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.

Device Description

The Spineology Rampart O and P Devices 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

This document is a 510(k) summary for the Spineology Rampart O and P Devices, which are intervertebral body fusion devices. The purpose of this 510(k) is to add devices as small as 20 mm in length and to add products that include features allowing for rotation of the devices after insertion on implants with tantalum markers.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets the criteria:

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

Acceptance Criteria (Implied)	Reported Device Performance
Substantial equivalence to predicate devices (materials, configuration, performance characteristics).	Demonstrated similar performance characteristics to the identified predicate devices in preclinical testing.
Compliance with FDA's "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device".	Tested in compliance with this guidance document.
Mechanical performance (static compression and static compression shear) comparable to predicate devices.	Preclinical testing included static compression and static compression shear according to ASTM F2077. This testing demonstrated similar performance characteristics.
Suitability for new sizes (as small as 20mm in length).	The 510(k) specifically adds devices as small as 20mm in length. Preclinical testing would have supported this.
Functionality of new features (rotation after insertion with tantalum markers).	The 510(k) adds products with features allowing for rotation of devices after insertion on implants with tantalum markers. Preclinical testing would have supported this.

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

Sample Size for Test Set: The document does not specify a "test set" in the context of human data. The testing mentioned is preclinical. For preclinical mechanical testing, sample sizes would typically be several units per test condition to ensure statistical robustness, but the exact numbers are not provided in this summary.
Data Provenance: The data is preclinical testing. The country of origin and whether it's retrospective or prospective are not applicable to the type of testing described (mechanical testing).

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 section is not applicable as the provided text describes preclinical mechanical testing of an intervertebral body fusion device, not an AI/software device that requires expert-established ground truth for a test set.

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

This section is not applicable for the same reason as point 3.

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

This section is not applicable. The device is an intervertebral body fusion device, which is a physical implant, not a software or AI tool requiring MRMC studies for human reader performance.

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

This section is not applicable as the device is not an algorithm or AI.

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

For the preclinical testing, the "ground truth" would be established by engineering standards and physical measurements based on ASTM F2077. For instance, load cells and displacement sensors would provide objective data on static compression and shear forces, which are then compared against performance characteristics of predicate devices.

8. The sample size for the training set

This section is not applicable as the device is not an AI/machine learning model that requires a training set.

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

This section is not applicable for the same reason as point 8.

Summary

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510(k) Summary

MAR 22 2013

Applicant:	Spineology Inc.7800 3rd Street N., Suite 600Saint Paul, MN 55128Phone: 651-256-8500 Fax: 651-256-8505
Contact Person:	Bryan Becker
Date Prepared:	November 21, 2012
Trade Name:	Rampart O and Rampart P
Product Classificationand Code:	Class II Medical Device, Product Code MAX, 21 CFR 888.3080
Predicate Device(s):	Spineology PEEK Lumbar Interbody Fusion Devices (K111880,K113030, and K120293)
Device Description:	The Spineology Rampart O and P Devices are designed for use withautograft as an adjunct to fusion and is intended for use with supplementalfixation systems cleared for use in the lumbar spine. The device isavailable in a range of lengths and heights. The device and associatedinstruments are provided non-sterile.
Intended Use:	The Rampart O and P Devices are an intervertebral body fusion deviceindicated 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.The Rampart O and P Devices are designed for use with autograft as anadjunct 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 as small as 20 mm in lengthand add products that include features that allow for rotation of thedevices after insertion on implants with tantalum markers.
Summary ofTechnologicalCharacteristics:	The device is shown to be substantially equivalent to the intended use,materials, configuration, and performance characteristics of the predicateproducts.
Testing	The Rampart O and P Devices were tested in compliance with FDA'sguidance document titled "Class II Special Controls GuidanceDocument: Intervertebral Body Fusion Device". Preclinical testingaccording to ASTM F2077, including static compression and staticcompression shear. This testing demonstrated similar performancecharacteristics to the identified predicate devices.
Conclusion:	The information submitted in this premarket notification supports adetermination that the Spineology Rampart O and P Devices aresubstantially equivalent in technological characteristics and intended useto the predicate devices.

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

March 22, 2013

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

Re: K123652

Trade/Device Name: Rampart O and Rampart P Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: February 20, 2012 Received: March 8, 2012

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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

ErinL.Keith

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

Enclosure

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K123652

Device Name: Rampart O and Rampart P

Indications for Use:

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.