(79 days)
The TraumaCAD program is indicated for assisting healthcare professionals in preoperative planning of orthopedic surgery. The device allows for overlaying of prosthesis templates on radiological images, and includes tools for performing measurements on the image and for positioning the template. Clinical judgments and experience are required to properly use the software.
TraumaCad allows surgeons to evaluate and manipulate digital images while performing various pre-operative surgical planning and evaluation of images. This software application enables surgeons to plan operations on screen, execute complex measurements in a click, and facilitate the film-less orthopedic practice. The program features full PACS integration and an extensive regularly updated library of digital templates from leading manufacturers. TraumaCad supports DICOM and enables the importing and exporting any PACS file (X-ray, CT or MR) from a central PACS system, a CD or from a local workstation. JPG, scanner or digital camera images can also be imported. TraumaCad software is installed and runs locally on a computer (PC) and interacts with a PACS system. Both a standalone and a client/server version of TraumaCad are available.
The provided 510(k) summary for TraumaCad Release 2.0 does not contain explicit acceptance criteria or a detailed study description with performance metrics in the format requested.
Missing Information:
The document primarily focuses on:
- Substantial equivalence to predicate devices (TraumaCad Release 1.0 and Agfa Orthopedic Software for Impax 3).
- Description of the device's functionality (pre-operative surgical planning, manipulation of digital images, measurements, prosthesis templating).
- Intended use (assisting healthcare professionals in pre-operative planning of orthopedic surgery).
- Technological characteristics (including 3D templating, features for foot, knee, hip, spine, and pediatric surgery).
It does not include:
- Specific quantitative acceptance criteria (e.g., accuracy thresholds for measurements, templating overlay precision).
- A formal study section detailing device performance against such criteria.
- Information on sample size, data provenance, expert adjudication, MRMC studies, standalone performance, ground truth establishment, or training set details.
Based on the provided text, I cannot complete the requested tables and sections as the information is not present in the 510(k) summary.
Disclaimer: This analysis is based solely on the provided text excerpts. 510(k) summaries often do not include the full detail of verification and validation studies. Such information would typically be available in the full 510(k) submission, which is not publicly disclosed in its entirety.
§ 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).