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When used as vertebral body replacement, the ATLAS Intervertebral Body Cage is indicated for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma. The ATLAS Intervertebral Body Cage is intended to be used with supplemental fixation systems that have been labeled for use in the thoracic and/or lumbar spine (i.e. posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems) the interior spacer may be packed with bone grafting material. The ATLAS Intervertebral Body Cage has been designed to provide anterior column support even in the absence of fusion for a prolonged period of time.

When used as a lumbar intervertebral body fusion device the ATLAS Intervertebral Body Cage is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature individuals with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 to S1. DDD is defined and discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have six months of non-operative treatment. These DDD patients may have had previous non-fusion spinal surgery at the involved spinal level(s). The ATLAS Intervertebral Body Cage is implanted via an anterior or posterior approach and is combined with supplemental fixation.

For either intended use, the ATLAS Intervertebral Body Cage must be used with supplemental internal fixation.

This submission is intended to seek clearance for a product line extension to the ATLAS Spinal Cage VBR. The extension includes the addition of 8mm, 10mm, 12mm, 14mm, and 16mm cages to the current offering. Additionally adding the product code MAX for Intervertebral body fusion devices CFR 21 888.3080.

The Spinal Edge ATLAS Intervertebral Body Cage is an Intervertebral Body Cage device used to provide structural stability in skeletally mature individuals following corpectomy or vertebrectomy. The system is comprised of spacers of various fixed heights and footprints to fit the anatomical needs of a wide variety of patients. Each cage has an axial hole to allow grafting material to be packed inside. Protrusions on the superior and inferior surfaces of the device will grip the cortical endplates of the adjacent vertebrae and resist expulsion. The Spinal Edge ATLAS Intervertebral Body Cage components are available in titanium alloy conforming to ASTM F-136 specifications.

This document describes the ATLAS Intervertebral Body Cage, a medical device, and its regulatory clearance. The information provided is primarily for a 510(k) submission, which demonstrates substantial equivalence to predicate devices, rather than a clinical study proving device performance against specific acceptance criteria in the manner one might expect for a diagnostic AI device.

Therefore, the requested details regarding acceptance criteria for device performance, sample size for test sets, expert involvement for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable in the context of this 510(k) submission for a spinal implant. This submission focuses on mechanical and material equivalence to existing devices, not on the diagnostic accuracy or interpretive performance often associated with AI algorithms.

However, I can extract the relevant information concerning the performance testing that was conducted to support the substantial equivalence claim.

Description of the Acceptance Criteria and Study Proving Device Meets Criteria

The ATLAS Intervertebral Body Cage is a spinal implant whose clearance was sought through a 510(k) submission, demonstrating substantial equivalence to predicate devices. The "acceptance criteria" here refer to meeting established mechanical performance standards for intervertebral body fusion devices, rather than criteria for diagnostic accuracy or clinical outcomes as might be seen with AI.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: "Representative samples of the ATLAS Intervertebral Body Cage device" were used for testing, specifically the largest size (17mm). The exact number of samples is not specified, but typically this would involve a small set for mechanical testing.
• Data Provenance: The testing was conducted as part of a regulatory submission in the United States (FDA 510(k)). This is a prospective test in the sense that it was performed specifically for this submission, using manufactured devices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Not Applicable. For a mechanical device, "ground truth" relates to physical properties and performance under stress, which are measured objectively by engineering tests, not subjectively by experts or interpreted from medical images.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods are typically used for assessing subjective interpretations or diagnostic accuracy. Mechanical testing results are objective measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• No. This is a mechanical device, not an AI or diagnostic tool where MRMC studies would be relevant.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

• Not Applicable. This is a physical medical implant, not an algorithm.

7. The Type of Ground Truth Used

• Engineering Measurements/Physical Properties: The "ground truth" for this device's performance is derived from standardized mechanical testing (axial compression, vertebrectomy model simulation) that measures physical characteristics like load-induced subsidence, strength, and stability.

8. The Sample Size for the Training Set

• Not Applicable. There is no "training set" in the context of mechanical device testing for a 510(k) submission. Design and manufacturing processes are based on engineering principles and material specifications, not machine learning training.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. As there is no training set, this question is not applicable.

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