The Renovis S141 Lumbar Interbody Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis at the involved level(s). Renovis S141 System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six months of non-operative treatment. The Renovis S141 System must be used with supplemental fixation cleared by FDA for use in the lumbar spine.

Device Description

The Renovis S141 Lumbar Interbody Cage System consist of 3 designs and each design is available in either PEEK or titanium alloy. The PLIF implants are available as a lordotic form, while the OLIF implants are provided with no lordosis. The implants are available in various heights and lengths to accommodate patients' anatomy. The implants are provided sterile, and a set of instrument for implantation is provided to facilitate implantation. Two radiographic markers made of tantalum per ASTM F650 are included in the PLIF and OLIF PEEK implants, and three radiographic markers made of tantalum per ASTM F560 are included in the TLIF PEEK implant to allow radiographic visualization.

AI/ML Overview

This document is a 510(k) summary for the Renovis S141 Lumbar Interbody Cage System. It primarily focuses on demonstrating substantial equivalence to predicate devices based on indications for use, materials, dimensions, function, and mechanical testing. It is not a study that proves a device meets acceptance criteria in the sense of a clinical trial or an AI/software performance study.

Therefore, many of the requested items related to AI/software performance, ground truth, expert adjudication, and clinical study details are not applicable or cannot be extracted from this type of regulatory submission. This document describes mechanical performance testing against established standards, not a clinical study with human subjects, AI algorithms, or expert readers.

Here's a breakdown of what can be extracted and what cannot:

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

Acceptance Criteria	Reported Device Performance
Testing Standards:	The Renovis S141 Lumbar Interbody Cage System was tested according to:
ASTM F2077	- Static and dynamic axial compression
ASTM F2267	- Subsidence
	- Expulsion
Outcome:	Test results demonstrate that the Renovis S141 Lumbar Interbody Cage System is substantially equivalent to the predicate devices.

Note: The document states the device was tested to these standards and found substantially equivalent, but it does not provide specific numerical acceptance criteria or performance metrics for each test (e.g., "subsidence must be less than X mm, and observed subsidence was Y mm"). It only states the overall conclusion of substantial equivalence.

Regarding the other requested information:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided. This document describes mechanical testing of physical devices, not a study involving human patient data or software/AI. The "test set" here refers to the physical samples of the interbody cage system tested mechanically. The sample size for these mechanical tests is not specified, nor is data provenance in the context of clinical/patient data.
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. Ground truth in the context of expert review applies to diagnostic devices or AI, not mechanical orthopedic implants. The "ground truth" for mechanical testing is defined by the physical properties and performance characteristics measured against engineering standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication is relevant for expert review or clinical event assessment, not for mechanical testing of physical devices.
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 mechanical device, not an AI or diagnostic imaging device. Therefore, no MRMC study, human readers, or AI assistance is involved.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is a physical medical device (lumbar interbody cage system), not an algorithm or software. No standalone algorithm performance was assessed.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable. For mechanical testing, the "ground truth" is defined by the established engineering standards (ASTM F2077 and ASTM F2267) and the measured physical performance (axial compression, subsidence, expulsion).
8. The sample size for the training set
- Not Applicable. This document does not describe a machine learning algorithm, so there is no "training set."
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set for a machine learning algorithm, this question is not relevant.

Summary

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February 6, 2015

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

Renovis Surgical Technologies % Rich Jansen, Pharm. D. President Silver Pine Consulting, LLC 11821 Bramble Cove Drive Fort Myers, Florida 33905

Re: K143126

Trade/Device Name: Renovis S141 Lumbar Interbody Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: November 11, 2014 Received: November 13, 2014

Dear Dr. Jansen:

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

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Page 2 - Rich Jansen, Pharm. D.

(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 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.

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/Resourcesfor You/Industry/default.htm. 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/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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Indications for Use

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

K143126

Page 1 of 1

510(k) Number (if known) K143126

Device Name

Renovis S141 Lumbar Interbody Cage System

Indications for Use (Describe)

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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."

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510(k) SUMMARY Renovis S141 Lumbar Interbody Cage System

Date:	January 30, 2015
Submitter:	Josh BrownRenovis Surgical Technologies, Inc.1901 W. Lugonia Ave, Ste 340Redlands, CA 92374Telephone: 909-557-2360Fax: 909-307-8751
Regulatory Contact:	Rich Jansen, Pharm. D.Silver Pine Consulting, LLC612-281-5505
ProductTrade Name:Common Name:Product Class:Classification:Product Code:	Renovis S141 Lumbar Interbody Cage SystemIntervertebral Body Fusion DeviceClass II888.3080MAX

Device Description

Predicate Device

The Renovis S141 Lumbar Interbody Cage System is substantially equivalent to legally marketed predicate devices. The primary predicate is the Renovis S134 ALIF cage (K142095) Additional predicate devices are the Ray Threaded Fusion Cage (P950019), Lumbar I/F Cage (P960025), and the K2M Aleutian Spinal System (K133614).

Intended Use / Indications for Use

The Renovis S141 Lumbar Interbody Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar

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spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Renovis S141 System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six months of non-operative treatment. The Renovis S141 Cage System must be used with supplemental fixation cleared by FDA for use in the lumbar spine.

Performance Testing

The Renovis S141 Lumbar Interbody Cage System was tested according to ASTM F2077 and ASTM F2267. Testing included static and dynamic axial compression, subsidence and expulsion. Test results demonstrate that the Renovis S141 Lumbar Interbody Cage System is substantially equivalent to the predicate devices.

Summary:

The Renovis S141 Lumbar Interbody Cage System is substantially equivalent to the predicate devices in regards to:

. Indications for Use
. Materials
. Dimensions
. Function
Mechanical testing

The Renovis S141 Interbody Cage System demonstrates substantial equivalence to the predicate devices based on the non-clinical performance testing.

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.