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The AERIAL™ Interspinous Fixation is a posterior non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), and/or tumor. AERIAL™ is intended for use with allograft bone and is not intended for stand-alone use.

AERIAL™ Interspinous Fixation is an expandable non-cervical interspinous fixation device used to provide supplemental stabilization of spinal segments to support fusion. The components are available in a range of sizes to fit the anatomical needs of a variety of patients.

This document describes the 510(k) summary for the AERIAL™ Interspinous Fixation device, a spinal implant. The information provided focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study of diagnostic accuracy or comparative effectiveness for an AI/ML powered device. Therefore, many of the requested elements are not applicable in this context.

Here's an analysis based on the provided text, addressing the applicable points:

1. A table of acceptance criteria and the reported device performance

2. Sample sized 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 in the document. The document describes mechanical and biocompatibility testing, which are typically performed on a set number of device samples or material samples, rather than a "test set" in the context of diagnostic data.

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)

This information is not applicable as the device is a spinal implant, not a diagnostic device requiring expert interpretation of data for ground truth establishment.

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

This information is not applicable for the reasons stated above.

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

This information is not applicable. The AERIAL™ Interspinous Fixation device is a physical medical implant, not an AI/ML powered device, so a MRMC study for AI assistance is irrelevant.

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

This information is not applicable as the device is a physical medical implant, not an AI/ML algorithm.

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

For mechanical performance, the "ground truth" would be established by validated engineering standards (e.g., ASTM or ISO standards for spinal implants) and internal acceptance criteria developed by Globus Medical. The tests demonstrate the device's ability to withstand specific forces and movements.
For biocompatibility, the "ground truth" is established by recognized standards like ANSI/AAMI ST-72:2011, which define acceptable endotoxin levels, and material certifications for components.

8. The sample size for the training set

This information is not applicable. There is no "training set" in the context of a physical medical implant's mechanical and biocompatibility testing. This concept applies to AI/ML model development.

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

This information is not applicable for the reasons stated above.

Summary of the Study:

The "study" described in the 510(k) summary for the AERIAL™ Interspinous Fixation device is a set of engineering performance tests and biocompatibility assessments designed to demonstrate that the device is substantially equivalent to legally marketed predicate devices.

• Mechanical Testing: Performed to assess the device's structural integrity and stability under various loads relevant to its intended use in the spine. This included axial compression, plate dissociation, offset torsion, and tension. The reported performance indicates that the device met the internal acceptance criteria for these tests, which are typically derived from relevant ASTM or ISO standards for spinal implants. The specifics of these acceptance criteria (e.g., maximum load, displacement) and the number of samples tested are not detailed in this summary.
• Biocompatibility Testing: Bacterial endotoxin testing (BET) was conducted according to ANSI/AAMI ST-72:2011. This standard sets limits for endotoxin levels in medical devices to ensure patient safety. The fact that the test was conducted in accordance with this standard implies that the device met the specified endotoxin limits. Additionally, the use of materials already established as biocompatible (meeting applicable standards or used in other cleared devices) further supports its safety.

The purpose of these tests is to establish that the new device's technological characteristics (design, intended use, material composition, function, and range of sizes) are sufficiently similar to the predicate devices and that it performs safely and effectively as intended. The "study" is a demonstration of adherence to established engineering and material science principles, rather than a clinical trial or a diagnostic accuracy study.

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