Search Results

Intended Use: The Optical Tracking ACCISS™ System is intended to be used in an identical manner as the predicate device (Mayfield®/ACCISS™ Stereotactic Workstation). It is used for guidance and localization in open craniotomies and for surgeries, which are traditionally performed with a stereotactic apparatus, such as biopsies, thalamotomies and electrode implants. The system may also be used to review medical images in a neurosurgical context.

The Optical Tracking ACCISS™ System is a computer-based system designed for use in the surgical theatre. It is a mobile design with the majority of the system components being self-contained in a cart. The camera assembly is separate from the cart components and it must be positioned above or beside the surgical site, preferably on a tripod or dedicated camera stand. The camera assembly tracks the position and orientation of digitizing probes and other instruments. The computer is loaded with the patient's computed tomography (CT) or magnetic resonance image (MRI) data and these images are correlated to the patient by physically matching points, such as scanned fiducial markers, anatomical landmarks, or surface features. The host computer, interfaced with CT and /or MRI images, provides probe position and orientation. The probe manipulation by the surgeon appears on a monitor as it moves through space. Three light-sensing cameras, the positions of which are known with respect to a predetermined coordinate system, detect the positions of at least two light-emitting diodes positioned on the probe. The cameras and probe transmit data to a computer and the position and orientation of the probe is determined relative to the coordinate system. The probe tip position is determined by correlating the tip position with the position of a scanned image of the object, both tip position and scanned image being defined relative to the predetermined coordinate system. A monitor connected to the computer indicates the location of the probe tip on the scanned image by displaying a representative location of the tip with respect to the model of the object. The Optical Tracking ACCISS™ System consists of the following: A. Workstation B. Software C. Probe Assembly D. Training Accessories (1) Plastic Skull 50 CT/MRI Fiducial Markers

This acceptance criteria and study information is not available in the provided text. The document is a 510(k) submission summary for the Mayfield® ACCISS™ Optical System, which focuses on establishing substantial equivalence to a predicate device. It describes the intended use, device description, and comparison to the predicate device in terms of indications, design, materials, manufacturing, and specifications.

However, it does not contain details about specific performance acceptance criteria or a study designed to prove the device meets such criteria. The document states that "No applicable performance standards have been established by FDA under section 514 of the Food, Drug and Cosmetic Act." This implies that the submission relies on substantial equivalence rather than meeting specific quantifiable performance benchmarks through a dedicated performance study.

Therefore, I cannot provide the requested table, sample sizes, expert details, adjudication methods, MRMC study, standalone performance, ground truth types, or training set information as this information is not present in the provided text.

Ask a specific question about this device