SPECTRUM SPINE FENESTRATED FACET SCREW SYSTEM by SPECTRUM SPINE, LLC

The SS Fenestrated Facet Screw System (FFS) is indicated for the posterior surgical treatment at L1-S1 (inclusive) spinal levels for the following: Spondylolisthesis; Spondylolysis; Pseudarthrosis or failed previous fusions which are symptomatic; Degenerative Disc Disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies and/or degenerative disease of the facets with instability. The system is intended for use with only autogenous bone graft material.

Device Description

The SS Fenestrated Facet Screw System (FFS) is a permanent implant device made from Cobalt Chrome Alloy Per ASTM 1537. It is to be implanted from the posterior approach. The device is provided in one diameter and multiple lengths to accommodate the various anatomy of the spine. The device is intended to provide mechanical support and stability to the implanted level until biologic fusion is achieved. The SS Fenestrated Facet Screw System is cannulated and fenestrated which allows it to be used as a delivery system for bone graft. The system is not to be used with bone cement.

AI/ML Overview

The provided text describes the regulatory submission for a medical device called the "SS Fenestrated Facet Screw System." It does not contain information about a study involving software or AI. Therefore, I cannot extract details about acceptance criteria or a study proving device performance in the context of AI.

The document discusses the substantial equivalence of the SS Fenestrated Facet Screw System to predicate devices based on performance testing for mechanical properties. However, this is for a physical implantable device, not an AI software.

Here's a breakdown of what is present in the document related to performance and testing for the physical device:

Device: SS Fenestrated Facet Screw System (FFS)

Acceptance Criteria and Reported Device Performance (for the physical device):

The document states:

"Testing of the FFS to demonstrate substantial equivalence included static and dynamic 3-point bending, screw axial pullout, and torque to failure."
"The testing standards utilized were, ASTM F543-07 'Standard Specification and Test Methods for Metallic Medical Bone Screws', F2193-02, 'Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System,' and ASTM F1264-03 'Standard Specification and Test Methods for Intrameduliary Fixation Devices.'"

While the specific numerical acceptance criteria and reported performance values are not detailed in the provided text, the successful 510(k) clearance implies that the device met the requirements outlined in these ASTM standards and was deemed substantially equivalent to its predicate devices in terms of safety and effectiveness.

Regarding your specific questions related to AI/Software:

A table of acceptance criteria and the reported device performance: This information is not present for an AI/software device. The document describes mechanical testing of a physical implant.
Sample sized used for the test set and the data provenance: Not applicable for an AI/software study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for an AI/software study.
Adjudication method: Not applicable for an AI/software study.
If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable for an AI/software study.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for an AI/software study.
The type of ground truth used: Not applicable for an AI/software study.
The sample size for the training set: Not applicable for an AI/software study.
How the ground truth for the training set was established: Not applicable for an AI/software study.

In summary, the provided text is a 510(k) summary for a physical medical implant (a facet screw system) and does not describe an AI or software device, nor does it contain the type of study data you are asking for regarding AI acceptance criteria and performance.

Summary

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Section 5 - 510(k) Summary or 510(k) Statement

APPLICANT:	Spectrum Spine IP Holdings, LLCAtlanta, GA
Contact Person:	Dr. James Robinson3045 Paces Lake CourtAtlanta, GA 30339Tel: (404) 550-1335	OCT 2 8 2013
Application Correspondent:	Ottie Pendleton, Spectrum Spine, LLCTel: 404-372-0389Email: ottie@spectrumspine.com
PROPOSED TRADE NAME:	SS Fenestrated Facet Screw System
PREPARATION DATE:	10/22/13
DEVICE CLASSIFICATION:	Unclassified
CLASSIFICATION NAME:	System, Facet Screw Spinal Device
PRODUCT CODE:	MRW
DEVICE DESCRIPTION:	The SS Fenestrated Facet Screw System (FFS) is a permanent implant device madefrom Cobalt Chrome Alloy Per ASTM 1537. It is to be implanted from theposterior approach. The device is provided in one diameter and multiple lengthsto accommodate the various anatomy of the spine. The device is intended toprovide mechanical support and stability to the implanted level until biologicfusion is achieved. The SS Fenestrated Facet Screw System is cannulated andfenestrated which allows it to be used as a delivery system for bone graft. Thesystem is not to be used with bone cement.
INDICATIONS FOR USE:	The SS Fenestrated Facet Screw System (FFS) is indicated for the posterior surgicaltreatment at L1-S1 (inclusive) spinal levels for the following: Spondylolisthesis;Spondylolysis; Pseudarthrosis or failed previous fusions which are symptomatic;Degenerative Disc Disease (DDD) as defined by back pain of discogenic origin withdegeneration of the disc confirmed by history and radiographic studies and/ordegenerative disease of the facets with instability. The system is intended for usewith only autogenous bone graft material.
MATERIALS:	Medical grade Cobalt Chrome Alloy.
PREDICATE DEVICES:	• Trans1 Facet Screw (K073515)• X-Spine Systems Zygafix Spinal Facet Screw System (K123932)
TECHNOLOGICCHARACTERISTICS:	The fundamental scientific principles and technological characteristics, includingthe intended use, general design, and sizes of the devices are the same as, or similarto, the predicate devices.
PERFORMANCE DATA:	Testing of the FFS to demonstrate substantial equivalence included static anddynamic 3-point bending, screw axial pullout, and torque to failure. The testingstandards utilized were, ASTM F543-07 "Standard Specification and Test Methodsfor Metallic Medical Bone Screws", F2193-02, "Standard Specifications and Test

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Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System," and ASTM F1264-03 "Standard Specification and Test Methods for Intrameduliary Fixation Devices."

The Spectrum Spine Fenestrated Facet Screw System (FFS) is substantially SAFETY & EFFECTIVENESS: equivalent to the predicate device (K073515). The devices have the same "Indications for Use", are available by prescription only, and are provided nonsterile for single-use only. The device has fenestrations to allow for the optional packing of bone graft similar to the predicate (K123932). The FFS system differs from the predicates in that the FFS is made from Cobalt Chrome alloy while the predicates are made from Titanium alloy. This differences does not negatively impact the overall safety and effectiveness of the device. Therefore it can be concluded that the FFS is both a safe and effective device and is substantially equivalent to the predicate device.

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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 symbol resembling an abstract human figure with three flowing lines, positioned to the right. Encircling the symbol is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The text is arranged in a circular fashion around the symbol.

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

October 28, 2013

Spectrum Spine, LLC Mr. Ottie Pendleton 3045 Pacer Lake Court Atlanta, Georgia 30339

Re: K132126

Trade/Device Name: Spectrum Spine (SS) Fenestrated Facet Screw System Regulatory Class: Unclassified Product Code: MRW Dated: July 17, 2013 Received: August 1, 2013

Dear Mr. Pendleton:

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 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.

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Page 2 - Mr. Ottie Pendleton

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/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.

Ronald帮剑ean -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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Section 4 - Indications for Use Statement

510(k) Number: K132126

Device Name: Spectrum Spine Fenestrated Facet Screw System

Prescription Use _____________________________________________________________________________________________________________________________________________________________ × or Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ronald®ªøJean -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K132126

Regulation Number and Section

N/A