Valeo™ Spacer System-C and Valeo™ II Interbody Fusion Device System -Cervical are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level or two contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Valeo™ Spacer System-C and Valeo™ II Interbody Fusion Device System -Cervical are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach from the C2-C3 disc space to the C7-T1 disc space using autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Valeo™ Spacer System-C and Valeo™ II Interbody Fusion Device System -Cervical are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

Valeo™ System-L and Valeo™ II Interbody Fusion Device System - Lumbar are indicated for use with autograft bone graft in patients with DDD at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Valeo™ Spacer System-L and Valeo™ II Interbody Fusion Device System - Lumbar are intended to be used with supplemental spinal fixation systems, such as Preference Pedicle Screw System. Patients should be skeletally mature and have six months of non-operative therapy prior to treatment with an intervertebral cage.

Device Description

The Valeo™ Spacer System and Valeo™ II Interbody Fusion Device System devices consist of a variety of hollow intervertebral body spacers featuring convex, bullet nose design and an axial void designed to hold bone graft material per the indications stated above. The subject device is offered in various geometries to accommodate different surgical approaches and vertebral body dimensions. The subject devices are designed with angular teeth to allow the implant to grip the superior and inferior end plates, thus allowing expulsion resistance. The Valeo™ Spacer System-C and Valeo™ II Interbody Fusion Device System -Cervical is manufactured from MC2 ceramic material (silicon nitride), and is provided sterile.

The purpose of the subject 510(k) was to expand the indications of the Valeo™ Spacer System-C and Valeo™ II Interbody Fusion Device System -Cervical devices to include use with allograft and use at two contiguous levels from C2/C3 to C7/T1.

AI/ML Overview

This is a 510(k) premarket notification for a medical device, the Valeo™ Spacer System and Valeo™ II Interbody Fusion Device System. This type of document is used to demonstrate that the device is substantially equivalent to a legally marketed predicate device, and thus does not typically contain efficacy studies or performance criteria in the way a pharmaceutical approval or a novel medical device approval might.

Therefore, the requested information regarding acceptance criteria, device performance, study details (sample sizes, ground truth, expert involvement, adjudication, MRMC studies, standalone performance), and training set information is generally not applicable to this type of regulatory submission.

The document primarily focuses on establishing "substantial equivalence" based on indications for use, design, and performance compared to a predicate device, rather than proving the device meets specific quantitative performance criteria through a dedicated study.

Here's what can be extracted based on the document's content, and where information is not present:

1. Table of acceptance criteria and the reported device performance:

Not Applicable. This document does not present quantitative acceptance criteria or detailed performance metrics from a study designed to prove such criteria. The "performance" mentioned is in the context of demonstrating similarity to a predicate device.

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. No specific test set or study data is presented to evaluate the device against pre-defined performance criteria. The submission relies on a "comprehensive clinical literature review" to assess additional safety concerns for expanded indications, not a direct study of the device.

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. As no specific "test set" with ground truth determination is mentioned, this information is not provided. The review of existing literature would implicitly involve expert knowledge, but not in the structured way of establishing ground truth for a device performance study.

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

Not Applicable. No test set or direct adjudication process for device performance is described.

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 device is an intervertebral body fusion device, not an AI-powered diagnostic or assistive technology for human readers. Therefore, an MRMC study related to AI assistance is irrelevant and not performed.

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

Not Applicable. This is a physical medical implant, not an algorithm. Standalone performance as an algorithm is not relevant.

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

Not Applicable. As no direct study on the device's performance against a ground truth is reported in this 510(k), this information is not available. The submission's argument for substantial equivalence relies on existing knowledge and a literature review.

8. The sample size for the training set:

Not Applicable. This device does not involve a "training set" in the context of machine learning or algorithm development.

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

Not Applicable. This device does not involve a "training set" or "ground truth" establishment in the context of machine learning.

Summary of what the document DOES state:

Purpose of current 510(k): To expand the indications for use of the Valeo™ Spacer System-C and Valeo™ II Interbody Fusion Device System -Cervical devices to include use with allograft and use at two contiguous levels (C2/C3 to C7/T1).
Predicate Device: ANATOMIC PEEK™ Cervical FUSION SYSTEM (K130177).
Basis for Substantial Equivalence: The Valeo™ system is similar in design and indicated use to the predicate. A "comprehensive clinical literature review" was conducted to assess any additional safety concerns for the expanded indications (use with allograft and at two contiguous levels). The conclusion was that there were no additional risks, and the device was substantially equivalent.

