The Amendia Cervical Plate System is intended for use in anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion. These implants have been designed to provide stabilization for the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fractures or dislocations), spinal stenosis, deformity (i.e. kyphosis, lordosis or scoliosis), tumor, pseudoarthosis or failed previous fusion.

Device Description

The Amendia Cervical Plate System is a multiple component system comprised of non-sterile, single-use implantable components fabricated from Titanium alloy (Ti-6Al-4V, ASTM F136). The Amendia Cervical Plate System provides stabilization of cervical segments of the spine. The system consists of self-tapping/self-drilling screws and plates. Screws are available in a variety of diameter and length combinations. Plates are available in a variety of lengths.

AI/ML Overview

This document describes the Amendia Cervical Plate System, a medical device. However, this document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way typically expected for AI/ML-based medical devices.

Instead, this is a 510(k) premarket notification for a traditional medical device (a cervical plate system) where substantial equivalence to a predicate device is being demonstrated. Therefore, most of the requested information (sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, ground truth types) is not applicable to this type of submission.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Explicitly Stated in Document)	Reported Device Performance (Explicitly Stated in Document)
Not applicable. The document does not specify quantitative performance acceptance criteria (e.g., sensitivity, specificity, accuracy) for the device.	Not applicable. The document states "The Subject Device was shown to be identical to the predicate device in terms of design, intended use, performance specifications, material specifications, and technological characteristics." and "Based on the comparison to predicate devices and performance testing, the Amendia Cervical Plate System has been shown to be substantially equivalent to the legally marketed predicate device." It doesn't provide specific device performance metrics against predefined acceptance criteria.

Acceptance Criteria (Explicitly Stated in Document)

Reported Device Performance (Explicitly Stated in Document)

Not applicable. The document does not specify quantitative performance acceptance criteria (e.g., sensitivity, specificity, accuracy) for the device.

Not applicable. The document states "The Subject Device was shown to be identical to the predicate device in terms of design, intended use, performance specifications, material specifications, and technological characteristics." and "Based on the comparison to predicate devices and performance testing, the Amendia Cervical Plate System has been shown to be substantially equivalent to the legally marketed predicate device." It doesn't provide specific device performance metrics against predefined acceptance criteria.

Explanation: In a 510(k) for a traditional device like this, the "acceptance criteria" generally revolve around demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is often achieved through comparative testing (e.g., mechanical, biocompatibility) rather than clinical performance metrics related to diagnostic accuracy or treatment efficacy as would be seen in an AI/ML context. The document mentions "performance testing" but does not detail the specific tests, their acceptance criteria, or the results.

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

Sample Size for Test Set: Not applicable. This document does not describe a test set for evaluating diagnostic or predictive performance in the context of AI/ML. The "testing" referred to is likely engineering/mechanical testing to ensure the device meets its design specifications and is comparable to the predicate.
Data Provenance (country of origin, retrospective/prospective): Not applicable.

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

Not applicable. Ground truth as typically understood for AI/ML performance evaluation (e.g., expert consensus on image findings) is not relevant to this submission for a traditional spinal implant.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable.

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:

Not applicable. This is not an AI-assisted device.

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

Not applicable. This is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable. For a traditional medical device like a spinal plate, the "ground truth" for demonstrating safety and effectiveness often comes from engineering standards, material properties, and potentially clinical literature or experience with similar predicate devices, rather than a diagnostic 'ground truth'.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable.

In summary: The provided document is a 510(k) clearance letter and summary for a traditional medical device (spinal implant). It establishes substantial equivalence to a predicate device based on design, intended use, materials, and "performance specifications." It does not involve AI/ML technology, and therefore, the questions about acceptance criteria, study design, sample sizes, and expert adjudication for AI/ML performance evaluation are not relevant to this specific document.

Summary

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

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 text "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.

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

October 15, 2015

Amendia, Incorporated Ms. Kristen Allen Senior Regulatory Affairs Specialist 1755 West Oak Parkway Marietta, Georgia 30062

Re: K152455

Trade/Device Name: Amendia Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: August 27, 2015 Received: August 28, 2015

Dear Ms. Allen:

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 (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set

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

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/ResourcesforYou/Industry/default.htm. 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

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

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

Indications for Use

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

K152455

Page 1 of 1

510(k) Number (if known)

K152455

Device Name Amendia Cervical Plate System

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

510(k) Summary

Amendia Cervical Plate System

Submitter:	Amendia, Inc.1755 W. Oak ParkwayMarietta, GA 30062
Contact Person:	Kristen AllenSr. Regulatory Affairs Specialist910-612-4153 (P), 877-420-1213 (F)kallen@amendia.com (e-mail)
Date Prepared:	August 27, 2015
Trade Name:	Amendia Cervical Plate System
Common Name:	Spinal Intervertebral body fixation orthosis
Device Product Codeand Classification:	KWQ, Class II (§888.3060)
Primary Predicate:	Zavation Cervical Plate System (K130030)

Device Description:

Indications and Intended use:

The Amendia Cervical Plate System is intended for use in anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion. These implants have been designed to provide stabilization for the treatment of the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fractures or dislocations), spinal stenosis, deformity (i.e. kyphosis, lordosis or scoliosis), tumor, pseudoarthosis or failed previous fusion.

Summary of Technological Characteristics:

The Amendia Cervical Plate System is substantially equivalent to predicate devices cleared by FDA for commercial distribution in the United States. The Subject Device was shown to be identical to the predicate device in terms of design, intended use, performance specifications, material specifications, and technological characteristics.

Summary of Performance Testing:

The substantial equivalence of the Subject Device to the predicate is shown by both having the same intended use, indications for use, materials, and performance specifications. A risk analysis

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

Image /page/4/Picture/0 description: The image shows the logo for Amendia. The logo features the word "AMENDIA" in a sans-serif font, with the "A" in a blue square. Below the word "AMENDIA" is the tagline "creating balanced solutions" in a smaller font. The logo is simple and modern, and the blue color gives it a sense of trust and reliability.

was performed, which demonstrated that the subject device does not introduce new issues of safety or effectiveness.

Conclusion:

Based on the comparison to predicate devices and performance testing, the Amendia Cervical Plate System has been shown to be substantially equivalent to the legally marketed predicate device.

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.