The Axle 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 Interspinous Fusion System is intended for use with bone graft material, and not for stand-alone use.

Device Description

The Axle 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 svstem 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 systems components are manufactured using standard manufacturing processes of medical grade Titanium alloy (Ti6Al4V) that complies with ASTM F136 - Standard Specifications for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications and Invibio PEEK Optima LT-1 in accordance with ASTM F2026 -Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications. The implant components are provided clean and non-sterile. These devices are supplied in a rigid sterilization tray and are to be sterilized by a healthcare professional using a Steam Autoclaye in accordance with the instructions for use provided by X-spine Systems Inc., as well as the instructions provided by the Autoclave manufacturer.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Axle™ Interspinous Fusion System, a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical studies to establish novel performance criteria. Therefore, the information requested in your prompt regarding acceptance criteria, study details, and AI-specific metrics is largely not applicable to this document.

Here's an breakdown of why and what information can be extracted based on the provided text:

General Context of the Document:

This is a 510(k) submission, specifically a "Special 510(k): Device Modification." This means X-spine Systems, Inc. is seeking to market a modified version of an already cleared device. The primary goal of a 510(k) is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device, meaning it's as safe and effective. This is typically achieved through comparison of design, materials, manufacturing processes, and sometimes non-clinical performance testing (bench testing), rather than large-scale clinical trials.

Missing Information (and why):

Most of the requested information (sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone AI performance, type of ground truth, etc.) is relevant for studies conducted to establish the de novo efficacy or safety of a new and novel device, particularly those involving AI/ML components for diagnostic or prognostic purposes. The Axle Interspinous Fusion System is a mechanical implant, and its 510(k) submission does not involve AI or these types of clinical study methodologies.

Information Extracted from the Document:

Despite the above, I can provide a limited answer based on the provided text, focusing on what is relevant to a 510(k) for a mechanical device:

1. A table of acceptance criteria and the reported device performance

For a mechanical implant like the Axle Interspinous Fusion System, "acceptance criteria" and "reported device performance" are typically defined by engineering standards and successful completion of specified mechanical tests, demonstrating equivalence to the predicate device. The document states:

Acceptance Criteria (Implied by Standards)	Reported Device Performance (Summary)
ASTM F1717 - Static Compression Bending	Tested successfully.
ASTM F1717 - Static Torsion	Tested successfully.
ASTM F1717 - Fatigue Compression Bending	Tested successfully.
Spike Pullout	Tested successfully (no cited standard).
Dissociation	Tested successfully (no cited standard).
Overall Goal:	The modified device substantially meets the performance criteria established by the cleared parent device.

Self-correction/Clarification: The document doesn't explicitly list numerical "acceptance criteria" (e.g., "must withstand X N of compression"). Instead, it states that the device was tested using specific ASTM standards and additional tests. The acceptance for a 510(k) is that the device performs comparably to the predicate device under these tests, thereby demonstrating "substantial equivalence." The document concludes that the modified device "substantially meet[s] the performance criteria established by the cleared parent device," implying it met the unstated performance thresholds benchmarked against the predicates.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided as the device is a mechanical implant primarily evaluated through bench testing. The "test set" here refers to the physical samples of the device undergoing mechanical scrutiny, not a clinical data set. There is no mention of country of origin or retrospective/prospective data collection as it's not a clinical study in that sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable/provided. "Ground truth" in the context of mechanical testing refers to the physical properties and performance characteristics of the materials and device components. Experts in this field would be engineers and material scientists interpreting the results of mechanical tests, but their number and specific qualifications are not detailed in this 510(k) summary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/provided. Adjudication methods are typically for subjective clinical assessments or image interpretations, not for objective mechanical testing.

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

This information is not applicable. The Axle Interspinous Fusion System is a surgical implant, not an AI-powered diagnostic or assistive tool. No MRMC study was conducted, nor is AI involved.

