The standard and oblique Rampart One devices are integrated 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 I 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 non-operative treatment.

The standard and oblique Rampart One devices are designed for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and are intended for use with supplemental fixations systems cleared by FDA for use in the lumbar spine.

Device Description

Rampart One 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 manufactured from PEEK-OPTIMA HA Enhanced (spacer), titanium alloy (face plate), and tantalum (radiopaque markers) materials. Rampart One devices incorporate integrated fixation in the form of titanium allov screws. Rampart One devices are provided in standard and oblique configurations. The standard device accommodates four screws and the oblique device accommodates two screws. In each device the screws are inserted through the anteriorly-located face plate into the adjacent vertebral bodies. Rampart One devices are provided in various heights and lordotic angles and contain a hollow core to receive autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. Placement is achieved with an insertion instrument that allows for manipulation of the implant in the intervertebral disc space.

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device called the "Rampart One Lumbar Interbody Fusion Device." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical efficacy or diagnostic performance. Therefore, the information typically requested in your prompt (such as a table of acceptance criteria, sample sizes for test/training sets for AI, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) is not part of this document.

The document primarily addresses the device's design, materials, indications for use, and non-clinical mechanical testing to show that it is as safe and effective as existing predicate devices.

Here's a breakdown of the available information in relation to your request, with an emphasis on what is not present because it's not a required component of a 510(k) for this type of device:

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

Acceptance Criteria for Substantial Equivalence: The primary acceptance criterion for a 510(k) is the demonstration of "substantial equivalence" to a predicate device. This is achieved by showing that the new device has the same intended use and technological characteristics as the predicate, or that any differences do not raise new questions of safety or effectiveness.
Reported Device Performance (Non-Clinical): Mechanical testing was conducted. The document states:
- ASTM F2077: Static and Dynamic Compression, Static and Dynamic Compression Shear tests were performed.
- ASTM F2267: Subsidence test was performed.
- ASTM F543-13: Axial Pullout test was performed.
- Anti-Screw Backout Expulsion: A test was performed.
- Bacterial endotoxin testing (BET): Conducted in accordance with ANSI/AAMI ST-72:2011.
- Specific performance metrics (e.g., precise load limits, displacement values, or pass/fail thresholds) are NOT detailed in this summary. The FDA review process would have evaluated the raw data and compared it against established standards or predicate device performance, but these specific numbers are not public in this summary document. The "Conclusion" states: "Spineology has demonstrated that the Rampart One Lumbar Interbody Fusion Device is substantially equivalent to the predicate devices."

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

Not Applicable in the traditional sense for this type of device: For a mechanical device like an interbody fusion device, "test set" typically refers to the samples of the device itself (e.g., a certain number of devices tested for mechanical properties). The document does not specify the number of devices tested for each mechanical test.
Data Provenance: The tests were conducted according to ASTM and ANSI/AAMI standards, likely in a laboratory setting. Country of origin for data is not specified, but the submitter is Spineology Inc. in Saint Paul, Minnesota, USA. The testing is prospective in the sense that the manufacturer specifically conducted these tests for this submission.

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: This is not a diagnostic device or an AI/ML algorithm that requires expert ground truth labeling. Mechanical properties are measured objectively by instrumentation in a laboratory, not by expert opinion.

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

Not applicable: No expert adjudication is involved in evaluating the primary performance of this mechanical device.

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 implantable device, not a diagnostic imaging or AI-assisted device. No human reader studies (with or without AI assistance) are relevant or mentioned.

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

Not applicable: This is a physical medical device, not an algorithm.

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

Mechanical Standards: The "ground truth" for the mechanical testing is adherence to established industry standards (ASTM, ANSI/AAMI) for biocompatibility, sterility, and mechanical strength, often compared against performance data from predicate devices. Clinical "outcomes data" is generally part of a PMA (Premarket Approval) process, not a 510(k), unless specific new safety/effectiveness questions arise.

8. The sample size for the training set:

Not applicable: This is not an AI/ML device that requires a "training set."

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

Not applicable: As above, no training set is involved.

