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The Endius Endoscopic Access System is indicated for use in instrumented posterolateral fusion procedures where the TriFix Spinal Instrumentation System is utilized. The Endius Endoscopic Access System is also intended to be used for posterior endoscopic access to the lumbar spine for various endoscopic spinal procedures such as discectomy, nucleotomy, non-instrumented posterolateral fusion procedures.

The Endoscopic Access System includes instruments used to access the spine by dilation of the overlying tissues, as well as a retracting device that is used to maintain the access. Once the retractor is in place, the visualization components of the system may be used. These include, an endoscope, a light source, light guide, a camera control unit, and a camera head. The Endoscope may be used to visualize the operative site. When using the system for discectomy, nucleotomy, or non-instrumented posterolateral fusion procedures the retractor used with the system has a 16mm diameter tube portion and expands distally in the range of 25-35mm. When the system is used for the placement of pedicle screws a larger retractor may be used. The larger sized retractor has a 20mm diameter tube portion and expands distally in the range of 30-40mm. The camera head, scope, and light guide are supported by a circular mount, which allows manual 360-degree rotation of the scope. The mount is connected to a vacuum powered arm that may be used to manipulate the construct in any position.

This document is a 510(k) summary for the Endius Endoscopic Access System. It describes the device and its intended use, and claims substantial equivalence to a predicate device (Sofamor Danek Microendoscopic Discectomy System). However, it does not contain any information regarding acceptance criteria, device performance metrics, or study details such as sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is absent from the provided text.

The document primarily focuses on:

• Identifying the submitter and device.
• Classifying the device.
• Stating its indications for use.
• Claiming substantial equivalence to a predicate device, along with a table comparing features of the two systems.
• The FDA's letter of clearance (K002437).

There is no section dedicated to preclinical or clinical studies, performance data, or an analysis of how the device met specific acceptance criteria.

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