(206 days)
Acorn Segmentation is intended for use as a software interface and image segmentation system for the transfer of CT or CTA medical images to an output file. Acorn Segmentation is also intended for measuring and treatment planning. The Acorn Segmentation output can also be used for the fabrication of the output file using additive manufacturing methods, Acorn 3DP Models. The physical replica can be used for diagnostic purposes in the field of musculoskeletal and craniomaxillofacial applications.
Acorn Segmentation and 3DP Models should be used in conjunction with expert clinical judgment.
Acorn Segmentation is an image processing software that allows the user to import, visualize and segment medical images, check and correct the segmentations, and create digital 3D models. The models can be used in Acorn Segmentation for measuring, treatment planning and producing an output file to be used for additive manufacturing (3D printing). Acorn Segmentation is structured as a modular package. This includes the following functionality:
- Importing medical images in DICOM format
- Viewing images and DICOM data
- Selecting a region of interest using generic segmentation tools
- Segmenting specific anatomy using dedicated semi-automatic tools or automatic algorithms
- Verifying and editing a region of interest
- Calculating a digital 3D model and editing the model
- Measuring on images and 3D models
- Exporting 3D models to third-party packages
Acorn Segmentation contains both machine learning based auto-segmentation as well as semi-automatic and manual segmentation tools. The auto-segmentation tool is only intended to be used for thoracic and lumbar regions of the spine (T1-T12 and L1-L5). Semi-automatic and manual segmentation tools are intended to be used for all musculoskeletal and craniomaxillofacial anatomy.
Acorn 3DP Model is an additively manufactured physical replica of the digital 3D model generated in Acorn Segmentation. The output file from Acorn Segmentation is used to additively manufacture the Acorn 3DP Model.
The provided text describes the acceptance criteria and the study that proves the device meets those criteria for the Acorn 3D Software (AC-SEG-4009) and Acorn 3DP Model (AC-101-XX).
Here's the breakdown:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Metric) | Target Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Geometric accuracy of digital models (Dice-Sorensen Coefficient) - Automatic Segmentation (Thoracic and Lumbar spine) | Average Dice-Sorensen Coefficient ≥ 0.93 | Average Dice-Sorensen Coefficient > 0.93 |
| Geometric accuracy of digital models (Dice-Sorensen Coefficient) - Semi-automatic and Manual Segmentation (Musculoskeletal & Craniomaxillofacial bone) | Average Dice-Sorensen Coefficient ≥ 0.93 | Average Dice-Sorensen Coefficient > 0.93 |
| Geometric accuracy of physical replicas (Mean Deviation) | Mean Deviation |
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).