, proposals for measurement of spinal parameters. The device can be used in combination with spinal navigation software during surgery, where pre-planned or intra-operatively created information can be displayed, or solely as a pre-operative tool to prepare the surgery. AI/ML algorithms are used in Spine Planning for detection of landmarks on 2D images for vertebrae labeling and measurement and vertebra detection on Digitally Reconstructed Radiograph (DRR) images of 3D datasets for atlas registration (labeling of the vertebra). The AI/ML algorithm is a Convolutional Neuronal Network (CNN) developed using a Supervised Learning approach. The algorithm was developed using a controlled internal process that defines activities from the inspection of input data to the training and verification of the algorithm.
Summary parsed at:2026-06-19 05:41:58 UTC
Predicate devices
2Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection, Fluoro 3D, Registration Software Fluoro 3D, Registration Software Paired Point, Registration Software Spine Surface Matching, Spine Planning, Elements Screw Planning Spine, Elements Spine Screw Planning
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Not ingested
K223553 references 2 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K223553 as a predicate
