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The EDEN Peek Cage - PLIF Type 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 involvedlevel(s).This device is to be used with autogenous bone graft. The EDEN Peek Cage System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The EDEN Peek Cage - ACIF Type is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six weeks of non-operative treatment with an intervertebral cage.

The EDEN Peek Cage is offered in various device configurations based on based on surgical approach and patient anatomy, and consist of:

Cervical Interbody Fusion Device (ACIF Type) which may be implanted as a single device via an anterior approach.

Lumbar Interbody Fusion Device (PLIF Type) which can be implanted Bi-laterally via a posterior approach.

• · As a single device via an Anterior approach;(ACIF Type)
• · Bi-laterally via a posterior approach:(PLIF Type)

The EDEN Peek Cage is made of polyether ether ketone (VESTAKEEP® i4 R) that conforms to ASTM F2026 and they have tantalum markers (ASTM F560) to assist the surgeon for proper placement of the device. The subject devices are offered gamma sterile.

The provided text describes a medical device submission (K201793) for the "EDEN Peek Cage," an intervertebral body fusion system, to the FDA. The document focuses on regulatory approval, particularly establishing "substantial equivalence" to predicate devices. It does not contain information about acceptance criteria, device performance, or a study to prove the device meets acceptance criteria in the context of AI/machine learning.

The non-clinical testing section (Section 8) lists:

• Sterilization validation testing
• 36-month shelf life validation
• Mechanical tests (static and dynamic axial compression, static and dynamic torsion per ASTM F2077, and subsidence per ASTM F2267)

These are standard engineering and material tests for intervertebral fusion devices, not studies of AI/machine learning performance.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving a device meets them for an AI/ML device based on the provided text. The document is a 510(k) summary for a physical medical implant, not an AI/ML diagnostic or therapeutic device.

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