The Spectrum SPINOUS PROCESS DEVICE is a posterior, non-pedicle supplemental fixation device, intended for use at a single-level in the non-cervical spine (T1-S1 inclusive). It is intended for plate fixation and attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain or discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation), and/or tumor. The Spectrum Spine SPINOUS PROCESS DEVICE is intended for use with bone graft, and is not intended for standalone use.

Device Description

The Spectrum Spine Spinous Process Device is a permanent implant device with plates and rods made from Titanium Alloy per ASTM F136 and Commercially Pure Titanium per ASTM F67 and cages made from polyetheretherketone (Zeniva PEEK 500 per ASTM F2026-10, PEEK Polymer for surgical implant applications). It is a posterior, non-pedicle supplemental fixation device. The device provides plates, cages and connecting rods of various shapes and sizes to provide supplemental stabilization of the spinous process to support fusion.

AI/ML Overview

The provided text describes the Spectrum Spine SPINOUS PROCESS DEVICE and its 510(k) summary for FDA clearance. However, it does not include information about acceptance criteria or a study that specifically proves the device meets such criteria in terms of diagnostic performance or clinical outcomes.

The "Performance Data" section solely refers to mechanical testing of the device: "Performance data for the Spectrum Spine SPINOUS PROCESS DEVICE included static and dynamic compression bend, static torsion, locking screw torque strength, axial push off strength from simulated bone and rod dissociation strength. Most testing was completed per ASTM 1717-12 and ASTM F1798-97."

This type of testing is to ensure the device's structural integrity and physical properties meet established standards for medical implants, not to evaluate diagnostic accuracy or compare its performance against a ground truth.

Therefore, I cannot populate the requested table or answer the questions related to acceptance criteria for diagnostic performance, sample sizes for test sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details from the provided text.

The document indicates that the device was deemed "substantially equivalent" to predicate devices based on:

Indications for Use
Materials
Means of fixation

This implies that the lack of new performance studies concerning diagnostic accuracy or extensive clinical outcomes was acceptable because the device was not presenting a novel diagnostic function or significantly different mechanism of action that would necessitate such studies for substantial equivalence.

Summary

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510(k) SUMMARY Spectrum Spine's SPINOUS PROCESS DEVICE

Date:

October 15, 2013

Contact:

Dr. Jim Robinson 404-550-1335

Spectrum Spine IP Holdings, LLC 3045 Paces Lake Court Atlanta, GA 30339

Trade Name:	Spectrum Spine SPINOUS PROCESS DEVICE
Common Name:	Interspinous Process Device
Product Class:	Class II
Classification:	21 CFR §888.3050
Product Code:	PEK
Panel Code:	87

Name/Address of Sponsor

NOV 1 2 2013

Spectrum Spine IP Holdings, LLC 3045 Paces Lake Court . Atlanta, GA 30339 404-550-1335

Purpose:

The purpose of this submission is clearance of the Spectrum Spine SPINOUS PROCESS DEVICE as a new medical device that is substantially equivalent to the predicate devices.

Device Description

Predicate Device

The predicate devices are the Lanx Aspen Spinous Process Fusion Plate (K071877) and the X-spine Axle device (K112592).

Intended Use / Indications for Use

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purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain or discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation), and/or tumor. The Spectrum Spine SPINOUS PROCESS DEVICE is intended for use with bone graft, and is not intended for standalone use.

Performance Data

Performance data for the Spectrum Spine SPINOUS PROCESS DEVICE included static and dynamic compression bend, static torsion, locking screw torque strength, axial push off strength from simulated bone and rod dissociation strength. Most testing was completed per ASTM 1717-12 and ASTM F1798-97.

Summary:

The Spectrum Spine SPINOUS PROCESS DEVICE is substantially equivalent to the predicate devices in regards to:

Indications for Use .
. Materials
. Means of fixation

There are no significant differences in technological characteristics compared to the predicate devices. Spectrum Spine considers this device to be substantially equivalent to the predicate devices.

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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

November 12, 2013

Spectrum Spine % Silver Pine Consulting Rich Jansen, Pharm.D. 13540 Guild Avenue Apple Valley, Minnesota 55124

Re: K130066

Trade/Device Name: Spectrum Spine Spinous Process Device Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: PEK Dated: October 15, 2013 Received: October 17, 2013

Dear Dr. Jansen:

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 r ou may, dierely mains 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 I hat FDA has made a determination that your device complies with other requirements of the Act and Federal statutes and regulations administered by other Federal agencies. You must or any 1 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 - Rich Jansen. Pharm.D.

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/Safetv/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Ronald P. Jean -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

K130066 510(k) Number (if known): Device Name: Spectrum Spine SPINOUS PROCESS DEVICE

Indications for Use:

The Spectrum SPINOUS PROCESS DEVICE is a posterior, non-pedicle supplemental fixation device, intended for use at a single-level in the non-cervical spine (T1-51 inclusive). It is intended for plate fixation and attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain or discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation), and/or tumor. The Spectrum Spine SPINOUS PROCESS DEVICE is intended for use with bone graft, and is not intended for standalone use.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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 P. Jean -S

(Division Sign-Off) Division of Orthopedic Devices . 510(k) Number: K130066

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.