The Axle PEEK Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1 inclusive). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); and/or tumor. The Axle PEEK Interspinous Fusion System is intended for use with bone graft material, and not for stand-alone use.

Device Description

The Axle PEEK Interspinous Fusion System consists of plates and inserts of various sizes that are used to provide supplemental stabilization of the spinous processes to support fusion. The system components can be assembled in a variety of configurations so that adaptations can be made to take into account pathology and individual patient anatomy. The implant components are provided clean and non-sterile.

The plate components of the device are made from titanium alloy per ASTM F136 and the insert components are made from polyetheretherketone (Invibio PEEK-Optima LT1).

AI/ML Overview

The provided 510(k) summary (K112592) concerns the Axle PEEK Interspinous Fusion System, a medical device. This document does not describe an AI/ML-based device and therefore does not contain information on acceptance criteria for an algorithm's performance, sample sizes for test or training sets, expert review, or MRMC studies.

Instead, the document focuses on demonstrating the device's substantial equivalence to a predicate device through biomechanical performance data. The "acceptance criteria" and "study" are interpreted in the context of a traditional medical device's engineering and performance standards rather than AI model metrics.

Here's a breakdown of the information as it relates to the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

For this physical medical device, "acceptance criteria" are not reported as numerical thresholds, but rather as meeting the standards set by the predicate device through specific biomechanical tests. The reported performance is that it met those standards.

Acceptance Criteria (Standard)	Reported Device Performance
ASTM F1717 – Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
Static Compression Bending	Substantially equivalent to predicate device performance.
Static Torsion	Substantially equivalent to predicate device performance.
Fatigue Compression Bending	Substantially equivalent to predicate device performance.

The conclusion states that "biomechanical testing results indicate that the Axle PEEK Interspinous Fusion System is substantially equivalent to predicate device performance and is capable of safely and effectively performing in accordance with its intended use."

2. Sample Size Used for the Test Set and Data Provenance

This document describes biomechanical testing of a physical implant, not a software algorithm. Therefore, "test set" and "data provenance" as typically understood for AI/ML validation are not applicable. The testing was conducted on samples of the device components (plates and inserts) in a lab setting according to specified ASTM standards. The provenance is internal to the manufacturer's testing process.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This is not a study assessing interpretations by experts, but rather a mechanical performance test. The "ground truth" is defined by the objective physical properties and performance characteristics as measured against established engineering standards.

4. Adjudication Method for the Test Set

Not applicable. There was no need for adjudication as the data consists of physical measurements of the device's performance.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No. This is a biomechanical study, not a clinical or reader-based study.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by validated engineering and biomechanical standards (ASTM F1717). The device's performance is compared against the performance of a legally marketed predicate device as measured by these same standards.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an algorithm, so there is no "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable. There is no "training set" for physical device manufacturing and testing in this context.

Summary

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2112592

DEC - 5 2011

510(k) Summary

ADMINISTRATIVE INFORMATION

Manufacturer Name:	X-spine Systems, Inc.
	452 Alexandersville Rd.
	Miamisburg, OH 45342
	Telephone (937) 847-8400
	FAX (937) 847-8410
Official Contact:	David Kirschman, MD
	Chief Medical Officer
Date Prepared:	September 6, 2011

DEVICE NAME

Trade/Proprietary Name:	Axle PEEK Interspinous Fusion System
Common Name(s):	Interspinous Process Fixation System
Classification Name(s):	Spinal Interlaminal Fixation Orthosis
Device Class:	Class II

$888.3050

KWP

ESTABLISHMENT REGISTRATION NUMBER

X-spine Systems, Inc. has submitted an Establishment Registration to FDA. The Establishment Registration number is 3005031160. The owner/operator number for X-spine Systems, Inc. is 9063903.

INTENDED USE

Classification(s):

Product Codes(s):

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DEVICE DESCRIPTION

The plate components of the device are made from titanium alloy per ASTM F136 and the insert components are made from polyetheretherketone (Invibio PEEK-Optima LT1).

COMPARISON TO CLEARED DEVICE

X-spine Systems, Inc. has submitted information to demonstrate that, for the purposes of FDA's regulation of medical devices, the Axie PEEK Interspinous Fusion System substantially meets the performance criteria established by the cleared parent device. The modified device is substantially equivalent to predicate device based on a comparison including the following characteristics:

. FDA Product Code
. Intended Uses
. Surgical Approach
. Anatomical Region
. Product Dimensions
. Mechanical Performance

PERFORMANCE DATA

The implant components were tested using the following standards:

ASTM F1717 – Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model

Static Compression Bending .
. Static Torsion
Fatigue Compression Bending .

In conclusion, biomechanical testing results indicate that the Axle PEEK Interspinous Fusion System is substantially equivalent to predicate device performance and is capable of safely and effectively performing in accordance with its intended use.

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

DEC - 5 2011

X-spine Systems, Inc. % David Kirschman, MD Chief Medical Officer 452 Alexandersville Road Miamisburg, Ohio 45342

Re: K112592

Trade/Device Name: Axle PEEK Interspinous Fusion System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP Dated: November 04, 2011 Received: November 07, 2011

Dear Dr. Kirschman:

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

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Page 2 - David Kirschman, MD

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 forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K112592

Device Name: Axle PEEK Interspinous Fusion System

Indications for Use:

Prescription Use __ × (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

17 1.4 21 0.80

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

KI12592 510(k) Number_

Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.