(103 days)
Customize for shoulder arthroplasty is intended to be used as a software interface to assist in:
- Visualization, modification, validation of the planning of shoulder arthroplasty
- Communication of treatment options
- Segmentation of CT-scan data
- 3D CAD models generation
- Managing timeline and cases
Customize is not intended to be used for
- Spine surgeries
- Implant and instrument design
Experience in usage and clinical assessment are necessary for a proper use of the software. It is to be used for adult patients only and should not be used for diagnostic purposes.
Customize is intended to be used during the preparation of shoulder arthroplasties. It visualizes surgical treatment options that were previously created based on 3D CAD files generated from multi-slice DICOM data from a CT scanner. It consists of a single software user interface where the physician can review the CAD files in 3D and modify the position and orientation of the different 3D objects. Customize includes an implant library with 3D digital representations of various implant models so that the right implant positioning and sizing can be achieved based on the physician's input. After approval by the physician, the treatment plan is saved on the server and can be used as a reference during surgery.
Customize is prescription use only.
This 510(k) summary for the "Customize" device describes its intended use for shoulder arthroplasty planning. However, it does not provide specific acceptance criteria or a dedicated study report that details how the device meets those criteria with numerical performance metrics.
The document states that "Non-clinical performance data was included in the 510(k)-submission demonstrating Customize has been validated for its intended use and substantial equivalence to the predicate device." It also mentions "Software verification and validation was performed" and "performance testing included 1) segmentation validation of the Customize software, 2) Repeatability and Reproducibility study on the segmentation of shoulder anatomies and 3) accuracy study on 3D model generation for humerus and scapula."
However, the summary itself does not contain the detailed results, acceptance criteria, or study methodologies that would allow for a comprehensive answer to your request. It only broadly states that these tests were performed and that the device was deemed "substantially equivalent."
Therefore, I cannot populate the table or provide the detailed information requested regarding acceptance criteria and study particulars based solely on the provided text. The requested data points (sample sizes, ground truth details, expert qualifications, etc.) are not present in this summary.
§ 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).