(105 days)
The mediCAD classic V3.0 is a medical stand-alone software, which allows professional orthopedics preoperative measurements of existing x-rays. The software is intended to read in diagnostic images (e.g. digitized x-rays) from PACS-systems or conventional medias and to dimension them. An integrated database of orthopedic implant geometries can be overlayed to aid surgeons in their planning of orthopedic surgeries. mediCAD classic 3.0 can hand over the digital plannings as DICOMs to PACS-systems. Federal law restricts this device to sale by or on the order of a health professional.
mediCAD will also support the proper workflow necessary to effectively compare pre and post-operative radiograph studies for a unique understanding of the patient's surgical outcome. Intearating this workflow with the orthopedic surgeons existing workflow and combining it with the data produced from the patient physical exam, provides a comprehensive data set for the continued prescription of a patient's relevant treatment and therapy.
The system is designed for the following medical specialties:
- Orthopedics .
- . Surgery and Traumatology
- Rheumatology t
- . Pediatric Orthopedics
MediCAD is designed for pre-operative planning for the following applications:
- Hip Manual Planning .
- Hip Automatic Planning t
- Hip Biometry .
- . Hip - Coxometrv
- . Hip - Wear Measurement
- . Hip - FAI
- Knee Prosthetic Planning .
- Biometry Planning takes into account patient motion and metrics .
- Coxometry tracking of known measurement values in pediatrics to . determine surqical intervention
- . Osteotomy - determines optimum osteotomy locations
- . Osteotomy bv Dror Palev
- Osteotomy (DualSide)
- Spine
- Foot
- Upper Extremities
- Biological Age Determination by Hand
- Trauma
Concentrating within the specialty of joint replacement, mediCAD 3.0 will provide an orthopedic surgeon with the ability to produce pre-surgical plans and distribute those plans for intra operative guidelines. It will also support the proper workflow necessary to effectively compare pre and post-operative radiograph studies for a unique understanding of the patient's surgical outcome. Integrating this workflow with the orthopedic surgeons existing workflow and combining it with the data produced from the patient physical exam, mediCAD provides a comprehensive data set for the continued prescription of a patient's relevant treatment and therapy.
The proper choice of prosthesis implant, size and placement is critical to postoperative success and minimizing intra operative complications. Proper presurgical planning is key for identifying the correct choices and decisions an orthopedic surgeon makes.
The device has been designed and manufactured to conform to the following standards: Digital Imaging and Communications in Medicine (DICOM) V3.0, ISO/IEC 90003:2004 Software engineering - Guidelines for the application of ISO 9001:2000 to Computer software. ISO 14971:2007 Application of Risk Management of Medical Devices and ISO 13485:2003 Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes.
I'm sorry, but the provided text does not contain the specific information required to complete the table and answer the questions related to the acceptance criteria and the study proving the device meets those criteria.
Here's why:
- No explicit acceptance criteria are listed. The document states that "Validation testing through professional medics in clinical environment confirm that the device meets performance, measurement and usability requirements," but it does not specify what those "performance, measurement, and usability requirements" are, nor does it provide a table of acceptance criteria and reported device performance.
- Details of the validation study are missing. While it mentions "Validation testing through professional medics in clinical environment," it does not provide details such as:
- Sample size used for the test set or its data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for the test set.
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size.
- Whether a standalone (algorithm only) performance study was done.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document primarily focuses on establishing substantial equivalence to predicate devices and lists the intended uses and technical specifications. It does not delve into the detailed performance validation study as requested.
§ 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).