The Genesys Spine Anterior Cervical Plate system is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e. fractures or dislocations), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, failed previous fusion, and/or spinal stenosis.

Device Description

The Genesys Spine Anterior Cervical Plate System is indicated for temporary stabilization of the cervical spine during the development of solid spinal fusion. The system consist of multiple sizes (lengths) of plates, and screws that are to be inserted into the anterior surface of adjacent cervical vertebrae. The proposed device is applied after discectomy and insertion of either an autograft material in the interbody space, and acts to stabilize the spine during fusion. The plates are offered in 1, 2, 3, and 4 level constructs in various lengths to accommodate a variety of patient anatomies. Each plate has a pre-bent sagittal and lordotic curve as well as posterior ridges to aid in the placement. Fixation is achieved by inserting bone screws through the openings in the plate into the vertebral bodies of the cervical spine. The bone screws are offered in lengths of 10, 12, 14, and 16mm. The screws are offered in a Fixed or Variable angle option. The fixed screw has a larger 'neck' outer diameter that engages with the plate thereby limiting the conical rotation of the screw while the variable screw 'neck' outer diameter which allows for 24 degrees of motion during screw insertion. This feature will allow the surgeon more flexibility when inserting and seating the screws. The screws are offered in four (4) colors based on fixed or variable geometry or 3.75mm or 4.25mm OD. The plates include a nitinol securement tab, preassembled to the plate that covers the heads of the bone screws on the lateral sides to reduce the potential for screw backout. Additionally, there is a ratcheting feature that provides an audible and tactile feel for the surgeon population during insertion.

AI/ML Overview

Here's an analysis of the provided text regarding the Genesys Spine Anterior Cervical Plate System, focusing on acceptance criteria and supporting studies.

Important Note: The provided document is a 510(k) premarket notification for a medical device. This type of submission primarily focuses on demonstrating substantial equivalence to a previously marketed (predicate) device, rather than proving novel clinical efficacy or establishing specific performance metrics against a predefined acceptance criterion in the way a clinical trial for a new drug or a more complex diagnostic algorithm might. Therefore, many of the requested categories (like "effect size of human readers improved with AI," "standalone algorithm performance," "sample size for training set," etc.) are not applicable to this type of device and submission.

Acceptance Criteria and Supporting Study for Genesys Spine Anterior Cervical Plate System

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated Goal)	Reported Device Performance
Substantial equivalence to predicate devices (general)	Demonstrated substantial equivalence through nonclinical testing (static compression bending, static torsion, dynamic compression bending, finite element analysis, material property analysis, design verification).
Meet ASTM F1717 standards for worst-case construct	Testing performed on worst-case construct per ASTM F1717; results demonstrate substantial equivalence to predicate device.

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

Sample Size for Test Set: Not applicable in the context of this 510(k) submission. The testing was focused on device mechanics rather than patient-specific data or clinical outcomes. The "test set" here refers to the physical constructs tested (e.g., worst-case construct).
Data Provenance: Not applicable for patient data. The data originates from nonclinical, benchtop mechanical testing performed by or for Genesys Spine.

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

Number of Experts: Not applicable. Ground truth for mechanical testing is established by engineering principles, industry standards (like ASTM F1717), and material science, not by expert medical consensus on individual cases.
Qualifications of Experts: Not applicable. The "experts" would be the engineers and technicians conducting the ASTM F1717 physical testing and FEA.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. Mechanical test results (e.g., force, displacement, cycles to failure) are objective measurements, not subject to human adjudication in the way clinical diagnoses or image interpretations are.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study Done: No. This is a mechanical surgical implant, not an imaging or diagnostic AI device that would utilize MRMC studies.
Effect Size of Human Readers Improve with AI vs. Without AI Assistance: Not applicable.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

Standalone Study Done: Not applicable. This device does not involve an algorithm, AI, or software for clinical decision-making. The "standalone performance" is the mechanical performance of the physical device itself. The nonclinical testing evaluates the device's mechanical integrity and behavior.

7. Type of Ground Truth Used

Type of Ground Truth: The ground truth for this device's "performance" is based on established engineering principles, material science properties, and adherence to recognized industry standards (like ASTM F1717) for spinal implant mechanical testing. The goal is to show that the device performs mechanically at least as well as its predicate devices under specified test conditions.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This device does not use machine learning or AI, and therefore has no "training set."

