The EMERGE™ Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (DDD) (defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors (primary and metastatic), deformity (kyphosis, lordosis), failed previous fusions (pseudarthrosis), spondylolisthesis, and spinal stenosis. The EMERGE™ Anterior Cervical Plate System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

Device Description

The EMERGE™ Anterior Cervical Plate System consists of cervical plates offered in various sizes to accommodate surgical needs and anatomic requirements. The plate attaches to the anterior portion of the vertebral body of the cervical spine. The plates can be used with fixed angle screws. The system is comprised of a Titanium Alloy (Ti-6Al-4V ELI) plates and bone screws. The subject 510(k) adds additional 3-screw plates to the system.

AI/ML Overview

This document describes the FDA's 510(k) clearance for the EMERGE™ Anterior Cervical Plate System. It details the device's indications for use, its substantial equivalence to predicate devices, and the performance testing conducted.

However, the provided text does not contain information related to an AI/ML-driven medical device. It describes a traditional implanted medical device (a spinal plate system). Therefore, it is not possible to answer the specific questions about acceptance criteria, study design, ground truth, expert adjudication, or MRMC studies for an AI/ML device, as these concepts are not applicable to the information given in the document.

The document focuses on:

Device Type: Anterior Cervical Plate System (a mechanical implant).
Purpose: Spinal fixation.
Regulatory Pathway: 510(k) clearance, establishing substantial equivalence to existing predicate devices.
Performance Data: Mechanical testing (static compression, static torsion, dynamic compression) according to ASTM F1717, demonstrating compliance with performance criteria for Spinal Plating Systems.

In summary, this document does not provide the information needed to answer your questions about the acceptance criteria and study proving an AI/ML device meets those criteria.

Summary

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March 18, 2022

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Evolution Spine % Todd Wallenstein VP Regulatory/Quality Evolution Spine 2300 N Haskell Ave Dallas. Texas 75204

Re: K220275

Trade/Device Name: Emerge Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: December 20, 2021 Received: February 3, 2022

Dear Todd Wallenstein:

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,

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) K220275

Device Name EMERGE™ Anterior Cervical Plate System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D)	□ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR §807.92, the following summary of information is provided:

Company:	Evolution Spine2300 N Haskell RdDallas, TX 75204
Contact:	Todd WallensteinEvolution Spine2300 N Haskell AveDallas, TX 75204Phone: 571-594-7409twallenstein@evolutionspine.com
Date Prepared:	March 16, 2022
Device Trade Name:Common Name:Classification:Class:Product Code:	EMERGE™ Anterior Cervical Plate SystemSpinal Plating System21 CFR §888.3060 Spinal Intervertebral Body Fixation OrthosisIIKWQ, Appliance, Fixation, Spinal Intervertebral Body
Primary Predicate:Additional Predicate:	EMERGE™ Anterior Cervical Plate System (K212405)Atlas Spine V3 Segmental Plating System (K182418)

Device Description:

Indications For Use:

The EMERGE™ Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (DDD) (defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors (primary and metastatic), deformity (kyphosis, lordosis or scoliosis), failed previous fusions (pseudarthrosis), spondylolisthesis, and spinal stenosis. The EMERGE™ Anterior Cervical Plate System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

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Substantial Equivalence:

The subject EMERGE™ Anterior Cervical Plate System possesses the same technological characteristics as the predicate devices. These include:

Same Intended Use,
Same Product Code, Class, and Classification, ●
. Design features,
Material,
Anatomic location,
Mechanical performance,
Dimensional attributes.

Therefore, the fundamental scientific technology of the EMERGE™ Anterior Cervical Plate System devices is the same as previously cleared devices.

Performance Data:

Testing on the EMERGE™ Anterior Cervical Plate System included static compression, static torsion, and dynamic compression per ASTM F1717. The results demonstrate that the EMERGE™ Anterior Cervical Plate is substantially equivalent to the performance criteria identified in Spinal Plating Systems -Performance Criteria for Safety and Performance Based Pathway Guidance document; FDA-2019-D-1647.

Conclusion:

Based on the indications for use, technological characteristics, performance testing, and comparison to predicate devices, the subject EMERGE™ Anterior Cervical Plate System has been shown to be substantially equivalent to legally marketed predicate devices.

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.