The Amendia Cervical Interbody Fusion Devices are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level or two contiguous levels. DDD is defines as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The Amendia Cervical Interbody Fusion Devices are used to facilitate intervertebral body fusion in the C3 to C7 disc levels using autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage.

The Amendia Lumbar Interbody Fusion Devices are indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radios. These DDD patients may also have up to Grade I spondylolisthesis at the involved level. Amendia Lumbar Interbody Fusion Devices are to be used with autograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Device Description

The Amendia Interbody Fusion Devices consist of multiple components comprised of sterile and/or non-sterile, single-use implants fabricated from Titanium alloy (Ti6AI4V ELI, ASTM F136) or Invibio PEEK-Optima® LT1 or Solvay Advanced Polymers Zeniva™ ZA-500 PEEK (ASTM F2026) with tantalum (ASTM F560) x-ray markers. The Amendia Interbody Fusion Devices are used to provide structural stability and maintain disc space distraction in skeletally mature adults requiring intervertebral body fusion. They are designed to be used in conjunction with supplemental spinal fixation instrumentation.

The Amendia Interbody Fusion Devices are comprised of implants designed to treat the cervical and lumbar spine. The implants are available in a range of sizes and shapes to accommodate variations in surqical approach and patient anatomy. Each cage has a hollow center to allow placement of autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. Ridges on the superior and inferior surfaces of the device help to grip the endplates and prevent expulsion. The surface of the ridges on the titanium implants are roughened.

AI/ML Overview

The provided text is a 510(k) Summary for Amendia Interbody Fusion Devices, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study proving the device meets specific acceptance criteria through clinical performance metrics like sensitivity, specificity, or reader improvement.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC comparative effectiveness studies cannot be extracted from this document. This document primarily addresses the mechanical and material equivalence of the device to previously approved devices.

Here's what can be inferred about "acceptance criteria" in the context of this 510(k) and the "study" that proves it:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied for 510(k) Clearance): The primary acceptance criterion for a 510(k) submission is demonstrating substantial equivalence to a predicate device. This is typically achieved by showing similar intended use, indications for use, materials, performance (mechanical), and fundamental scientific technology.
Reported Device Performance: The document states: "The substantial equivalence of the Amendia Lumbar Interbody Fusion Devices to the predicate is shown by similarity in intended use, indications for use, materials, performance and fundamental scientific technology."
- Performance aspects mentioned (though no specific numerical criteria or results are given): The device is made of specific materials (Titanium alloy, PEEK, Tantalum), has various sizes/shapes, a hollow center for bone graft, and ridges for gripping endplates. "Performance testing" is mentioned, implying mechanical and material characterization, but no results are provided.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable/Not provided. Clinical performance testing on a test set (as would be done for an AI device) is not detailed in this document. The "test set" here refers to the device itself and its components undergoing mechanical/material testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not provided. Ground truth establishment by clinical experts for a performance study is not described.

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

Not applicable/Not provided.

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/Not provided. This is a medical device (interbody fusion device), not an AI diagnostic/imaging device that would typically undergo MRMC studies.

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

Not applicable/Not provided. This is a physical medical device.

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

For the purpose of substantial equivalence, the "ground truth" would be the established performance and safety profile of the predicate devices, along with adherence to relevant ASTM standards for material and mechanical properties. No clinical ground truth is discussed.

8. The sample size for the training set

Not applicable/Not provided. The document does not describe a machine learning algorithm or training set.

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

Not applicable/Not provided.

In summary: This document focuses on demonstrating substantial equivalence for a physical medical implant (Interbody Fusion Device) based on its design, materials, and mechanical properties compared to already cleared predicate devices. It does not present clinical performance data or details about studies that would evaluate diagnostic accuracy or compare human reader performance, which are typical for AI/software devices. The "studies" implied are likely non-clinical (e.g., bench testing for mechanical properties, material biocompatibility, etc.) to show consistency with predicate devices and relevant standards.

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 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, creating a sense of depth and unity.

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

November 8, 2016

Amendia, Inc. Chelsea Proffitt Regulatory Affairs Specialist 1755 West Oak Parkway Marietta, Georgia 30062

Re: K160924

Trade/Device Name: Amendia Interbody Fusion Devices Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, ODP Dated: October 12, 2016 Received: October 13, 2016

Dear Chelsea Proffitt:

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 (reporting of medical devicerelated 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.

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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

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Indications for Use

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

K160924

Page 1 of 1

510(k) Number (if known)

K160924

Device Name Amendia Interbody Fusion Devices

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.

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510(k) Summary

Amendia Interbody Fusion Devices

Submitter:	Amendia, Inc.1755 W. Oak ParkwayMarietta, GA 30062
Contact Person:	Chelsea ProffittRegulatory Affairs Specialist770-575-5181 (W), 877-420-1213 (F)cproffitt@amendia.com (e-mail)
Date Prepared:	November 4, 2016
Trade Name:	Amendia Interbody Fusion Devices
Common Name:	Intervertebral body fusion device
Device Product Codeand Classification:	MAX, 888.3080, Class II, Intervertebral FusionDevice with Bone Graft, Lumbar
	ODP, 888.3080, Class II, Intervertebral FusionDevice with Bone Graft, Cervical
Predicate Device:	Amendia Interbody Fusion Devices (K151322)
Additional Predicate Devices:	Amendia Interbody Fusion Devices (K151310)Talos Intervertebral Body Fusion Devices, Talos-CCervical Intervertebral Body Fusion Device, Talos-C(HA) Cervical Intervertebral Body Fusion Devices(K150788)

Device Description:

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Indications and Intended use:

The Amendia Cervical Interbody Fusion Devices are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level or two contiquous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The Amendia Cervical Interbody Fusion Devices are used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage.

The Amendia Lumbar Interbody Fusion Devices are indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level. Amendia Lumbar Interbody Fusion Devices are to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

Summary of Technological Characteristics:

The subject device is substantially equivalent to the predicate devices as well as other similar devices cleared by FDA for commercial distribution in the United States. The Subject Device is equivalent to the predicates in regards to technological characteristics including design, intended use, material composition, and function.

Summary of Performance Testing:

The substantial equivalence of the Amendia Lumbar Interbody Fusion Devices to the predicate is shown by similarity in intended use, indications for use, materials, performance and fundamental scientific technology.

Conclusion:

Based on the comparison to predicate devices, the Subject Device has been shown to be substantially equivalent to legally marketed predicate devices.

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.