Summary of what the document does provide:

Device Name: Rampart One Lumbar Interbody Fusion Device
Intended Use: Intervertebral body fusion at one or two contiguous levels in the lumbar spine (L2-S1) for patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis, who are skeletally mature and have had six months of non-operative treatment.
Materials: PEEK-OPTIMA HA Enhanced (spacer), titanium alloy (face plate), tantalum (radiopaque markers).
Mechanisms of Action: Integrated fixation with titanium alloy screws, hollow core for bone graft.
Non-Clinical Testing Conducted: Mechanical tests (Static/Dynamic Compression/Shear, Subsidence, Axial Pullout, Anti-Screw Backout Expulsion) and Bacterial Endotoxin Testing, all performed according to recognized standards.
Predicate Devices: Several predicate devices are listed, including other Spineology Rampart devices and devices from Cutting Edge Spine, Synthes Spine, and Biomet Spine. The new device is compared to these predicates to demonstrate substantial equivalence in intended use, indications for use, fundamental scientific technology, principle of operation, biological safety, base materials, and size offering.

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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, with flowing lines extending downward from the bottom profile.

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

May 8, 2017

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

Re: K163670

Trade/Device Name: Rampart One Lumbar Interbody Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD Dated: April 10, 2017 Received: April 11, 2017

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 (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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.

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

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

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

510(k) Number (if known)

K163670 Page 1 of 1

Device Name

Rampart One Lumbar Interbody Fusion Device

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the word "Spineology" in a bold, sans-serif font. To the right of the word is a purple graphic that looks like a cluster of dots arranged in a circular pattern. The logo appears to be for a company or organization named Spineology.

Date Prepared:	May 3, 2017
Submitter:	Spineology Inc.7800 3rd Street NorthSuite 600Saint Paul, MN 55128Establishment Registration Number: 2135156
Contact Person:	Jacqueline A. HaugeRegulatory Affairs ManagerPhone: 651.256.8534Fax: 651.256.8505Email: jhauge@spineology.com

Device Name and Classification

Trade Name:	Rampart One Lumbar Interbody Fusion Device
Common Name:	Intervertebral fusion device with integrated fixation
Product Codes:	OVD
Regulatory Class:	Class II
Regulation Number:	21 CFR 888.3080
Panel:	Orthopedic

Predicate Devices
Primary:	K153082	Rampart A Lumbar Interbody Fusion Device (Spineology Inc.)
Additional:	K111880	Rampart P Lumbar Interbody Fusion Device (Spineology Inc.)
	K160906	Rampart A, O, T Lumbar Interbody Fusion Devices (Spineology Inc.)
	K150321	EVOS Lumbar Interbody Fusion Device (Cutting Edge Spine, LLC)
	K072253	SynFix LR (Synthes Spine)
	K163543	Durango Stand-Alone ALIF System (Biomet Spine)

I. Purpose

The purpose of this premarket notification is to obtain initial 510(k) clearance of Spineology's Rampart One Lumbar Interbody Fusion Device.

II. Submission History

There have been no prior submissions submitted to FDA for the Rampart One Lumbar Interbody Fusion Device.

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

III. Device Description

IV. Indications for Use

The standard and oblique Rampart One devices are designed for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and are intended for use with supplemental fixation systems cleared by FDA for use in the lumbar spine.

V. Comparison to Predicate

When compared to the predicate devices, Rampart One Lumbar Interbody Fusion Device has the same or similar:

Intended Use ●
. Indications for Use
. Fundamental Scientific Technology
Principle of Operation
Biological Safety ●
Base Materials
. Size Offering

VI. Non-Clinical Testing

The following mechanical testing was conducted in accordance with FDA's Class II Special Controls Guidance Document: Intervertebral Fusion Device (2007) and applicable American Society for Testing and Materials (ASTM) standards:

ASTM F2077	ASTM F2267	ASTM F543-13
• Static and Dynamic Compression• Static and Dynamic Compression Shear	• Subsidence	• Axial Pullout

. Static and Dynamic Compression Shear
Anti-Screw Backout Expulsion Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011.

VII. Conclusion

Spineology has demonstrated that the Rampart One Lumbar Interbody Fusion Device is substantially equivalent to 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.