XCAGE INTERBODY FUSION SYSTEM

• K Number: K133514
• Device Name: XCAGE INTERBODY FUSION SYSTEM
• Manufacturer: OUROBOROS MEDICAL
• Date Cleared: 2014-05-01 ( 167 days)
• Product Code: MAX
• Regulation Number: 888.3080
• Type: Traditional
• Panel: OR
• Reference & Predicate Devices: K102293 , K072970 , K123461

Intended Use

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.

Device Description

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.

AI/ML Overview

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.

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.