The Life Spine SIMPACT Sacroiliac Joint Fixation System is intended for sacroiliac fusion for the following conditions: · Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the period and have persisted postpartum for more than 6 months. · To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion. · Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.

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. 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

Here's a breakdown of the acceptance criteria and study information for the Life Spine SIMPACT Sacroiliac Joint Fixation System, based on the provided FDA 510(k) summary:

This device is not an AI/ML powered device, therefore no AI-specific information is available. The submission is for a traditional medical device (sacroiliac joint fixation system) and focuses on demonstrating substantial equivalence to existing predicate devices through material and mechanical performance testing, rather than clinical performance or AI algorithm validation.

However, I can extract the information relevant to a traditional medical device submission.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Test)	Reported Device Performance (Result)
Static Screw Pull-Out (ASTM F543 A1.A2 & A3)	Presented to demonstrate substantial equivalency to predicate device. (Specific numerical results are not provided in this summary, but the implication is that it met the required thresholds for equivalence.)
Screw Driving Torque (ASTM F543 A1.A2 & A3)	Presented to demonstrate substantial equivalency to predicate device. (Specific numerical results are not provided in this summary, but the implication is that it met the required thresholds for equivalence.)
Indications for Use	Substantially equivalent to predicate devices.
Design	Substantially equivalent to predicate devices.
Materials Used	Substantially equivalent to predicate devices (Titanium alloy 6AL-4V-ELI per ASTM F-136).
Mechanical Performance	Substantially equivalent to predicate devices.

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

The document does not explicitly state the sample size (e.g., number of screws tested) for the ASTM F543 tests. These are typically benchtop mechanical tests performed on a sufficient number of samples to ensure statistical validity and representativeness. The data provenance is laboratory testing rather than patient data.

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

Not applicable. This device is not AI-powered, and ground truth in the context of clinical expert consensus is not relevant for this type of mechanical testing. The "ground truth" here is adherence to mechanical standards.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical consensus in diagnostic studies, not for mechanical bench testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size of Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This device is not an AI-assisted diagnostic tool, so no MRMC study or AI-related comparative effectiveness was performed.

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

Not applicable. This device is not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this submission is established through adherence to recognized international standards for medical device materials and mechanical testing (ASTM F543). The performance is compared to that of legally marketed predicate devices, implying that the predicate devices' performance against these standards sets the benchmark for substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a training set as it is not an AI/ML algorithm.

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

Not applicable. This device does not involve a training set.

Summary

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September 18, 2020

Image /page/0/Picture/1 description: The image contains 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 is 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.

Life Spine Inc. Angela Batker RA/QA Manager 13951 S Quality Drive Huntley, Illinois 60142

Re: K201538

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: HWC, OUR Dated: June 8, 2020 Received: June 9, 2020

Dear Ms. Batker:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

for

Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201538

Device Name

Life Spine SIMPACT Sacroiliac Joint Fixation System

Indications for Use (Describe)

· To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.

· Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.

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 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:	Angela BatkerLife Spine, Inc.13951 S. Quality DriveHuntley, IL 60142Telephone: 847-884-6117Fax: 847-884-6118
Date Prepared:	June 8th, 2020
Trade Name:	Life Spine SIMPACT Sacroiliac Joint Fixation System
Common Name:	Spinal Interlaminal Fixation Orthosis
Classification:	HWC, CFR 888.3040, Class IIOUR, CFR 888.3040, Class II
Primary Predicate:	Life Spine Sacroiliac Joint Fixation Screw System (K141246)
Additional Predicates:	Life Spine Sacroiliac Joint Fixation Screw System (K180749)Zyga Tech. Simmetry Sacroiliac Joint Fixation Screw System (K141549)Si-Bone iFuse Implant System (K193524)

Device Description:

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.

Indications for Use:

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The Life Spine SIMPACT Sacroiliac Joint Fixation System is intended for sacroiliac fusion for the following conditions:

· Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.

· To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.

· Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.

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:

Testing according to Static Screw Pull-Out & Screw Driving Torque testing to ASTM F543 (A1.A2 & A3) was presented to demonstrate the substantial equivalency of the Life Spine Slotted 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.