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 carcellous and/or corticocancellous bone graft.

The standard Rampart One device may be used with or without supplemental fixation systems cleared by FDA for use in the lumbar spine. When used without supplemental fixation, the standard Rampart One device must be used with four (4) screws.

The oblique Rampart One device must be used with two (2) screws and with supplemental fixation 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 alloy 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

This document, K191091, is a 510(k) premarket notification for the Rampart™ One Lumbar Interbody Fusion System, specifically concerning the addition of a new Implant Inserter and modified Inserter Guides. It asserts substantial equivalence to a predicate device.

Crucially, this submission does not describe an AI/ML-driven device or diagnostic software that would typically have acceptance criteria related to classification metrics (e.g., sensitivity, specificity, AUC). Instead, it pertains to a physical medical device (intervertebral body fusion system) and its associated surgical instruments. The "acceptance criteria" and "study" described in the document are engineering and non-clinical performance tests for these physical instruments, not clinical performance metrics for an AI algorithm.

Therefore, many of the requested items in the prompt (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, MRMC study, standalone performance) are not applicable to this type of device submission.

However, I can extract the relevant "acceptance criteria" and "proof" as described for this mechanical device:

Acceptance Criteria and Study for the Rampart™ One Lumbar Interbody Fusion System (Focus on Inserter and Guides)

Device Under Review: New Implant Inserter and modified Inserter Guides for the Rampart™ One Lumbar Interbody Fusion System.

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical/Engineering Focus):

Acceptance Criterion (Implicitly "Met" or Verified)	Reported Device Performance/Confirmation
Functional Performance: The new Implant Inserter and modified Inserter Guides must properly function for the intended purpose of implanting the Rampart One Lumbar Interbody Fusion Device.	Design verification testing was conducted to "confirming function and performance in simulated use." (See section E. Non-Clinical Testing)
Interface Compatibility: The new Inserter and Guides must correctly interface with the existing Rampart One Implant.	"The instrument interface with the Rampart One Implant remains unchanged." (See section E. Non-Clinical Testing)
No Alteration to Intended Use: The modifications should not change the fundamental intended use of the instruments.	"A review of the design changes was performed and confirmed that these modifications do not alter the intended use of the instruments..." (See section E. Non-Clinical Testing)
No New Technological Characteristics: The modifications should not introduce new technological characteristics.	"...or present new technological characteristics." (See section E. Non-Clinical Testing)
No Alteration to Primary Control Mechanism/Operating Principle: The modifications should not change how the instruments are controlled or operate.	"The design changes do not alter the primary control mechanism or operating principle of the instruments." (See section E. Non-Clinical Testing)
Risk Profile Consistency: The modifications should not introduce new risks or alter the existing risk profile.	"A risk assessment was performed and confirmed that the modifications to the instruments do not alter the risk profile for the device or present new issues of safety or effectiveness when compared to the predicate device." (See section E. Non-Clinical Testing)
Substantial Equivalence: The modified components, in conjunction with the system, must be substantially equivalent to the predicate device.	"Based on the intended use, technological characteristics, and comparison to the predicate device, Spineology has demonstrated that the new Rampart One Implant Inserter and modified Inserter Guides have been shown to be substantially equivalent to the legally marketed predicate device." (See section F. Conclusion)

2. Sample size used for the test set and the data provenance:

Not Applicable in the context of clinical AI/ML studies. This submission refers to "design verification testing" and "simulated use" for physical instruments. The sample size would refer to the number of tests/cycles performed on the instruments, which is not detailed in this summary.
Data Provenance: Not specified as clinical data. It refers to internal engineering tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. Ground truth, in the AI/ML sense, is not relevant here. The "ground truth" for a mechanical device is simply its physical performance against engineering specifications, likely established by internal engineers and quality control personnel.

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

Not Applicable. Adjudication methods are for human interpretation of clinical data, not for engineering tests of physical instruments.

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 not an AI-assisted diagnostic device.

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

Not Applicable. This is not an algorithm.

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

Not Applicable in the AI/ML sense. The "ground truth" is the engineering specifications and functional requirements of the device's mechanical performance.

8. The sample size for the training set:

Not Applicable. No training set for an AI/ML model is involved.

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

Not Applicable. No training set for an AI/ML model is involved.

