INDEPENDENCE® (including INDEPENCE® MIS) Spacers 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 non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). INDEPENDENCE® Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.

The INDEPENDENCE® Spacer is a stand-alone interbody fusion device intended to be used with three titanium alloy screws which accompany the implant.

The INDEPENDENCE® MIS Spacer is an interbody fusion device to be used with three titanium alloy screws or anchors which accompany the implants. When used with screws, the INDEPENDENCE® MIS Spacer is a stand-alone interbody fusion device. When used with anchors, the INDEPENDENCE® MIS Spacer is intended for use with supplemental fixation (e.g. facet screws or posterior fixation). Hyperlordotic implants (≥25° lordosis) are intended for use with supplemental fixation (e.g. facet screws or posterior fixation).

Device Description

INDEPENDENCE® MIS Spacers are anterior lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The spacers 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 the device grip the endplates of the adjacent vertebrae to aid in expulsion resistance. Screws and/or anchors are inserted through the anterior titanium portion of the implant into adjacent vertebral bodies for bony fixation.

INDEPENDENCE® MIS Spacers are made from titanium alloy, or titanium alloy and radiolucent polymer with titanium alloy or tantalum markers, as specified in ASTM F136, F560, F1295, and F2026. All PEEK implants are additionally available with a commercially pure titanium plasma spray coating, as specified in ASTM F1580. The mating screws and anchors are manufactured from titanium alloy, as specified in ASTM F136 and F1295, and the screws and anchors are available with or without hydroxyapatite (HA) coating, as specified in ASTM F1185.

AI/ML Overview

This document is a 510(k) Pre-Market Notification from the FDA regarding Globus Medical, Incorporated's INDEPENDENCE® MIS Spacers. It describes the device, its intended use, and the basis for its substantial equivalence to previously cleared devices.

Acceptance Criteria and Device Performance:

The document doesn't explicitly state "acceptance criteria" in terms of specific numerical thresholds for performance. Instead, it relies on demonstrating substantial equivalence to predicate devices through mechanical testing. The implication is that if the new device performs comparably to the legally marketed predicate devices under standard testing, it meets the "acceptance criteria" for market clearance.

Here's a table summarizing the performance data presented and the implied criteria:

Acceptance Criteria (Implied)	Reported Device Performance
Demonstrated substantial equivalence in mechanical performance to predicate devices.	"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 spacers." The document concludes: "INDEPENDENCE® MIS Spacers have been found to be substantially equivalent to the predicate devices with respect to technical characteristics, performance, and intended use."
Compliance with relevant ASTM standards for interbody fusion devices.	Mechanical testing was conducted in accordance with "ASTM F2077" and "ASTM F2267."
Materials meet specified standards.	"INDEPENDENCE® MIS Spacers are made from titanium alloy, or titanium alloy and radiolucent polymer with titanium alloy or tantalum markers, as specified in ASTM F136, F560, F1295, and F2026. All PEEK implants are additionally available with a commercially pure titanium plasma spray coating, as specified in ASTM F1580. The mating screws and anchors are manufactured from titanium alloy, as specified in ASTM F136 and F1295, and the screws and anchors are available with or without hydroxyapatite (HA) coating, as specified in ASTM F1185."

Study Information (Based on the provided text):

