The ELSA™ 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 ELSA™ Spacer is to be filled with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone, may be used with two bone screws, and is to be used with supplemental fixation. Hyperlordotic (≥20°) implants must be used with the two bone screws and supplemental fixation in addition to the bone screws.

Device Description

ELSA™ Spacers are expandable lateral lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The devices are available in various heights 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.

ELSA™ Spacers are manufactured from titanium alloy, as specified in ASTM F136 and F1295, and include an internal component manufactured from radiolucent PEEK polymer, as specified in ASTM F2026. The screws used with ELSA™ are manufactured from titanium allov, 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, the ELSA™ Spacer, which is an intervertebral body fusion device. The document is a 510(k) premarket notification summary submitted to the FDA. The submission seeks to demonstrate substantial equivalence to legally marketed predicate devices.

However, the provided text does not include information about acceptance criteria for a device's performance (such as a diagnostic algorithm or AI system) or a study that specifically proves the device meets such criteria in terms of clinical accuracy or effectiveness. Instead, it describes mechanical and material performance testing for the physical implant itself, aimed at demonstrating functional equivalence to existing devices.

Therefore, many of the requested categories about acceptance criteria, clinical study design, ground truth establishment, and AI performance metrics cannot be answered from the provided document.

Here's a breakdown of what can be extracted and what is missing:

1. Table of acceptance criteria and the reported device performance

The document lists performance tests conducted for the physical device, not for a diagnostic algorithm's accuracy. The "acceptance criteria" here relate to the mechanical integrity and safety of the implant itself, aligning with established ASTM standards for intervertebral fusion devices.

Test Type	Standard/Guidance	Reported Performance
Mechanical Testing (Static & Dynamic)	"Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Intervertebral Fusion Device," June 12, 2007, ASTM F2077, and ASTM F2267	Conducted to demonstrate substantial equivalence to predicate devices (Implies successful completion and meeting of standard requirements for safety and function, but specific numerical performance is not detailed)
Subsidence (Mechanical)	ASTM F2077, ASTM F2267	Conducted to demonstrate substantial equivalence to predicate devices
Expulsion (Mechanical)	ASTM F2077, ASTM F2267	Conducted to demonstrate substantial equivalence to predicate devices
Bacterial Endotoxin Testing (BET)	ANSI/AAMI ST-72:2011	Conducted (Implies successful completion within acceptable endotoxin levels)

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

Not applicable. This document describes mechanical and material testing of a physical implant, not a clinical study involving a test set of patient data or images. The "samples" would refer to the number of devices subjected to various mechanical stress tests, which is not specified in this summary.

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)

Not applicable. Ground truth establishment by clinical experts is relevant for diagnostic or AI devices, not for the mechanical testing of an interbody fusion device.

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

Not applicable. This pertains to clinical studies for diagnostic accuracy, not mechanical testing.

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

Not applicable. This is for AI-assisted diagnostic devices. The ELSA™ Spacer is a physical implant.

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

Not applicable. There is no algorithm or AI component described for the ELSA™ Spacer.

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

Not applicable. For mechanical testing, the "ground truth" is adherence to established engineering standards (ASTM and FDA guidance) for device strength, durability, and biocompatibility.

8. The sample size for the training set

Not applicable. There is no AI training set mentioned for this physical device.

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

Not applicable. No training set or ground truth in the AI context are relevant to this document.

Summary of Device and Study Type:

The ELSA™ Spacer is an interbody fusion device, a physical implant used in spinal surgery. The "study" described in this document is a series of mechanical and material performance tests (e.g., static and dynamic compression, subsidence, expulsion, bacterial endotoxin) conducted in accordance with established ASTM standards and FDA guidance. The purpose of these tests is to demonstrate the substantial equivalence of the ELSA™ Spacer to legally marketed predicate devices in terms of safety, function, and mechanical integrity, rather than clinical diagnostic performance or AI accuracy.

Summary

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

September 29, 2016

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

Re: K161379

Trade/Device Name: ELSA™ Spacers Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD, MAX Dated: August 31, 2016 Received: September 1, 2016

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 Parts 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/ResourcesforYou/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,

Mark N. Melkerson -S

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

Enclosure

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Indications for Use

510(k) Number (if known) K161379

Device Name ELSATM 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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

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

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510(k) Summary: ELSA™ Spacers

Company:	Globus Medical, Inc.2560 General Armistead Ave.Audubon, PA 19403610-930-1800
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Contact: Kelly J. Baker, Ph.D. Senior Vice President, Regulatory and Clinical Affairs
September 23, 2016 Date Prepared:
Device Name: ELSA™ Spacers
Classification: Per 21 CFR as follows: §888.3080 Intervertebral Body Fusion Device Product Codes: OVD, MAX Requlatory Class: II, Panel Code: 87

Primary Predicate: CALIBER® Spacer (K102293 & K123231)

Additional	InterContinental® Plate-Spacer (K103382)
Predicates:	Centinel Spine STALIF (K150643)
	NuVasive CoRoent (K140479 & K141665)
	Medtronic PIVOX (K152277)

Purpose:

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

Device Description:

Indications for Use:

The ELSA™ Spacer is an interbody fusion device 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). The ELSA™ Spacer is to be filled with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone, may be used with two bone screws, and is to be used with supplemental fixation. Hyperlordotic (≥20°) implants must be used with the two bone screws and supplemental fixation in addition to the bone screws.

Performance Data:

Mechanical testing (static and dynamic compression and 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. Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011.

Technological Characteristics

The ELSA™ implants have the same technological characteristics as the predicate devices including design, intended use, material composition, and range of sizes.

Basis of Substantial Equivalence:

ELSA™ 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. ELSA™ 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.