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Alphatec Spine Navigated Reusable Instruments are intended to be used during the preparation and placement of Alphatec screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Alphatec Spine Navigated Reusable Instruments are specifically designed for use with the Medtronic StealthStation System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, along bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.

The Alphatec NAV Instruments are Class II, manual, surgical instruments for use with Medtronic SteathStation Navigation system to assist surgeons in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures for preparation and placement of pedicle screw system implants. This surgical imaging technology provides surgeons visualization for complex and MIS procedures and confirms the accuracy of advanced surgical procedures. Use of these navigation systems provides the surgeon access to real-time, multi-plane 3D images (and 2D images) providing confirmation of hardware placement.

The provided text describes the Alphatec Navigation Instruments and its 510(k) submission for market clearance. While it outlines the device's intended use, comparison to a predicate device, and general performance data, it does not provide detailed acceptance criteria or a specific study proving the device meets those criteria with the level of detail requested in the prompt.

The document states that "Engineering analysis and performance data demonstrate that the subject Alphatec Spine Navigation Instruments are substantially equivalent to the predicate in compatibility, accuracy, function, and performance." It mentions "Validation testing includes 1:1 accuracy and performance testing of the subject and predicate device in a simulated surgical navigation use environment," but does not provide the quantitative results or specific criteria for acceptance.

Therefore, many of the requested details cannot be extracted from this document.

Here's an attempt to answer based on the available information, with notations where information is missing:

1. A table of acceptance criteria and the reported device performance

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