The document describes a regulatory submission to demonstrate substantial equivalence for a medical device, not a typical clinical study with patient outcomes or a multi-reader, multi-case study for AI performance. Therefore, many of the requested points are not applicable.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Test Set Sample Size: Not specified in terms of clinical patient numbers. The "test set" for this submission was the INDEPENDENCE® MIS Spacers themselves, subjected to various mechanical tests. The number of physical units tested is not provided, but typically this involves multiple samples to ensure reproducibility and statistical validity within engineering testing.
- Data Provenance: The mechanical testing was conducted according to US FDA guidance documents and ASTM standards. The location where the testing was performed, or details about the specific test articles' origin, are not specified, but it's presumed to be from the manufacturer (Globus Medical Inc. in Audubon, Pennsylvania, USA) or a certified testing facility. This is a pre-market performance evaluation, not clinical data.
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. This is a mechanical device performance evaluation, not an analysis requiring expert interpretation of diagnostic images or patient physiology. The "ground truth" for mechanical testing is established by the defined test methodologies in the ASTM standards and FDA guidance, measured by engineering instruments.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or studies involving human readers to resolve discrepancies in diagnoses or interpretations. This document describes mechanical engineering tests.
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. The device in question is an intervertebral body fusion device (a physical implant), not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI-related effectiveness was assessed or is relevant here.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. As above, this is a physical medical implant, not an algorithm or software device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" in this context is the established mechanical performance parameters as defined by the relevant ASTM standards (F2077, F2267) and FDA guidance for intervertebral fusion devices. The device's performance (e.g., load-to-failure, subsidence, expulsion resistance) is objectively measured against the requirements of these standards and compared to the predicate devices.
The sample size for the training set:
- Not Applicable. This is a physical device, not an AI model, so there is no "training set."
How the ground truth for the training set was established:
- Not Applicable. There is no training set.

In summary, this FDA 510(k) clearance document focuses on demonstrating that a new intervertebral fusion device is substantially equivalent to existing, legally marketed devices primarily through mechanical testing that adheres to established engineering standards and FDA guidance. It is not an evaluation of an AI-driven device or a clinical outcome study.

Summary

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

August 29, 2016

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

Re: K160597

Trade/Device Name: INDEPENDENCE® MIS Spacers Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD, MAX Dated: July 27, 2016 Received: July 28, 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 Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K160597

Device Name INDEPENDENCE® MIS Spacers

Indications for Use (Describe)

The INDEPENDENCE® Spacer is a stand-alone interbody fusion device intended to be used with three titanium alloy screws which accompany the implant.

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

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)

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

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510(k) Summary: INDEPENDENCE® MIS Spacers

Company:	Globus Medical Inc.2560 General Armistead Ave.Audubon, PA 19403610-930-1800
----------	-----------------------------------------------------------------------------------------

Kelly J. Baker, Ph.D. Contact: Senior Vice President, Regulatory and Clinical Affairs
Date Prepared: July 27, 2016

Device Name: INDEPENDENCE® MIS Spacers

Classification: Per 21 CFR as follows: §888.3080 Intervertebral Body Fusion Device Product Code(s): OVD, MAX Regulatory Class: II, Panel Code: 87
Primary Predicate: INDEPENDENCE® Spacers (K082252)

Additional	INDEPENDENCE® Spacers (K120101)
Predicates:	ROI-A Implant System (K110327)
	STALIF TT (K150643)
	Brigade Hyperlordotic System (K123045)

Purpose:

The purpose of this submission is to request clearance for additional INDEPENDENCE® MIS implants; and to update indications for use with allogenic bone graft for all INDEPENDENCE® Spacers.

Device Description:

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available with or without hydroxyapatite (HA) coating, as specified in ASTM F1185.

Indications for Use:

INDEPENDENCE® (including INDEPENDENCE® MIS) Spacers are 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 non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). INDEPENDENCE® Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.

The INDEPENDENCE® Spacer is a stand-alone interbody fusion device intended to be used with three titanium alloy screws which accompany the implant. The INDEPENDENCE® MIS Spacer is an interbody fusion device to be used with three titanium alloy screws or anchors which accompany the implants. When used with screws, the INDEPENDENCE® MIS Spacer is a stand-alone interbody fusion device. When used with anchors, the INDEPENDENCE® MIS Spacer is intended for use with supplemental fixation (e.g. facet screws or posterior fixation). Hyperlordotic implants (≥25° lordosis) are intended for use with supplemental fixation (e.g. facet screws or posterior fixation).

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 spacers.

Technological Characteristics:

INDEPENDENCE MIS implants have the same technological characteristics as the predicate devices including design, intended use, material composition, function, and range of sizes.

Basis of Substantial Equivalence:

INDEPENDENCE® MIS 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 of the subject spacers to 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.