degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

Device Description

Rex Cervical Plate System consists of a variety of shapes and sizes of Main Plates, screw, sub-plate, rivets and the associated instruments. The sub-plate is pre-assembled to the main plate and designed to prevent screws from backing out using the elastic behavior during the screw insertion. The rivets are also pre-assembled to the main plate and designed to assemble the sub-plate to the main plate firmly. Each component is subjected to a color anodizing process to differentiate the screw type and diameter and to make the surgical process easy. The plates range in length to accommodate one, two, three, and four level procedures. Main plate are available from 20mm to 110mm. Screws are available in lengths from 10mm to 20mm in 2mm increments. The screws have either a 3.5mm or 4.0mm diameter. They are fixed self-tapping, Variable self-tapping screw, fixed self-drilling screw, Variable self-drilling and are available in lengths ranging from 10mm to 20mm in 2mm increments

The Rex Cervical Plate System components are supplied non-sterile, are single use and are fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F 136.

AI/ML Overview

The provided text is a 510(k) summary for the Rex Anterior Cervical Plate System. It describes the device, its intended use, and its performance data, primarily focusing on its substantial equivalence to predicate devices.

However, the document does not contain information related to a study proving the device meets acceptance criteria in the context of AI/ML performance, such as sensitivity, specificity, or F1 score. The performance data mentioned refers to mechanical tests (static compression, torsion, and fatigue) performed according to ASTM F1717 to characterize the physical properties of the cervical plate components.

Therefore, I cannot fulfill the request for information on acceptance criteria and study details related to AI/ML device performance. The document focuses on regulatory approval for a physical medical device based on material, design, and operational principles, and substantial equivalence to existing predicate devices.

Here's what I can extract from the provided text, acknowledging the lack of AI-specific performance data:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Mechanical Performance	Static Compression	Performed per ASTM F1717
	Torsion	Performed per ASTM F1717
	Fatigue	Performed per ASTM F1717
Material	Titanium alloy (Ti-6AI-4V ELI) conforms to ASTM F 136	Conforms to ASTM F 136
Design	-	Substantially equivalent to predicate devices (K061002, K061274)
Operational Principles	-	Substantially equivalent to predicate devices (K061002, K061274)
Intended Use	Anterior fixation to the cervical spine for various conditions	Substantially equivalent to predicate devices (K061002, K061274)

Regarding the other requested information, there is no mention in the provided text for:

Sample size for the test set or training set.
Data provenance (country of origin, retrospective/prospective).
Number of experts or their qualifications for ground truth establishment.
Adjudication method for the test set.
MRMC comparative effectiveness study or effect size of AI assistance.
Standalone algorithm performance.
Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for any AI/ML model.
How ground truth for the training set was established.

This document is a 510(k) summary for a spinal implant, which is a hardware device, not an AI/ML software device. The "performance data" refers to the physical and mechanical characteristics of the plate system.

Summary

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510(k) Summary

Submitter: DIO Medical Co., Ltd. Sung-Hee Lee 103~105 Megacenter, SK Technopark 190-1 Sangdaewon-dong, Jungwon-guSungnam-si Kyunggi-do, South Korea Phone: 82-31-776-3690 Fax: 82-31-776-3691

Official Correspondent: Kodent Inc. April Lee 325 N. Puente St. Unit B Brea CA 92821 Email: kodentinc@gmail.com Phone: 714-525-0114 Fax: 714-525-0116

Device Information

Trade Name: Common Name: Classification Name: Product Code: Regulation Number: Date prepared:

Rex Anterior Cervical plate System Anterior cervical plate system Spinal intervertebral body fixation orthosis KWO 888.3060 10/12/2012

General Description

The Rex Cervical Plate System components are supplied non-sterile, are single use and are fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F 136.

Indication for Use

The REX Anterior Cervical Plate System is intended for anterior fixation to the cervical spine. The specific clinical indications include:

K121802

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K121 862

page 2 of 2

Performance Data:

Performance tests per ASTM F1717 such as static compression, torsion, and fatigue were performed to characterize the subject Rex Cervical System components addressed in this notification.

Predicate Devices:

The subject device is substantially equivalent to the following predicate devices:

*U&I corporation, Maxima "M Anterior Cervical Plate System (K061002)

Medtronic Sofamor Danek, VENTURE™ Anterior Cervical Plate System (K061274)

Comparison to Predicate Devices:

The Substantial equivalence of this device is based on equivalence in intended use, material, designs, and operational principles to the predicate devices, Maxima™ Anterior Cervical Plate System (K061002) by U&I Coporation and VENTURE™ Anterior Cervical Plate System (K061274) by Medtronic Sofamor Danek.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around it. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with stylized wings and tail feathers.

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

OCT 3 1 2012

DIO Medical Company, Limited % Kodent, Incorporated Ms. April Lee 325 North Puente Street, Unit B Brea, California 92821

Re: K121862

Trade/Device Name: Rex 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: October 15, 2012 Received: October 17, 2012

Dear Ms. Lee:

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 for associated 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 r ou may , ater sever sisions 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 r hat 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

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Page 2 - Ms. April Lee

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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

For

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

Enclosure

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Indication for Use

K121 862

510(K) Number (if known):

Device Name: RexAnterior Cervical plate system

Indication for Use:

The REX Anterior Cervical Plate System is intended for anterior fixation to the cervical spine. The specific clinical indications include:

degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

Prescription Use

AND/OR Over-The-Counter

(Part 21 CFR 801 Subpart D)

. (Per 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

(Division Sign-Oit) Division of Surgical. Orthopedic, and Restorative Devices

KI 21 86 Z 510(k) Number_

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.