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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 JBF 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 disc disease (DDD) with up to Grade I 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 Invibio™ 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 provided text describes a medical device submission (510(k)) for the Aleutian IBF System. It outlines the device's description, intended use, and substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way an AI/ML device submission would.

This document pertains to a traditional medical device (an intervertebral body fusion device made of PEEK, Tantalum) and its substantial equivalence to other physically similar medical devices already on the market. The evaluation criteria for such a device are primarily based on material properties, mechanical testing, and comparison with predicate devices, not on performance metrics like accuracy, sensitivity, or specificity against a ground truth dataset, which would be typical for AI/ML devices.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size, ground truth for training set) are not applicable to the information contained in this 510(k) summary for a physical implant.

Here's a breakdown based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

• Cervical Intervertebral Body Fusion (C2-T1 for cervical disc disease)
• Lumbar Intervertebral Body Fusion (L2-S1 for DDD with Grade I spondylolisthesis)
• Vertebral Body Replacement (T1-L5 for tumors/trauma/fracture)
  (Substantially equivalent to predicates K082698, K071795, K100042). |
  | Design/Function Equivalence:
  Design and function must be substantially equivalent to predicate devices. | Description: Hollow tube or horseshoe-shaped structures from PEEK with machined teeth.
  Function: Provides support and stabilization for spinal fusion.
  (Substantially equivalent to predicates K082698, K071795, K100042). |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• This information is not provided. The study conducted was primarily mechanical testing and finite element analysis, not a clinical study with a "test set" of patients or data in the typical sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not applicable for this type of device and study. The ground truth for mechanical performance typically relies on established engineering principles, material standards (ASTM), and validated testing methods.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable, as this is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable, as this is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• The "ground truth" in this context is based on established engineering standards (ASTM F2077 for static compression and torsion testing) and the mechanical performance and material properties of the predicate devices. The finite element analysis (FEA) was validated against these physical tests.

8. The sample size for the training set:

• Not applicable. There is no "training set" in the context of this device and the provided study, which involves mechanical testing and FEA.

9. How the ground truth for the training set was established:

• Not applicable.

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