Rampart™ O, Rampart™ T, and Rampart™ A implants are intervertebral body fusion devices indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

Rampart™ O, Rampart™ T, and Rampart™ A implants are designed for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion and are intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.

Device Description

Rampart O, Rampart T, and Rampart A implants are intervertebral body fusion devices for use with bone graft in the intervertebral disc space to stabilize spinal segments as an adjunct to fusion. These devices are made of PEEK-OPTIMA LT1 with titanium or tantalum markers and are provided in various configurations and heights, containing a hollow core to receive bone autograft and/or allograft. Placement is achieved with an insertion instrument that allows for manipulation of the implant in the intervertebral disc space.

AI/ML Overview

The provided document is a 510(k) premarket notification for intervertebral body fusion devices, seeking clearance to expand the indications for use. It primarily focuses on demonstrating substantial equivalence to predicate devices and does not contain information about the performance of a device that relies on AI or algorithms, nor does it present acceptance criteria or a study proving that a device meets such criteria in the context of an AI/algorithmic medical device.

Therefore, most of the requested information cannot be extracted from this document.

Here's what can be gathered based on the available text:

A table of acceptance criteria and the reported device performance:
Not applicable. This document is a 510(k) submission for an intervertebral body fusion device, not an AI/algorithmic device. No performance metrics or acceptance criteria for an AI system are present.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. No test set for an AI/algorithmic device is mentioned.
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. No ground truth establishment for an AI/algorithmic device is mentioned.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No test set adjudication for an AI/algorithmic device is mentioned.
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. No MRMC study or AI assistance is mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. No standalone algorithm performance is mentioned.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. No ground truth for an AI/algorithmic device is mentioned. The document references "published clinical data for lumbar intervertebral body fusion devices" and a "clinical literature review," but this is for predicate device comparison and safety profile, not for establishing ground truth for an AI algorithm.
The sample size for the training set:
Not applicable. No training set for an AI/algorithmic device is mentioned.
How the ground truth for the training set was established:
Not applicable. No training set or ground truth for an AI/algorithmic device is mentioned.

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 seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol representing the human form, depicted as three stylized profiles facing to the right. The profiles are connected and flow together, creating a sense of unity and collaboration.

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

July 14, 2016

Spineology, Incorporated Ms. Jacqueline A. Hauge Regulatory Affairs Manager 7800 3rd Street, Suite 600 Saint Paul, Minnesota 55128

Re: K160906

Trade/Device Name: Rampart™ O Lumbar Interbody Fusion Device, Rampart™ T Lumbar Interbody Fusion Device, Rampart™ A Lumbar Interbody Fusion Device

Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: April 15, 2016 Received: April 18, 2016

Dear Ms. Hauge:

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 Parts 801); medical device reporting (reporting of medical devicerelated 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/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, Lori A. Wiggins -S

for

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K160906

Device Name

Rampart™ O Lumbar Interbody Fusion Device Rampart™ T Lumbar Interbody Fusion Device Rampart™ A Lumbar Interbody Fusion Device

Indications for Use (Describe)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Date Prepared:	June 30, 2016
Submitter:	Spineology Inc.7800 3rd Street NorthSuite 600Saint Paul, MN 55128Establishment Registration Number: 2135156
Contact Person:	Jacqueline A. HaugeRegulatory Affairs MangerPhone: 651.256.8534Fax: 651.256.8505Email: jhauge@spineology.com

Device Name and Classification

Trade Name:	Rampart™ O Lumbar Interbody Fusion Device
	Rampart™ T Lumbar Interbody Fusion Device
	Rampart™ A Lumbar Interbody Fusion Device
Common Name:	Spinal implant
Classification Name:	Intervertebral body fusion device
Product Codes:	MAX
Regulatory Class:	Class II
Regulation Number:	21 CFR 888.3080
Panel:	Orthopedic
Predicate Devices

Predicate Devices
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Primary:	K150788	Talos Intervertebral Body Fusion Devices (Meditech Spine, LLC)
Additional:	K132053	Rampart O, Rampart T Lumbar Interbody Fusion Device
	K153082	Rampart A Lumbar Interbody Fusion Device

Purpose

The purpose of this 510(k) is to obtain clearance to expand the current indications for use to include use of either autograft and/or allograft as a substitute/addition to autologous bone.

Device Description

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Indications for Use

Rampart O, Rampart T, and Rampart A implants are intervertebral body fusion devices indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar soine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

Rampart 0, Rampart T, and Rampart A implants are designed for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion and are intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.

Technological Characteristics

The technological characteristics of Rampart O, Rampart T, and Rampart A are identical to the additional predicate devices in terms of intended use and design. The indications for use are similar. The addition of allograft comprised of cancellous and/or corticocancellous bone graft to Rampart O. Rampart T, and Rampart A does not increase the risks associated with use of the device.

Non-Clinical Testing

There have been no design changes made to the Rampart 0, Rampart T, and Rampart A devices to support use of allograft material. No design changes were made to the existing devices, nor were any new components added to these systems; therefore, mechanical testing was not required or performed to support substantial equivalence.

Bacterial Endotoxin testing (BET), also known as the Limulus amebocyte lysate (LAL) test, was performed per ANSI/AAMI/ST72 to a limit of <20 EU/Device.

Clinical Testing

A review of published clinical data for lumbar intervertebral body fusion devices similar to the Rampart O, Rampart T, and Rampart A devices was provided in support of this application. The published clinical outcomes demonstrate that the use of allograft in interbody fusion procedures to treat patients with degenerative disc disease, as defined above, pose no new risks to patients. No design changes were made to the exiting devices, nor were any new components added to these systems; therefore, clinical testing was not required or performed to support substantial equivalence.

Conclusion

The Spineology Rampart O, Rampart T, and Rampart A devices have the same intended use, technological characteristics, design, and principles of operation as their predicate devices; as well as similar indications for use. The clinical literature review presented in this application supports a substantial equivalence determination of the Rampart O, Rampart T, and Rampart A 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.