Rampart™ O is an 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 non-operative treatment.

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

Rampart™ O is 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™ O devices are designed for use with autograft as an adjunct to fusion and are 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 describes a 510(k) premarket notification for the Rampart™ O intervertebral body fusion device. This type of submission is for medical devices, not AI/ML-driven diagnostic tools, therefore many of the requested categories are not applicable.

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance

The device under review is an intervertebral body fusion device, which is a physical implant. The acceptance criteria and "performance" in this context refer to the device's physical properties and its ability to function as intended within the human body, not diagnostic accuracy.

Acceptance Criteria	Reported Device Performance
Mechanical Performance: - Static Compression Strength - Static Compression Shear Strength	Substantial Equivalence Demonstrated: - Previous preclinical testing according to ASTM F2077 (static compression and static compression shear) was used to justify substantial equivalence. - Testing demonstrated similar performance characteristics to the identified predicate devices.
Material Biocompatibility:	Assumed to be met as it's an extension of existing cleared devices.
Sterility:	Device and associated instruments are provided non-sterile (implies sterilization by user).
Design/Configuration: - Range of lengths and heights (for new sizes)	Extended range of sizes for lordotic and non-lordotic implants. Design is similar to predicate devices.
Intended Use Safety & Efficacy:	Similar to predicate devices, for lumbar interbody fusion (L2-S1) in patients with DDD and up to Grade I spondylolisthesis, with autograft and supplemental fixation.

Study Details (Applicability to AI/ML is explained)

This document is for a traditional medical device (implant), not an AI/ML diagnostic. Therefore, many of the questions related to AI/ML performance studies, ground truth, and expert evaluation are not directly applicable.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- N/A (for AI/ML): This is not an AI/ML device. The "test set" in this context refers to the samples used for mechanical testing.
- Mechanical Testing Samples: Not explicitly stated, but typically involves a sufficient number of devices to meet ASTM F2077 statistical requirements for each test type (static compression and static compression shear). The provenance for these physical devices would be their manufacturing origin, not patient data.
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):
- N/A (for AI/ML): This is not an AI/ML device. "Ground truth" in this context would implicitly refer to established standards for mechanical properties and material science, not clinical expert consensus. Testing is performed by engineers/technicians in a lab setting.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A (for AI/ML): This is not an AI/ML device. Adjudication methods like 2+1 are for clinical judgments or diagnostic accuracy, not mechanical testing.
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:
- No: This is a physical implant, not an AI-assisted diagnostic tool. MRMC studies are not relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No: This is a physical implant, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- N/A (for AI/ML): For this physical device, the "ground truth" for proving substantial equivalence relies on established preclinical mechanical testing standards (ASTM F2077) that define acceptable performance parameters for intervertebral body fusion devices. This is a material and mechanical engineering 'ground truth'.
The sample size for the training set:
- N/A (for AI/ML): This is a physical implant. There is no concept of a "training set" for an AI/ML model.
How the ground truth for the training set was established:
- N/A (for AI/ML): This is a physical implant. There is no "training set ground truth."

In summary, the provided document is a 510(k) summary for a physical medical implant (Rampart™ O). The study described is a preclinical mechanical testing study demonstrating substantial equivalence to predicate devices, as required for traditional device clearances, not an AI/ML performance study.

Summary

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510(k) Summary

MAY 3 0 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:	April 2, 2013
Trade Name:	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, K120293, K123652 and K130396)
Device Description:	Rampart™ O devices are designed for use with autograft as an adjunct tofusion and are intended for use with supplemental fixation systems clearedfor use in the lumbar spine. The device is available in a range of lengthsand heights. The device and associated instruments are provided non-sterile.
Intended Use:	Rampart™ O is an intervertebral body fusion device indicated forintervertebral body fusion at one level or two contiguous levels in thelumbar spine from L2 to S1 in patients with degenerative disc disease(DDD) with up to Grade I spondylolisthesis at the involved level(s). DDDis defined as back pain of discogenic origin with degeneration of the discconfirmed by patient history and radiographic studies. These patientsshould be skeletally mature and have had six months of non-operativetreatment.These devices may be implanted singly or in pairs via an open or aminimally invasive posterior or transforaminal approach.Rampart™ O is designed for use with autograft as an adjunct to fusionand is intended for use with supplemental fixation systems cleared by theFDA for use in the lumbar spine.
Purpose of this 510(k):	The purpose of this 510(k) is to extend the range of sizes of Rampart Olordotic and non-lordotic implants.
Summary ofTechnologicalCharacteristics:	The device is shown to be substantially equivalent to the intended use,materials, configuration, and performance characteristics of the predicateproducts.

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Testing	Previous preclinical testing according to ASTM F2077, including static compression and static compression shear was used to justify substantial equivalence. This testing demonstrated similar performance characteristics to the identified predicate devices.
Conclusion:	The information submitted in this premarket notification supports a determination that RampartTM O is substantially equivalent in technological characteristics and intended use to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

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

May 30, 2013

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

Re: K131216

Trade/Device Name: Rampart™ O Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: April 29, 2013 Received: April 30, 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 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.

For

Sincerely yours.

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

Enclosure

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510(k) Number (if known): K131216

Device Name: Rampart™ O

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 is 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. Dmitřiev, PhD Division of Orthopedic Devices

Premarket Notification for Rampart O Fusion 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.