The Rampart™ D Lumbar Interbody Fusion Device is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to L5 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 of non-operative treatment. The Rampart D device is designed for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion and is intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.

Device Description

The Rampart™D Lumbar Interbody Fusion Device is an intervertebral implant designed to provide mechanical support within the intradiscal space as an adjunct to fusion. The device is made of PEEK-OPTIMA® LT-1, titanium alloy, polyethylene terephthalate (PET), and tantalum markers. It is available in varying lengths and heights with two lordotic configurations, and is provided sterile. It is designed with a porous central cavity for graft containment. The device features a rounded nose to aid implant insertion and includes ridged teeth to resist migration.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "Rampart™ D Lumbar Interbody Fusion Device." It is not an AI/ML device, and therefore the information requested about acceptance criteria and study proving adherence to criteria in the context of AI/ML are not applicable here.

This document describes a traditional medical device (an interbody fusion device) and demonstrates its "substantial equivalence" to legally marketed predicate devices, as required for 510(k) clearance by the FDA. The "testing" section refers to non-clinical (bench) testing and patient-level clinical data supplemented by a literature review to support this substantial equivalence.

Therefore, the requested information which pertains to AI/ML device evaluation criteria, such as "number of experts used to establish ground truth," "adjudication method for the test set," "MRMC comparative effectiveness study," "standalone performance," "sample size for training set," and "how ground truth for training set was established," are not relevant to this type of device submission and are not found in the provided text.

The "acceptance criteria" for this device are meeting the performance standards of the predicate devices through the non-clinical and clinical testing mentioned, demonstrating it is "substantially equivalent" in safety and effectiveness.

Here's a breakdown of the relevant information from the document:

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

Since this is a non-AI/ML medical device, the "acceptance criteria" are not based on metrics like sensitivity, specificity, or AUC, but rather on demonstrating substantial equivalence to a predicate device through various physical and mechanical tests, and clinical data. The document states:

Acceptance Criteria (Implied)	Reported Device Performance
Substantial Equivalence to Predicate Devices for Intended Use	The Rampart™ D device has the same intended use and Indications for Use statement as the predicate devices identified (Rampart™L (K133371), Interfuse L (K131540), Elite L Expandable Lumbar Fusion System (K150954)). The differences in technological characteristics between Rampart D and the predicate devices do not raise different safety or effectiveness questions.
Mechanical and Physical Performance (ASTM standards)	Non-clinical testing was performed according to ASTM F2077 (static and dynamic axial compression and compression shear), ASTM F2267 (subsidence) and expulsion testing. Particulate analysis, bench-top and cadaveric implantation evaluations and load sharing tests were completed. All testing was conducted on worst case configurations for both sizing and recommended graft fill.
Biocompatibility	Existing biological data on device materials (PEEK-OPTIMA® LT-1, titanium alloy, polyethylene terephthalate (PET), and tantalum) was used to support the performance and biological safety of the device.
Clinical Safety and Effectiveness (compared to predicate device)	Patient-level clinical data that was supplemented with a literature review was provided to support the substantial equivalence of the subject device. (No specific numerical performance metrics like success rates are detailed in this summary, as the goal is demonstrating equivalence rather than a new clinical claim).

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

Test Set (Clinical Data): "Patient-level clinical data" was provided, but the specific sample size, country of origin, or whether it was retrospective or prospective, is not detailed in this 510(k) summary. This information would typically be in the full submission, not in this publicly accessible summary.
Bench Testing: "All testing was conducted on worst case configurations for both sizing and recommended graft fill." No specific numerical sample sizes for non-clinical (bench) tests are provided in this summary.

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):

This is not applicable to this device type. Ground truth in the context of an AI/ML device refers to human expert annotations. For a traditional medical device, clinical data (patient outcomes, imaging findings relevant to the DDD diagnosis, etc.) forms part of the supporting evidence, but there's no "ground truth" derived from expert consensus in the same way as for an AI/ML diagnostic algorithm.

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

Not applicable for this traditional medical 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 as this is not an AI/ML device assisting human readers.

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

Not applicable as this is a physical medical implant, not an algorithm.

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

For the clinical support, it refers to "patient history and radiographic studies" for the diagnosis of Degenerative Disc Disease (DDD) and overall "patient-level clinical data." The "ground truth" for the device's performance would ultimately be patient outcomes related to successful fusion and safety, compared to the predicate device. However, the details are not provided in this summary.

