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Z-Box 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.

Z-Box 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 procedure

The Z-Box System is an image guided surgical device that includes an optical detector (infrared sensor), computer, dedicated instrumentation, and operating software. Z-Box uses diagnostic images of the patient to assist the physician with presurgical planning and interpretive/interoperative navigation. Diagnostic image datasets describing internal patient anatomy or time sequences may be combined (superimposed) for comparison or to facilitate navigation during surgery.

Z-Box will consist of following basic components:

• High Resolution color liquid crystal display (LCD) touch screen monitor
• Uninterruptible Power Supply (UPS)
• Central Processing Unit (CPU)
• Isolation Transformer
• Keyboard and Mouse
• Optical Detector (on wheeled-base pedestal)
• Operating Room Cart
• Tool and accessories surgical tools and accessories instrumented with LEDs or reflective markers
• dMIS kit surgical instrument kit containing IGS tools and accessories and dMIS key
• dMIS key electronic storage media containing disposable software application

This document is a 510(k) summary for the Z-Box Stereotaxic Instrument. It does not contain information about specific acceptance criteria, device performance metrics, or the details of a study that proves the device meets such criteria.

The document focuses on:

• Device Description: What the Z-Box is and its components.
• Intended Use: The clinical applications for which the Z-Box is designed.
• Substantial Equivalence: Claiming equivalence to a previously cleared device (Voyager Linux; Z-KAT, Inc., K023975).
• Regulatory Clearance: The FDA's letter granting clearance for the device.

Therefore, I cannot provide the requested information from the provided text. To answer your questions, I would need a different type of document, such as a clinical study report, a verification and validation report, or a more detailed technical specification.

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