Search Results

The device is intended for the manipulation and displaying of medical images. It can show images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards.

The device assists orthopedic surgeons when doing preoperative planning and post-operative follow-up.

STARPACS ™ Orthopedics System handles and displays various objects in a Picture Archive and Communication System (PACS) environment and is intended to assist orthopedic surgeons when doing preoperative planning and post-operative follow-up. The device is used to overlaying prosthesis templates on radiological images, tools for repositioning the templates, and tools for measurements in the images.

I am sorry, but the provided text is a 510(k) Summary of Safety and Effectiveness for the STARPACS Orthopedics™ System. This document focuses on demonstrating substantial equivalence to a predicate device and fulfilling regulatory requirements.

It does not contain information about acceptance criteria, detailed study designs, performance metrics, ground truth establishment, or sample sizes for specific tests as requested.

The document states that the device "has been and will be manufactured in accordance with... the enclosed voluntary standard survey" and that "analysis and the 'Level of Concern' for potential hazards have been classified as 'minor'". This implies that general software validation and risk assessment processes were followed, but it does not provide the specific performance study details you are looking for.

Therefore, I cannot extract the requested information regarding acceptance criteria and the study that proves the device meets them from the provided text.

Ask a specific question about this device