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The Curiteva Porous PEEK Lumbar Interbody Fusion System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 - S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radios. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Implants are intended to be used with autograft and/or allograft bone (comprised of cancellous and/or corticocancellous bone graft) or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion and supplemental spinal fixation systems that have been cleared for use in the lumbar spine. Patients should receive at least six (6) months of non-operative treatment with the device.

The Curiteva Porous PEEK Lumbar Interbody Fusion System implants are sterile, single-use devices and available in a variety of different footprints, styles and sizes to accommodate the individual pathology and anatomical conditions of the patient. The implants are generally rectangle-shaped with an open central corridor to permit packing with bone graft to facilitate fusion. The implants have a dense outer ring with a porous structure lining the central graft corridor. The lateral sides of the implant may contain additional porous structures to allow for improved vascularization of the graft site to aid in fusion.

The Curiteva Porous PEEK Lumbar Interbody Fusion System implants are manufactured from implant-grade PEEK (per ASTM F2026) with Titanium alloy markers (per ASTM F136). Each implant has been surface treated with a hydroxyapatite (HA) coating that is approximately 20nm thick.

The provided document is a 510(k) premarket notification for a medical device called the "Curiteva Porous PEEK Lumbar Interbody Fusion System." This document does not pertain to an AI/ML powered device, and therefore, does not contain information about acceptance criteria, study details, or other parameters typically associated with the evaluation of AI/ML devices.

The document discusses the substantial equivalence of the new device to previously cleared predicate devices based on:

• Indications for Use: Treatment of degenerative disc disease (DDD) in the lumbar spine.
• Design Principles: Rectangle-shaped implants with an open central corridor for bone graft, a dense outer ring, and porous structures.
• Material Composition: Implant-grade PEEK with Titanium alloy markers and a hydroxyapatite (HA) coating.
• Performance Testing: Static and dynamic axial compression, static and dynamic compression-sheer, subsidence, expulsion, and particle characterization according to ASTM standards.

The document concludes that the Curiteva Porous PEEK Lumbar Interbody Fusion System is substantially equivalent to the predicate devices and is as safe, effective, and performs as well as, or better than, the predicate devices.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI/ML device based on the provided text.

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