The Cervical Plating system is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine from C2 to T1 during the development of cervical spinal fusions in patients with: 1.) Deqenerative disc disease, DDD (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies); 2). Spondylolisthesis; 3.) Trauma (including fractures or dislocations); 4.) Spinal cord stenosis; 5.) Deformity or curvatures (i.e. kyphosis, lordosis or scoliosis); 6.) Tumors; 7.) Pseudarthrosis; and/or 8.) Failed previous fusions.

When used and connected to a Life Spine cervical interbody, the Cervical Plating System can only be used to treat cervical degenerative disc disease.

Nota Bene: This device system is intended for anterior cervical intervertebral body fusions only.

Device Description

The Life Spine Cervical Plating System consists of a variety of sizes of plates, screws, and associated instruments. Fixation is provided by bone screws inserted through the plates and into the vertebral body of the cervical spine using an anterior approach.

The Life Spine Cervical Plating System implant components are made from titanium alloy described by ASTM F136. Stainless steel and titanium implant components must not be used together in a construct.

All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the components with components from any other system or manufacturer. The Cervical Plating System components should never be reused under any circumstances.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Cervical Plating System, specifically noting what information is available and what is not present in the given document.

It's important to understand that the provided text is an FDA 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed clinical study report for AI/software devices. Therefore, many of your requested items, particularly those related to AI algorithm performance, human expert evaluation, and training data specifics, will not be found as this is a physical medical device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (What was measured?)	Reported Device Performance (Results)
Mechanical Performance:
Dynamic Axial Compression Bending (according to ASTM F1717)	Meets ASTM F1717 standards (Implied by "Performance Data" and "demonstrates the substantial equivalency")
Static Axial Compression Bending (according to ASTM F1717)	Meets ASTM F1717 standards (Implied by "Performance Data" and "demonstrates the substantial equivalency")
Static Torsion (according to ASTM F1717)	Meets ASTM F1717 standards (Implied by "Performance Data" and "demonstrates the substantial equivalency")
Material:
Titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136	The device material is titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136 (stated explicitly)
Indications for Use Equivalence:
Similar indications for use as predicate devices	Substantially equivalent to predicate devices (K152282, K103423, K190227) in indications (stated explicitly)
Design Equivalence:
Similar design as predicate devices	Substantially equivalent to predicate devices in design (stated explicitly)
Function Equivalence:
Similar function as predicate devices	Substantially equivalent to predicate devices in function (stated explicitly)

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

This information is not provided in the document. For mechanical testing of physical implants, "sample size" would refer to the number of implants tested per configuration. The document does not specify these details or data provenance beyond stating that testing was done according to ASTM F1717.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable/provided. This device is a physical implant, not an AI/software device requiring expert ground truth for image interpretation or diagnosis. The "ground truth" here is the physical properties and mechanical performance determined through standardized experimental testing, not human expert consensus on medical images.

4. Adjudication method for the test set

This information is not applicable/provided. No adjudication method is mentioned as this is not a study involving human interpretation of data for medical diagnosis.

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

This information is not applicable/provided. This document concerns a physical medical implant, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance would not be part of this submission.

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

This information is not applicable/provided. This document concerns a physical medical implant, not an algorithm, so standalone algorithm performance is irrelevant.

7. The type of ground truth used

The "ground truth" for this device's performance is established through standardized mechanical testing according to ASTM F1717. This provides quantitative data on the device's physical properties and performance under various loads, which is compared against established engineering standards and the performance of predicate devices.

8. The sample size for the training set

This information is not applicable/provided. There is no "training set" in the context of this device as it is a physical implant, not a machine learning model.

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

This information is not applicable/provided. As there is no training set mentioned, the method of establishing its ground truth is also not relevant.

Summary

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December 11, 2024

Image /page/0/Picture/1 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.

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

Re: K243369

Trade/Device Name: Cervical Plating System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: October 24, 2024 Received: October 30, 2024

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).

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Sincerely,

Ethan R. Naylor -S

For Ronald P. Jean, Ph.D. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Submission Number (if known)

K243369

Device Name

Cervical Plating System

Indications for Use (Describe)

When used and connected to a Life Spine cervical interbody, the Cervical Plating System can only be used to treat cervical degenerative disc disease.

Nota Bene: This device system is intended for anterior cervical intervertebral body fusions only.

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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Expiration Date: 07/31/2026 See PRA Statement below.

Form Approved: OMB No. 0910-0120

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510(k) Summary Cervical Plating 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:	October 25th, 2024
Trade Name:	Cervical Plating System
Common Name:	Spinal intervertebral body fixation orthosis
Classification:	KWQ, CFR 888.3060, Class II
Primary Predicate:	Life Spine GRUVE Anterior Cervical Plating System K152282
Additional Predicate:	Life Spine Neo-UL K103423Choice Spine, Inc. Boomerang ACPS K190227

Device Description:

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Intended Use of the Device:

The Cervical Plating system is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine from C2 to T1 during the development of cervical spinal fusions in patients with: 1.) Degenerative disc disease, DDD (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies); 2). Spondylolisthesis; 3.) Trauma (including fractures or dislocations); 4.) Spinal cord stenosis; 5.) Deformity or curvatures (i.e. kyphosis, lordosis or scoliosis); 6.) Tumors; 7.) Pseudarthrosis; and/or 8.) Failed previous fusions.

When used and connected to a Life Spine cervical interbody, the Cervical Plating System can only be used to treat cervical degenerative disc disease.

Nota Bene: This device system is intended for anterior cervical intervertebral body fusions only

Material:

This submission seeks clearance of a device made from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136. This is the same material used in the predicate devices.

Performance Data:

Dynamic and Static testing in Axial Compression Bending and Static Torsion according to ASTM F1717.

Substantial Equivalence:

The Cervical Plating 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 Cervical Plating System.

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.