The Life Spine Sacroiliac Joint Fixation System is intended for sacroiliac joint fusion for conditions including sacrolliac joint disruptions and degenerative sacroiliitis.

Device Description

The Life Spine Sacroiliac Joint Fixation System consists of fully threaded screws and partially threaded cannulated screws in various diameters and lengths to enhance sacroiliac joint fusion. All components are fabricated and manufactured from titanium alloy 6AL-4V-ELI per ASTM F-136.

AI/ML Overview

The provided document is a 510(k) summary for the Life Spine Sacroiliac Joint Fixation System, which is a medical device. This document focuses on demonstrating that the device is substantially equivalent to a predicate device, rather than providing a detailed study proving it meets specific acceptance criteria based on clinical outcomes or diagnostic performance.

Therefore, many of the requested categories for AI/diagnostic device studies (like expert ground truth, adjudication methods, MRMC studies, training set details) are not applicable to this type of submission.

Here's a breakdown of the information that can be extracted or inferred:

1. Table of Acceptance Criteria and Reported Device Performance

Criterion/Test Type	Acceptance Criteria (Implied)	Reported Device Performance
Material Composition	Titanium alloy 6AL-4V-ELI per ASTM F-136	Fabricated from titanium alloy 6AL-4V-ELI per ASTM F-136
Static Cantilever Bending	Demonstrate substantial equivalence to predicate device (Globus SI-LOK K112028)	Performed, contributes to demonstration of substantial equivalence
Dynamic Cantilever Bending	Demonstrate substantial equivalence to predicate device (Globus SI-LOK K112028)	Performed, contributes to demonstration of substantial equivalence
Screw Pullout	Demonstrate substantial equivalence to predicate device (Globus SI-LOK K112028)	Performed, contributes to demonstration of substantial equivalence
Screw Insertion	Demonstrate substantial equivalence to predicate device (Globus SI-LOK K112028)	Performed, contributes to demonstration of substantial equivalence
Design Characteristics	Substantially equivalent to predicate device	Stated to be substantially equivalent
Sizing	Substantially equivalent to predicate device	Stated to be substantially equivalent
Indications for Use	Substantially equivalent to predicate device	Stated to be substantially equivalent
Intended Use	Sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.	Same as predicate; stated as intended use.

Explanation of Acceptance Criteria: The primary acceptance criterion for this 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device (Globus SI-LOK Sacroiliac Joint Fixation System, K112028) in terms of safety and effectiveness. This is shown through comparisons of design, materials, indications for use, sizing, and performance testing. The "reported device performance" effectively states that these equivalence criteria were met.

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: Not specified in terms of number of devices tested or iterations for each test. The document refers to "Performance testing" conducted in accordance with ASTM F543 and ASTM F2191. These standards typically involve a specific number of samples for mechanical tests, but the exact count isn't stated here.
Data Provenance: The testing was likely conducted in a laboratory setting by Life Spine, Inc. or a contracted testing facility. No country of origin for data is stated beyond the company's US location. It is prospective testing, as it's performed on the device to be marketed.

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 question is Not Applicable in the context of this device and submission type. The device is a bone fixation system, not a diagnostic or AI-driven tool. Ground truth in this context typically refers to validation against clinical outcomes or expert consensus for diagnostic accuracy. Here, "ground truth" for device performance is defined by adherence to material specifications and mechanical test standards.

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

Not Applicable. Adjudication methods are used in studies where human interpretation (e.g., of images) is being evaluated for accuracy. For mechanical testing of a medical implant, results are typically objective measurements against engineering standards, not subject to human adjudication of subjective interpretations.

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 is not an AI-driven or diagnostic device. MRMC studies are designed for evaluating diagnostic accuracy, particularly with AI assistance.

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

Not Applicable. This is a physical medical device (sacroiliac joint fixation system), not an algorithm or AI.

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

The "ground truth" for this device's performance is established by engineering standards and material specifications (ASTM F136, ASTM F543, ASTM F2191). The demonstration of substantial equivalence to the predicate device also acts as a form of "ground truth" for its safety and effectiveness profile.

8. The sample size for the training set:

Not Applicable. This is not an AI/machine learning device. No "training set" of data for an algorithm is relevant here.

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

Not Applicable. As above, 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

February 22, 2015

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

Re: K141246

Trade/Device Name: Sacroiliac Joint Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: OUR, HWC Dated: January 5, 2015 Received: January 7, 2015

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Randy Lewis

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/Resourcesfor You/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 vours.

Lori A. Wiggins -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) K141246

Device Name Sacroiliac Joint Fixation System

Indications for Use (Describe)

The Life Spine Sacroiliac Joint Fixation System is intended for sacroiliac joint fusion for conditions including sacrolliac joint disruptions and degenerative sacroiliitis.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary Life Spine Sacroiliac Joint Fixation System

Submitted By:	Life Spine, Inc.13951 S Quality DriveHuntley, IL 60142Telephone: 847-884-6117Fax: 847-884-6118
510(k) Contact:	Randy LewisLife Spine13951 S Quality DriveHuntley, IL 60142Telephone: 847-884-6117Fax: 847-884-6118
Date Prepared:	February 17th, 2015
Trade Name:	Life Spine Sacroiliac Joint Fixation System
Common Name:	Smooth or Threaded Metallic Bone Fixation Fastener
Classification:	HWC, CFR 888.3040, Class IIOUR, CFR 888.3040, Class II
Predicate Device:	Globus SI-LOK Sacroiliac Joint Fixation System (K112028)

Device Description:

Intended Use of the Device:

The Life Spine Sacroiliac Joint Fixation System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

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Technological Characteristics:

The Life Spine Sacroiliac Joint Fixation System is substantially equivalent to the predicate systems in terms of design, materials, indications for use and sizing.

Material:

The Life Spine Sacroiliac Joint 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:

Performance testing was conducted in accordance with ASTM F543 and ASTM F2191 including static and dynamic cantilever bending, screw pullout and insertion tests. Engineering analysis is presented to demonstrate the substantial equivalence of the Life Spine Sacroiliac Joint Fixation System to the predicate device.

Conclusion:

The information presented demonstrates the substantial equivalency of the Life Spine Sacroiliac Joint Fixation System.

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.