Rampart™ P and Rampart™ O 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 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.
These devices may be implanted singly or in pairs via an open or a minimally invasive posterior or transforaminal approach.
Rampart™ P and Rampart™ O are designed for use with autograft 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

Rampart™ P and Rampart™ O are designed for use with autograft as an adjunct to fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The device is available in a range of lengths and heights. The device and associated instruments are provided non-sterile.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (Rampart™ P and Rampart™ O), specifically intervertebral body fusion devices. This document focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use.

Based on the provided text, there is no information regarding acceptance criteria or a study proving the device meets acceptance criteria related to AI/algorithm performance for image analysis or other diagnostic purposes, as implied by the questions. The "testing" section explicitly states "Preclinical testing according to ASTM F2077, including static compression and static compression shear. This testing demonstrated similar performance characteristics to the identified predicate devices." This refers to biomechanical testing of the implant itself, not a study evaluating human reader performance with or without AI, or standalone algorithm performance.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria (including the table, sample sizes, expert qualifications, adjudication, MRMC study, standalone performance, and ground truth information) because such information is not present in the provided 510(k) summary. These questions are typically relevant for AI/ML devices or diagnostic imaging devices, not for an intervertebral body fusion implant as described here.

Summary

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510(k) Summary

MAR 2 5 2013

Applicant:	Spineology Inc.7800 3rd Street N., Suite 600Saint Paul, MN 55128Phone: 651-256-8500Fax: 651-256-8505
Contact Person:	Bryan Becker
Date Prepared:	February 15, 2013
Trade Name:	Rampart™ P and Rampart™ O
Product Classificationand Code:	Class II Medical Device, Product Code MAX, 21 CRF 888.3080
Predicate Device(s):	Spineology PEEK Lumbar Interbody Fusion Devices (K111880,K113030, and K120293)
Device Description:	Rampart™ P and Rampart™ O are designed for use with autograft asan adjunct to fusion and is intended for use with supplemental fixationsystems cleared for use in the lumbar spine. The device is available in arange of lengths and heights. The device and associated instruments areprovided non-sterile.
Intended Use:	Rampart™ P and Rampart™ O are intervertebral body fusion devicesindicated for intervertebral body fusion at one level or two contiguouslevels in the lumbar spine from L2 to S1 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 and radiographicstudies. These patients should be skeletally mature and have had sixmonths of non-operative treatment.These devices may be implanted singly or in pairs via an open or aminimally invasive posterior or transforaminal approach.Rampart™ P and Rampart™ O are designed for use with autograft asan adjunct to fusion and is intended for use with supplemental fixationsystems cleared by the FDA for use in the lumbar spine.
Purpose of this 510(k):	The purpose of this 510(k) is to add devices with no lordotic angle.
Summary ofTechnologicalCharacteristics:	The device is shown to be substantially equivalent to the intended use,materials, configuration, and performance characteristics of the predicateproducts.
Testing	Preclinical testing according to ASTM F2077, including static compression and static compression shear. This testing demonstrated similar performance characteristics to the identified predicate devices.
Conclusion:	The information submitted in this premarket notification supports a determination that RampartTM P and RampartTM O are substantially equivalent in technological characteristics and intended use to the predicate device.

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K130396

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

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

March 25, 2013

Spineology Incorporated % Mr. Bryan Becker Regulatory Affairs Manager 7800 3rd Street North, Suite 600 Saint Paul. Minnesota 55128

Re: K130396

Trade/Device Name: Rampart™ P and Rampart™ O Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: March 7, 2013 Received: March 8, 2013

Dear Mr. Becker:

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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Page 2 - Mr. Bryan Becker

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours,

Erin DKeith

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

Enclosure

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KI30396

Device Name: Rampart O and Rampart P

Indications for Use:

Rampart O and Rampart P are intervertebral body fusion device 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 of nonoperative treatment.

These devices may be implanted singly or in pairs via an open or a minimally invasive posterior or transforaminal approach.

Rampart O and Rampart P are designed for use with autograft as an adjunct to fusion and is intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anton E. Dmitriev, PhD Division of Orthopedic 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.