The Marauder™ Cervical-Thoracic Spinal Fixation System implants are intended to be used as a temporary construct that assists in normal healing and are not intended to replace normal body structures. The system is intended to stabilize the spinal operative site during posterior fusion procedures, attaching to the spine by means of hooks and screws joined with spinal rods and should be removed after fusion.

The Marauder™ Cervical-Thoracic Spinal Fixation System is intended to promote fusion of the cervical and thoracic spine (C1-T3) for the following conditions: degenerative disc disease (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); spondylolisthesis; spinal stenosis; trauma (fracture/dislocation); failed previous fusion; and/or tumors.

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (CI-T3) spine.

The use of screws is limited to placement in TI-T3 vertebrae for treating thoracic conditions only. Screws.are not intended to be placed in the cervical spine.

Device Description

The Marauder™ Cervical-Thoracic Spinal Fixation System consists of a polyaxial bone screw with a spherical-shape head, and a standard thread for interfacing bone. Screws are available in 3.5 mm and 4.0 mm diameters and lengths from 10mm to 30mm.

In addition to polyaxial screws, hooks are provided for use in the cervical and thoracic spine. Three hook geometry variations are offered with the Marauder™ Cervical-Thoracic Spinal Fixation System. The hooks use the same rod locking means as the polyaxial screw implants.

Titanium rods are provided in various lengths and are used to connect pedicle screws and create a rigid structure. The rods are connected to the implants by interference with the rod saddle and held into position by the locking caps.

All implant components of the Marauder™ Cervical-Thoracic Spinal Fixation System are manufactured from Ti-6Al-4V alloy, conforming to ASTM F136.

AI/ML Overview

The provided text describes a medical device, the "Marauder™ Cervical-Thoracic Spinal Fixation System," and its performance testing. However, it does not describe an AI/ML powered device or software. Therefore, many of the requested fields related to AI/ML device evaluations (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or cannot be extracted from the provided document.

The document discusses the mechanical performance testing of a physical spinal fixation system.

Here's an attempt to answer the applicable parts based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard)	Reported Device Performance
Testing per ASTM F1798-08:
Static Flexion-Extension Strength Requirement	"The mechanical testing revealed that the Marauder™ Cervical-Thoracic Spinal Fixation System behaves as expected and is typical of competitive systems. In all instances, the Marauder™ Cervical-Thoracic Spinal Fixation System functioned as intended and the testing results observed were as expected."
Static Rod Gripping Capacity Strength Requirement	(Same as above)
Static A-P Pullout Strength Requirement	(Same as above)
Testing per ASTM F1717-12:
Static Compression Bending Requirement	(Same as above)
Static Torsional Bending Requirement	(Same as above)
Dynamic Compression Bending Requirement	(Same as above)

Note: The document states that the testing was conducted according to methods defined in ASTM F 1798 and ASTM F 1717. It then lists the types of tests performed. The "acceptance criteria" are implied to be meeting the requirements of these standards, and the "reported device performance" is a general statement that the device performed "as expected" and "typical of competitive systems," and "functioned as intended." Specific numerical performance data or pass/fail thresholds for each test are not provided in this summary.

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: This refers to the number of physical components or constructs tested in the mechanical performance evaluations. The document does not specify the exact sample size for each test (e.g., "n=5 constructs for static flexion"). It only lists the types of tests performed.
Data Provenance: Not applicable in the context of mechanical device testing for substantial equivalence. The tests are laboratory-based mechanical tests, not clinical or observational data.

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)

Not applicable. This is a mechanical device, not an AI/ML system requiring expert ground truth for image interpretation or diagnosis.

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

Not applicable. This is a mechanical device, not an AI/ML system requiring adjudication of expert interpretations.

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 a mechanical device, not an AI/ML system, so no MRMC study or assessment of human reader improvement with AI assistance was performed.

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

Not applicable. This is a mechanical device, not an algorithm.

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

The "ground truth" for the mechanical testing is defined by the ASTM F1798 and ASTM F1717 standards themselves, which specify test methods, fixtures, loading conditions, and acceptance criteria for spinal implant constructs. The device's direct performance against these standards constitutes the "ground truth" in this context.

8. The sample size for the training set

Not applicable. This is a mechanical device; there is no "training set" in the AI/ML sense.

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

Not applicable. As there's no AI/ML training set, the concept of establishing its ground truth does not apply.

