(103 days)
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No
The description focuses on image processing and fusion techniques, explicitly stating the system has the same technological characteristics as a predicate device from 1996, which predates widespread clinical AI/ML use in this context. There is no mention of AI, ML, or related terms.
No.
The device is used for image processing and comparison for treatment planning, not for direct therapeutic intervention.
No
The device is described as an image processing workstation used for manipulating and comparing MR and CT image data, primarily for treatment planning in stereotactic neurosurgery, radiosurgery, and radiotherapy procedures. It does not provide a diagnosis.
No
The device description explicitly states it includes an "image processing work station," which implies hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The described device, ImageFusion, is used for image processing and comparison of medical images (MR and CT). It's used in the context of treatment planning for stereotactic neurosurgery, radiosurgery, and radiotherapy procedures.
- Lack of Specimen Handling: There is no mention of the device interacting with or analyzing biological specimens from the human body. Its input is medical imaging data.
Therefore, the function and intended use of the ImageFusion system clearly fall outside the scope of In Vitro Diagnostics. It is a medical imaging software/system used for treatment planning based on existing medical images.
N/A
Intended Use / Indications for Use
Image processing and comparing an MR and a CT image set or two different CT image sets.
Product codes
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Device Description
The ImageFusion system includes an image processing work station used to evaluate, manipulate, and compare MR and CT image data. In addition, ImageFusion software can reconstruct (fuse) nonstereotactic MR images into the image space of a reference CT stereotactic image set for subsequent stereotactic use, eliminating the need for the localizing hardware required in StereoPlan to define stereotactic locations in MR images. Subsequently, fused images can be used in the treatment planning for stereotactic neurosurgery, radiosurgery and radiotherapy procedures in the same way that supplementary stereotactic MR or CT images are utilized in StereoPlan.
Mentions image processing
Yes
Mentions AI, DNN, or ML
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Input Imaging Modality
MR, CT
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
RSA ImageFusion system testing verifies that the registration of MR images in stereotactic CT space is accurate and is approximately 1.5 ± 0.6 mm on average and 2.5 mm maximum for individual landmarks. Further, system and unit testing verify that features such as bone segmentation and landmark alignment, which form the basis of a fusion session, are accurate.
Key Metrics
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Predicate Device(s)
Not Found
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
0
Summary of Safety and Effectiveness
General Information
| Classification: | Class II | |||
|---|---|---|---|---|
| Common Name | Image Correlation System | APR 17 | ||
| Device Trade Name: | ImageFusion | |||
| Intended Uses | Image processing and comparing an MR and a CT image set or two different CT image sets. | |||
| Predicate Device: | RSA StereoPlan | APR 17 1996 | ||
| Establishment Name and Address: | Radionics Software Applications, Inc. | |||
| 22 Terry Avenue | ||||
| Burlington, MA 01803 | ||||
| Contact Name and Phone: | Amy J. LaForte, Ph.D. | |||
| (617) 272-1233 | ||||
| Establishment Registration Number: | 1222895 | |||
| Performance Standard | None established under Section 514 |
Substantial Equivalence Determination
A summary of the information contained in this premarket notification that addresses safety and effectiveness follows.
Safety Summary
RSA ImageFusion system testing verifies that the registration of MR images in stereotactic CT space is accurate and is approximately 1.5 ± 0.6 mm on average and 2.5 mm maximum for individual landmarks. Further, system and unit testing verify that features such as bone segmentation and landmark alignment, which form the basis of a fusion session, are accurate.
General Safety and Effectiveness Concerns
The device labeling contains instructions for use. It includes indications for use, cautions, warnings and user quality assurance procedures. The training and installation sessions provide assurance that the user understands all aspects of the ImageFusion System and its intended functionality. This information promotes safe and effective use of the device.
Description of the Device and Basis for Substantial Equivalence
The ImageFusion system, addressed in this premarket notification, has the same intended use and technological characteristics as the commercially available StereoPlan system. Like StereoPlan, the ImageFusion system includes an image processing work station used to evaluate, manipulate, and compare MR and CT image data. In addition, ImageFusion software can reconstruct (fuse) nonstereotactic MR images into the image space of a reference CT stereotactic image set for subsequent stereotactic use, eliminating the need for the localizing hardware required in StereoPlan to define stereotactic locations in MR images. Subsequently, fused images can be used in the treatment planning for stereotactic neurosurgery, radiosurgery and radiotherapy procedures in the same way that supplementary stereotactic MR or CT images are utilized in StereoPlan.