Summary of the Study Proving Acceptance (for this specific device and its modifications):

The "study" cited in this 510(k) summary is comprised of non-clinical engineering design verification tests and a risk assessment.

Methodology: The submission states "Design verification testing was conducted to support the new Implant Inserter and modified Inserter Guides confirming function and performance in simulated use." This would typically involve mechanical tests, durability tests, dimensional checks, and functional tests to ensure the instruments properly hold, insert, and release the interbody fusion device.
Proof: The success of these tests, combined with a review of design changes and a risk assessment, led the manufacturer (Spineology) to conclude that the modified components maintained the same intended use, technological characteristics, principle of operation, and risk profile as the predicate device. This forms the basis for their claim of substantial equivalence, which is the primary "acceptance criterion" for a 510(k) submission of this type. The FDA's clearance letter indicates their agreement with this conclusion.

Summary

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

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

Spineology, Inc. % Mr. Andrew Adams Director of Regulatory Affairs 7800 3rd Street North, Suite 600 Saint Paul, Minnesota 55128

Re: K191091

Trade/Device Name: Rampart™ One Lumbar Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD Dated: April 22, 2019 Received: April 24, 2019

Dear Mr. Adams:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

May 23, 2019

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

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

for CAPT Raquel Peat, PhD, MPH, USPHS Director OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K191091

Device Name

Rampart™ One Lumbar Interbody Fusion System

Indications for Use (Describe)

The oblique Rampart One device must be used with two (2) screws and with supplemental fixation systems cleared by FDA for use in the lumbar spine.

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)

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

Spineology.

510(k) Summary

Date Prepared:	May 22, 2019
Submitter:	Spineology, Inc.7800 3rd Street NorthSuite 600Saint Paul, MN 55128
	Establishment Registration Number: 2135156
Contact Person:	Andrew AdamsDirector of Regulatory AffairsPhone: 651.256.8534Fax: 651.256.8505Email: aadams@spineology.com
Device Name and Classification
Trade Name:	Rampart™ One Lumbar Interbody Fusion System
Common Name:	Intervertebral fusion device with integrated fixation
Classification Name:	OVD
Regulatory Class:	Class II
Regulation Number:	21 CFR 888.3080
Panel:	Orthopedic

Predicate Device

K180002 Rampart™ One Lumbar Interbody Fusion Device (Spineology Inc.) Primary:

A. Purpose of Premarket Notification

The purpose of this premarket notification is to obtain FDA clearance to introduce a new Implant Inserter and modified Inserter Guides to the Rampart One Lumbar Interbody Fusion System. The subject Implant Inserter provides an alternative design for ease of use based on user feedback. While previously classified as Class I devices, the Inserter Guides were modified to interface with the new Implant Inserter and are presented as Class II devices within this submission as they are unique to the implantation of the Rampart One Implant.

B. Device Description

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

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.

C. Indications for Use

The standard Rampart One device may be used with or without supplemental fixation using fixation systems cleared by FDA for use in the lumbar spine. When used without supplemental fixation, the standard Rampart One device must be used with four (4) screws.

The oblique Rampart One device must be used with two (2) screws and with supplemental fixation systems cleared by FDA for use in the lumbar spine.

D. Comparison to Predicate Device

When compared to the predicate device, the new Implant Inserter and modified Inserter Guides have the same or equivalent:

Intended Use
Indications for Use
Fundamental Scientific Technology ●
Principle of Operation ●
Primary Design Features
Materials of Construction
Function / Performance
Risk Profile

E. Non-Clinical Testing

Design verification testing was conducted to support the new Implant Inserter and modified Inserter Guides confirming function and performance in simulated use.

. A review of the design changes was performed and confirmed that these modifications do not alter the intended use of the instruments or present new technological characteristics.
The design changes do not alter the primary control mechanism or operating principle of ● the instruments.
The instrument interface with the Rampart One Implant remains unchanged. ●
A risk assessment was performed and confirmed that the modifications to the instruments ● do not alter the risk profile for the device or present new issues of safety or effectiveness when compared to the predicate device.

{5}------------------------------------------------

F. Conclusion

Based on the intended use, technological characteristics, and comparison to the predicate device, Spineology has demonstrated that the new Rampart One Implant Inserter and modified Inserter Guides have been shown to be substantially equivalent to the legally marketed 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.