The HAVEN™ Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3-T3) in laminoplasty procedures. The HAVEN™ Laminoplasty System is used to hold bone allograft material in place in order to prevent the graft from expulsion or impinging the spinal cord.

The CANOPY® Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3) in laminoplasty procedures. The CANOPY® Laminoplasty Fixation System is used to hold bone allograft or autograft material in place in order to prevent the graft from expulsion or impinging the spinal cord.

Device Description

The HAVEN™ Laminoplasty System consists of spinal fixation plates for use in Laminoplasty. These implants are composed of titanium or titanium alloy (per ASTM F67, F136, F1295, and F1472). HAVEN™ implants may be used with previously cleared CANOPY®, RELIEVE®, QUARTEX™, ELLIPSE®, PROTEX CT® screws and CANOPY® Spacer.

The CANOPY® Laminoplasty Fixation System consists of spinal fixation plates and screws for use in laminoplasty procedures. CANOPY® implants are inserted through a posterior cervical or thoracic approach, and are available in various sizes and geometric options to fit individual patient anatomy. Fixation plates may be used with bone graft material. Hinge plates may be used to stabilize a weakened or displaced lamina. Screws are used to attach the plates to bone and are available in a variety of lengths and diameters to fit patient anatomy.

CANOPY® plates and screws are manufactured from titanium or titanium alloy, as specified in ASTM F67, F136, F1295 and F1472. Optional graft chambers are manufactured from radiolucent PEEK as specified in ASTM F2026 and contain tantalum or titanium alloy markers to permit radiographic visualization, per ASTM F67, F136, F560, F1295 or F1472.

AI/ML Overview

This document describes the FDA's clearance of the HAVEN™ Laminoplasty System and CANOPY® Laminoplasty Fixation System. It is a 510(k) premarket notification, which establishes substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with acceptance criteria based on patient outcomes.

Therefore, the requested information about acceptance criteria and specific study details (like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth for test and training sets, and training set sample size) is largely not applicable in the context of this 510(k) submission.

Explanation:

510(k) Premarket Notification: This type of submission aims to demonstrate that a new device is "substantially equivalent" to a device already on the market (a predicate device). This often relies on comparing technical characteristics, materials, and mechanical or non-clinical performance, rather than clinical efficacy against pre-defined acceptance criteria for patient outcomes.
Mechanical Testing vs. Clinical Studies: The performance data section explicitly states, "Compression, cantilever bending and expulsion testing performed on the HAVEN™ plates demonstrates substantial equivalence to the predicate devices. No additional testing for CANOPY® plates was performed." This indicates that the primary basis for clearance was a comparison of mechanical properties, not clinical performance against specific metrics.
Absence of Clinical Study Details: The document does not mention any clinical studies, patient data, ground truth establishment by experts, or statistical analyses of human reader performance (MRMC) or standalone algorithm performance that would be typical for AI/ML device clearances requiring such details.

However, based on the provided document, I can extract the following relevant information regarding performance and its basis for substantial equivalence:

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

Performance Metric	Acceptance Criteria (Implicit from Substantial Equivalence to Predicate)	Reported Device Performance
Mechanical Performance	Equivalent to predicate devices (CANOPY® K121732, RELIEVE® K080664, Mountaineer K091994)	Compression, cantilever bending, and expulsion testing demonstrated substantial equivalence to predicate devices for HAVEN™ plates. (No additional testing for CANOPY® plates noted).
Biocompatibility	Acceptable (standard for implantable devices)	Bacterial endotoxin testing was performed.
Material Composition	Compliant with ASTM standards for titanium/titanium alloy (F67, F136, F1295, F1472) and PEEK (F2026)	HAVEN™ and CANOPY® implants are composed of specified titanium, titanium alloy, and optional PEEK with tantalum/titanium markers.
Function/Design	Similar to predicate devices	The devices have the same technological characteristics as predicate devices including design, intended use, material composition, function, and range of sizes.

2. Sample size used for the test set and the data provenance:

Not Applicable in the traditional sense for clinical data. The performance claims are based on mechanical testing of the devices themselves, not on a test set of patient data.
Data Provenance: The mechanical testing was performed by the manufacturer, Globus Medical Inc.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. No expert-established ground truth for patient data is mentioned as part of this 510(k) clearance.

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

Not Applicable. No adjudication method for expert review of patient data is mentioned.

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 a physical medical device (spinal fixation system), not an AI/ML algorithm for image interpretation or diagnosis. Therefore, no MRMC study or AI assistance evaluation was performed.

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

Not Applicable. This is a physical medical device, not an algorithm.

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

Not Applicable for clinical ground truth. For the mechanical testing, the "ground truth" would be the engineering specifications and performance benchmarks derived from the predicate device's established mechanical properties.

8. The sample size for the training set:

Not Applicable. This is not an AI/ML device relying on a training set of data.

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

Not Applicable. As above, no training set for an algorithm is involved.

In summary: The provided document is a 510(k) clearance for a spinal implant system. The "study" referenced is mechanical performance testing to demonstrate substantial equivalence to predicate devices, not a clinical study involving patient data, expert review, or AI performance metrics.

Summary

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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol often associated with healthcare. The caduceus is depicted with three lines forming a shape that resembles a bird or a stylized human figure.

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

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

July 14, 2017

Re: K171413

Trade/Device Name: HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: NOW Dated: May 12, 2017 Received: May 15, 2017

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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 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" (21 CFR 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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Indications for Use

510(k) Number (if known) K171413

Device Name HAVEN™ Laminoplasty System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subnart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Indications for Use

510(k) Number (if known) K171413

Device Name

CANOPY® Laminoplasty Fixation System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) Summary: HAVEN™ Spinal System

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:	May 12, 2017
Device Name:	HAVENTM Laminoplasty SystemCANOPY® Laminoplasty Fixation System
Common Name:Classification:	Spinal interlaminal fixation orthosis (NQW)Per 21 CFR as follows:§888.3050 Spinal Interlaminal Fixation OrthosisProduct Code: NQWRegulatory Class: II, Panel Code: 87
PrimaryPredicate:	CANOPY® Laminoplasty Fixation System (K121732)
AdditionalPredicates:	RELIEVE® Laminoplasty Fixation System (K080664)Mountaineer Laminoplasty System (K091994)
ReferenceDevice:	REVERE® Stabilization System (K133350)

Purpose:

The purpose of this submission is to request clearance for HAVEN™ implants and additional CANOPY® implants, and additional indications for CANOPY®

Device Description:

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used with bone graft material. Hinge plates may be used to stabilize a weakened or displaced lamina. Screws are used to attach the plates to bone and are available in a variety of lengths and diameters to fit patient anatomy.

Indications for Use:

The HAVEN™ Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3-T3) in laminoplasty procedures. The HAVEN™ Laminoplasty System is used to hold bone allograft or autograft material in place in order to prevent the graft from expulsion or impinging the spinal cord.

Performance Data:

Performance of the HAVEN™ Laminoplasty System was evaluated in accordance with the "Guidance for Industry and FDA Staff, Guidance for Spinal Systems 510(k)s," May 3, 2004. Compression, cantilever bending and expulsion testing performed on the HAVEN™ plates demonstrates substantial equivalence to the predicate devices. No additional testing for CANOPY® plates was performed. Bacterial endotoxin testing was also performed.

Technological Characteristics:

The HAVEN™ and additional CANOPY® 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:

The HAVEN™ Laminoplasty System and CANOPY® Laminoplasty Fixation System 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 laminoplasty devices to the predicate devices.

Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.