Internal fixation implants are load-sharing devices intended to stabilize and maintain alignment until normal healing occurs. Implants are not intended to replace normal body structures or bear the weight of the body in the presence of incomplete bone healing.

The Aileron Interspinous Fixation System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous processes in skeletally mature patients for the purpose of achieving, in conjunction with autogenous bone graft, single level supplemental fusion in the following conditions: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies), (2) trauma (i.e., fracture or dislocation), (3) spinal tumor, (4) spondylolisthesis. The Aileron Interspinous Fixation System is not intended for stand-alone use.

Device Description

The Aileron Interspinous Fixation System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). Implants are manufactured from titanium alloy per ASTM F136 and are available in a range of sizes to suit the individual pathology and anatomical conditions of the patient. The purpose of this submission is to clear device modifications to the Aileron Interspinous Fixation System.

AI/ML Overview

This document is a 510(k) premarket notification for the "Aileron Interspinous Fixation System," a medical device. It is primarily concerned with establishing substantial equivalence to previously cleared devices rather than presenting a detailed study of the device's performance against specific acceptance criteria for a new medical AI or diagnostic device.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria for a diagnostic or AI device is largely not applicable to this document. This document focuses on the mechanical and material properties of an implantable spinal fixation device.

However, I can extract the relevant "performance data" that the FDA considered in its substantial equivalence determination, and infer some "acceptance criteria" related to mechanical strength.

Here's the breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state numerical acceptance criteria in the format typically seen for diagnostic performance measures (e.g., sensitivity, specificity). Instead, it refers to performance testing done "in accordance with a modified ASTM F1717 setup" and other specific mechanical tests. The "acceptance" is implicitly that the device performs equivalently to the predicate devices when subjected to these tests.

Acceptance Criteria (Inferred from Test Types)	Reported Device Performance
Mechanical Strength (Static Compression): Demonstrate adequate strength under static compressive loads.	Testing performed in accordance with a modified ASTM F1717 setup (implying comparable or better performance to predicate).
Mechanical Strength (Dynamic Compression): Demonstrate adequate strength under dynamic/cyclic compressive loads.	Testing performed in accordance with a modified ASTM F1717 setup (implying comparable or better performance to predicate).
Mechanical Strength (Torsion): Demonstrate adequate strength under torsional loads.	Testing performed in accordance with a modified ASTM F1717 setup (implying comparable or better performance to predicate).
Spike Pull-off Strength: Demonstrate resistance to pull-out once implanted.	Testing performed (implying comparable or better performance to predicate).
Static Axial Grip Strength: Demonstrate resistance to axial displacement.	Testing performed (implying comparable or better performance to predicate).
Material Composition: Conformance to medical-grade material standards.	Manufactured from 6AL-4V-ELI titanium according to ASTM F136.
Intended Use: Compatibility with specified spinal conditions and level, and as supplemental fixation (not stand-alone).	Stated as a posterior, non-pedicle supplemental fixation device for T1-S1, for single-level supplemental fusion in specific conditions (degenerative disc disease, trauma, spinal tumor, spondylolisthesis), not for stand-alone use.

The study that "proves" the device meets these criteria is referred to as "Performance Data" in the 510(k) summary. The conclusion explicitly states: "The information presented demonstrates the substantial equivalency of the Aileron Interspinous Fixation System." This means the device's mechanical performance was demonstrated to be equivalent to its predicate devices through the listed tests.

Regarding the specific questions about "diagnostic/AI device" studies:

2. Sample size used for the test set and the data provenance: Not applicable. This is not a study using a test set of data (e.g., medical images or patient records) for diagnostic assessment. The "test set" here refers to physical specimens of the device used for mechanical testing in a lab setting. No patient data provenance is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of diagnostic devices, would typically refer to clinical diagnosis or pathology. For mechanical implant testing, the "ground truth" is established by relevant engineering standards (e.g., ASTM F1717) and the results of the physical tests themselves. No medical experts are mentioned as establishing ground truth for these mechanical tests.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This relates to consensus readings for diagnostic images or data, which is not relevant here.

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 a mechanical implant, 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 device does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" in this context is the engineering standard (ASTM F136 for material, modified ASTM F1717 for mechanical testing) and the physical properties/performance of the device itself as measured under laboratory conditions.

8. The sample size for the training set: Not applicable. This device does not involve machine learning algorithms that require a training set.

9. How the ground truth for the training set was established: Not applicable. There is no training set for this type of device.

Summary

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

October 20, 2014

Life Spine, Incorporated Mr. Randy Lewis General Manager 2401 West Hassell Road, Suite 1535 Hoffman Estates, Illinois 60169

Re: K140236

Trade/Device Name: Aileron Interspinous Fixation System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: PEK Dated: September 24, 2014 Received: September 25, 2014

Dear Mr. Lewis:

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" (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 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 yours.

Ronald#Alean -S for

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) K140236

Device Name Aileron Interspinous Fixation System

Indications for Use (Describe)

The Aileron Interspinous Fixation System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous processes in skeletally mature patients for the purpose of achieving, in conjunction with autogenous bone graft, single level supplemental fusion in the following conditions: (1) degenerative discase (is defined as back pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies), (2) trauma (i.e., fracture or dislocation), (3) spinal tumor, (4) spondylolisthesis. The Aileron Interspinous Fixation System is not intended for stand-alone use.

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)

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510(k) Summary Aileron Interspinous Fixation System

Submitted By:	Life Spine, Inc.2401 W. Hassell Road, Suite 1535Hoffman Estates, IL 60169Telephone: 847-884-6117Fax: 847-884-6118
510(k) Contact:	Randy LewisLife Spine2401 W. Hassell Road, Suite 1535Hoffman Estates, IL 60169Telephone: 847-884-6117Fax: 847-884-6118
Date Prepared:	September 24th, 2014
Trade Name:	Aileron Interspinous Fixation System
Common Name:	Spinal interlaminal fixation orthosis
Classification:	PEK, 888.3050, Class II, Spinal interlaminal fixation orthosis
Predicate Device:	Primary Predicate: Aileron Interspinous Fixation System (K113157)Additional Predicates: Life Spine Interspinous Fixation System (K100407)Lanx Spinal Fixation System (K090252)

Device Description:

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Intended Use of the Device:

Technological Characteristics:

The Aileron Interspinous Fixation System is substantially equivalent to the predicate systems in terms of design, materials, and indications for use.

Material:

The Aileron Interspinous Fixation System is 6AL-4V-ELI titanium manufactured according to ASTM F136. The device is comprised of a variety of non-sterile titanium, single use components.

Performance Data:

Static and dynamic compression and torsion testing in accordance with a modified ASTM F1717 setup, in addition to Spike Pull-off and Static Axial Grip testing, was presented to demonstrate substantial equivalency.

Conclusion:

The information presented demonstrates the substantial equivalency of the Aileron Interspinous Fixation System.

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.