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Peridot Intervertebral body fusion system is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).This device is to be used with autogenous bone graft. Peridot Intervertebral body fusion system is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

The Peridot Intervertebral Body Fusion System is intervertebral body fixation devices intended for use as an aid in spinal fixation. The Peridot Intervertebral fusion system is made from PEEK as per ASTM F2026 and Tantalum marker as per ASTM F560. And some cage holders are made of titanium alloy as per ASTM F136.

X-ray markers system on the cages permits the identification of cage position and allows post-operative assessment.

The device is available in a variety of different sizes and heights to match more closely the patient's anatomy. The ends of the implants have machined teeth which are designed to engage with the vertebral body end plates.

The device is supplied non-sterile.

The device consists of cages differentiated by their approach, with varying dimensions and ancillary products for placement of the cages.

The device is supplied with their specific instrument. The specific instrument is supplied dedicated tray and non-sterile. The device and instrument are supplied separately.

The device must be used in combination with the dedicated instrument supplied.

The hyperlordotic lumbar cages (>20 degree) the form of supplemental fixation should be an anterior plate system.

This document is a 510(k) premarket notification for a medical device called the "Peridot Intervertebral body fusion system." It is a submission to the FDA to demonstrate substantial equivalence to legally marketed predicate devices, not a study presenting the performance of an AI/ML powered device against acceptance criteria.

The document does not contain any information about acceptance criteria or a study proving that an AI/ML powered device meets those criteria.

Instead, it describes the device, its intended use, and compares it to existing predicate devices to show substantial equivalence for regulatory clearance. It focuses on mechanical testing of the physical implant according to ASTM standards, not on the performance of a software algorithm.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving an AI/ML device meets them based on the provided text.

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