When used as lumbar intervertebral body fusion devices, SUSTAIN® Spacers (including SUSTAIN® R and SUSTAIN®-IR) are 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 at the involved level(s). SUSTAIN® Spacers are to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. These devices are intended to be used with supplemental fixation.

Device Description

SUSTAIN®-IR Spacers are lumbar intervertebral fusion devices used to provide structural stability in skeletally mature individuals following discectomy and may be inserted using a posterior or transforaminal approach. The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. SUSTAIN® IR Spacers are inserted into the disc space and rotated 90° to the final position. Ridges on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. SUSTAIN®-IR Spacers have an axial hole to allow autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to be packed inside the spacer.

SUSTAIN®-IR Spacers are made from radiolucent PEEK polymer with titanium alloy or tantalum markers as specified in ASTM F136, F560, F1295, and F2026.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called "SUSTAIN® Additional Implants," which are intervertebral body fusion devices. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than robust clinical studies with acceptance criteria for device performance as would be seen for a novel device.

Therefore, the document does not contain information on:

Acceptance criteria for device performance based on clinical outcomes. The "acceptance criteria" discussed are primarily related to mechanical testing standards for intervertebral fusion devices.
A study proving the device meets clinical acceptance criteria (e.g., diagnostic accuracy, sensitivity, specificity, clinical efficacy endpoints).
Sample sizes for a test set (clinical data), data provenance, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance studies. These are typically associated with performance evaluations of AI/ML-driven devices or devices requiring clinical outcome validation beyond substantial equivalence.
Training set sample size or how ground truth was established for a training set. This information is also typically for AI/ML devices.

Instead, the document focuses on bench testing (mechanical testing) and a cadaver implantation study to demonstrate substantial equivalence for a physical implant device.

Here's the information that can be extracted or inferred from the document regarding "acceptance criteria" and "study":

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a submission for an implantable device focused on mechanical efficacy, the "acceptance criteria" are implied by adherence to recognized standards for intervertebral fusion devices. The document states that testing was conducted in accordance with these standards. Quantitative performance metrics against specific acceptance thresholds are not provided in this summary.

Acceptance Criteria (Implied by Standards)	Reported Device Performance
Mechanical Testing:
Static Compression (per Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document, ASTM F2077, ASTM F2267)	Conducted and demonstrated substantial equivalence to predicate devices.
Dynamic Compression (per Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document, ASTM F2077, ASTM F2267)	Conducted and demonstrated substantial equivalence to predicate devices.
Static Compression-Shear (per Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document, ASTM F2077, ASTM F2267)	Conducted and demonstrated substantial equivalence to predicate devices.
Dynamic Compression-Shear (per Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document, ASTM F2077, ASTM F2267)	Conducted and demonstrated substantial equivalence to predicate devices.
Subsidence (per Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document, ASTM F2077, ASTM F2267)	Conducted and demonstrated substantial equivalence to predicate devices.
Implantation Feasibility & Endplate Damage Assessment (Cadaver Study)	Demonstrated feasibility of device insertion and assessed potential endplate damage.
Material Composition (Radiolucent PEEK polymer with titanium alloy or tantalum markers)	Meets specified ASTM standards (F136, F560, F1295, F2026).

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

Test Set Sample Size: Not specified for the mechanical or cadaver studies in this summary. For mechanical testing, samples typically refer to a number of devices/constructs. For the cadaver study, the number of cadaveric spines or segments is not mentioned.
Data Provenance: Not explicitly stated, but mechanical testing is typically performed in a laboratory setting. The cadaver study would be performed in a lab or research institution. Data is prospective in the sense that the testing was conducted specifically for this submission.

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

This is not applicable in the context of this 510(k) submission for a physical implant. "Ground truth" as expert consensus on medical images or patient outcomes is not relevant here. The "truth" for mechanical testing is based on standard test methods and measurements. For the cadaver study, the assessment of insertion feasibility and endplate damage would be observational by the study team, likely including surgeons or anatomists, but their specific number or qualifications are not provided.

4. Adjudication Method for the Test Set

Not applicable in this context. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations (e.g., in reading medical images), which is not part of this type of device evaluation.

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

No, an MRMC study was not done. This type of study is specifically designed for evaluating the impact of AI on human reader performance, which is not relevant for this physical intervertebral fusion device.

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

No, a standalone algorithm performance study was not done. This is not an AI/ML device but a physical implant.

7. The Type of Ground Truth Used

Mechanical Testing: The "ground truth" is derived from physical measurements and adherence to specified ASTM and FDA guidance document standards.
Cadaver Implantation Study: The "ground truth" relates to direct observation of device insertion feasibility and any associated endplate damage in cadaveric tissue.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device.

Summary

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

March 16, 2016

Globus Medical Incorporated % Dr. Kellv Baker Senior Vice President, Regulatory and Clinical Affairs Valley Forge Business Center 2560 General Armistead Avenue Audubon, Pennsylvania 19403

Re: K151665

Trade/Device Name: SUSTAIN® Additional Implants Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: February 12, 2016 Received: February 16, 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 yours,

Mark N. Melkerson -S

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

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K151665

Device Name SUSTAIN® Additional Implants

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)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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K151665 Page 1 of 1

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510(k) Summary: SUSTAIN® Additional Implants

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:	March 15, 2016
Device Name:	SUSTAIN® Additional Implants
Classification:	Per 21 CFR as follows:§888.3080 Intervertebral Body Fusion DeviceProduct Codes: MAXRegulatory Class: II, Panel Code: 87

Primary Predicate: SUSTAIN® Spacers (K130478)

AdditionalPredicates:	CALIBER® Spacer (K102293 & K123231)
	Medtronic Capstone Control (K120368)
	NuVasive CoRoent (K100043)
	Stryker AVS PL PEEK Spacers (K143163)

Purpose:

The purpose of this submission is to request clearance for SUSTAIN® Additional Implants (SUSTAIN®-IR Spacers) and to update indications for use with allogenic bone graft comprised of cancellous and/or corticocancellous bone graft for SUSTAIN® Spacers (including SUSTAIN® R and SUSTAIN®-IR).

Device Description:

SUSTAIN®-IR Spacers are made from radiolucent PEEK polymer with titanium alloy or tantalum markers as specified in ASTM F136, F560, F1295, and F2026.

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Indications for Use:

When used as lumbar intervertebral body fusion devices, SUSTAIN® Spacers (including SUSTAIN® R and SUSTAIN®-IR) are 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). SUSTAIN® Spacers are to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. These devices are intended to be used with supplemental fixation.

Performance Data:

Mechanical testing (static and dynamic compression, static and dynamic compression-shear, and subsidence) 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. A cadaver implantation study was also performed to demonstrate feasibility of device insertion and assess potential endplate damage.

Basis of Substantial Equivalence:

SUSTAIN® Additional Implants 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. SUSTAIN® Additional Implants 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.