The VALEO® C+CSC with Lumen Interbody Fusion Device is 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® C+CSC with Lumen Interbody Fusion Device is 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® C+CSC with Lumen Interbody Fusion Device is to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage.

Device Description

The Valeo® C+CSC with Lumen Interbody Fusion Device consists of cervical spine interbody fusion devices, as well as instrumentation designed specifically for the implantation of these implants. The Valeo C+CSC with Lumen is manufactured from Amedica's Silicon Nitride ceramic material and is provided sterile.

AI/ML Overview

This document describes the Valeo® C+CSC with Lumen Interbody Fusion Device and its acceptance criteria, focusing on performance and biocompatibility testing to demonstrate substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for each test are implicitly set by the "PASS" result, meaning the device met all applicable requirements of the specified standards.

Test / Biological Endpoint	Standard	Acceptance Criteria (Implicit)	Reported Device Performance
Mechanical Testing
Static Compression	ASTM F2077	PASS (meet standard req.)	PASS
Dynamic Compression	ASTM F2077	PASS (meet standard req.)	PASS
Static Torsion	ASTM F2077	PASS (meet standard req.)	PASS
Dynamic Torsion	ASTM F2077	PASS (meet standard req.)	PASS
Subsidence	ASTM F2267	PASS (meet standard req.)	PASS
Expulsion	ASTM F2267	PASS (meet standard req.)	PASS
Biocompatibility Evaluations
Cytotoxicity	ISO 10993-5:1999	PASS (meet standard req.)	PASS
Maximization Sensitization	ISO 10993-10:2002	PASS (meet standard req.)	PASS
ISO Intracutaneous Extract	ISO 10993-10:2002	PASS (meet standard req.)	PASS
ISO Systemic Toxicity Study	ISO 10993-11:2006	PASS (meet standard req.)	PASS
Genotoxicity	ISO 10993-3:2003	PASS (meet standard req.)	PASS
ISO Muscle Implantation Study	ISO 10993-6:1994	PASS (meet standard req.)	PASS
System Toxicity	ISO 10993-11:2006	PASS (meet standard req.)	PASS
Bacterial Endotoxin Testing (LAL assay)	ANSI/AAMI ST72:2011	PASS (meet standard req.)	PASS

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

The document does not explicitly state the sample sizes used for each specific test in the performance testing. It only states that "Testing performed on this device indicates that the Valeo C+CsC with Lumen Device is substantially equivalent to the Valeo Spacer System-C devices cleared under K142264. ASTM F2077 and ASTM F2267 performance standards were adhered to and all applicable requirements were met. Any deviations to the standards are noted at appropriate sections." This implies that the sample sizes were in accordance with the specified ASTM and ISO standards for mechanical and biocompatibility testing, respectively.

Data provenance: The tests were conducted internally or by a contracted lab to meet regulatory requirements for a medical device cleared in the U.S.

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

This type of testing (mechanical and biocompatibility) does not typically involve human experts establishing "ground truth" in the same way clinical studies or diagnostic AI evaluation would. The "ground truth" is established by the specifications and acceptance criteria defined within the ASTM and ISO standards themselves. Compliance is verified by technical experts in materials science, biomechanics, and toxicology. The document does not specify the number or qualifications of these technical experts.

4. Adjudication Method for the Test Set

Not applicable for this type of performance and biocompatibility testing. Results are determined by adherence to established test protocols and comparison against pre-defined acceptance criteria within the standards.

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 a premarket notification for an interbody fusion device, not a diagnostic or AI-powered device that involves human readers.

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 a software algorithm.

7. The Type of Ground Truth Used

The ground truth for the performance testing is based on:

Engineering Standards: Established criteria within ASTM F2077 (for mechanical testing) and ASTM F2267 (for subsidence and expulsion).
Biocompatibility Standards: Established criteria within ISO 10993 series (various parts) and ANSI/AAMI ST72:2011 (for bacterial endotoxin testing).
Compliance with these standards forms the basis for demonstrating safety and effectiveness for a physical implant.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical implant, not an AI model that requires a training set.

