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

Device Description

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

All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Life Spine SIMPACT Sacroiliac Joint Fixation System components with components from any other system or manufacturer. The Life Spine SIMPACT Sacroiliac Joint Fixation System components should never be reused under any circumstances.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called the Life Spine SIMPACT Sacroiliac Joint Fixation System. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing raw performance data or detailed study results for a new AI/software-as-a-medical-device.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria, specifically concerning AI/ML performance, ground truth establishment, sample sizes for training/test sets, expert adjudication, or MRMC studies.

The performance data mentioned in the document is limited to:

Engineering analyses
Static Screw Pull-Out & Screw Driving Torque testing to ASTM F543 (A2 & A3)

This testing was done to demonstrate substantial equivalency in mechanical performance to the predicate device (Life Spine Sacroiliac Joint Fixation System (K141246)), not to assess the performance of an AI/ML algorithm or a diagnostic device.

To directly answer your request based on the provided text:

A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on showing mechanical/design equivalence to a predicate, not meeting specific performance metrics for an AI/ML or diagnostic device.
Sample sizes used for the test set and the data provenance: Not applicable/not present. The testing mentioned (screw pull-out, torque) would have specific sample sizes for mechanical tests, but these are not for a "test set" in the context of AI/ML or clinical imaging data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not present. This is not an AI/ML or diagnostic device requiring expert-established ground truth from images or clinical data.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/not present.
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/not present. This device is a mechanical fixation system, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/not present.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable/not present in the context of what you're asking. The "ground truth" for this device would be its mechanical properties matching the standard or predicate.
The sample size for the training set: Not applicable/not present. This is not an AI/ML device requiring a training set.
How the ground truth for the training set was established: Not applicable/not present.

In summary, the provided document is a 510(k) for a mechanical spinal implant, not a software or AI-based medical device. Therefore, the detailed questions about AI acceptance criteria, ground truth, and study methodologies for AI/ML performance do not apply to the contents of this document.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 15, 2018

Life Spine Inc. Mr. Randy Lewis General Manager 13951 South Quality Drive Huntley, Illinois 60142

Re: K180749

Trade/Device Name: Life Spine SIMPACT 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: March 12, 2018 Received: March 22, 2018

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 forth in the quality systems (QS) regulation (21 CFR Part 820);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Ronald P. Jean -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) K180749

Device Name

Life Spine SIMPACT Sacroiliac Joint Fixation System

Indications for Use (Describe)

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

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary Life Spine SIMPACT 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 Spine, Inc.13951 S. Quality DriveHuntley, IL 60142Telephone: 847-884-6117Fax: 847-884-6118
Date Prepared:	June 12th, 2018
Trade Name:	Life Spine SIMPACT Sacroiliac Joint Fixation System
Common Name:	Spinal Sacroiliac Device
Purpose:	Life Spine SIMPACT Sacroiliac Joint Fixation System
Classification:	OUR, CFR 888.3040 Smooth or threaded metallic bone fixation fastener, Class IIHWC, CFR 888.3040 Smooth or threaded metallic bone fixation fastener, Class II
Primary Predicate:	Life Spine Sacroiliac Joint Fixation System (K141246)

Device Description:

Indications for Use:

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

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Technological Characteristics:

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

Material:

This submission seeks clearance of a device made from implant grade (Ti-6AL-4V) Titanium alloy according to F136. This this is the same material used in the predicate devices.

Performance Data:

Engineering analyses and Static Screw Pull-Out & Screw Driving Torque testing to ASTM F543 (A2 & A3) were presented to demonstrate the substantial equivalency of the Life Spine Sacroiliac Joint Fixation System (K141246).

Substantial Equivalence:

The Life Spine SIMPACT Sacroiliac Joint Fixation System was shown to be substantially equivalent to the predicate devices in indications for use, design, function, materials used and mechanical performance.

Conclusion:

The information presented demonstrates the substantial equivalency of The Life Spine SIMPACT 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.