The Renovis Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7).The system is indicated for use in the temporary stabilization of the anterior spine during the development of fusion in patients with the following conditions:

· degenerative disc disease(DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)

· spondylolisthesis
· trauma (i.e., fracture or dislocation)
· spinal stenosis
· tumor
· pseudoarthrosis
· failed previous fusion

WARNING: The Renovis Anterior Cervical Plate System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

Device Description

The Renovis Anterior Cervical Plate System consists of various shapes and sizes of plates and screws, and associated instruments. The plates are available in multiple lengths to accommodate single or multi-level surgeries. The plates and screws are manufactured from titanium alloy and the locking clip is manufactured from nickel-titanium alloy.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the Renovis Anterior Cervical Plate System. This is a medical device submission, and the content focuses on demonstrating substantial equivalence to a predicate device rather than describing a study with acceptance criteria and device performance in the way one might for an AI/algorithm-based diagnostic product.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable or not provided in this type of document. This document details the physical and mechanical performance of an implantable medical device, not the diagnostic performance of a software or AI.

However, I can extract the relevant information from the performance testing section.

Acceptance Criteria and Study for Renovis Anterior Cervical Plate System

The Renovis Anterior Cervical Plate System is a physical medical device. Its "performance" refers to its mechanical and material properties, not diagnostic accuracy. The "acceptance criteria" are implicitly met by passing the specified ASTM standards and internal protocols.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Test Performed	Acceptance Criteria (Implicitly met by standard)	Reported Device Performance (as stated in document)
Static Axial Compression Bending (ASTM F1717)	Acceptable (as per ASTM F1717)	Found to be acceptable
Static Torsion (ASTM F1717)	Acceptable (as per ASTM F1717)	Found to be acceptable
Dynamic Axial Compression Bending (ASTM F1717)	Acceptable (as per ASTM F1717)	Found to be acceptable
Corrosion Testing (ASTM F2129)	Acceptable (as per ASTM F2129)	Found to be acceptable
Auger Emission Spectroscopy (AES) analysis of nitinol clip	Acceptable (as per internal protocol/standard)	Found to be acceptable
Screw Push-out Testing (per protocol)	Acceptable (as per internal protocol)	Found to be acceptable

2. Sample size used for the test set and the data provenance

Sample Size: Not specified. For mechanical testing of medical devices, sample sizes are typically determined by statistical methods for engineering testing (e.g., to achieve a certain confidence level or power for a material property) but are usually much smaller than clinical study sample sizes.
Data Provenance: Not applicable in the context of this device's performance testing. These are laboratory-based mechanical and material tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. This is a mechanical device, and "ground truth" as it relates to expert consensus for diagnostic performance does not apply. The "truth" is determined by standardized laboratory measurements.

4. Adjudication method

Not Applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No. This is a mechanical device, not a diagnostic tool requiring human interpretation.

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

Not Applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

N/A (for "ground truth" in diagnostic terms). The "truth" is established by adherence to specified ASTM standards and internal engineering protocols for mechanical and material properties. For example, for corrosion testing, the "ground truth" is that the device passes or fails the specified electrochemical impedance parameters defined by ASTM F2129.

8. The sample size for the training set

Not Applicable. This is a physical medical device. There is no "training set" in the context of machine learning or algorithms. Its design and manufacturing process are validated, but not "trained."

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

Not Applicable.

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 an abstract symbol that resembles a stylized caduceus or a representation of the human form.

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

Renovis Surgical Technologies, Incorporated % Sharyn Orton, Ph.D. Senior Consultant MEDIcept Incorporated 200 Homer Avenue Ashland, Massachusetts 01721

September 25, 2015

Re: K152193

Trade/Device Name: Renovis Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: July 30, 2015 Received: August 5, 2015

Dear Dr. Orton:

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

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Page 2 - Sharyn Orton, Ph.D.

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.

