When used as a cervical intervertebral body fusion device, the CONSTRUX Mini PEEK Spacer System is indicated for spinal fusion procedures at one level in the cervical spine (C2-T1), in skeletally mature patients with desc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.

The CONSTRUX Mini PEEK Spacer System is intended for use with autograft and /or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation, e.g.: the Ascent™ or Ascent LE™ POCT System.

Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the CONSTRUX Mini PEEK Spacer System in the cervical spine.

When used as a Partial Vertebral Body Replacement (VBR) System, the CONSTRUX Mini PEEK Spacer System is indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The CONSTRUX Mini PEEK Spacer System is also indicated for treating fractures of the thoracic and lumbar spine.

The CONSTRUX Mini PEEK Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period of time. The Partial VBR device is intended to be used with autograft or allograft.

The CONSTRUX Mini PEEK Spacer System is intended for use with internal fixation. The supplemental internal fixation system that may be used with the CONSTRUX Mini PEEK Spacer System is the Orthofix Spinal Fixation System (SFS) or the Firebird Spinal Fixation System.

CONSTRUX Mini PEEK Ti Spacer System

The CONSTRUX Mini PEEK Ti Spacer System is indicated for spinal fusion procedures at one level in the cervical spine (C2-T1), in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.

The CONSTRUX Mini PEEK Ti Spacer System is intended for use with autograft and /or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation system (i.e. anterior cervical plate such as the Orthofix ACP or Hallmark® System).

Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the CONSTRUX Mini PEEK Ti Spacer System in the cervical spine.

Cervical Stand Alone System

The Cervical Stand Alone System is indicated for spinal fusion procedures at one level in the cervical spine (C2-T1), in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.

The Cervical Stand Alone System is used with autograft comprised of cancellous and/or corticocancellous bone graft and the two titanium alloy screws which accompany the implant.

Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the Cervical Stand Alone System in the cervical spine.

Device Description

CONSTRUX Mini PEEK Spacer System:

The CONSTRUX Mini PEEK Spacer System is comprised of a variety of implants manufactured from PEEK and with titanium markers. The implants are available in two footprint sizes, a small and a large. The implants are available in various heights, in one-millimeter increments. The superior and inferior surfaces of the implant have a pattern of ridges to provide increased stability and help prevent anterior/posterior movement of the device.

CONSTRUX Mini PEEK Ti Spacer System:

The CONSTRUX Mini PEEK Ti Spacer System is comprised of a variety of implants that has a PEEK core with integrated porous Titanium end plates. The superior and inferior Titanium plate surfaces of the implant provide increased stability for the implants are available in three footprint sizes and various heights. The CONSTRUX Mini PEEK Ti spacer is implanted in the cervical intervertebral disc space and is intended to facilitate vertebral fusion by stabilizing adjacent vertebrae, maintaining disc height, and preventing the collapsing of one vertebrate onto another.

Cervical Stand Alone System

The Cervical Stand Alone Spacer system is designed 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. The Cervical Stand Alone spacer is manufactured from PEEK and Titanium bone screws that allow intradiscal fixation to the vertebral body. The superior and inferior surfaces of the implant have a pattern of ridges that provide increased stability and help prevent migration of the device.

AI/ML Overview

This document is a 510(k) premarket notification for the CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System, and Cervical Stand Alone System. It primarily addresses expanded indications for use, specifically the inclusion of allograft bone.

Based on the provided text, there is no acceptance criteria or a study proving the device meets specific performance criteria in the context of an AI/ML powered medical device. The document is for a medical implant (intervertebral body fusion device) and discusses its substantial equivalence to predicate devices, focusing on materials, design, and indications for use.

Therefore, most of the requested information regarding AI/ML device performance metrics, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance is not applicable to this document.

However, I can extract information related to the clinical data that supported the expanded indication:

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

Not Applicable. The document does not define specific performance acceptance criteria for an AI/ML device. It discusses the "substantial equivalence" of the implant system to predicate devices based on design, materials, and intended use, and the safety of using allograft bone.

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

Sample Size: Not explicitly stated. The document refers to "Published retrospective clinical data," not a specific test set with a defined sample size for this submission.
Data Provenance: The data was "Published retrospective clinical data." The country of origin is not specified but implicitly relates to the use of similar cervical interbody fusion devices.

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. No ground truth establishment by experts for a specific test set is mentioned in the context of this 510(k) submission. The clinical data referred to supports the safety of using allograft bone.

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

Not Applicable. No adjudication method 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 document is for a physical medical implant, not an AI/ML device, so an MRMC study related to AI assistance is irrelevant here.

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

Not Applicable. This document is for a physical medical implant, not an AI/ML device.

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

Not Applicable in the context of an AI/ML ground truth. However, the "Published retrospective clinical data" would have relied on clinical outcomes data related to spinal fusion procedures and the use of allograft. The "outcomes demonstrated that the use of allograft... poses no new risks to patients."

8. The sample size for the training set:

Not Applicable. No training set is mentioned as this is not an AI/ML device submission.

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

Not Applicable. No training set or ground truth establishment for a training set is mentioned.

