The Luna 360 Interbody Fusion System consists of the Luna 360 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 360 System is to be used with autogenous bone graft. Patients receiving the device should have had at least six months of nonoperative treatment prior to receiving the Luna 360 Implant. The Luna 360 System is to be used with supplemental fixation.

Device Description

The Benvenue Luna 360 System consists of the Luna 360 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 360 System are identical to predicate interbody lumbar cages. The Luna 360 Implant is provided pre-loaded and sterile within a single-use Insertion Tool.

The Luna 360 Implant is available in heights ranging from 8mm to 13mm 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 360 Implant is manufactured from polyetheretherketone (PEEK Optima LT-1), stainless steel, tantalum, and silicone lubricant (NuSil MED-360).

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Luna 360 Interbody Fusion System." This document is primarily concerned with establishing substantial equivalence to legally marketed predicate devices, rather than presenting a clinical study with detailed acceptance criteria and performance metrics typically found in AI/ML medical device submissions.

Therefore, the requested information regarding acceptance criteria, reported performance, sample sizes for test and training sets, expert qualifications, and adjudication methods is not available in the provided text, as this type of information is generally not required for this specific device type and approval pathway.

The device is an intervertebral body fusion device, not an AI/ML algorithm, and thus the concepts of "acceptance criteria" for algorithm performance, "test set," "training set," "ground truth," "MRMC studies," or "standalone performance" as they relate to AI/ML devices do not apply here.

However, the document does contain information about performance testing relevant to a medical device's physical and mechanical properties.

Here's a breakdown of the relevant information provided:

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

Acceptance Criteria (Implicit): The implicit acceptance criterion is that the device demonstrates mechanical properties that are "substantially equivalent" to legally marketed predicate devices, particularly regarding static/dynamic compression, shear-compression, torsion, subsidence, and expulsion. The specific numerical thresholds for "acceptance" are not explicitly stated as they would be in an AI/ML performance summary, but rather implied by meeting the standards of similar devices.
Reported Device Performance:
- Mechanical Testing: The tests demonstrated that the Luna Interbody System is "substantially equivalent" to legally marketed predicate devices in static/dynamic compression, static/dynamic shear-compression, static/dynamic torsion testing (per ASTM F2077), static subsidence (ASTM F2267), and expulsion testing (ASTM Draft Standard F-04.25.02.02).
- Cadaveric Testing: Performed to validate the surgical technique.
- MR Compatibility Testing: Performed to demonstrate MR safety.

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 for this type of device and testing. The "test set" in this context refers to the physical devices undergoing mechanical and material testing, not a dataset of patient images or clinical outcomes.

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 this context would likely refer to engineering specifications or validated test methods, rather than expert diagnostic opinions.

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

Not applicable.

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 device is not an AI-assisted diagnostic tool.

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

Not applicable.

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

For the mechanical testing, the "ground truth" would be the established ASTM standards (F2077, F2267, and ASTM Draft Standard F-04.25.02.02) and engineering principles for mechanical performance. For MR compatibility, the "ground truth" would be established MR safety protocols.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of this device.

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

Not applicable.

In summary, the provided document details the regulatory clearance of a physical medical device (intervertebral body fusion system) based on substantial equivalence to existing devices, supported by a series of mechanical and material performance tests. It does not involve a clinical study or AI/ML algorithm, and therefore the specific questions related to AI/ML validation are not addressed by the text.

Summary

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

November 20, 2014

Benvenue Medical, Incorporated % Ms. Cindy Domecus Principal Domecus Consulting Servics LLC 1171 Barroilhet Drive Hillsborough, California 94010

Re: K142023

Trade/Device Name: Luna 360 Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: October 22, 2014 Received: October 23, 2014

Dear Ms. Domecus:

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

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device-related adverse events) (21 CFR 803); 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.

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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Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K142023

Device Name

Benvenue Medical, Inc. Luna 360 Interbody Fusion System

Indications for Use (Describe)

The Luna 360 Interbody Fusion System consists of the Luna 360 Implant and associated accessories. This system is indicated for spinal fusion procedures in skeletally mature patients with symptomatic degenerative dise disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degenerations of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to grade I snoondsylolisthesis or retrolisthesis at the involved level(s). The Luna 360 Interbody Fusion System is to be used with autogenous bonsitissis. Patients receiving the device should have had at least six months of nonoperative treatment prior to receiving books Lona 360 Implant. The Luna 360 Interbody Fusion System is to be used with supplemental fixation.

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)

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FOR FDA USE ONLY

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

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5. 510(k) Summary

Device Trade Name:	Luna 360 Interbody System
Manufacturer:	Benvenue Medical, Inc.3052 Bunker Hill Lane, Suite 120Santa Clara, California 95054 USA
510(k) Owner:	Barbara S. LindsayVice President, Clinical and Regulatory AffairsBenvenue Medical, Inc.3052 Bunker Hill Lane, Suite 120Santa Clara, California 95054 USATelephone: +1 (408) 454-9300
Application Correspondent:	Cindy Domecus, R.A.C. (US & EU)PrincipalDomecus Consulting Services LLCConsultant to Benvenue Medical, Inc.Office: 650-343-4813Fax: 650-343-7811domecusconsulting@comcast.net
Date Prepared:	November 18, 2014
Classifications:	21 CFR §888.3080: Intervertebral body fusion device
Class:	II
Product Codes:	MAX

Indications for Use:

The Luna 360 System consists of the Luna 360 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 360 System is to be used with autogenous bone graft. Patients receiving the device should have had at least six months of nonoperative treatment prior to receiving the Luna 360 Implant. The Luna 360 System is to be used with supplemental fixation.

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Device Description:

The Luna 360 Implant is manufactured from polyetheretherketone (PEEK Optima LT-1), 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.

Predicate Device Comparison:

Comparative information presented in the 510(k) supports the substantial equivalence of the Luna Interbody System to the primary predicate of the NLT Prow Fusion (K130254) and other predicates, including R Tree Innovations Epicage (K092901), SeaSpine Hollywood (K082310), Spinal Elements Lucent (K122967, K071724) and CoAlign Innovations AccuLIF TL-PEEK Cage (K112095 and K093669). Comparisons were designed to show the indications, intended use, design, and performance are equivalent between the Benvenue Luna 360 System and predicate devices.

Performance Testing:

The non-clinical tests performed included static/dynamic compression, static/dynamic shearcompression, and static/dynamic torsion testing per ASTM F2077, static subsidence (ASTM F2267), and expulsion testing (ASTM Draft Standard F-04.25.02.02). The results of the performed tests demonstrated that the Luna Interbody System is substantially equivalent to legally marketed predicate devices. Additional cadaveric testing has been performed to validate the surgical technique. MR Compatibility testing was performed to demonstrate MR safety.

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.

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.