The Life Spine ALIF Buttress Plate System in conjunction with traditional rigid fixation is intended for use in spinal fusion procedures of the thoracolumbar to S1 spinal region as a means to maintain the relative position of weak bony tissue such as allografts or autografts. This device is not intended for load bearing applications.

Device Description

The Life Spine ALIF Buttress Plate System consists of a variety of plates and screws to suit the individual pathology and anatomical conditions of the patient. All components are fabricated and manufactured from titanium alloy Ti-6A1-4V-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 ALIF Buttress Plate System components with components from any other system or manufacturer. The ALIF Buttress Plate System components should never be reused under any circumstances.

AI/ML Overview

This is a 510(k) premarket notification for a medical device (Life Spine ALIF Buttress Plate System), not a study demonstrating device performance against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics is not present in this document.

The document states that the device is "substantially equivalent" to predicate devices based on design, materials, indications for use, and sizing. Substantial equivalence is the basis for 510(k) clearance, meaning no new clinical studies are typically required to demonstrate safety and effectiveness if the device is similar enough to an already cleared device.

Here's what can be extracted and what cannot:

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

Cannot be provided. This document does not present specific acceptance criteria or performance data from a study. It asserts substantial equivalence based on comparisons to predicate devices.

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

Cannot be provided. No clinical or performance test sets are described in this document.

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):

Cannot be provided. No 'ground truth' establishment using experts for a test set is discussed.

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

Cannot be provided. No test set or adjudication method is described.

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:

Cannot be provided. This device is a spinal implant, not an AI-assisted diagnostic tool. An MRMC study would not be applicable.

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

Cannot be provided. This device is a physical implant, not an algorithm.

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

Cannot be provided. There is no discussion of ground truth as no clinical or performance study data is presented.

8. The sample size for the training set:

Cannot be provided. There is no mention of a training set as this is not an AI/algorithm-based device.

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

Cannot be provided. No training set and therefore no ground truth for a training set is discussed.

Information that can be extracted relevant to the submission:

Device Name: Life Spine ALIF Buttress Plate System
Indications for Use: The Life Spine ALIF Buttress Plate System in conjunction with traditional rigid fixation is intended for use in spinal fusion procedures of the thoracolumbar to S1 spinal region as a means to maintain the relative position of weak bony tissue such as allografts or autografts. This device is not intended for load-bearing applications.
Regulatory Class: Class II
Product Code: KWQ
Material: Titanium alloy (Ti-6Al-4V ELI) per ASTM F-136.
Basis for Clearance: Substantial Equivalence to predicate devices (Vail Buttress Plate System K180755, RCS Anterior Buttress Plate System K092659, Life Spine Sentry Lateral Plate System K180166) in terms of design, materials, indications for use, and sizing.

Summary

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November 16, 2022

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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

Re: K222628

Trade/Device Name: Life Spine ALIF Buttress Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: August 22, 2022 Received: August 31, 2022

Dear Angela 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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 mediation-emitting products, including information about labeling regulations, please see Device Advice (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,

Anne D. Talley -S
for

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

Enclosure

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Indications for Use

510(k) Number (if known) K222628

Device Name Life Spine ALIF Buttress Plate System

Indications for Use (Describe)

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 ALIF Buttress Plate

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:	August 24th, 2022
Trade Name:	Life Spine ALIF Buttress Plate System
Common Name:	Appliance, Fixation, Spinal Intervertebral Body
Classification:	KWQ, 21 CFR 888.3060 Spinal Intervertebral Body Fixation Orthosis,Class II
Primary Predicate:	Vail Buttress Plate System (K180755)
Additional Predicate:	RCS Anterior Buttress Plate System (K092659)Life Spine Sentry Lateral Plate System (K180166)

Device Description:

Indications for Use of the Device:

The Life Spine ALIF Buttress Plate System in conjunction with traditional rigid fixation is intended for use in spinal fusion procedures of the thoracolumbar to S1 spinal region as a means to maintain the relative position of weak bony tissue such as allografts. This device is not intended for load bearing applications.

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K222628 Page 2 of 2

Technological Characteristics:

The ALIF Buttress Plate 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 titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136. This this is the same material used in the predicate devices.

Substantial Equivalence:

The ALIF Buttress Plate System was shown to be substantially equivalent to the predicate devices in indications for use, design, function, materials used and performance.

Conclusion:

The information presented demonstrates the substantial equivalency of the ALIF Buttress Plate System.

Regulation Number and Section

N/A