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The SNN System is indicated for patients who have space-occupying lesions or malformations (both soft tissue and osseous) in the head. It is also indicated for patients who require decompressive or reconstructive surgery of the spine, or who have imaged space-occupying lesions or malformations of the spine. The SNN System is contraindicated for patients suspected of having Creutzfeld-Jacob's disease if adequate sterilization of the instruments cannot be assured.

The SNN Fluoro Navigation Module is also indicated for situations where reference to a rigid anatomical structure such as the skull, a long bone or vertebra can be identified relative to a fluoroscopic image of the anatomy.

The SNN Fluoro Navigation System is a module of the SNN System to provide image-guided surgery based on an intra-operative fluoroscopic image of the patient anatomy.

The provided document describes the SNN Fluoro Navigation System (K993673), an image-guided surgical system that uses intra-operative fluoroscopic images for localization and navigation.

Unfortunately, the document does not contain any information regarding acceptance criteria, study details, performance data, or ground truth establishment.

The document primarily consists of:

• 510(k) Summary: This section provides a brief description of the device, its intended use, a comparison to predicate devices, and contact information for the submitter.
• FDA Clearance Letter: This letter from the FDA confirms the device's substantial equivalence to previously marketed devices and grants permission to market it.
• Indications for Use: This section outlines the medical conditions and scenarios for which the device is intended.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, and performance based on the provided text.

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