The Renovis Tesera SC Stand-alone ACF System is indicated for intervertebral body fusion procedures in skeletally mature patients with cervical degenerative disc disease at one level from C2-T1. Renovis Tesera SC Stand-alone ACF System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six weeks of non-operative treatment prior to implantation.

The Renovis Tesera SC Stand-alone ACF System is a stand-alone system when used with the cover plate and screws provided, and requires no additional supplemental fixation. When used as a stand-alone system, the cages require the use of three (3) screws and the cover plate assembly. When used without the cover plate and three screws the Renovis Tesera SC Stand-alone ACF System is a non-stand-alone system and requires additional supplemental fixation cleared by the FDA for use in the cervical spine to augment stability.

The Renovis Tesera C ACF System is indicated for intervertebral body fusion procedures in skeletally mature patients with cervical degenerative disc disease at one level from C2-T1. Renovis Tesera C ACF System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six weeks of non-operative treatment prior to implantation.

The Renovis Tesera C ACF System is a non-stand-alone system and requires additional supplemental fixation cleared by the FDA for use in the cervical spine to augment stability.

Device Description

Tesera (or T3) describes Renovis' proprietary Tesera Trabecular Technology™ Porous Structure for the manufacture of the porous titanium on the superior and inferior surfaces of the implant.

The Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System is a single, cervical implant System that includes two (2) "subsystems", the:

Renovis Tesera C Anterior Cervical Fusion (ACF) System
Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System .

The Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System cages are additively manufactured from Ti-6Al-4V and are available in a variety of sizes (widths, heights, and lordotic angles) to suit the individual pathology and anatomical conditions of the patient.

The Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System includes cages, and existing bone screws (self-drilling and self-tapping options) and anterior cover plate assembly. When used with the cover plate and screws, the Tesera SC ACF System cages require no supplementary fixation systems. The screws protrude through the interbody portion of the device into the adjacent vertebral bodies. The cages have windows in the side for visualization of the bone graft. When used without the cover plate and three screws the Renovis Tesera SC Stand-alone ACF cages require supplemental fixation.

The Renovis Tesera C Anterior Cervical Fusion (ACF) System is not stand alone and requires supplemental fixation.

The Renovis Tesera C/Tesera SC ACF System cages comply with ASTM F2924-14 Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium with Powder Bed Fusion.

The system also consists of reusable instrumentation. The instruments comply with ASTM A564/A64M-13e1 Standard Specification for Hot-Rolled and Cold-Finished Age-Hardening Stainless Steel Bars and Shapes or ASTM F136-13 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System. This submission focuses on establishing substantial equivalence to a predicate device through mechanical testing and does not involve a study evaluating AI performance. Therefore, many of the requested sections related to AI acceptance criteria, ground truth, expert involvement, and reader studies are not applicable.

Here's an analysis of the provided information, focusing on what is available:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Standard)	Reported Device Performance
Mechanical Testing:
ASTM F2077 (Static Compression, Dynamic Compression, Static Shear Compression, Dynamic Shear Compression, Static Torsion, Dynamic Torsion Testing)	Conducted and found to be acceptable
Expulsion testing	Conducted and found to be acceptable
Subsidence testing (with and without screws) per ASTM F2267	Conducted and found to be acceptable
Sterilization Validation:	Completed
AAMI/ANSI/ISO 10993-1 (Biological Evaluation)	(Implied acceptable, no specific result mentioned)
AAMI/ANSI ST72 (Bacterial Endotoxins)	(Implied acceptable, no specific result mentioned)
AAMI/ANSI/ISO 11137-2 (Radiation Sterilization Dose)	(Implied acceptable, no specific result mentioned)
AAMI/ANSI/ISO 11737-1 (Microbiological Methods)	(Implied acceptable, no specific result mentioned)
ISO 11607-2 (Packaging for Sterilized Devices)	(Implied acceptable, no specific result mentioned)
ISO 17665-1 (Moist Heat Sterilization)	(Implied acceptable, no specific result mentioned)
Materials/Manufacturing:
ASTM F2924-14 (Additive Manufacturing Titanium)	Complies
ASTM A564/A64M-13e1 (Stainless Steel for Instruments)	Complies
ASTM F136-13 (Titanium for Instruments)	Complies
Porous Structure:
T3 porous shell evaluation	Successfully tested
Other Standards:
ASTM F1854-15 (Stereological Evaluation of Porous Coatings)	(Implied acceptable, no specific result mentioned)
ASTM F1147-05 (Tension Testing of Coatings)	(Implied acceptable, no specific result mentioned)
ASTM F1044-05 (Shear Testing of Coatings)	(Implied acceptable, no specific result mentioned)
ASTM F1160-14 (Shear and Bending Fatigue)	(Implied acceptable, no specific result mentioned)
ASTM F1978-17 (Abrasion Resistance of Coatings)	(Implied acceptable, no specific result mentioned)
ISTA 2A:2011 (Packaged-products weighing 150 lbs.)	(Implied acceptable, no specific result mentioned)
ASTM D4169:2016 (Performance Testing of Shipping Containers)	(Implied acceptable, no specific result mentioned)

