(29 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 is a software application to be used by licensed physicians for preoperative planning of orthopedic surgical procedures. The application can be used in a workstation or in a PC as standalone software. The system allows the physician to import medical images, and to overlay them with templates of medical prosthesis and to perform measurements to facilitate surgical planning. The surgical plan is available on the hospital network, and can be sent to the Operating Room prior to surgery. The TarumaCAD does not have any image acquisition or image storage functionality, this is the responsibility of the systems alongside which TraumaCAD. In addition the system does not specify the requirements for the prosthetic template - this is the responsibility of the prosthetic manufacturer.
Here's a breakdown of the acceptance criteria and the study details for the TraumaCAD device, based on the provided 510(k) summary:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Total Hip Replacement (Stem Size): A similar or improved level of accuracy in templating stem sizes compared to standard acetate overlays. This implies that the percentage of implanted stems being the same size, within one size, or within two sizes of the templated size should be comparable to or better than the acetate overlay method. | Total Hip Replacement (Stem Size): |
- Standard Templating (Acetate Overlays):
- 60% same size
- 30% within 1 size
- 10% within 2 sizes
- Digital Templating (TraumaCAD):
- 65% same size
- 23% within 1 size
- 11% within 2 sizes
(The device produced slightly better or comparable results: 5% more cases matched exactly, and the overall deviation within two sizes was similar (98% vs 99%).) |
| Total Hip Replacement (Acetabular Component Size): A similar or improved level of accuracy in templating acetabular components compared to standard acetate overlays. The percentage of implanted cups being the same size, within 2 mm, or within 4 mm of the templated size should be comparable to or better than the acetate overlay method. | Total Hip Replacement (Acetabular Component Size):
- Standard Templating (Acetate Overlays):
- 40% same size
- 30% within 2 mm
- 30% within 4 mm
- Digital Templating (TraumaCAD):
- 47% identical size
- 47% within 2 mm
- 6% within 4 mm
(The device produced significantly better results: 7% more cases matched exactly, and 94% were within 2mm compared to 70% for acetate overlays, indicating higher precision.) |
| Clinical Outcomes: No intraoperative or postoperative fractures related to the templating method. | Clinical Outcomes: All postoperative films show good fit of the components and there were no intraoperative or postoperative fractures. |
| Overall Equivalence: TraumaCAD's performance in preoperative planning should be comparable to or better than planning using acetate overlays, while offering additional advantages of digital planning (ease of use, improved documentation, wider tools, greater accessibility). | Overall Equivalence: The non-clinical testing of pre-operative planning using TraumaCAD produces results comparable to planning using acetate overlays, with additional advantages. |
Study Information:
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Sample size used for the test set and the data provenance:
- Sample Size: 20 cases for standard templating (acetate overlays) and 20 cases for digital templating (TraumaCAD).
- Data Provenance: Not explicitly stated, but the study compares pre-operative planning methods. It doesn't specify if the cases were retrospective or prospective, nor does it specify the country of origin.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the summary. The study compares two planning methods, but doesn't detail the process of establishing a "ground truth" for each case in terms of expert consensus before the planning, other than the implication that the outcome (implanted size) serves as a form of reference.
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Adjudication method for the test set:
- This information is not provided. The comparison is based on the final implanted size versus the templated size. It's unclear if there was an adjudication panel for discrepancies in templating or outcomes.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study, in the typical sense of evaluating human readers' diagnostic performance with and without AI, was not conducted. This study compares two methods of planning (manual acetate vs. digital software) and the accuracy of the templated size relative to the implanted size. The device (TraumaCAD) is presented as an assistance tool for "healthcare professionals," implying a human-in-the-loop, but the study doesn't quantify improvement in human reader performance.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, a standalone performance study was not explicitly stated. The device is described as "assisting healthcare professionals" and requiring "clinical judgments and experience." The study explicitly compares "pre-operative planning methods," which inherently involve human input.
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The type of ground truth used:
- The "ground truth" used in this study appears to be the actual implanted prosthesis size and the fit of components on postoperative films. This is an outcome-based ground truth, where the accuracy of the prediction (templated size) is compared against the real-world outcome (implanted size).
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The sample size for the training set:
- The summary does not mention a training set nor any machine learning component of the TraumaCAD device that would typically require a training set. The device is described as a software application for pre-operative planning, providing tools for measurements and prosthesis overlay, rather than an AI/ML algorithm that requires training data in the modern sense. The "Performance Data" section states "The subject device is developed according to IS0 9001:2000," which relates to quality management systems, not algorithm training.
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How the ground truth for the training set was established:
- Since a training set is not mentioned and the device doesn't appear to be an AI/ML device requiring such, this information is not applicable/provided.
§ 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).