The Luna 3D Interbody Fusion System consists of the Luna 3D Implant and associated accessories. This system is indicated for spinal fusion procedures in skeletally mature patients with symptomative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to grade I spondylolisthesis or retrolisthesis at the involved level(s). The Luna 3D Interbody Fusion System is to be used with autogenous bone graft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft to facilitate fusion. Patients receiving the device should have had at least six months of nonoperative treatment prior to receiving the Luna 3D Implant. The Luna 3D Interbody Fusion System is to be used with supplemental fixation.

Device Description

The Benvenue Luna 3D Interbody Fusion System consists of the Luna 3D Implant and associated accessories set of disposable accessories for use in lumbar fusion procedures to treat degenerative disc disease. The proposed indications for use for the Luna 3D Interbody Fusion System are identical to predicate interbody lumbar cages. The Luna 3D Implant is provided pre-loaded and sterile within a single-use Insertion Tool.

The Luna 3D Implant is available in heights ranging from 8mm to 15mm in 1mm increments. A series of vertically oriented slots allows the device to flex and enables it to be inserted from a straight cannula and then attain a closed, fixed, and circular shape upon being placed into the disc space with a bone graft pocket. Teeth engage the implant into the adjacent endplates.

The Luna 3D Implant is manufactured from polyetheretherketone (PEEK Optima LT-1 or Evonik VESTAKEEP i4R), stainless steel, tantalum, and silicone lubricant (NuSil MED-360).

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria in the way a diagnostic algorithm or AI product would be evaluated (e.g., sensitivity, specificity, or reader studies). This document is a 510(k) premarket notification for a medical device called the "Luna 3D Interbody Fusion System," which is an implant for spinal fusion procedures.

The "Performance Testing" section describes bench testing conducted to evaluate the impact of design changes on product performance. This is typical for mechanical devices and focuses on physical and mechanical properties, not diagnostic accuracy or human-AI comparative effectiveness.

Here's an analysis of the information that is available in relation to your request, and where the requested information is missing:

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

Missing. The document describes a medical implant, not an AI or diagnostic device that would have performance criteria like sensitivity or specificity. The "performance testing" referred to are mechanical bench tests.

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

Missing. The "performance testing" involved mechanical bench tests (static/dynamic compression, shear-compression, torsion, and subsidence testing). These do not involve "test sets" in the context of patient data or AI evaluation.

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)

Missing. This concept is not applicable to the type of device and testing described.

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

Missing. This concept is not applicable to the type of device and testing described.

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

Missing. This is not an AI or diagnostic imaging device.

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

Missing. This is not an AI or algorithm-based device.

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

Missing. For mechanical testing, the "ground truth" would be the engineering specifications and established mechanical testing standards (e.g., ASTM F2077, ASTM F2267). The document states the results "confirmed that this design is substantially equivalent to legally marketed predicate devices," implying successful adherence to these standards and equivalence criteria.

8. The sample size for the training set

Missing. This concept is not applicable to the type of device and testing described.

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

Missing. This concept is not applicable to the type of device and testing described.

Summary of available information related to performance:

The document describes performance testing for the Luna 3D Interbody Fusion System, which is a physical implant. This testing was primarily bench testing (mechanical tests) to confirm the new design's equivalence to predicate devices and ensure its structural integrity and performance under various loads.

Tests Conducted:
- Static/dynamic compression
- Static/dynamic shear-compression
- Static/dynamic torsion tests (per ASTM F2077)
- Subsidence testing (per ASTM F2267)
Purpose: To evaluate the impact of minor design changes (e.g., addition of an 8-degree lordotic version, expansion of implant height, use of alternative PEEK material, alternative trial instrument) on product performance.
Conclusion of Testing: The results "confirmed that this design is substantially equivalent to legally marketed predicate devices."

In essence, for this medical implant, the "acceptance criteria" were implied to be meeting the mechanical performance characteristics demonstrated by predicate devices, as assessed through standardized bench tests. This is a very different type of evaluation compared to the performance assessment of AI/diagnostic software.

Summary

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

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 stylized graphic of three human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, creating a sense of depth. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.

