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The X-MESH™ Expandable Cage System is indicated for use in the thoracolumbar spine (i.e., T1 to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The X-MESH™ Expandable Cage System is also indicated for treating fractures of the thoracic and lumbar spine. The X-MESH™ Expandable Cage System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. The X-MESH™ Expandable Cage System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used include titanium plate or rod systems (i.e., KANEDA™ SR, UNIVERSITY PLATE™ M-2 ANTERIOR PLATE™ . ISOLA® . VSP®, MOSS®MIAMI, TiMX™, MONARCH™ EXPEDIUM™, VIPER™, and PROFILE™).

The X-MESH™ Expandable Cage System comes in three approach-specific shapes for the anterior lateral, direct anterior and posterior approaches. Each cage comes fully assembled with rough, convex endplates containing spikes that help anchor the device in the vertebral endplates, and provide resistance to migration and rotation. This mesh cage contains diamond pattern, side slots and large graft windows for graft material. The cage can be expanded axially and has a setscrew for locking it in position.

The provided [K080568](https://510k.innolitics.com/search/K080568) document describes a medical device, the X-MESH™ Expandable Cage System, and its clearance through the 510(k) pathway. This pathway is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and efficacy through clinical trials. Therefore, the document does not describe a study that proves the device meets specific acceptance criteria in the way a clinical trial for a novel AI/software medical device would.

Instead, the "acceptance criteria" here refer to the performance data submitted to characterize the device to demonstrate substantial equivalence to predicate devices for its intended use.

Based on the provided text, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document does not quantify specific acceptance criteria values (e.g., "withstanding X N of force") nor does it provide detailed raw performance data. The phrase "Performance data were submitted to characterize the subject X-MESH™ Expandable Cage System" is a general statement indicating that this information was provided to the FDA as part of the 510(k) submission to demonstrate that the device performs as intended and is substantially equivalent to predicate devices. The materials specification (ASTM F 136 titanium alloy) and the description of the device's design (spikes, expansion mechanism) are implicitly part of this performance characterization.

Regarding the other requested information, the document does not contain the specified details as it pertains to a traditional hardware medical device clearance, not an AI/software medical device with a diagnostic or predictive function.

Here's why and what's missing:

• 2. Sample sized used for the test set and the data provenance: Not applicable. No clinical test set data is described. The performance data would likely involve mechanical testing, not a "test set" of patient data.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth associated with a test set (e.g., for diagnoses) is mentioned.
• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set requiring expert adjudication is described.
• 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. This is a hardware implant, not an AI diagnostic tool.
• 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a hardware implant, not an algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of an AI/software device. The "ground truth" for this device would be its mechanical properties, material composition, and biological response, which are assessed through engineering tests, material certifications, and potentially animal/cadaver studies (though not detailed here).
• 8. The sample size for the training set: Not applicable. There is no AI model or training set described.
• 9. How the ground truth for the training set was established: Not applicable. There is no AI model or training set described.

In summary, the provided document relates to a 510(k) premarket notification for a physical medical implant (an expandable cage system). The "performance data" mentioned refers to engineering and material characterization data to demonstrate substantial equivalence to existing predicate devices, not clinical studies or AI/software validation as implied by the detailed questions.

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