The SEEplate Cervical Plate System is intended for anterior screw fixation at the vertebral bodies of the cervical spine (C2-C7). The SEEplate Cervical Plate System is indicated for use in temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain in discogenic origin of the disc confirmed by patient history and radiographic studies), spinal stenosis, spondylolisthesis, deformity (defined as kyphosis, and scoliosis), trauma (including fractures), tumors, pseudoarthrosis, and/or failed previous fusions.

This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. The device is intended for anterior cervical intervertebral body fusions only.

Device Description

The SEEplate Cervical Plate System is comprised of an assortment of titanium alloy plates and screws that act to stabilize the spine during the intervertebral fusion process. The SEEplate Cervical Plate System is manufactured from wrought Ti-6Al-4V in accordance with ISO 5832-3.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Amedica SEEplate Cervical Plate System. This is a medical device for spinal fixation, and the documentation pertains to its substantial equivalence to a predicate device, not to its performance against specific acceptance criteria in a clinical study as would be seen for AI/ML devices or novel therapies.

Therefore, many of the requested categories are not applicable to this type of device submission. The submission relies on establishing substantial equivalence to a legally marketed predicate device rather than presenting performance data from a clinical study with detailed acceptance criteria.

Here's an analysis based on the provided text, addressing the points where information is available or indicating when it's not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Substantial Equivalence to Predicate Device	The SEEplate Cervical Plate System was shown to be substantially equivalent to the Amedica Valeo Cervical Plate System (K071990).
Indications for Use	Same indications for use as the predicate device.
Design	Same design as the predicate device.
Function	Same function as the predicate device.
Materials Used	Same materials used (wrought Ti-6Al-4V in accordance with ISO 5832-3) as the predicate device.
Performance Standards	Testing performed indicates the subject device is substantially equivalent to predicate devices. (Specific performance parameters or numerical criteria are not detailed in this summary.)

Explanation: The acceptance criteria for this 510(k) clearance are primarily based on demonstrating "substantial equivalence" to a predicate device (Amedica Valeo Cervical Plate System, K071990) across key attributes: indications for use, design, function, and materials. The document states that "Testing performed indicates the subject device is substantially equivalent to predicate devices," implying that any relevant performance standards (likely mechanical and biocompatibility tests for an implantable device) were met to support this claim, but the specific numerical acceptance criteria or detailed results are not included in this summary.

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

Not applicable. This 510(k) summary does not describe a clinical study with a test set of data. The "testing performed" mentioned refers to non-clinical performance standards to demonstrate equivalence.

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

Not applicable. This is not a study requiring expert-established ground truth for a test set.

4. Adjudication Method for the Test Set

Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This type of study is typically done for diagnostic imaging devices or AI tools assisting human interpretation, not for an implantable cervical plate system seeking 510(k) clearance based on substantial equivalence.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This is not an AI/ML algorithm or diagnostic tool.

7. Type of Ground Truth Used

Not applicable in the context of data for an AI/ML algorithm. For this device, the "ground truth" equivalent would be established engineering and biocompatibility standards, and clinical outcomes data from the predicate device that inform the safety and effectiveness profile.

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML algorithm requiring a training set.

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

Not applicable.

Summary

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K082037
Page 1 of 2

Amedica SEEplate Cervical Plate System Special 510(k)

SEP & 6 2008

5. 510(k) Summary

Contact:	Mr. Adam HerderMusculoskeletal Clinical & Regulatory Advisers, LLC1331 H Street NW, 12th FloorWashington, DC 20005202.552.5800
Device Trade Name:	SEEplate Cervical Plate System
Manufacturer:	Amedica Corp.615 Arapeen Drive, Suite 302Salt Lake City, UT 84108
Classification:	21 CFR §888.3060, Spinal intervertebral body fixationorthosis
Class:	II
Product Code:	KWO

Indications For Use:

Device Description:

Predicate Device(s):

The SEEplate Cervical Plate System was shown to be substantially equivalent to the Amedica Valeo Cervical Plate System (K071990) and has the same indications for use, design, function, and materials used.

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K082037
Page 2 of 2

Amedica SEEplate Cervical Plate System Special 510(k)

Performance Standards:

Testing performed indicates the subject device is substantially equivalent to predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 6 2008

Amedica Corporation % Musculoskeletal Clinical Regulatory Advisers Mr. Adam Herder 1331 H Street Northwest, 12th Floor Washington, District of Columbia 20005

K082037 Trade/Device Name: SEEplate Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: September 15, 2008 Received: September 16, 2008

Dear Mr. Herder:

Re:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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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Page 2 – Mr. Adam Herder

This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark of Milker

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Amedica SEEplate Cervical Plate System Special 510(k)

4. Indications for Use

K082037 510(k) Number (if known): _

Device Name: SEEplate Cervical Plate System

Prescription Use V (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation

Mark A. Millerson

Division Sign-Off) Division of General, Restorative, and Neurological De

510(k) Number K082037

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.