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

This information is not applicable as the submission describes a medical device, not an AI/software device that would typically use a "test set" of data in the common sense. The testing described is bench testing of the physical implant.

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)

This information is not applicable. Ground truth, expert consensus, and expert qualifications are relevant for studies evaluating human or AI performance on diagnostic tasks. This submission is for a physical implant, where ground truth is established through standardized engineering and biological tests.

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

This information is not applicable. Adjudication methods are relevant for resolving discrepancies in expert interpretations during diagnostic studies.

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

This information is not applicable. MRMC studies are used to evaluate the impact of an AI system on human reader performance. This submission is for a physical medical implant.

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

This information is not applicable. "Standalone" performance refers to an AI algorithm operating independently, which is not relevant to a physical medical implant.

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

The "ground truth" for the device's performance is established through adherence to recognized ASTM, AAMI/ANSI, and ISO standards for mechanical properties, biocompatibility, and sterilization. For example, the mechanical strength of the implant components and assemblies is evaluated against the parameters outlined in ASTM F2077. The porous structure's characteristics were "successfully tested," implying adherence to relevant specifications.

8. The sample size for the training set

This information is not applicable. A "training set" is used for machine learning. This submission is for a physical implant.

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

This information is not applicable. This is relevant for machine learning models.

Summary

{0}------------------------------------------------

December 7, 2018

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Renovis Surgical Technologies % Sharyn Orton Senior Consultant MEDIcept, Inc. 200 Homer Ave Ashland, Massachusetts 01721

Re: K182007

Trade/Device Name: Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE, ODP Dated: November 5, 2018 Received: November 7, 2018

Dear Ms. 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

{1}------------------------------------------------

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-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,

Melissa Hall -S

For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K182007

Device Name

Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System

Indications for Use (Describe)

The Renovis Tesera SC Stand-alone ACF System is indicated for intervertebral body fusion procedures in skeletally mature patients with cervical degenerative disc disease at one level from C2-T1. Renovis Tesera SC Stand-aCF System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six weeks of non-operative treatment prior to implantation.

The Renovis Tesera SC Stand-alone ACF System is a stand-alone system when used with the cover plate and screws provided, and requires no additional supplemental fixation. When used as a stand-alone system, the use of three (3) screws and the cover plate assembly. When used without the cover plate and three screws the Renovis Tesera SC Stand-alone ACF System is a non-stand-alone system and requires additional supplemental fixation cleared by the FDA for use in the cervical spine to augment stability.

The Renovis Tesera C ACF System is a non-stand-alone system and requires additional supplemental fixation cleared by the FDA for use in the cervical spine to augment stability.

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.

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:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Traditional 510(k) Summary as required by 21 CFR 807.92(a) K182007

A ) Submitted by: Renovis Surgical Technologies Inc. 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
Date prepared: December 7, 2018
B) Device Name: Intervertebral fusion device with integrated fixation, cervical Intervertebral fusion device with bone graft, cervical
- Proprietary Name: Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System
- Device Class: Class II
- Regulation number: 21 CFR 888.3080
- Regulation name: Intervertebral body fusion device
- Product code: OVE - intervertebral fusion device with integrated fixation, cervical ODP - intervertebral fusion device, cervical
- Classification panel: Orthopedic
C) Primary predicate: K153250-Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System
D) Additional Predicate: K181655-Renovis S180 Lateral Lumbar Interbody Fusion System
E) Device Description:

Tesera (or T3) describes Renovis' proprietary Tesera Trabecular Technology™ Porous Structure for the manufacture of the porous titanium on the superior and inferior surfaces of the implant.

{4}------------------------------------------------

The Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System is a single, cervical implant System that includes two (2) "subsystems", the:

Renovis Tesera C Anterior Cervical Fusion (ACF) System ●
Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System .

The Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System includes cages, and existing bone screws (self-drilling and self-tapping options) and anterior cover plate assembly. When used with the cover plate and screws, the Tesera SC ACF System cages require no supplementary fixation systems. The screws protrude through the interbody portion of the device into the adjacent vertebral bodies. The cages have windows in the side for visualization of the bone graft. When used without the cover plate and screws, the Tesera SC ACF cages require supplemental fixation.

The Renovis Tesera C Anterior Cervical Fusion (ACF) System is not stand alone and requires supplemental fixation.

The Renovis Tesera C/Tesera SC ACF System cages comply with ASTM F2924-14 Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium with Powder Bed Fusion.

F) Indications For Use:

{5}------------------------------------------------

The Renovis Tesera C ACF System is a non-stand-alone system and requires additional supplemental fixation cleared by the FDA for use in the cervical spine to augment stability.

G) Substantial Equivalence Discussion

The Renovis Tesera C/Tesera SC ACF System has the same Indication for Use, includes the same geometric and lordotic offerings, are provided standalone or non-standalone, are terminally gamma sterilized, and are additively manufactured from biocompatible materials like the predicate devices.

Differences include manufacturing method, new geometric and lordotic options and packaging. These differences do not raise different issues of safety or effectiveness. Risk analysis conducted under Design Control assessed all differences. Successful manufacturing validation was conducted. The T3 porous shell was evaluated and successfully tested per standards. Mechanical testing of the implant/implant assemblies were tested per standards and found to be acceptable.

The Tesera C/Tesera SC ACF System is substantially equivalent to the predicate devices.

H) Performance Testing - Bench

Mechanical testing of the Renovis Tesera C/Tesera SC ACF System was conducted and found to be acceptable for the following:

Static Compression, Dynamic Compression, Static Shear Compression, Dynamic Shear . Compression, Static Torsion and Dynamic Torsion Testing per ASTM F2077.
Expulsion testing ●
Subsidence testing with and without screws per ASTM F2267

Sterilization validation was completed.

Conclusion

The Renovis Tesera C/Tesera SC ACF System has the same Indication for Use as the Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System.

Differences between the Renovis Tesera C/Tesera SC ACF System and the predicate devices were assessed under Design Control by risk analysis and FEA raises no new safety or effectiveness questions when compared to the predicate device. Mechanical testing was conducted and found to be acceptable. The Renovis Tesera SC ACF System is substantially equivalent to the Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System.

{6}------------------------------------------------

I) Consensus Standards and FDA Guidance
- AAMI/ANSI/ISO 10993-1:2009/(R)2013 Biological Evaluation Of Medical Devices ● Part 1: Evaluation And Testing Within a Risk Management Process
- ASTM F2077-14: Test Methods For Intervertebral Body Fusion Devices ●
- . ASTM F1854-15: Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants
- ASTM F1147-05 (R)2017e1 Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings
- . ASTM F1044-05 (R)2017e1 Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings
- ASTM F1160-14 (R)2017e1 Standard Test Method for Shear and Bending Fatigue . Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings
- ASTM F1978-17 Standard Test Method for Measuring Abrasion Resistance of Metallic ● Thermal Spray Coatings by Using the Taber Abraser
- ASTM F2267-01(R)2011 Standard Test Method for Measuring Load Induced Subsidence ● of Intervertebral Body Fusion Device Under Static Axial Compression
- AAMI/ANSI ST72:2011/(R)2016 Bacterial Endotoxins - Test Methods, Routine Monitoring, And Alternatives To Batch Testing
- AAMI/ANSI/ISO 11137-2:2013 Sterilization Of Health Care Products Radiation Part ● 2: Establishing The Sterilization Dose
- . AAMI/ANSI/ISO 11737-1:2006 R(2011) Sterilization of health care products microbiological methods - part 1: determination of the population of microorganisms on product
- ISO 11607-2:2006 Packaging for Terminally Sterilized Medical Devices - Part 2: Validation requirements for forming, sealing and assembly processes
- ISTA 2A:2011 Packaged-products weighing 150 lbs. (68kg) or less
- ASTM D4169:2016 Standard Practice for Performance Testing of Shipping Containers ● and Systems
- ISO 17665-1 1st Edition 2006-08-15 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 F 983-86 (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
- . Class II Special Controls Guidance Document: Intervertebral Body Fusion Device, June 2007
- Guidance for Industry and FDA Staff Technical Considerations for Additive . Manufactured Medical Devices, December 2017
- Guidance for Industry and FDA Staff Reporting of Computational Modeling Studies in ● Medical Device Submissions, September 2016

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.