The VerteLP is indicated for use in skeletally mature patients with Degenerative Disc Discase (DDD) at one or two contiguous levels from L2-L5. 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). Patients should have received 6 months of non-operative treatment with the devices. The device is intended to be used with supplemental fixation to the integrated fixation jaws, and must be used with autograft bone.

Device Description

The Vertel.P implant is an Intervertebral Body Fusion Device (IBFD) intended to be used in the lumbar spine via a lateral surgical approach. It is intended to stabilize a spinal segment to promote fusion between adjacent vertebral bodies. It also provides indirect decompression to relieve constricted nerve roots. Center apertures have been designed into the VerteLP implant for placement of bone graft to promote fusion through the center of the implant. The device has integrated fixation in the form of laterally- locking jaws to facilitate additional stability. VerteLP is available in a variety of sizes and shapes in order to better accommodate each patient's unique anatomy. The implant is made from Ti6Al4V alloy per ASTM F-136, Zeniva PEEK ZA-500 per ASTM F2026, UHMWPE per ASTM F648 and tantalum per ASTM F560. The devices are available in two widths, heights from 7-17mm and in both parallel and lordotic shapes to accommodate varied patient's anatomy.

AI/ML Overview

The provided document is a 510(k) premarket notification for the "VerteLP Interbody Fusion Device." This type of document is for a medical device that does not require extensive clinical trials to prove safety and effectiveness but rather demonstrates "substantial equivalence" to a predicate device already on the market.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving a device meets these criteria in the context of an AI/algorithm-based medical device. This document describes a physical interbody fusion device, not a software algorithm.

Here's why the requested information cannot be extracted from the provided text:

Acceptance Criteria for AI/Software Performance: The document does not discuss performance metrics like sensitivity, specificity, accuracy, or any other statistical measures typically used for AI-powered diagnostic or predictive tools. Its "performance standards" section refers to mechanical testing for a physical implant.
Study Design for AI/Software: There is no mention of a test set, training set, data provenance (e.g., country of origin for images), expert adjudication, multi-reader multi-case studies, or standalone algorithm performance. The study described is mechanical testing of the physical implant.
Ground Truth: The concept of "ground truth" as it applies to AI/software (e.g., expert consensus, pathology, outcome data) is not relevant to this physical device's evaluation. The mechanical tests use specified physical standards.

Instead, the document focuses on:

Substantial Equivalence: The primary goal of a 510(k) is to demonstrate that a new device is as safe and effective as a legally marketed predicate device.
Mechanical Testing: Performance is assessed through mechanical tests (static compression, shear, torsion, subsidence, dynamic compression, dynamic compression shear) against established ASTM standards (ASTM F2077-14 and F2267-04).
Materials and Design: Comparison of material properties (Ti6Al4V alloy, Zeniva PEEK, UHMWPE, tantalum) and physical dimensions (sizes, shapes, heights) to predicate devices.
Indications for Use: Defining the medical conditions for which the device is intended.

In summary, the provided text does not contain the specific information requested about acceptance criteria and a study proving device performance for an AI/algorithm-based medical device. It pertains to the regulatory submission for a physical interbody fusion device.

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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, resembling a bird-like shape.

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

January 13, 2016

VGI Medical, LLC % Rich Jansen, Pharm.D. Consultant Silver Pine Consulting, LLC 11821 Bramble Cove Drive Fort Myers, Florida 33905

Re: K151312

Trade/Device Name: VerteLP Interbody Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: December 11, 2015 Received: December 14, 2015

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 (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

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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/ResourcesforYou/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

510(k) Number (if known) K151312

Device Name VerteLP Interbody Fusion Device

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)

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FOR FDA USE ONLY

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

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510(k) Summary

Date Prepared:	January 12, 2016
Contact:	Tov Vestgaarten, Ph.D. PresidentVGI Medical, LLC150 153rd Ave., Suite 201St. Petersburg, FL 33708Phone: 727-565-1235Fax: 727-388-0227
Regulatory Contact:	Rich Jansen, Pharm. D.Silver Pine Consulting, LLCrichj@s-pineconsulting.com
Trade Name:Product Class:Classification:Common Name:Product Codes:Panel Code:	VerteLP Interbody Fusion DeviceClass II21 CFR §888.3080Intervertebral Body Fusion DeviceOVD87

Indications for Use:

The Vertel.P is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-L5. 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 at the involved level(s). Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device is intended to be used with supplemental fixation in addition to the integrated fixation jaws, and must be used with autograft bone.

Device Description:

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VerteLP is available in a variety of sizes and shapes in order to better accommodate each patient's unique anatomy. The implant is made from Ti6Al4V alloy per ASTM F-136, Zeniva PEEK ZA-500 per ASTM F2026, UHMWPE per ASTM F648 and tantalum per ASTM F560.

The devices are available in two widths, heights from 7-17mm and in both parallel and lordotic shapes to accommodate varied patient's anatomy.

Predicate Device(s):

The VGI VerteLP is substantially equivalent to the Primary Predicate device, the Coroent XL-F from Nuvasive (K140479). Additional predicate devices include the Avenue L device from LDR (K113285) and the Intercontinental device from Globus (K103382).

Performance Standards:

Mechanical testing was completed by an independent laboratory, Orthokinetic Testing Technologies, following ASTM F2077-14 and F2267-04. Testing was conducted on the worst case implant for each test completed and included the following:

Static Compression Static Compression Shear Static Torsion Subsidence Dynamic Compression Dynamic Compression Shear

Technological Characteristics:

The VerteLP device is similar in sizes, materials, function and indications for use as the predicate devices. One feature that the VerteLP device has that is different than the predicate devices is the method of fixing the device to the superior and inferior vertebral bodies to minimize any chance of implant migration.

Conclusion:

VGI Medical, LLC concludes that the VerteLP device is substantially equivalent to the predicate devices and that the minor differences do not raise any new questions of safety or efficacy.

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.