8. The sample size for the training set:

Not applicable as 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 this is not an AI/ML device.

Summary

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

October 18, 2016

Spineology Inc. Ms. Karen Roche VP. Operations & Technology 7800 Third Street North, Suite 600 Saint Paul, Minnesota 55128

Re: K160074

Trade/Device Name: Rampart™ D Lumbar Interbody Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: September 7, 2016 Received: September 8, 2016

Dear Ms. Roche:

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 Parts 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,

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

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

510(k) Number (if known) K160074

K160074

Page 1 of 1

Device Name

Rampart™ D Lumbar Interbody Fusion Device

Indications for Use (Describe)

The Rampart™ D Lumbar Interbody Fusion Device is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to L5 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 six months of non-operative treatment. The Rampart™ D device is designed for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion and is intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

Applicant:	Spineology Inc.7800 3rd Street N., Suite 600Saint Paul, MN 55128-5455Phone: 651-256-8500Fax: 651-256-8505
Contact Person:	Karen Roche
Date Prepared:	October 17, 2016
Trade Name:	Rampart™ D Lumbar Interbody Fusion Device
Common Name:	Interbody Spacer
Product Classificationand Name:	21 CFR § 888.3080 - Intervertebral body fusion device(Class II, Special Controls)
Product Code:	MAX - Intervertebral Fusion Device With Bone Graft, Lumbar
Predicate Device(s):	Primary Predicate:	Rampart™L (K133371); Spineology Inc.
	Additional Predicates:	1. Interfuse L (K131540);Vertebral Technologies, Inc.
		2. Elite L Expandable Lumbar Fusion System(K150954); Innova Spinal Technologies, LLC
Reference Device:	OptiMesh (K014200); Spineology Inc.
Device Description:	The Rampart™D Lumbar Interbody Fusion Device is an intervertebralimplant designed to provide mechanical support within theintradiscal space as an adjunct to fusion. The device is made ofPEEK-OPTIMA® LT-1, titanium alloy, polyethylene terephthalate(PET), and tantalum markers. It is available in varying lengths andheights with two lordotic configurations, and is provided sterile. It isdesigned with a porous central cavity for graft containment. Thedevice features a rounded nose to aid implant insertion and includesridged teeth to resist migration.
Indications for Use:	The Rampart™D Lumbar Interbody Fusion Device is indicated forintervertebral body fusion at one level or two contiguous levels inthe lumbar spine from L2 to L5 in patients with degenerative discdisease (DDD) with up to Grade I spondylolisthesis at the involvedlevel(s). DDD is defined as back pain of discogenic origin withdegeneration of the disc confirmed by patient history andradiographic studies. These patients should be skeletally mature and
	have had six months of non-operative treatment. The Rampart Ddevice is designed for use with autograft and/or allograft comprisedof cancellous and/or corticocancellous bone graft as an adjunct tofusion and is intended for use with supplemental fixation systemscleared by the FDA for use in the lumbar spine.
Purpose of this 510(k):	To receive FDA clearance to market the Rampart D LumbarInterbody Fusion Device in the US.
Summary ofTechnologicalCharacteristics:	The Rampart D Lumbar Interbody Fusion Device and the predicatesshare some technological characteristics, including materials ofconstruction, comparable profile, dimensions and lordotic angles,serrated surfaces for endplate contact, similar graft containmentareas and graft volume capacities. The reference device shares thesame material and design features for use in graft containment.
Testing	Non-clinical testing was performed according to ASTM F2077 (staticand dynamic axial compression and compression shear), ASTM F2267(subsidence) and expulsion testing. Particulate analysis, bench-topand cadaveric implantation evaluations and load sharing tests werecompleted. All testing was conducted on worst case configurations forboth sizing and recommended graft fill. Existing biological data ondevice materials was used to support the performance and biologicalsafety of the device. Patient-level clinical data that was supplementedwith a literature review was also provided to support the substantialequivalence of the subject device.
Conclusion:	The Rampart D device has the same intended use and Indications forUse statement as the predicate devices identified. The differencesin technological characteristics between Rampart D and thepredicate devices do not raise different safety or effectivenessquestions. Non-clinical and clinical testing demonstrates substantialequivalence to legally marketed predicate devices when used underthe labeled conditions.

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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.