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

How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for this type of device.

Summary of Device Performance and Equivalence Claim:

The Genesys Spine Anterior Cervical Plate System demonstrated substantial equivalence to its predicate devices (Synthes Anterior CSLP System, Venus Anterior Cervical Plate Systems, Spider Cervical Plating System, Trestle Anterior Cervical Plating System, and SmartLox Anterior Cervical Plate) through a series of nonclinical biomechanical tests. These tests included:

Static compression bending
Static torsion
Dynamic compression bending

All these tests were performed on the "worst-case construct" as per the requirements of ASTM F1717. Additionally, finite element analysis (FEA) and material property analysis, along with design verification results, further supported the claim of substantial equivalence. The document explicitly states that "Clinical data and conclusions were not needed for this device," indicating that the nonclinical data was sufficient for the 510(k) clearance based on substantial equivalence.

Summary

{0}------------------------------------------------

k////32

DEC - 9 2011

Genesys Spine Anterior Cervical Plate System

Premarket Notification

SUBMITTED BY

Genesys Spine 1250 Capital of Texas Highway South Building Three, Suite 600 Austin, TX 78746

ESTABLISHMENT REGISTRATION NUMBER 3008455034

OWNER/OPERATOR NUMBER

10033848

NUMBER

CONTACT PERSON

Primarv: Brian J. Bergeron VP of Engineering Genesys Spine Phone: (512) 381-7071 Fax: (800) 817-4938

Alternate: William Sowers VP of Quality & Regulatory Genesys Spine Phone: (512) 381-7070 Fax: (800) 817-4938

DATE PREPARED

9 September 2011

CLASSIFICATION NAME / Spinal Intervertebral Body Fixation Orthosis. REFERENCE / PRODUCT CODE 21 CFR § 888.3060, KWQ

DEVICE CLASS

PREDICATE DEVICES

Class II

COMMON NAME Spinal Fixation System

PROPRIETARY NAME

Genesys Spine Anterior Cervical Plate System

The Genesys Spine Anterior Cervical Plate System was determined to be substantially equivalent to the Synthes Anterior CSLP System [Synthes Spine, K000536 / K9457001, Venus Anterior Cervical Plate Systems [Verticor LTD, K103137], Spider Cervical Plating System [X-Spine Systems, K052292], Trestle Anterior Cervical Plating System [Alphatec, K102820], and SmartLox Anterior Cervical Plate [Captiva].

1250 Capital of Texas Highway South Building Three, Suite 600 Austin, Texas 78746

Genesys Spine

Phone: (512) 381-7071 Fax: (800) 817-4938

eg l of a

{1}------------------------------------------------

KII1122

DEVICE DESCRIPTION

INDICATIONS:

TEST DATA:

Static compression bending, static torsion, and dynamic compression bending were performed on the worst case construct per ASTM F1717. Test results demonstrate that the Genesys Spine Anterior Cervical Plate System is substantially equivalent to the predicate device.

PERFORMANCE DATA (NONCLINICAL AND/OR CLINICAL):

NONCLINICAL PERFORMANCE AND CONCLUSION: Finite element and material property analysis as well as design verification results demonstrate that the proposed device is substantially equivalent to the predicate device.

CLINICAL PERFORMANCE AND CONCLUSIONS: Clinical data and conclusions were not needed for this device.

1250 Capital of Texas Highway South Building Three, Suite 600 Austin, Texas 78746

Genesys Spine

hone: (512) 381-7071 Fax: (800) 817-4938

pcr l of:

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird in flight, composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

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

DEC - 9 2011

Genesys Spine % Mr. Brian J. Bergeron Vice President of Engineering 1250 Capital of Texas Highway South Building Three, Suite 600 Austin, Texas 78746

Re: K111132

Trade/Device Name: Genesys Spine 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 01. 2011 Received: December 02, 2011

Dear Mr. Bergeron:

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.

{3}------------------------------------------------

Page 2 - Mr. Brian J. Bergeron

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); good manufacturing practice requirements as set forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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

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

Enclosure

{4}------------------------------------------------

INDICATIONS FOR USE

510(k) Number (if known): K111132

Device Name:

Genesys Spine Anterior Cervical Plate System

Indications for Use:

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-C)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number__ KIII32

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.