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The Life Spine Hinged Laminoplasty System is indicated for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The Life Spine Hinged Laminoplasty System is used to hold or butresses the allograft or autograft material in place to prevent the graft material from expulsion or impinging the spinal cord.

The Life Spine Hinged Laminoplasty System consists of various plates and screw configurations to address surgeon and patient needs. The plates have screw holes at the ends that allow attachment to bone. The center hole of the plate allows it to be affixed to allograft or autograft material. All components are fabricated and manufactured from titanium alloy 6AL-4V-ELI per ASTM F-136.

All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Life Spine Hinged Laminoplasty System components with components from any other system or manufacturer. The Life Spine Laminoplasty System components should never be reused under any circumstances.

The provided text is a 510(k) summary for the Life Spine Hinged Laminoplasty System. It is a submission to the FDA for market clearance of a medical device, specifically a spinal interlaminal fixation orthosis.

This document describes the device itself (its components, materials, and intended use) and its substantial equivalence to previously cleared predicate devices. It does not describe a study involving an AI/software device that measures or analyzes data, nor does it provide acceptance criteria or performance data for such a device.

Therefore, I cannot provide the requested information about acceptance criteria or a study proving that an AI/software device meets acceptance criteria, as the input document is about the physical Life Spine Hinged Laminoplasty System and not an AI/software device.

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