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

Not applicable.

Summary

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March 5, 2018

Amedica Corporation Shanna Ryan Regulatory Affairs Project Manager 63 East 11400 South 192 Sandy, Utah 84070

Re: K173453

Trade/Device Name: Valeo® C+CSC with Lumen Interbody Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: February 3, 2018 Received: February 5, 2018

Dear Ms. Ryan:

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

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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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Katherine D. Kavlock -S

for 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)

K173453

Device Name

Valeo® C+CSC with Lumen Interbody Fusion Device

Indications for Use (Describe)

Valeo® C+CSC with Lumen Interbody Fusion Device is used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach from the C2-C3 disc space using autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.

VALEO® C+CSC with Lumen Interbody Fusion Device is 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.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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SECTION 2

VOLUME 2

Date of summary: 2 February 2018 (Updated)

Applicant

AMEDICA® Corporation 1885 West 2100 South Salt Lake City, UT 84119 Phone: 801.839.3562 Fax: 801.839.3605 Contact: Shanna Ryan, Regulatory Affairs Project Manager Email: shanna.ryan@gmail.com

Device Classification

Trade Name:	Valeo® C+CSC with Lumen Interbody Fusion Device System
Class:	II
Panel:	Orthopedic
Product Code:	ODP
Regulation:	21 CFR 888.3080
Classification Name:	Intervertebral body fusion device, cervical

Predicate Device

Primary
510k:	K142264
Trade Name:	Valeo Spacer System and Valeo II Interbody Fusion Device
Manufacturer:	Amedica® Corporation
Secondary
510k:	K103033
Trade Name:	Zimmer Trabecular Metal Fusion Device
Manufacturer:	Zimmer

Device Description

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Valeo® C+CSC with Lumen Traditional 510(k) Summary 21 CFR 807.92(a)

VOLUME 2

SECTION 2

Indications for Use

VALEO® C+CSC with Lumen Interbody Fusion Device is to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage.

Technological Characteristics and Comparison to the Predicate Device

The Valeo® C+CSC with Lumen Interbody Fusion Device System is substantially equivalent to the predicates with respect to intended use, indications, design, and performance.

Performance Testing Summary

Testing performed on this device indicates that the Valeo C+CsC with Lumen Device is substantially equivalent to the Valeo Spacer System-C devices cleared under K142264. ASTM F2077 and ASTM F2267 performance standards were adhered to and all applicable requirements were met. Any deviations to the standards are noted at appropriate sections.

Mechanical Testing

Test	Result
Static Compression	PASS
Dynamic Compression	PASS
Static Torsion	PASS
Dynamic Torsion	PASS
Subsidence	PASS
Expulsion	PASS

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VOLUME 2

Biocompatibility evaluations

Test / Biological Endpoint	Standard	Result
Cytotoxicity	ISO 10993-5:1999	PASS
Maximization Sensitization	ISO 10993-10:2002	PASS
ISO Intracutaneous Extract	ISO 10993-10:2002	PASS
ISO Systemic Toxicity Study	ISO 10993-11:2006	PASS
Genotoxicity	ISO 10993-3:2003	PASS
ISO Muscle Implantation Study	ISO 10993-6:1994	PASS
System Toxicity	ISO 10993-11:2006	PASS
Bacterial Endotoxin Testing (LAL assay)	ANSI/AAMI ST72:2011	PASS

Conclusions

In summary, the Valeo C+CSC with Lumen has the same indications for use, technological characteristics, principle of operation, materials, and sterilization method as the cited predicate devices. Based on this and data provided in this pre-market notification, the subject device has been shown to be substantially equivalent to the predicate devices. Performance testing demonstrate the subject device performs as well or better than the predicate, therefore, is substantially equivalent.

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.