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mediCAD Web is a medical browser-based software, which allows professional orthopedics preoperative measurements of existing x-rays (2D) and CT (3D). The software is intended to read in diagnostic images (e.g. digitized x-rays) from PACS 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 Web can hand over the digital plannings as DICOMs to PACS-systems.

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. Integrating 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 software is not for primary image interpretation. The software is not for use on mobile phones.

mediCAD Web is a medical browser-based software, which allows professional orthopedics preoperative measurements of existing x-rays (2D) and CT (3D). The software is intended to read in diagnostic images (e.g. digitized x-rays) from PACS 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 Web can hand over the digital plannings as DICOMs to PACS-systems.

The provided document is a 510(k) clearance letter for the mediCAD Web software. It states the device's indications for use and its substantial equivalence to predicate devices. However, this document does not contain any information regarding acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment, which are direct requests in your prompt.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for training and test sets, or data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication methods.
5. MRMC study details and effect sizes.
6. Standalone performance details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The FDA 510(k) clearance letter primarily focuses on the regulatory determination of substantial equivalence and does not typically include the detailed technical study information you are asking for. Such information would usually be found in the manufacturer's 510(k) submission itself, which is not publicly available in this format, or in associated clinical or validation reports.

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The mediCAD classic V4.0 is a medical stand-alone software, which allows professional orthopedics preoperative measurements of existing x-rays (2D) and CT (3D). 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 4.0 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. Integrating 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
• · Pediatric Orthopedics

MediCAD is designed for pre-operative planning for the following applications:

• · Hip Manual Planning
• Hip Automatic Planning
• · Hip Biometry
• · Hip Intertrochanteric osteotomy
• · Hip Coxometry
• · 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 surgical intervention
• · Osteotomy determines optimum osteotomy locations
• Osteotomy by Dror Paley
• · Osteotomy (DualSide)
• · Spine
• Foot Hallux Valgus
• · Foot Ankle Joint
• · Upper Extremities
• · Biological Age Determination by Hand
• Trauma
• · Hip 3D
• · Spine 3D

The mediCAD classic V4.0 is a medical stand-alone software, which allows professional orthopedics preoperative measurements of existing x-rays (2D) and CT (3D). 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 4.0 can hand over the digital plannings as DICOMs to PACS-systems.

This looks like an FDA 510(k) clearance letter for the mediCAD 4.0 device. Unfortunately, this document does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria.

Regulatory clearance letters typically confirm that a device is "substantially equivalent" to a predicate device, meaning it has the same intended use and technological characteristics, and raises no new questions of safety or effectiveness. They do not usually include the comprehensive clinical study data, acceptance criteria, or performance metrics. That information would be found in the original 510(k) submission itself, which is not publicly released in its entirety in this format.

Therefore, I cannot provide the requested information based on the provided text. To answer your questions, I would need access to the actual 510(k) summary, clinical study reports, or performance testing documentation submitted to the FDA for mediCAD 4.0.

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