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The intended use of the Nomad™ ND1000M system is to display video data or images while worn on the user's head.

The Nomad™ ND1000M Augmented Vision System is a monochromatic head-worn monocular display. The intended use of the Nomad™ ND1000M system is to display video data or images while worn on the user's head. It can be connected to any SVGA video source. The display combines the ambient environment with the displayed image (the image is superimposed over the normal field of vision). The display may be adjusted over either eve. Optionally, the display may be used in a non see-through fashion (occluded) with addition of the provided ocular cover.

The system consists of a display module, attached to headgear, that is connected via a .non-detachable interconnecting cable to a video control electronics module. The video input is connected to the video control electronics module. The device accepts power from a battery or an optional medical grade AC to DC power supply, both supplied with the device. A beit to hold the video control module and battery is provided. A rechargeable Li-Ion battery is also supplied along with a battery charger.

This document is a 510(k) submission for the Microvision Nomad™ ND1000M Augmented Vision System, seeking clearance from the FDA. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria related to AI or diagnostic accuracy. Instead, it focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance as a medical video monitor.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, ground truth, or multi-reader studies, as this document does not describe such a study or performance metrics. It's an administrative document for regulatory approval based on equivalence, not a clinical or performance validation study.

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