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

This information is not applicable. As stated, this is a mechanical implant with no AI component.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's evaluation is primarily engineering specifications and measurements from mechanical (bench) testing against established ASTM standards and comparable performance to the predicate devices.

8. The sample size for the training set

This information is not applicable/provided. The concept of a "training set" is relevant for machine learning models, which are not involved here.

9. How the ground truth for the training set was established

This information is not applicable/provided for the same reasons as #8.

Summary

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510(k) Summary

ADMINISTRATIVE INFORMATION

JUN 2 7 2013

Manufacturer Name:	X-spine Systems, Inc.452 Alexandersville Rd.Miamisburg, OH 45342
Official Contact:	David Kirschman, M.D.Chief Medical Officer
Date Prepared:	February 20, 2013
DEVICE NAME
Trade/Proprietary Name:	Axle™ Interspinous Fusion System
Common Name:	Spinous Process Plate
Classification Name:	Spinal Interlaminal Fixation Orthosis
Product Code:	PEK
Classification:	§888.3050
Device Class:	Class II

ESTABLISHMENT REGISTRATION NUMBER

The X-spine Systems, Inc. establishment registration number is 3005031160. The owner/ operator number for X-spine Systems, Inc. is 9063903.

INTENDED USE

DEVICE DESCRIPTION

The systems components are manufactured using standard manufacturing processes of medical grade Titanium alloy (Ti6Al4V) that complies with ASTM F136 - Standard

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Specifications for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications and Invibio PEEK Optima LT-1 in accordance with ASTM F2026 -Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications.

The implant components are provided clean and non-sterile. These devices are supplied in a rigid sterilization tray and are to be sterilized by a healthcare professional using a Steam Autoclaye in accordance with the instructions for use provided by X-spine Systems Inc., as well as the instructions provided by the Autoclave manufacturer.

EQUIVALENCE TO MARKETED PRODUCT

X-spine Systems. Inc. has submitted information to demonstrate that, for the purposes of FDA's requlation of medical devices, the Axle Interspinous Fusion System is substantially equivalent to the predicate device based on a comparison including the following characteristics:

FDA Product Code .
. Intended Uses
. Surgical Approach
Anatomical Region .
. Implant Materials
. Product Features

PREDICATE DEVICES

. X-spine Systems, Inc. - Axle Interspinous Fusion System (K101471)
. X-spine Systems. Inc. - Axle PEEK Interspinous Fusion Svstem (K112592)
Medtronic-Sofamor-Danek-CD Horizon Spinal System Spinous Process Plate . (K091445)
. Lanx, LLC - Aspen Spinous Process Fusion Plate (K071877)

PERFORMANCE COMPARISON

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 addition to the above standard testing, spike pullout and dissociation tests were performed as part of this submission. There are no cited standards for these tests.

The modified device is used to treat the same indications for use, utilizes the same scientific and operational principles, and is manufactured using the same manufacturing practices from identical materials as the parent device.

In conclusion, X-spine Systems, Inc. has submitted information to demonstrate that, for the purposes of FDA's requlation of medical devices, the Axle Interspinous Fusion System modifications substantially meet the performance criteria established by the cleared parent device.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird-like figure.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

June 27, 2013

X-Spine Systems, Incorporated % David Kirschman, M.D. Chief Medical Officer 452 Alexandersville Road Miamisburg, Ohio 45342

Re: K130438

Trade/Device Name: Axle™ Interspinous Fusion System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: PEK Dated: May 30, 2013 Received: May 31, 2013

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 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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Page 2 - David Kirschman. M.D.

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21 CFR 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,

Erin-Keith

For

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

Enclosure

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Special 510(k): Device Modification

Axle Interspinous Fusion System

Indications for Use

510(k) Number (if known): K130438

Device Name: Axle™ Interspinous Fusion System

Indications for Use:

Prescription Use

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

Ronald P. Jean -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K130438

Page 15 of 47

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.