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 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 alloy (per ASTM F136) and PEEK radiolucent polymer (per ASTM F2026).

AI/ML Overview

The provided text is for a 510(k) summary for the SP-Fix™ Spinous Process Fixation Plate, a medical device. It does not describe or include an AI device or a study involving AI. Therefore, I cannot provide information regarding acceptance criteria and studies that prove an AI device meets acceptance criteria.

The information provided pertains to the mechanical testing of a physical medical device to demonstrate its substantial equivalence to predicate devices, which is a standard regulatory pathway for non-AI medical devices.

Here's what I can extract from the provided text about the device and its testing:

Acceptance Criteria Category	Description from Document	Reported Device Performance
Device Substantial Equivalence	The purpose of the submission is to add the SP-Fix™ Spinous Process Fixation Plate to the REVERE® Stabilization System. The device must demonstrate substantial equivalence to predicate devices (Medtronic Spire™, LANX Aspen™, NuVasive AFFIX™) in terms of technical characteristics, performance, and intended use to be cleared by the FDA for marketing.	"The SP-Fix™ has been demonstrated to be substantially equivalent to predicate system(s) with respect to technical characteristics, performance, and intended use. The information provided within this premarket notification supports substantial equivalence of the subject device to the predicate device(s)." This statement implies that the device met the necessary criteria to be considered substantially equivalent to the predicates.
Mechanical Performance	Mechanical testing must be conducted to prove the device's functional integrity and safety under various loading conditions, comparable to predicate devices. This includes static and dynamic compression, static torsion, static and dynamic plate dissociation, and static tension. The implied acceptance criterion is that the SP-Fix™ performs similarly or better than the predicate devices under these tests.	"Mechanical testing (static and dynamic compression, static torsion, static and dynamic plate dissociation, and static tension) was conducted to demonstrate substantial equivalence to the predicate system(s)." The successful clearance by the FDA (K102195) confirms that these tests were sufficient to establish acceptable performance relative to the predicates.

Regarding the specific questions about AI device studies:

Since this document describes a physical medical device and its mechanical testing for regulatory clearance, the following points are not applicable and cannot be answered based on the provided text:

Sample size used for the test set and the data provenance: Not relevant for mechanical testing of a physical device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not relevant for mechanical testing.
Adjudication method for the test set: Not relevant for 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: Not relevant for a physical medical device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not relevant for a physical medical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not relevant for mechanical testing. The "ground truth" for mechanical testing is typically engineering specifications and performance benchmarks derived from predicate devices or industry standards.
The sample size for the training set: Not relevant as there is no AI model being trained.
How the ground truth for the training set was established: Not relevant as there is no AI model being trained.

The document states that mechanical testing was performed to demonstrate substantial equivalence. This type of testing involves subjecting the device to various physical forces and measuring its response, not analyzing data with an AI algorithm.

Summary

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

Company:	Globus Medical Inc.
	2560 General Armistead Ave.
	Audubon, PA 19403
	(610) 930-1800	JAN 19 20
Contact:	Kelly J. Baker, Ph.D
	Director, Clinical Affairs & Regulatory

Date Prepared: November 10, 2010

SP-Fix™ Spinous Process Fixation Plate Device Name:

Classification: Regulation Number: 21 CFR §888.3050 Regulation Name: Spinal Interlaminal Fixation Orthosis Product Code: KWP Regulatory Class II, Panel code 87.
Medtronic Spire™ (K032037), LANX Aspen™ (K071877), Predicate(s): NuVasive AFFIX™ (K073278)

Purpose:

The purpose of this submission is the addition of the SP-Fix™ Spinous Process Fixation Plate to the REVERE® Stabilization System.

Device Description:

Indications for Use:

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Performance Data:

Mechanical testing (static and dynamic compression, static torsion, static and dynamic plate dissociation, and static tension) was conducted to demonstrate substantial equivalence to the predicate system(s).

Basis of Substantial Equivalence:

The SP-Fix™ has been demonstrated to be substantially equivalent to predicate system(s) with respect to technical characteristics, performance, and intended use. The information provided within this premarket notification supports substantial equivalence of the subject device to the predicate device(s).

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the eagle. The text is in all caps and is in a simple, sans-serif font.

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

JAN 19 2011

Globus Medical, Inc. % Kelly J. Baker, Ph.D. Director, Clinical Affairs and Regulatory Valley Forge Business Center 2560 General Armistead Avenue Audubon, Pennsylvania 19403

Re: K102195

Trade 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: KWP Dated: December 30, 2010 Received: January 03, 2011

Dear Dr. Baker:

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.

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Page 2 – Kelly J. Baker, Ph.D.

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.

Sincerely yours,

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

Enclosure

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Indications for Use Statement

510(k) Number: K102195 Device Name: SP-Fix™ Spinous Process Fixation Plate

INDICATIONS:

OR Prescription Use × (Per 21 CFR §801.109)

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)

Digit Sign Off

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K102195

Globus Medical K102195 SP-Fix™ CONFIDENTIAL

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.