In essence, this document is a regulatory filing demonstrating equivalence, not a detailed clinical study report with performance metrics against predefined acceptance criteria.

Summary

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

December 8, 2014

Amedica® Corporation % Justin Eggleton Director, Spine Regulatory Affairs Musculoskeletal Clinical Regulatory Advisors, LLC 1331 H Street, Northwest 12th Floor Washington DC, 20005

Re: K142264

Trade/Device Name: Valeo™ Spacer System, Valeo™ II Interbody Fusion Device System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP, MAX Dated: September 8, 2014 Received: September 9, 2014

Dear Mr. Eggleton:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Justin Eggleton

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 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 vours.

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

510(k) Number (if known) K142264

Device Name

Valeo™ Spacer System and Valeo™ II Interbody Fusion Device System

Indications for Use (Describe)

Valeo™ Spacer System-C and ValerM II Interbody Fusion Device System -Cervical are indicated for use in sketally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level or two contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Valeo™ Spacer System-C and Valeo™ II Interbody Fusion Device System -Cervical are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach from the C2-C3 disc space to the C7-T1 disc space using autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Valeo™ System-C and Valeo™ II Interbody Fusion Device System -Cervical are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

Valeo™ Spacer System-L and Valeo™ II Interbody Fusion Device System - Lumbar are indicated for use with autograft bone graft in patients with DDD at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Valeo™ Spacer System-L and Valeo™ II Interbody Fusion Device System - Lumbar are intended to be used with supplemental spinal fixation systems, such as Preference Pedicle Screw System. Patients should be skeletally mature and have six months of non-operative therapy prior to treatment with an intervertebral cage.

Type of Use (Select one or both, as applicable)

ال Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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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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:

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510(k) Summary

Device Trade Name:	Valeo™ Spacer System (Valeo™ Spacer System –C and Valeo™Spacer System –L)Valeo™ II Interbody Fusion Device System (Valeo™ II InterbodyFusion Device System -Cervical and Valeo™ II Interbody FusionDevice System – Lumbar)
Manufacturer:	AMEDICA® Corporation1885 West 2100 SouthSalt Lake City, UT 84119Phone: (855) 839-3500
Contact:	Mr. William D. JordanSenior Director Regulatory Affairs and Quality Assurance
Prepared by:	Mr. Justin EggletonMusculoskeletal Clinical Regulatory Advisers, LLC1331 H Street NW, 12th FloorWashington, DC 20005Phone: (202) 552-5800jeggleton@mcra.com
Date Prepared:	December 5, 2014
Classifications:	21 CFR §888.3080, Intervertebral Body Fusion Device
Class:	II
Product Codes:	MAX, ODP

Indications For Use:

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Device Description:

Predicate Device:

The modifications to the Valeo™ Spacer System and Valeo™ II Interbody Fusion Device System are substantially equivalent to the predicate ANATOMIC PEEK™ Cervical FUSION SYSTEM (K130177) with respect to indications, design, and performance.

Substantial Equivalence:

The Valeo™ Spacer System and Valeo™ II Interbody Fusion Device System and predicate ANATOMIC PEEK™ Cervical FUSION SYSTEM are similar in design and indicated use, and are both cleared devices. They do differ in that the ANATOMIC PEEK "" is indicated for use with allogenic bone graft. A comprehensive clinical literature review was conducted to assess any additional safety concern for the use of this device at two cervical levels with the use of allograft. The review of the literature concluded that there were no additional risks due to the modification of indications for this device and that the device was substantially equivalent to the predicate device.

Conclusion:

This 510(k) was submitted on behalf of the Valeo™ Spacer System and Valeo™ II Interbody Fusion Device System (cervical interbody cages only) to expand the indications for use to include use with allograft and use at two contiguous levels from C2/C3 to C7/T1. Substantial equivalence was determined in response to sufficient comparisons to a predicate device.

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.