Summary

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510(k) SUMMARY

Intelligent Implant Systems' Marauder™ Cervical-Thoracic Spinal Fixation System

Company Name:

Intelligent Implant Systems, LLC 3300 International Airport Drive, Suite 1100 Charlotte, NC 28208 (704) 424-1009 (704) 424-1011 (FAX)

510(k) Contact:

Michael Nutt Chief Operations Officer (704) 424-1009

OCT 2 5 2013

October 23, 2013 Date Prepared:

Common Name:

Spinal Fixation System

Classification:

888.3070. Pedicle Screw Spinal System 888.3050, Spinal Interlaminal Fixation Orthosis

Device Class:

MNI, KWP Device Product Code:

Predicate Devices:

Aesculap: S4@ Spinal Fixation System (K050979)

K2M, Inc .: MESA® Mini Spinal Fixation System (K081107)

Synthes, Inc .: Synapse System (K070573)

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Intended Use / Indications for Use

Intended Use:

Indications for Use:

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (CI-T3) spine.

The use of screws is limited to placement in TI-T3 vertebrae for treating thoracic conditions only. Screws.are not intended to be placed in the cervical spine.

Device Description

All implant components of the Marauder™ Cervical-Thoracic Spinal Fixation System are manufactured from Ti-6Al-4V alloy, conforming to ASTM F136.

Technological Characteristics

The polyaxial and rod locking mechanisms of the polyaxial screw are locked using linear force as opposed to torque. The spherical head of the screw is designed to fit within a locking spherical seat housed in the lower portion of the body. The locking mechanism utilizes an external locking sleeve that when pressed into position over the spherical seat,

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compresses the spherical seat against the spherical head of the screw. locking the screw angularity of the assembly. The rod locking mechanism includes a rod saddle that is integrated in the upper portion of the body. Pressing the locking cap onto the body in turn presses the rod into the rod saddle. The cap has a tapered internal borc. When the cap is in the locked position, the tapered internal bore engages an external taper on the body, securing the cap and rod to the screw assembly. Additionally, there is a snap ring at the base of the body that snaps into an internal groove in the bore of the cap, which assists in holding the cap in position on the construct.

Performance Testing

To validate the strength and safety of the system, testing was conducted according to methods defined in ASTM F 1798, "Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants", and ASTM F 1717, "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model". The types of testing performed on the polyaxial screw assemblies and/or hook assemblies are listed below.

Testing per ASTM F1798-08

The following types of testing were performed on the Marauder™ Cervical-Thoracic Spinal Fixation System per ASTM F1798-08:

1. Static Flexion-Extension Strength
1. Static Rod Gripping Capacity Strength
1. Static A-P Pullout Strength

Testing per ASTM F1717-12

The following types of testing were performed on the Marauder™ Cervical-Thoracic Spinal Fixation System per ASTM F1717-12:

1. Static Compression Bending
1. Static Torsional Bending
1. Dynamic Compression Bending

Conclusions

The mechanical testing revealed that the Marauder™ Cervical-Thoracic Spinal Fixation System behaves as expected and is typical of competitive systems. In all instances, the Marauder™ Cervical-Thoracic Spinal Fixation System functioned as intended and the testing results observed were as expected.

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Substantial Equivalence

Intelligent Implant Systems believes that the new Marauder™ Cervical-Thoracic Spinal Fixation System is substantially equivalent in design to:

S4® Spinal System (K050979) 0
MESA® Mini Spinal Fixation System (K081107) o
Synthes Inc. Synapse System (K070573) .

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

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

October 25, 2013

Intelligent Implant Systems, LLC Mr. Michael Nutt Chief Operating Officer 3300 International Airport Drive, Suite 1100 Charlotte, North Carolina 28208

Re: K132900

Trade/Device Name: Marauder™ Cervical-Thoracic Spinal Fixation System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP, MNI Dated: September 13, 2013 Received: September 16, 2013

Dear Mr. Nutt:

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. Iisting 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. Michael Nutt

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/ResourcesforYou/Industry/default.htm. 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 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,

Ronald®½Jean -S for

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 Statement

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: Marauder™ Cervical-Thoracic Spinal Fixation System

Intended Use / Indications for Use:

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

The use of screws is limited to placement in T1-T3 for treating thoracic conditions only. Screws are not intended to be placed in the cervical spine.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ronald#Jean -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K132900

Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.