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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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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 nonexpanded 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 Ouroboros XCage™ Shell is manufactured from polyetheretherketone (PEEK) per ASTM F2026, and has integrated tantalum radiographic markers per ASTM F560. The XCageTM Shim and Core are made from Titanium alloy per ASTM F136. The Ouroboros XCage™ Interbody Fusion System includes a set of re-useable manual surgical instruments for delivery of the device.

This document is a 510(k) summary for the XCage™ Interbody Fusion System, a medical device. It does not contain information about acceptance criteria or a study proving that the device meets those criteria, as that is not typically part of a 510(k) summary.

510(k) submissions, like this one, aim to demonstrate substantial equivalence to a predicate device already on the market, rather than proving safety and effectiveness through a comprehensive efficacy study with defined acceptance criteria and a detailed statistical analysis.

The document states:

• Performance Data: "Mechanical testing was conducted in accordance with Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Intervertebral Fusion Device, June 12, 2007. The following tests were performed to support the substantial equivalence of the XCage™ Interbody Fusion System to its predicates: Static and dynamic axial compression (ASTM F2077), Static and dynamic compression shear (ASTM F2077), Subsidence (ASTM F2267). In addition, Simulated Use testing of the XCage™ Interbody Fusion System was performed using both bench and cadaveric models."

This indicates that mechanical tests were performed against established industry standards (ASTM F2077, ASTM F2267) which define specific test methods and performance considerations for intervertebral body fusion devices. However, the specific acceptance criteria (e.g., specific deflection limits, force thresholds, cycles to failure) or the numerical results achieved by the device are not provided in this 510(k) summary. It merely states that "performance data" was gathered to support substantial equivalence.

Therefore, I cannot provide the requested information for the following points as they are not present in the provided text:

1. A table of acceptance criteria and the reported device performance: Not provided. The 510(k) summary only lists the types of tests performed (e.g., mechanical tests per ASTM standards, simulated use) but not the specific thresholds for acceptance or the numerical performance results of the XCage™ device against those thresholds.
2. Sample size used for the test set and the data provenance: Not explicitly stated for each test. The document mentions "bench and cadaveric models" for simulated use testing but does not specify sample sizes or data provenance (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or provided. The mechanical testing and simulated use are primarily engineering/biomechanical evaluations, not clinical studies requiring expert ground truth establishment in the typical sense (e.g., for image interpretation).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable or provided.
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 device is an interbody fusion system, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the mechanical tests, the "ground truth" would be the engineering specifications and performance requirements defined by the ASTM standards (e.g., a certain number of cycles without failure, remaining within specific deflection limits). For cadaveric models, it relates to biomechanical stability and integrity.
8. The sample size for the training set: Not applicable. This is a physical device, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

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