(180 days)
TraumaCad Neo is indicated for assisting healthcare professionals to analyze orthopedic conditions and to plan orthopedic procedures by overlaying on relevant radiological images visual information such as measurements and prosthesis templates. Clinical judgment and experience are required to properly use the software is not intended for primary radiological image interpretation or radiological appraisal. Device is not intended for use on mobile phones.
TraumaCad Neo allows surgeons to evaluate digital images while performing various pre-operative surgical planning and evaluation of images. This software application enables surgeons to plan operations on screen, execute measurements, and facilitates the film-less orthopedic practice. TraumaCad Neo allows post-operative review of images obtained after the surgical procedure. The program features an extensive regularly updated library of digital templates from leading manufacturers. TraumaCad Neo supports DICOM and is integrated to communicate with Quentry®, a proprietary web-based cloud service from Brainlab. It is through Quentry®, where the medical staff can upload images to plan their expected results prior to the procedure to create a smooth surgical workflow from start to finish.
The provided text describes the regulatory clearance of a medical device, TraumaCad Neo, and compares it to a predicate device, TraumaCad Mobile 2.0. However, it does not contain specific acceptance criteria, reported device performance metrics, or details about a study designed to prove the device meets acceptance criteria.
Instead, the document highlights that:
- The performance evaluation was based on "well-established test methods which demonstrated conformity to the intended use."
- These methods were the "same which were used to demonstrate the substantial equivalence of the predicate device TraumaCad Mobile 2.0."
- "The performance tests have been completed and successfully confirm the performance of the device."
Without an actual study described, I cannot populate the table or answer most of the requested questions. The document focuses on regulatory equivalence rather than a detailed performance study with specific metrics.
Here's how I can address the request based on the absence of the detailed information you are looking for in the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Example - Not provided in the text) | Reported Device Performance (Example - Not provided in the text) |
|---|---|
| [Specific metric 1, e.g., Measurement accuracy within X mm] | [Actual performance, e.g., 0.5 mm deviation] |
| [Specific metric 2, e.g., Template overlap accuracy] | [Actual performance, e.g., 95% overlap within tolerance] |
| [Specific metric 3, e.g., Processing time] | [Actual performance, e.g., |
§ 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).