The SP-Fix® Spinous Process Fixation Plate is a posterior non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), and/or tumor. The SP-Fix® spinous process fixation plate is intended for use with bone graft material and is not intended for stand-alone use.

Device Description

The SP-Fix® Spinous Process Fixation Plate System consists of plates, rods, and barrels that are used to build a construct to provide supplemental stabilization of spinal segments to support fusion. The components are available in a range of sizes to fit the anatomical needs of a variety of patients. SP-Fix® implants are composed of titanium allov (per ASTM F136) and PEEK radiolucent polymer (per ASTM F2026).

AI/ML Overview

Here's an analysis of the provided 510(k) summary for the Globus Medical Inc. SP-Fix® Spinous Process Fixation Plate, specifically addressing the requested information about acceptance criteria and the supporting study:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It is not a detailed clinical study report or a comprehensive technical specification. Therefore, much of the requested information (like specific acceptance criteria values, detailed study designs, and ground truth establishment for AI systems) is not present in this type of document, as it's not typically required for a 510(k) for this type of device (a spinal fixation plate). This submission relies on engineering rationale and mechanical testing, not a clinical effectiveness study with human readers or AI.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Criterion: Substantial equivalence in technological characteristics (design, dimensions, intended use, materials, performance characteristics) compared to predicate devices.	Performance: Mechanical testing (static plate dissociation) was conducted, and an engineering rationale was provided. The results demonstrated substantial equivalence. Additional SP-Fix® implants perform "as well as or better than the predicate device."
Criterion: Ability to provide supplemental stabilization of spinal segments to support fusion.	Performance: Indicated for use in achieving supplemental fusion for specified conditions (degenerative disc disease, spondylolisthesis, trauma, tumor). The mechanical testing and engineering rationale support this function in comparison to the predicate device.
Criterion: Mechanical strength sufficient for the intended use and to be "as well as or better than the predicate device."	Performance: Static plate dissociation testing was performed. The exact values or specific acceptance thresholds are not provided in this summary, but the conclusion is that the new implants perform "as well as or better than the predicate device."

Explanation: The primary "acceptance criterion" for a 510(k) is demonstrating substantial equivalence to a legally marketed predicate device. The performance data presented (mechanical testing) supports this determination by showing that the new device's mechanical properties are comparable or superior to the predicate. Specific quantifiable thresholds for "static plate dissociation" are not typically disclosed in a public 510(k) summary, as they are part of the detailed testing protocol submitted to the FDA.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable in the context of this 510(k) summary for a spinal implant. The "test set" here refers to the samples used in mechanical testing, not a clinical dataset for an AI or human reader study. The number of physical units tested for "static plate dissociation" is not specified in this summary.
Data Provenance (e.g., country of origin, retrospective/prospective): Not applicable. The data is from laboratory mechanical testing, not human patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This submission is for a medical device (spinal fixation plate) and relies on mechanical testing and engineering rationale, not expert clinical review (e.g., radiologist consensus) to establish ground truth.

4. Adjudication Method for the Test Set

Not applicable. This relates to clinical studies with human observers or AI outputs, which is not the basis of this 510(k) submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No. An MRMC study was not done. This device is a physical implant, not an AI diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. This device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used

Mechanical Testing Measurements: The "ground truth" for this device's performance is established through physical measurements and destructive testing in a laboratory setting (e.g., force required for static plate dissociation). This is compared against the known performance characteristics of the predicate device.

8. The Sample Size for the Training Set

Not applicable. This refers to machine learning algorithms. The device does not involve a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. The device does not involve a "training set" or AI.

Summary

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K132191

510(k) Summary: SP-Fix® Spinous Process Fixation Plate

Company:	Globus Medical Inc.2560 General Armistead Ave.Audubon, PA 19403610-930-1800
Contact:	Christina KichulaRegulatory Affairs Group Manager
Date Prepared:	July 12, 2013
Device Name:	SP-Fix® Spinous Process Fixation Plate
Classification:	Per 21 CFR as follows:§888.3050 Spinal Interlaminal Fixation OrthosisProduct Code: PEKRegulatory Class: Class II, Panel Code 87.
Predicate(s):	SP-Fix® Spinous Process Fixation Plate (K102195)Medtronic SPIRE® (K032037)

Purpose:

The purpose of this submission is to request clearance for additional SP-Fix® implants, including taller barrels and additional plate options.

Device Description:

Indication for Use:

The SP-Fix® Spinous Process Fixation Plate is a posterior non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1), It is intended for plate fixation/attachment to the spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), and/or tumor. The SP-Fix® spinous process fixation plate is intended for use with bone graft material and is not intended for stand-alone use.

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Technological Characteristics:

The technological characteristics of the additional SP-Fix® implants are similar to the predicate devices in terms of design, dimensions, intended use, materials, and performance characteristics.

Performance Data:

Mechanical testing (static plate dissociation) was conducted and an engineering rationale was provided to demonstrate substantial equivalence to the predicate system.

Basis of Substantial Equivalence:

The additional SP-Fix® implants have been demonstrated to be substantially equivalent to predicate systems with respect to technical characteristics, performance, and intended use. The information provided within this premarket notification supports substantial equivalence to the predicate devices. Additional SP-Fix® implants perform as well as or better than the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) of the United States. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol, which is the HHS symbol, consisting of three abstract shapes that resemble human figures or birds in flight.

Public Health Service

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

November 22, 2013

Globus Medical, Incorporated Ms. Christina Kichula Regulatory Affairs Group Manager 2560 General Armistead Avenue Audubon, Pennsylvania 19403

Re: K132191

Trade/Device Name: SP-Fix® Spinous Process Fixation Plate Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: PEK Dated: September 30, 2013 Received: October 1, 2013

Dear Ms. Kichula:

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 - Ms. Christina Kichula

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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mark New elkerson -S

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

Enclosure

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1. 2. 2. 1.

Indications for Use Statement

510(k) Number:

K132191

SP-Fix® Spinous Process Fixation Plate Device Name:

INDICATIONS:

The SP-Fix® Spinous Process Fixation Plate is a posterior non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), and/or tumor. The SP-Fix Spinous Process Fixation Plate is intended for use with bone graft material and is not intended for stand-alone use.

OR Prescription Use _ × (Per 21 CFR §801.109)

Over-The-

Over-The-Counter Use_

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

RonaldiPAJean -S

(Division Sign-Off) Division Of Orthopedic Devices 510 (k) Number: K132191

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.