The DeGen Medical Hyper-C Anterior Cervical Plate system is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation. The Hyper-C Anterior Cervical Plate system is intended for anterior intervertebral screw fixation of the cervical spine at levels C2 to T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with following indications:
• Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
• Spinal Stenosis
• Trauma (i.e. fracture or dislocation)
• Deformity or curvatures (including scoliosis, kyphosis, or lordosis)
• Spinal Tumors
• Pseudoarthrosis or failed previous fusion
• Spondylolisthesis
• Decompression of the spine following total or partial cervical vertebrectomy

Device Description

The DeGen Medical Hyper-C Anterior Cervical Plate Systems consists of cervical plates and bone screws. All implants are intended to provide stabilization of the cervical vertebrae. The HACP provides anterior fixation from either fixed or variable angle construct in self-tapping or self-drilling bone screw options.

The system is provided in both sterile and non-sterile versions. The system is constructed from Titanium alloy (Ti-6Al-4V ELI) per ASTM F136.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "Hyper-C Anterior Cervical Plate System." This document is a regulatory approval letter and a summary of the device, not a study report demonstrating the device meets specific acceptance criteria through clinical or AI performance metrics.

Therefore, I cannot extract the information required to answer your questions as they pertain to the evaluation of an AI/ML-driven device or a medical imaging study. The document explicitly states:

Non-Clinical Performance Testing Conclusion: "Non-clinical testing was performed to demonstrate the DeGen Medical Hyper-C Anterior Cervical Plate System (HACP) is substantially equivalent to other predicate devices in accordance with "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004. The following tests were performed: Static and dynamic compression testing per ASTM F1717, Static torsion testing per ASTM F1717, Screw strength via ASTM F543, Push-out testing for Locking Screws."

This indicates that the device's performance was evaluated through mechanical and material testing (non-clinical), not studies involving image analysis, AI algorithms, human readers, or clinical outcomes that would generate the kind of data you're asking for.

The questions you've posed (e.g., sample size for test/training sets, experts for ground truth, MRMC study, standalone performance) are highly relevant for the assessment of AI/ML-enabled medical devices, especially those involved in diagnostic imaging or similar analytical tasks. However, the Hyper-C Anterior Cervical Plate System is a physical orthopedic implant, and its approval is based on demonstrating substantial equivalence to existing devices primarily through mechanical integrity and biocompatibility, as outlined in the non-clinical testing section.

In summary, the provided document does not contain the information needed to answer your questions because it describes the regulatory clearance of a physical medical implant, not an AI/ML diagnostic or image analysis system.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in a simple, flowing line style.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 28, 2015

DeGen Medical % Linda Braddon, Ph.D. President/Chief Executive Officer Secure BioMed Evaluations 7828 Hickory Flat Highway, Suite 120 Woodstock, Georgia 30188

Re: K150759

Trade/Device Name: Hyper-C Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWO Dated: June 25, 2015 Received: July 1, 2015

Dear Dr. Braddon:

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

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Page 2 - Linda Braddon, Ph.D.

(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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known)	K150759
K150759	Page 1 of 1
Device Name

Hyper-C Anterior Cervical Plate System

Indications for Use (Describe)

Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
Spinal Stenosis
· Trauma (i.e. fracture or dislocation)
Deformity or curvatures (including scoliosis, kyphosis, or lordosis)
Spinal Tumors
Pseudoarthrosis or failed previous fusion
Spondylolisthesis
Decompression of the spine following total or partial cervical vertebrectomy

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

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary of Safety and Effectiveness

In accordance with 21 CFR 807.87 (h) and 21 CRF 807.92, the 510(k) summary for the DeGen Medical HACP is provided below.

Date Summary Prepared	June 25, 2015
Manufacturer/Distributor/Sponsor	DeGen Medical1321-C North Cashua DriveFlorence, SC 29501Phone 877-240-7838Fax 843-407-0545
510(k) Contact	Secure BioMed EvaluationsLinda Braddon, Ph.D.7828 Hickory Flat HighwaySuite 120Woodstock, GA 30188770-837-2681LGB@SecureBME.com
Trade Name	Hyper-C Anterior Cervical Plate System
Common Name	Spinal intervertebral body fixation orthosis
Code -Classification	KWQ21 CFR 888.3060 : Class II
Primary Predicate	K142237 Stryker Aviator Anterior Cervical Plating System
Reference Devices	K083562 Stryker Aviator Anterior Cervical Plating SystemK971883 Synthes Small Stature Anterior Cervical Locking Plate SystemK030866, K031276, K926453, K945700 Synthes CSLPK052292 X-Spine Spider Cervical PlateK01387, K121658 Orthofix Hallmark Anterior Cervical Plate System
Device Description	The DeGen Medical Hyper-C Anterior Cervical Plate Systems consists ofcervical plates and bone screws. All implants are intended to providestabilization of the cervical vertebrae. The HACP provides anteriorfixation from either fixed or variable angle construct in self-tapping orself-drilling bone screw options.The system is provided in both sterile and non-sterile versions. Thesystem is constructed from Titanium alloy (Ti-6Al-4V ELI) per ASTM F136.
Indications for Use	The DeGen Medical Hyper-C Anterior Cervical Plate system is intended foruse as an aid in cervical spinal fusion and is intended for unilateralfixation. The Hyper-C Anterior Cervical Plate system is intended foranterior intervertebral screw fixation of the cervical spine at levels C2 toT1. The system is indicated for temporary stabilization of the anteriorspine during the development of cervical spine fusions in patients withfollowing indications:• Degenerative Disc Disease (as defined by neck pain ofdiscogenic origin with degeneration of the disc confirmed bypatient history and radiographic studies)• Spinal Stenosis• Trauma (i.e. fracture or dislocation)• Deformity or curvatures (including scoliosis, kyphosis, orlordosis)• Spinal Tumors• Pseudoarthrosis or failed previous fusion• Spondylolisthesis• Decompression of the spine following total or partial cervicalvertebrectomy
Technological Characteristics	As was established in this submission, the subject Hyper-C AnteriorCervical Plate System (HACP) is substantially equivalent to other predicatedevices cleared by the FDA for commercial distribution in the UnitedStates. The subject device was shown to be substantially equivalent andhas the same technological characteristics to its predicate devices throughcomparison in areas including design, intended use, material composition,function, and range of sizes.
Non-Clinical Performance TestingConclusion	Non-clinical testing was performed to demonstrate the DeGen MedicalHyper-C Anterior Cervical Plate System (HACP) is substantially equivalentto other predicate devices in accordance with "Guidance for Industry andFDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004. Thefollowing tests were performed:• Static and dynamic compression testing per ASTM F1717• Static torsion testing per ASTM F1717• Screw strength via ASTM F543• Push-out testing for Locking ScrewsThe results of these studies show the subject DeGen Medical Hyper-CAnterior Cervical Plate System (HACP) meets or exceeds the performanceof the predicate devices, and the device was therefore found to besubstantially equivalent.
Substantial EquivalenceSummary (Conclusion)	Based on the indications for use, technological characteristics,performance testing, and comparison to predicate devices, the subjectDeGen Medical Hyper-C Anterior Cervical Plate System (HACP) has beenshown to be substantially equivalent to legally marketed predicatedevices

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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.