RISE™ Spacers are lumbar interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of nonoperative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).

RISE™ Spacers are to be filled with autogenous bone graft material. This device is intended to be used with supplemental fixation, such as the REVERE® or REVOLVE™ Stabilization Systems.

Device Description

RISE™ Spacers are lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. RISE™ Spacers are provided in different shapes to accommodate various surgical approaches to the lumbar spine (posterior, transforaminal [posterolateral] or lateral) and can expand to the desired height. The implants are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. This device is to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.

RISE™ Spacers are manufactured from titanium alloy, as specified in ASTM F136 and F1295. An internal component is manufactured from radiolucent PEEK polymer, as specified in ASTM F2026.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the RISE™ Spacer:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance Statement
Mechanical Performance	Demonstrated substantial equivalence to predicate in:	"Mechanical testing (static and dynamic compression, static and dynamic compression-shear and subsidence) was conducted to demonstrate substantial equivalence to the predicate device."
	- Static compression	(Implied: Met or exceeded predicate performance)
	- Dynamic compression	(Implied: Met or exceeded predicate performance)
	- Static compression-shear	(Implied: Met or exceeded predicate performance)
	- Dynamic compression-shear	(Implied: Met or exceeded predicate performance)
	- Subsidence	(Implied: Met or exceeded predicate performance)
Substantial Equivalence	Demonstrated substantial equivalence to predicate device with respect to:	"The RISE™ Spacer has been found to be substantially equivalent to the predicate with respect to technical characteristics, performance, design, materials, performance, and intended use."
	- Technical characteristics	(Implied: Met or exceeded predicate characteristics)
	- Performance	(Implied: Met or exceeded predicate performance)
	- Design	(Implied: Met or exceeded predicate design criteria)
	- Materials	(Implied: Met or exceeded predicate material criteria)
	- Intended use	(Implied: Met predicate intended use)

Explanation of "Acceptance Criteria": In this context of a 510(k) submission, the "acceptance criteria" are not explicitly listed numerical thresholds as one might find in a clinical trial. Instead, the primary acceptance criterion is "substantial equivalence" to a predicate device. The performance data provided (mechanical testing) serves to demonstrate that this substantial equivalence is met for critical aspects of device function. The implied acceptance for each specific test (e.g., static compression) is that the RISE™ Spacer performs at least as well as, or within an acceptable margin of, the predicate CALIBER™ Spacer.

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

Sample Size: The document does not explicitly state the sample size used for the mechanical testing (e.g., number of devices tested for static compression).
Data Provenance: The mechanical testing was conducted by or on behalf of the manufacturer, Globus Medical Inc. (presumably at their facilities or a contracted lab). The document does not specify a country of origin for this data beyond the company's location in Audubon, PA, USA. This is an engineering/bench test, not patient data, so "retrospective or prospective" does not directly apply in the same way it would to a clinical study.

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

This document describes a premarket submission for a medical device (510(k)) based on mechanical testing and substantial equivalence to a predicate device. It does not involve a study with a "test set" of patient data or the establishment of "ground truth" by clinical experts in the way a diagnostic AI device would. Therefore, this section is not applicable.

4. Adjudication Method for the Test Set

As there is no "test set" requiring expert ground truth in the clinical sense, an adjudication method is not applicable. The assessment for substantial equivalence is based on the mechanical test results and a comparison to the predicate device's characteristics, likely performed by the manufacturer's engineers and regulatory specialists.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is an implantable medical device (intervertebral body fusion device), not a diagnostic AI tool that assists human readers.

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

Not applicable. This is a physical implantable device, not an algorithm or software.

7. The Type of Ground Truth Used

The "ground truth" for this submission is implicitly defined by the performance characteristics and safety profile of the predicate device, CALIBER™ Spacer (K102293). The RISE™ Spacer aims to demonstrate that its mechanical properties and design fall within acceptable parameters established by the predicate, thus proving it is as safe and effective. The type of data proving this is mechanical test data (static and dynamic compression, compression-shear, and subsidence).

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of an implantable physical device. The design and manufacturing process are informed by general engineering principles, material science, and prior experience with similar devices, not a digital training dataset.

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

Not applicable. As there is no training set, there is no ground truth to establish for it. The "ground truth" for device design and safety is based on established engineering standards for medical devices and the performance history of predicate devices.

Summary

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510(k) SUMMARY: RISE™ Spacer

Company:	Globus Medical Inc.2560 General Armistead Avenue.Audubon, PA 19403(610) 930-1800
Contact:	Kelly J. Baker, Ph.D.Vice President, Regulatory and Clinical Affairs
Date Prepared:	November 18, 2011
Device Name:	RISETM Spacer
Classification:	Per 21 CFR as follows:§888.3080 Intervertebral Body Fusion device.Product Code: MAXRegulatory Class: II, Panel Code: 87
Predicate(s):	Globus Medical CALIBERTM Spacer (K102293)SE date: January 5, 2011

Purpose:

The purpose of this submission is to request clearance for RISE™ Spacers, which have an all titanium design, a smaller overall implant profile, and a modified expansion mechanism, compared to the predicate titanium/PEEK CALIBER device.

Device Description:

RISE™ Spacers are manufactured from titanium alloy, as specified in ASTM F136 and F1295. An internal component is manufactured from radiolucent PEEK polymer, as specified in ASTM F2026.

Indications for Use:

RISE™ Spacers are lumbar interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the

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lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of nonoperative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).

RISE™ Spacers are to be filled with autogenous bone graft material. This device is intended to be used with supplemental fixation, such as the REVERE® or REVOLVE™ Stabilization Systems.

Performance Data:

Mechanical testing (static and dynamic compression, static and dynamic compression-shear and subsidence) was conducted to demonstrate substantial equivalence to the predicate device.

Basis for Substantial Equivalence:

The RISE™ Spacer has been found to be substantially equivalent to the predicate with respect to technical characteristics, performance, design, materials, performance, and intended use. The information provided within this premarket notification supports substantial equivalence to the predicate device.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and a ribbon-like element flowing beneath it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

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

JAN 26 2012

Globus Medical, Inc. % Kelly J. Baker, Ph.D. Vice President, Regulatory and Clinical Affairs 2560 General Armistead Avenue Audubon, Pennsylvania 19403

Re: K113447

Trade/Device Name: RISE™ Spacer Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: December 29, 2011 Received: December 30, 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,
Erin Keith

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

K113447 510(k) Number:

Device Name: RISE™ Spacer

Indications:

RISE™ Spacers are lumbar interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the DDD is defined as discogenic back pain with lumbosacral spine (L2-S1). degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of nonoperative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).

RISE™ Spacers are to be filled with autogenous bone graft material. This device is intended to be used with supplemental fixation, such as the REVERE® or REVOLVE™ Stabilization Systems.

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)

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

KI 1 344 7 510(k) Number_

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.