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When used as a cervical intervertebral body fusion device, the Aleutian implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. Cervical IBF implants are intended for use at one level in the cervical spine, from C2 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment.

When used as a lumbar intervertebral body fusion device, the Aleutian implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The lumbar IBF implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non-operative treatment.

When used as vertebral body replacement devices the Aleutian implants are indicated for use in the thoracolumbar spine (T1 to L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body, resected or excised for the treatment of tumors or trauma/fracture in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Aleutian implants are designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.

For all the above indications the Aleutian implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including K2M Pedicle Screw and Hook Systems, and K2M Spinal Plate Systems.

The Aleutian Spinal System consists of a hollow tube or horseshoe-shaped structures manufactured from Medical Grade PEEK (Polyetheretherketone). The devices are 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.

Materials: The implants are manufactured from PEEK Optima LT1 per ASTM F2026. Tantalum beads/ rods are to be made of Grade UNS R05200, UNS R05400 according to ASTM F560.

Function: The system functions as an intervertebral body fusion device to provide support and stabilization of the cervical and lumbar segments of the spine.

The purpose of this submission is to incorporate additional lumbar implants into the system.

The provided text describes a 510(k) premarket notification for the Aleutian Spinal System, an intervertebral body fusion device. It does not contain information about acceptance criteria or a study proving the device meets said criteria in the context of AI/ML performance.

Instead, the document focuses on:

• Substantial Equivalence: The core of the submission is to demonstrate that the expanded Aleutian Spinal System (incorporating additional lumbar implants) is substantially equivalent to previously cleared Aleutian Spinal System devices and another predicate device (Zimmer InFix).
• Device Description: Details on material (PEEK, Tantalum), function (support and stabilization for cervical and lumbar spine fusion), and available sizes.
• Intended Use: Specific indications for cervical, lumbar, and vertebral body replacement, including conditions, levels, and required co-use with other fixation systems.
• Biocompatibility and Mechanical Testing: The document mentions that previously cleared Aleutian spacers were tested in static compression, static torsion, and dynamic compression per ASTM F2077. It states that the proposed spacers were determined not to represent a new worst case based on Finite Element Analysis (FEA) and thus are considered substantially equivalent to predicates.

Therefore, I cannot populate the requested table or answer the specific questions about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/ML, as this information is not present in the provided text. The document is for a traditional medical device (spinal implant) and does not discuss AI/ML components or their performance studies.

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