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The XCage™ Interbody Fusion System is indicated for spinal intervertebral body fusion with autogenous bone graft in skeletally mature individuals with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1, following discectomy. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have at least six (6) months of non-operative treatment. Additionally, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). XCage™ System Spacers are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine.

The Ouroboros XCage™ Interbody Fusion System is an expandable lumbar intervertebral body fusion device intended for use in the lumbosacral spine from L2 to S1 and is intended for intervertebral lumbar fusion. The XCage™ Spacer consists of a Shell and a Shim component that are offered in a range of sizes to accommodate variation in patient anatomy. The Shell component is a rectangular frame with struts on all four sides that allow for insertion into the intervertebral body space in a non-expanded form, and subsequent expansion following the insertion of the Shim component. The Shim component has a tapered front end that inserts into and expands the Shell component to the desired vertical and horizontal dimensions. When fully inserted, the Shim locks within the Shell to provide structural stability for interbody fusion. An integrated "Core" in the Shell serves to anchor the delivery instrument during Shim insertion. Protrusions on the superior and inferior surfaces of the Spacer grip the adjacent vertebral endplates to resist expulsion. The XCage™ Spacer is to be filled with autogenous bone graft material. Once implanted, the XCage™ Spacer is designed to restore intervertebral disc height, provide anterior column support and maintain structural stability of the motion segment to facilitate intervertebral body fusion.

The XCage Interbody Fusion System includes:

• 1. The spacer components: shell and shim
• 2. A set of re-useable manual surgical instruments for delivery of the device
• 3. 23 mm and 27 mm implant lengths
• 4. 0 and 6 degrees lordotic angles on the implant

The XCage™ shell is made from polyetheretherketone (PEEK) per ASTM F2026, and integrated tantalum radiographic markers per ASTM F560. The XCage™ Shim and Core are made from Titanium alloy per ASTM F136.

The re-usable surgical instruments are made from stainless steel.

This document is a 510(k) premarket notification for a medical device called the XCage™ Interbody Fusion System. It describes the device, its intended use, and provides a summary of performance data to demonstrate substantial equivalence to predicate devices. However, it does not contain the detailed acceptance criteria or the study that proves the device meets specific acceptance criteria in the format requested.

Here's an analysis of why the requested information cannot be fully extracted and what is present:

Missing Information:

• Detailed Acceptance Criteria Table and Reported Device Performance: While the document lists mechanical tests performed (Static and dynamic axial compression, Static and dynamic compression shear, Subsidence), it does not provide specific numerical acceptance criteria (e.g., minimum load bearing capacity in kN, maximum subsidence in mm) or the actual performance values achieved by the XCage™ device for each criterion.
• Sample Size for Test Set and Data Provenance: The document mentions "Mechanical testing was conducted," but does not specify the sample size (e.g., number of devices tested) for these tests, nor the data provenance (e.g., country of origin, retrospective/prospective).
• Number of Experts, Qualifications, and Adjudication Method for Ground Truth: These points are relevant for studies involving human interpretation or clinical outcomes. This document focuses on mechanical testing of an implant, which typically doesn't involve "experts establishing ground truth" in the same way as, for example, an AI diagnostic tool.
• MRMC Comparative Effectiveness Study: This type of study assesses how AI assistance impacts human reader performance. The document describes a mechanical device, not an AI system, so an MRMC study is not applicable here.
• Standalone Performance: This also relates to AI algorithms. The performance discussed is the mechanical integrity of the implant itself.
• Type of Ground Truth Used: For mechanical tests, the "ground truth" is typically the physical and mechanical properties measured under controlled laboratory conditions, not expert consensus, pathology, or outcomes data in the clinical sense.
• Sample Size for Training Set and How Ground Truth for Training Set was Established: These points are applicable to AI models. This document describes a physical medical device.

What can be extracted (and what cannot, with explanation):

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criteria (Implied by standard)	Reported Device Performance
   Static and dynamic axial compression (ASTM F2077)	The document states this test was performed.
   Static and dynamic compression shear (ASTM F2077)	The document states this test was performed.
   Subsidence (ASTM F2267)	The document states this test was performed.
   Note: Specific numerical criteria and results are NOT provided in this document.
   Explanation: The document lists the types of mechanical tests performed and the ASTM standards they conform to. However, it does not provide the specific numerical acceptance limits or the actual performance results for the XCage™ Interbody Fusion System for each test. It simply states that the tests were performed to support substantial equivalence.

2. Sample sized used for the test set and the data provenance:

   • Sample Size for Test Set: Not specified.
   • Data Provenance: Not specified, but implied to be laboratory testing as per ASTM standards for mechanical devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For mechanical testing, "ground truth" is defined by the physical measurements against established standards, not by expert consensus.

4. Adjudication method for the test set: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This is a mechanical device, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No. This is a mechanical device.

7. The type of ground truth used: Mechanical properties and structural integrity as measured against established ASTM standards (F2077, F2267).

8. The sample size for the training set: Not applicable. This is a mechanical device, not an AI system requiring a training set.

9. How the ground truth for the training set was established: Not applicable.

Summary of available information related to performance:

The device's performance was evaluated through mechanical testing, specifically:

• Static and dynamic axial compression (ASTM F2077)
• Static and dynamic compression shear (ASTM F2077)
• Subsidence (ASTM F2267)

These tests were conducted in accordance with the "Guidance for Industry and FDA Staff. Class II Special Controls Guidance Document: Intervertebral Fusion Device, June 12, 2007," to support the substantial equivalence of the XCage™ Interbody Fusion System to its predicate devices. The document explicitly states: "The information presented within this premarket notification demonstrates that it is substantially equivalent to the predicate Ouroboros XCage Interbody Fusion Spacer (K133514) the Globus Medical Caliber® Spacer (K102293)."

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