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ABARIS is a stereotaxic accessory for Computed Tomography (CT), Magnetic Resonance, (MR), Ultrasound (US), Position Emission Tomography (PET), Single Photon Prosonan Computed Tomography (SPECT), Fluoroscopy, Endoscopy and other imaging systems. It displays the simulated image of a tracked insertion tool such as a biopsy needle, guidewire or probe on a computer monitor screen that shows images of the target psy noeans, guidewire and the projected future path of the interventional instrument taking into account movements of the patient. This is intended for treatment planning and intra-onerative guidant for surgical procedures. The device also supports an image-free mode in which the proximity of the interventional device is displayed relative to another device.

The device is intended to be used in clinical interventions and for anatomical structures where imaging is currently used for visualizing such procedures. The device is also intended for use in clinical interventions to determine the proximity of one device relative to ano inchier.

The ABARIS is a computer assisted, image guided surgery system. It guides a surgical instrument to a target that has been defined by the physician. The target can be indicated either preoperatively or intraoperatively using images or relative to an indicated position on the patient.

The ABARIS provides real-time, three-dimensional visualization and navigation tools for all stages of surgery including preoperative planning and intra-operative navigation. ABARIS transforms two-dimensional patient images (scan sets), derived from Computed Tomography (CT), Magnetic Resonance Imaging (MR), Position Emission Tomography (PET), Single Photon Emission Computed Tomography (SPECT), Ultrasound (US), Fluoroscopy etc. into dynamic representations on which a tool can be navigated. The system performs spatial mapping from one inage space to another image space or from image space to physical space ("vegistation") allowing the physician to correlate scan sets with each other and to the patient The system facilitates minimally invasive surgical procedures. Like other commercially available image guided surgery systems, the ABARIS also offers computer assisted image-free and registration free navigation using the same instrumentation.

Targeted use areas for ABARIS include hospital operating rooms, outpatient surgery centers and procedure rooms.

The K053610 submission for ABARIS describes a computer-assisted image-guided surgery system. The submission does not contain a study to prove acceptance criteria in the format requested. Instead, it relies on substantial equivalence to predicate devices. It states that "The technological characteristics of the ABARIS are the same or similar to those found in the predicate devices."

Therefore, the following information cannot be extracted from the provided text:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for a test set or data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for a test set.
• Results of a multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
• Results of a standalone (algorithm only) performance study.
• Type of ground truth used (expert consensus, pathology, outcomes data).
• Sample size for a training set.
• How ground truth for a training set was established.

The submission is a 510(k) premarket notification, which often demonstrates substantial equivalence rather than presenting new clinical study data with explicit acceptance criteria. The FDA's letter (APR 19 2006) confirms this by stating, "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...".

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