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The Spinal Edge ATLAS Spinal Cage is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damage or unstable vertebral body due to tumor or trauma. The Spinal Edge ATLAS Spinal Cage is intended to be used with supplemental spinal fixation system(s) 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 of the spacer may if indicated be packed with bone grafting material. The Spinal Edge ATLAS Spinal Cage is designed to provide anterior spinal column support for a prolonged period of time even in the absence of fusion.

The Spinal Edge ATLAS Spinal Cage is a vertebral body replacement 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 spacer has an axial hole to allow optional grafting material to be packed inside of the spacer. Protrusions on the superior and inferior surfaces of each device will grip the cortical endplates of the adjacent vertebrae to resist expulsion

The provided text describes a medical device, the "Spinal Edge ATLAS Spinal Cage," and its premarket notification (510(k)) to the FDA. The document outlines the device's description, intended use, and substantial equivalence to predicate devices. It briefly mentions performance testing but does not provide specific acceptance criteria or detailed study results directly comparable to such criteria.

Therefore, I cannot fully answer your request for a table of acceptance criteria and reported device performance, nor can I provide information on sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone performance. The document focuses on regulatory compliance through substantial equivalence, primarily through material and functional similarity to existing devices and general performance testing against a standard.

Here's what can be extracted based on the provided text, while highlighting what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: The document states that testing was completed and demonstrated compliance with a specific FDA guidance and an ASTM standard. However, it does not detail the specific acceptance criteria (e.g., "device must withstand X Newtons of compression for Y cycles") or the actual test results (e.g., "device withstood Z Newtons for W cycles") that would allow for a direct comparison as typically presented in such a table for software or diagnostic devices. This is common for predicate device submissions where the focus is often on demonstrating comparable mechanical properties to legally marketed devices rather than establishing new performance benchmarks.

Missing Information from the Provided Text for all other points:

The provided document does not contain any information regarding:

• Sample sized used for the test set and the data provenance: This information is not present. The testing described is physical, mechanical testing of the device, not a study involving patient data or a "test set" in the context of AI/diagnostic device evaluation.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as the testing described is mechanical, not involving expert interpretation of data.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for the type of device and testing described.
• 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. This device is a physical implant, not an AI or diagnostic software.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): For mechanical testing, the "ground truth" would be the measured physical properties against the specified standard requirements. The document only states compliance with ASTM F2077-03 and FDA guidance.
• The sample size for the training set: Not applicable. There is no "training set" for physical device testing in this context.
• How the ground truth for the training set was established: Not applicable.

Summary of Device-Related Information:

• Device Name: ATLAS Spinal Cage
• Sponsor: Spinal Edge, LLC
• Intended Use: Thoracolumbar spine (T1-L5) vertebral body replacement due to tumor or trauma. To be used with supplemental spinal fixation systems. Provides anterior spinal column support for a prolonged period, even without fusion.
• Materials: Same as predicate devices (specific material not detailed, but implies biocompatibility and appropriate mechanical properties).
• Performance Testing Standard: MTI Protocol PR465-0001 and ASTM F2077-03, "Test Methods for Intervertebral Body Fusion Devices."
• FDA Determination: Substantially equivalent to predicate devices K990148 (Stackable Cage System - DePuy AcroMed, Inc.) and K040284 (Sustain Radiolucent Spacer - Globus Medical, Inc.).

The provided text focuses on the regulatory submission process for a physical medical implant based on substantial equivalence, rather than a detailed performance study with explicit acceptance criteria and corresponding results for a diagnostic or AI-driven device.

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