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

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

510(k) Number (if known) K152193

Device Name Renovis Anterior Cervical Plate System

Indications for Use (Describe)

· degenerative disc disease(DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)

· spondylolisthesis
· trauma (i.e., fracture or dislocation)
· spinal stenosis
· tumor
· pseudoarthrosis
· failed previous fusion

WARNING: The Renovis Anterior Cervical Plate System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

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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Traditional 510(k) Summary as required by 21 CFR 807.92(a)

A) Submitted by: Renovis Surgical Technologies 1901 W. Lugonia Ave, Ste 340 Redlands, CA 92374 Phone: 909-557-2360 Fax: 909-307-8571
Official Contact: Anthony DeBenedictis Vice President of Quality Assurance
Consultant: Sharyn Orton, Ph.D. MEDIcept, Inc. 200 Homer Ave Ashland, MA 01721
Prepared: September 23, 2015
B) Classification Name: Spinal Intervertebral Body Fixation Orthosis

Common Name:	Anterior Cervical Plate, Anterior Cervical Spinal Fixation System
Proprietary Name:	Renovis Anterior Cervical Plate System
Device Class:	Class II
Regulationand Product Code:	21 CFR 888.3060KWQ
Classification panel:	Orthopedic
C) Predicate:	K030866 Synthes Anterior CSLP System

D) Device Description
The Renovis Anterior Cervical Plate System consists of various shapes and sizes of plates and screws, and associated instruments. The plates are available in multiple lengths to accommodate single or multi-level surgeries. The plates and screws are manufactured from titanium alloy and the locking clip is manufactured from nickel-titanium alloy.

Renovis Anterior Cervical Plate System Traditional 510(k) Premarket Notification

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E) Intended Use/Indications For Use:

The Renovis Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of fusion in patients with the following conditions:

degenerative disc disease(DDD) (defined as back pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies)
spondylolisthesis ●
trauma (i.e., fracture or dislocation) ●
spinal stenosis
tumor
pseudoarthrosis
failed previous fusion .

WARNING: The Renovis Anterior Cervical Plate System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

F) Substantial Equivalence Comparison

The Renovis Anterior Cervical Plate System and predicate devices (K030866 Synthes Anterior CSLP System: K945700 Synthes Anterior Cervical Vertebrae Plate System: K102820 Trestle Luxe Anterior Cervical Plating System, Alphatec Spine) have the same intended use/ Indications for Use, are manufactured from the same or similar materials, have a screw retention system; and have similar dimensions.

H) Performance Testing

Performance testing of the Renovis Anterior Cervical Plate System under ASTM F1717, including static axial compression bending, static torsion and dynamic axial compression bending, was conducted and found to be acceptable. Corrosion testing under ASTM F2129 was conducted and found to be acceptable. Auger Emission Spectroscopy (AES) analysis of the nitinol clip was conducted and found to be acceptable. Screw push-out testing was conducted per protocol and found to be acceptable.

I) Compliance with Standards and Guidance

ASTM F136-13 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium . ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications
. ASTM F2063-12 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants
ASTM A564-13 Standard Specification for Hot-Rolled and Cold-Finished Age-. Hardening Stainless Steel Bars and Shapes
ASTM B211-12e1 Standard Specification for Aluminum and Aluminum-Alloy Rolled or . Cold Finished Bar, Rod, and Wire
ASTM B221-13 Standard Specification for Aluminum and Aluminum-Alloy Extruded ● Bars, Rods, Wire, Profiles, and Tubes

Renovis Anterior Cervical Plate System Traditional 510(k) Premarket Notification

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. EN 10088-3:2005 Stainless steels - Part 3: Technical delivery conditions for semifinished products, bars, rods, wire, sections and bright products of corrosion resisting steels for general purposes
ASTM F2129-08 Standard Test Method for Conducting Cyclic Potentiodynamic . Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices
ASTM F1717-14 Standard Test Methods for Spinal Implant Constructs in a . Vertebrectomy Model
ASTM F983-86 (Reapproved 2013) Standard Practice for Permanent Marking of . Orthopaedic Implant Components
ASTM F565-04 (Reapproved 2013) Standard Practice for Care and Handling of . Orthopedic Implants and Instruments
ISO 17665-1:2006 Sterilization of health care products Moist heat -- Part 1: . Requirements for the development, validation, and routine control of a sterilization process for medical devices
ASTM F86-13 Standard Practice for Surface Preparation and Marking of Metallic . Surgical Implants

Guidance for Industry and FDA Staff - Spinal System 510(k)s, May 3, 2004, where applicable to anterior cervical plate systems.

Conclusion

Given testing and other technological comparisons, the Renovis Anterior Cervical Plate System is substantially equivalent to the predicate devices.

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.