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

November 17, 2016

Benvenue Medical, Inc. % Mr. Justin Eggleton Senior Director, Spine Regulatory Affairs Musculoskeletal Clinical Regulatory Advisers, LLC 1331 H Street NW, 12th Floor Washington, District of Columbia 20005

Re: K162431

Trade/Device Name: Luna 3D Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: August 26, 2016 Received: August 31, 2016

Dear Mr. Eggleton:

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

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

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,

Mark N. Melkerson -S

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)

K162431

Device Name

Luna 3D Interbody Fusion System

Indications for Use (Describe)

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)

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."

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

5. 510(k) Summary

Device Trade Name:	Luna 3D Interbody Fusion System
Manufacturer:	Benvenue Medical, Inc.5403 Betsy Ross DriveSanta Clara, California 95054 USA
510(k) Owner:	Jeff EmeryVice President, R&DBenvenue Medical, Inc.5403 Betsy Ross DriveSanta Clara, California 95054 USATelephone: +1 (408) 454-9300
Application Correspondent:	Mr. Justin EggletonSenior Director, Spine Regulatory AffairsMusculoskeletal Clinical Regulatory Advisers, LLC1331 H Street NW, 12th FloorWashington, DC 20005Office: 202.552.5800jeggleton@mcra.com
Date Prepared:	August 25, 2016
Classifications:	21 CFR §888.3080: Intervertebral body fusion device
Class:	II
Product Codes:	MAX
Primary Predicate Device:	Orthofix FORZA PTC SYSTEM (K152475)

Additional Predicate Device: Benvenue Medical Luna 360 Interbody Fusion System (K142023)

Indications for Use:

The Luna 3D Interbody Fusion System consists of the Luna 3D Implant and associated accessories. This system is indicated for spinal fusion procedures in skeletally mature patients with symptomatic degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to grade I spondylolisthesis or retrolisthesis at the involved level(s). The Luna 3D Interbody Fusion System is to be used with autogenous bone graft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft to facilitate fusion. Patients receiving the device should have had at

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

least six months of nonoperative treatment prior to receiving the Luna 3D Implant. The Luna 3D Interbody Fusion System is to be used with supplemental fixation.

Device Description:

The Luna 3D Implant is manufactured from polyetheretherketone (PEEK Optima LT-1 or Evonik VESTAKEEP i4R), stainless steel, tantalum, and silicone lubricant (NuSil MED-360).

These design features were demonstrated to be equivalent to the predicate devices presented in the next section.

Performance Testing:

A comprehensive clinical literature review was conducted to assess any additional safety concern for the use of this device with the use of allograft in the lumbar spine. The review of the literature concluded that there were no additional risks due to the modifications for this device and that the device was substantially equivalent to the predicate devices.

This 510(k) also incorporates a series of minor design changes, including the addition of an 8degree lordotic version of the Luna 3D Implant, expansion of the implant height to 15mm, use of Evonik VESTAKEEP PEEK, and an alternative version of the trial instrument known as the Scout. To evaluate the impact of these changes on product performance, procedural validation and bench verification testing was conducted. The bench testing included static/dynamic compression, static/dynamic shear-compression, and static/dynamic torsion tests per ASTM F2077 as well as subsidence testing per ASTM F2267. The results of these tests confirmed that this design is substantially equivalent to legally marketed predicate devices.

Substantial Equivalence Summary:

Comparative information presented in the 510(k) supports the substantial equivalence of the Luna 3D Interbody Fusion System to the following predicate devices: Orthofix FORZA PTC SYSTEM (K152475) and Benvenue Medical Luna 360 Interbody Fusion System (K142023). Comparisons were designed to show the indications, intended use, design, and performance are equivalent between the Benvenue Luna 3D Interbody Fusion System and predicate devices.

Conclusion:

The information and performance data demonstrate that the device is as safe, as effective, and performs as well as or better than the predicate devices. This 510(k) was submitted on behalf of the Luna 3D Interbody Fusion System to expand the indications for use to include use with allograft in lumbar interbody fusions. Substantial equivalence was determined in response to sufficient comparisons to a predicate device.

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.