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The Voyager/Tactile Guidance System - CT is intended for use as a device which uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide orientation and reference information during intra-operative procedures.

The Voyager/Tactile Guidance System - CT is indicated for any medical condition in which the use of stereotactic surgery may be considered to be safe and effective, and where a reference to a rigid anatomical structure may be made, such as:

• Intra-cranial surgical procedures involving space occupying lesions or malformations (including soft tissue, vascular and osseous)
• Spinal surgical procedures involving spinal stabilization, neural decompression, or resection of spinal neoplasms
• ENT Procedures
• Orthopedic surgical procedures

The VoyagerTactile Guidance System - CT is an image guided surgical device that includes an optical detector, computer, dedicated instrumentation, operating software, tools and accessories, and the TGS. VoyagerTactile Guidance System - CT uses patient CT data to assist the physician with presurgical planning and interpretive/intraoperative navigation. The TGS, which is an add-on to the Voyager platform, serves as an "intelligent" tool holder or tool guide used by a surgeon for stereotactic guidance during minimally invasive orthopedic surgical procedures. The TGS, an electromechanical arm, is passively constrained by software-defined spatial boundaries implemented through the use of the TGS and is designed to support a surgeon's preparation of an anatomical site for an orthopedic implant with standard surgical tools such as drills, awls, and 3ª party drill systems.

The provided text appears to be a 510(k) summary for a medical device and a clearance letter from the FDA. It describes the device and its intended use, and states that it has been found "substantially equivalent" to a previously cleared device. However, it does not contain a study that presents acceptance criteria and device performance metrics.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts and their qualifications for establishing ground truth.
• Adjudication method for the test set.
• MRMC comparative effectiveness study results or effect size.
• Standalone performance details.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

This document is a regulatory submission asserting substantial equivalence, not a detailed clinical or technical study report. Such details would typically be found in verification and validation reports or clinical study reports, which are usually not part of the publicly available 510(k) summary.

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