The Phantom Plus Ceramic Cages-Lumbar are intervertebral body fusion devices indicated for use with autogenous bone graft in patients with degenerative disc disease (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). These patients should be skeletally mature and have six (6) months of nonoperative therapy.

The Phantom Plus Ceramic Cage System-Lumbar is to be filled with autogenous bone graft material. The Phantom Plus Ceramic Cages-Lumbar are intended to be used with supplemental spinal fixation systems, such as Preference Pedicle Screw System.

The Phantom Plus Ceramic Cages-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.

DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Phantom Plus Ceramic Cages-Cervical are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 disc levels using autograft bone.

The Phantom Plus Ceramic Cages-Cervical are to used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

Device Description

The Phantom Plus Ceramic Cage System consists of a variety of hollow vertebral body spacers featuring convex, bullet nose design and an axial void designed to hold bone graft material. The subject device is offered in various lengths. 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 devices range from 6mm to 22mm in height and 14mm to 45mm in length.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Phantom Plus® Ceramic Cage System, which is an intervertebral body fusion device. The focus of this submission is to demonstrate substantial equivalence to previously cleared predicate devices, rather than establishing acceptance criteria and conducting a primary study to prove the device meets those criteria.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them, as well as details about sample sizes, expert involvement, and ground truth establishment, cannot be directly extracted from the provided text because such a study was not presented.

Instead, the submission relies on demonstrating compliance with recognized performance standards and substantial equivalence to predicate devices.

Here's a summary of what can be gathered, addressing the spirit of the request as much as possible given the available information:

1. Table of acceptance criteria and the reported device performance

Since this is a 510(k) submission focused on substantial equivalence to predicate devices and compliance with existing standards, explicit acceptance criteria for a novel performance study are not defined or reported in the text. Instead, the device's performance is demonstrated by meeting the requirements of recognized ASTM and AAMI standards.

Acceptance Criteria (Implied by Compliance with Standards & Predicate Equivalence)	Reported Device Performance
Mechanical Performance: - Adherence to ASTM F2077 (for lumbar intervertebral body fusion devices) - Adherence to ASTM F1839 (for ceramic materials for surgical implants) - Adherence to ASTM F1877 (for intervertebral body fusion devices with integrated plate fixation)	"Testing and engineering analyses on this device indicate that the Phantom Plus Cage System is substantially equivalent to predicate devices... all applicable requirements were met."
Material/Biocompatibility: - Adherence to AAMI TIR 33 (Guidance for biocompatibility risk management) - Same or equivalent materials as predicate devices (ceramic)	"Testing and engineering analyses on this device indicate that the Phantom Plus Cage System is substantially equivalent to predicate devices... all applicable requirements were met."
Design and Function: - Same or equivalent design and function as predicate devices (e.g., hollow vertebral body spacers, convex, bullet nose design, axial void for bone graft, angular teeth for expulsion resistance)	"The Phantom Plus Ceramic Cage System was shown to be substantially equivalent to previously cleared devices, including itself (K082801) and the Valeo® Spacer System (K091278), and has the same or equivalent indications for use, design, function, and materials used."
Indications for Use: - Equivalent indications for use as predicate devices (e.g., DDD patients with specific conditions, autogenous bone graft, supplemental fixation)	"The Phantom Plus Ceramic Cage System was shown to be substantially equivalent to previously cleared devices... and has the same or equivalent indications for use..."

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

The document does not describe a clinical "test set" in the context of a prospective clinical trial. The "testing and engineering analyses" mentioned likely refer to bench testing and mechanical studies conducted in a laboratory setting, not human clinical trials. Therefore, information about sample size (patients), data provenance, or retrospective/prospective nature is not provided.

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 a clinical test set with human subject data requiring expert ground truth establishment is not discussed in this 510(k) summary.

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 device is an implant, not an AI-assisted diagnostic tool, and therefore MRMC studies are not relevant.

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

Not applicable.

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

Not applicable, as a clinical study requiring ground truth is not presented. The "ground truth" for this submission is adherence to recognized performance standards and demonstrated mechanical equivalence to predicates.

8. The sample size for the training set

Not applicable, as this is not an AI/ML device requiring a training set. The "engineering analyses" would involve material samples and device prototypes.

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

Not applicable.

Summary

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1121892

510(k) Summary

AUG 2 4 2012

Contact:	Robert M. Wolfarth, CQAAmedica Corp.1885 West 2100 SouthSalt Lake City, UT 84119(801) 839-3500
Device Trade Name:	Phantom Plus® Ceramic Cage System
Manufacturer:	Amedica Corp.1885 West 2100 SouthSalt Lake City, UT 84119
Common Name:	Intervertebral body fusion device
Classification:	21 CFR §888.3080
Device Class:	II
Product Codes:	MAX, ODP
Date Summary Prepared:	June 28, 2012

Indications For Use:

The Phantom Plus Ceramic Cages-Cervical are to used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

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Device Description:

Predicate Device(s):

The Phantom Plus Ceramic Cage System was shown to be substantially equivalent to previously cleared devices, including itself (K082801) and the Valeo® Spacer System (K091278), and has the same or equivalent indications for use, design, function, and materials used.

Performance Standards:

Testing and engineering analyses on this device indicate that the Phantom Plus Cage System is substantially equivalent to predicate devices. ASTM F2077, ASTM F1839, ASTM F1839, ASTM F1877, ASTM F04.25.02.02, and AAMI TIR 33 performance standards were adhered to and all applicable requirements were met.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is composed of three curved lines that suggest the shape of the bird's body and wings.

Public Health Service

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

AUG 2 4 2012

Amedica Corporation % Mr. Robert M. Wolfarth Director of Regulatory Affairs 1885 West 2100 South Salt Lake City, Utah 84119

Re: K121892

Trade/Device Name: Phantom Plus® Ceramic Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, ODP Dated: August 3, 2012 Received: August 8, 2012

Dear Mr. Wolfarth:

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. Robert M. Wolfarth

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/ReportalProblem/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 yours,

Mark A. Millerson

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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Indications for Use

510(k) Number (if known): K121892

Device Name: Phantom Plus® Ceramic Cage System

The Phantom Plus Ceramic Cages-Cervical are to used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

イ Prescription Use (Part 29 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (29 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

K121892 510(k) Number_

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.