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Rampart™ P and Rampart™ O are intervertebral body fusion devices indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.
These devices may be implanted singly or in pairs via an open or a minimally invasive posterior or transforaminal approach.
Rampart™ P and Rampart™ O are designed for use with autograft as an adjunct to fusion and is intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.

Rampart™ P and Rampart™ O are designed for use with autograft as an adjunct to fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The device is available in a range of lengths and heights. The device and associated instruments are provided non-sterile.

The provided text is a 510(k) summary for a medical device (Rampart™ P and Rampart™ O), specifically intervertebral body fusion devices. This document focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use.

Based on the provided text, there is no information regarding acceptance criteria or a study proving the device meets acceptance criteria related to AI/algorithm performance for image analysis or other diagnostic purposes, as implied by the questions. The "testing" section explicitly states "Preclinical testing according to ASTM F2077, including static compression and static compression shear. This testing demonstrated similar performance characteristics to the identified predicate devices." This refers to biomechanical testing of the implant itself, not a study evaluating human reader performance with or without AI, or standalone algorithm performance.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria (including the table, sample sizes, expert qualifications, adjudication, MRMC study, standalone performance, and ground truth information) because such information is not present in the provided 510(k) summary. These questions are typically relevant for AI/ML devices or diagnostic imaging devices, not for an intervertebral body fusion implant as described here.

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