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 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
1. A set of re-useable manual surgical instruments for delivery of the device
1. 23 mm and 27 mm implant lengths
1. 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.

AI/ML Overview

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):

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.

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.
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.
Adjudication method for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This is a mechanical device, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No. This is a mechanical device.
The type of ground truth used: Mechanical properties and structural integrity as measured against established ASTM standards (F2077, F2267).
The sample size for the training set: Not applicable. This is a mechanical device, not an AI system requiring a training set.
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)."

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol consisting of three stylized human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 13, 2016

Ouroboros Medical, Inc. Mr. John To Chief Technical Officer, Regulatory Affairs 47757 Fremont Boulevard Fremont, California 94538

Re: K160076

Trade/Device Name: XCage™ Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: September 6, 2016 Received: September 7, 2016

Dear Mr. To:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Image /page/1/Picture/8 description: The image shows the name "Mark N. Melkerson -S" in a simple, sans-serif font. The text is black and appears to be the primary focus of the image. The background is plain white, which provides a clean contrast to the text.

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K160076

Device Name XCage™ Interbody Fusion System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary

XCage™ Interbody Fusion System

Traditional 510(k)

Company:	Ouroboros Medical, Inc.47757 Fremont Blvd.Fremont, CA 94538
FDA EstablishmentRegistration Number:	3010033846
Correspondent ContactInformation:	John ToCTO, Regulatory AffairsTel: (510) 676-0450Email: jto@ouromed.com
Date Prepared:	September 2, 2016
Device Common Name:	Intervertebral Body Fusion Device
Device Name:	XCage™ Interbody Fusion System
Device Classification:	Class II per 21 CFR 888.3080
Classification Name:	Intervertebral Fusion Device with Bone Graft, Lumbar
Product Code:	MAX
Predicate DeviceInformation:	Primary: Ouroboros XCage Interbody Fusion System (K133514)Additional: Globus Medical, Inc. Caliber® (K102293)

Purpose of Submission:

To achieve premarket clearance for the addition of the XCage Interbody spacer line.

Description of Device and Comparison:

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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
1. A set of re-useable manual surgical instruments for delivery of the device
1. 23 mm and 27 mm implant lengths
1. 0 and 6 degrees lordotic angles on the implant

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

Indications for Use:

Comparison to Predicate Device

The equivalence of XCage™ Interbody Fusion System to the predicates is supported by similarity in intended use, indications for use, technical characteristics, materials and performance.

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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) o

Proposed Labeling:

Draft labeling for the subject Ouroboros XCage™ Interbody Fusion spacer is provided in §14.0. The Indication for Use, Insert, and packaging labels are similar to those included for the predicate XCage Interbody Fusion System (K133514).

Conclusion:

The Ouroboros XCage™ Interbody Fusion System is similar to its predicate devices with respect to intended use, indications for use, technical characteristics, materials and performance. 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).

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.