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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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