The MAGNIFY™ Spacer is an interbody fusion device 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 non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The MAGNIFY™ Spacer is to be filled with autogenous bone graft material, and is to be used with supplemental fixation, such as the CREO®, REVERE® or REVOLVE® Stabilization Systems.

The MAGNIFY™-S Spacer is a stand-alone interbody fusion device 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 non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The MAGNIFY™-S Spacer is to be filled with autogenous bone graft material, and is to be used with three titanium alloy screws that accompany each implant.

Device Description

MAGNIFY™ Spacers are expandable anterior lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The devices are available in various height expansion ranges and geometric options to fit the anatomical needs of a wide variety of patients. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to aid in expulsion resistance. These devices are to be filled with autogenous bone graft material.

The MAGNIFY™ Spacer is to be used with supplemental fixation. The MAGNIFY™-S Spacer is to be used with three titanium alloy screws that accompany the implant.

MAGNIFY™ Spacers are manufactured from titanium alloy, as specified in ASTM F136, and include an internal component manufactured from radiolucent PEEK polymer, as specified in ASTM F2026. The screws used with MAGNIFY™-S are manufactured from titanium alloy, as specified in ASTM F136 and F1295, and are available with hydroxyapatite (HA) coating, as specified in ASTM F1185.

AI/ML Overview

The provided text describes a medical device called MAGNIFY™ and MAGNIFY™-S Spacers and its 510(k) clearance. It is a submission for a spinal interbody fusion device, not an AI/ML powered device. Therefore, the information required to answer the prompt for acceptance criteria and study proving device meets acceptance criteria for an AI/ML device (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) is not applicable or available in the provided text.

The closest relevant information is contained within the "Performance Data" section, which outlines mechanical testing performed for this physical medical device. This is not about software or AI/ML performance.

Here's an attempt to answer based on the provided text, acknowledging the limitations due to the nature of the device:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state numerical "acceptance criteria" for the mechanical tests, nor does it provide specific numerical "reported device performance" values. It only states that testing was conducted and demonstrated "substantial equivalence."

Acceptance Criteria (Implied)	Reported Device Performance
Meets standards of "Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Intervertebral Fusion Device," June 12, 2007, ASTM F2077, and ASTM F2267 for:	Substantially equivalent to predicate devices for mechanical performance
- Static compression strength/performance	(Not specified numerically, but met equivalence)
- Dynamic compression strength/performance	(Not specified numerically, but met equivalence)
- Static compression-shear strength/performance	(Not specified numerically, but met equivalence)
- Dynamic compression-shear strength/performance	(Not specified numerically, but met equivalence)
- Subsidence resistance	(Not specified numerically, but met equivalence)
- Expulsion resistance	(Not specified numerically, but met equivalence)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable to a physical device undergoing mechanical testing, and therefore, not present in the document. Mechanical tests typically use a defined number of test articles (e.g., several units of each device type) rather than "test sets" in the clinical or AI/ML sense. Data provenance regarding country of origin or retrospective/prospective is not relevant for this type of testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable, as this is a physical medical device undergoing mechanical testing, not a diagnostic or AI/ML device requiring expert ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable as there is no "test set" requiring adjudication in the context of an AI/ML device. Mechanical testing follows standardized protocols, not adjudication by human experts.

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 such study was done as the device is an interbody fusion spacer, not an AI-assisted diagnostic or analysis tool.

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

This concept is not applicable as the device is an implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For mechanical testing, the "ground truth" is defined by the objective physical measurements and engineering specifications outlined in the ASTM standards (F2077, F2267) and the specific FDA guidance document for intervertebral fusion devices. It's not based on expert consensus, pathology, or outcomes data in the traditional sense for diagnostic tools, but rather on material science and biomechanical principles.

8. The sample size for the training set

This information is not applicable. There is no "training set" for an interbody fusion device undergoing mechanical testing.

9. How the ground truth for the training set was established

This information is not applicable, as there is no "training set" for this type of device.

Summary

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

February 26, 2015

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

Re: K142498

Trade/Device Name: MAGNIFY™ and MAGNIFY™-S Spacers Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD, MAX Dated: January 29, 2015 Received: January 30, 2015

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.

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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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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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 N. Melkerson -S

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

Enclosure

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Indications for Use

510(k) Number (if known)

K142498

Device Name MAGNIFY™ and MAGNIFYTM-S Spacers

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary: MAGNIFY™ Spacers

Company:	Globus Medical Inc.2560 General Armistead Ave.Audubon, PA 19403610-930-1800
Contact:	Kelly J. Baker, Ph.D.Senior Vice President, Regulatory and Clinical Affairs
Date Prepared:	September 4, 2014
Device Name:	MAGNIFYTM and MAGNIFYTM.S Spacers
Classification:	Per 21 CFR as follows:§888.3080 Intervertebral Body Fusion DeviceProduct Codes: OVD, MAXRegulatory Class: II, Panel Code: 87

Primary Predicate: CALIBER® Spacer (K102293)

Additional	INDEPENDENCE® Spacer (K082252 & K120101)
Predicates:	CALIBER® Spacer (K123231)
	PATRIOT® Continental® (K072970 & K122097)

Purpose:

The purpose of this submission is to request clearance for the MAGNIFY™ Spacers.

Device Description:

The MAGNIFY™ Spacer is to be used with supplemental fixation. The MAGNIFY™-S Spacer is to be used with three titanium alloy screws that accompany the implant.

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manufactured from titanium alloy, as specified in ASTM F136 and F1295, and are available with hydroxyapatite (HA) coating, as specified in ASTM F1185.

Indications for Use:

The MAGNIFY™ Spacer is an interbody fusion device 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). The MAGNIFY™ Spacer is to be filled with autogenous bone graft material, and is to be used with supplemental fixation, such as the CREO®, REVERE® or REVOLVE® Stabilization Systems.

The MAGNIFY™-S Spacer is a stand-alone interbody fusion device 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). The MAGNIFY™-S Spacer is to be filled with autogenous bone graft material, and is to be used with three titanium alloy screws that accompany each implant.

Performance Data:

Mechanical testing (static and dynamic compression, static and dynamic compression-shear, subsidence, and expulsion) was conducted in accordance with the "Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Intervertebral Fusion Device," June 12, 2007, ASTM F2077, and ASTM F2267 to demonstrate substantial equivalence to the predicate devices.

Basis of Substantial Equivalence:

MAGNIFY™ Spacers have been found to be substantially equivalent to the predicate devices with respect to technical characteristics, performance, and intended use. The information provided within this premarket notification supports substantial equivalence to the predicate devices. MAGNIFY™ Spacers are as safe, as effective, and perform as well as or better than the predicate devices.

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.