In summary, this 510(k) submission focuses on the substantial equivalence of a spinal implant system with expanded indications for use (specifically regarding bone graft material), rather than the performance of an AI/ML powered device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, overlapping each other to create a sense of depth and connection.

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

January 8, 2015

Orthofix, Incorporated Ms. Natalia Volosen Senior Regulatory Affairs Specialist 3451 Plano Parkway Lewisville, Texas 75056

Re: K142152

Trade/Device Name: CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System, and Cervical Stand Alone System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP, OVE, MQP Dated: December 10, 2014 Received: December 11, 2014

Dear Ms. Volosen:

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

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(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related 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/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,

Lori A. Wiggins -S

for

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) K142152

K142152 Page 1 of 2

Device Name CONSTRUX Mini PEEK Spacer System CONSTRUX Mini PEEK Ti Spacer System Cervical Stand Alone System

Indications for Use (Describe)

CONSTRUX Mini PEEK Spacer System

Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the CONSTRUX Mini PEEK Spacer System in the cervical spine.

CONSTRUX Mini PEEK Ti Spacer System

Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the CONSTRUX Mini PEEK Ti Spacer System in the cervical spine.

Cervical Stand Alone System

The Cervical Stand Alone System is used with autograft comprised of cancellous and/or corticocancellous bone graft and the two titanium alloy screws which accompany the implant.

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Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the Cervical Stand Alone System in the cervical spine.

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)

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.

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:

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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Image /page/4/Picture/0 description: The image shows the word "ORTHOFIX" in bold, black letters. To the left of the word is a blue, abstract shape that resembles a stylized letter "O" or a curved arrow. A small "®" symbol is located to the upper right of the "X" in "ORTHOFIX", indicating that the name is a registered trademark. The overall design is clean and professional, suggesting a corporate logo.

510(k) SUMMARY

PEEK Cervical Interbody Device

510(k) Owner InformationName:	Orthofix Inc.
Address:	3451 Plano ParkwayLewisville, TX 75056
Telephone Number:Fax Number:Email:	214.937.2145214-937-3322nataliavolosen@orthofix.com
Registration Number:	3008524126
Contact Person:	Natalia VolosenSenior Regulatory Affairs Specialist
Date Prepared:	December 10, 2014
Name of DeviceTrade Name / ProprietaryName:	CONSTRUX Mini PEEK Spacer SystemCONSTRUX Mini PEEK Ti Spacer SystemCervical Stand Alone System
Common Name:	Intervertebral body fusion deviceSpinal intervertebral body fixation orthosis
Product Code:	ODP, MQP, OVE
Regulatory Classification:	Class II per 21 CFR § 888.3080Class II per 21 CFR § 888.3060
Review Panel:	Orthopedic Device Panel
Predicate Devices:	K130177 - Medtronic ANATOMIC PEEK™ CERVICAL FUSIONSYSTEM, SE 9/23/2013 (primary predicate)K133653 - Medtronic ANATOMIC PEEK PTC Cervical FusionSystem, SE 4/28/2014 (additional predicate)K132999 - Cervical Stand Alone System, SE 04/14/2014 (additionalpredicate)K101812 - CONSTRUX Mini PEEK Spacer System, SE 09/27/2010(additional predicate)K121649 - CONSTRUX Mini PEEK Ti Spacer System,SE 11/29/2012 (additional predicate)No reference devices were used in this submission

Reason for 510(k) Submission: Expanded Indications for Use

Device Description

CONSTRUX Mini PEEK Spacer System:

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superior and inferior surfaces of the implant have a pattern of ridges to provide increased stability and help prevent anterior/posterior movement of the device.

CONSTRUX Mini PEEK Ti Spacer System:

Cervical Stand Alone System

Intended Use / Indications for Use

CONSTRUX Mini PEEK Spacer System

When used as a cervical intervertebral body fusion device, the CONSTRUX Mini PEEK Spacer System is indicated for spinal fusion procedures at one level in the cervical spine (C2-T1), in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.

Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the CONSTRUX Mini PEEK Spacer System in the cervical spine.

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Image /page/6/Picture/0 description: The image shows the logo for Orthofix. The logo consists of a blue abstract shape on the left, followed by the word "ORTHOFIX" in black, bold letters. The "®" symbol is located to the right of the "X" in "ORTHOFIX".

CONSTRUX Mini PEEK Ti Spacer System

Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the CONSTRUX Mini PEEK Ti Spacer System in the cervical spine.

Cervical Stand Alone System

The Cervical Stand Alone System is used with autograft and /or allograft comprised of cancellous and/or corticocancellous bone graft and the two titanium alloy screws which accompany the implant.

Patients must have underqone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the Cervical Stand Alone System in the cervical spine.

Summary of the Technological Characteristics of the Device Compared to the Selected Predicate Devices

The technological characteristics of the CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System and Cervical Stand Alone Spacer System are similar to the predicate devices in terms of indication for use, intended use, design and materials.

There may be differences in implant foot print and size which will not introduce additional risk to the patients as these devices are currently being cleared for distribution. The addition of the allograft comprised of cancellous and/or corticocancellous bone graft to the CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System and Cervical Stand Alone Spacer System indication do not raise new types of safety and effectiveness questions (risks) not seen before. The same risks occur in the subject CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System and Cervical Stand Alone Spacer System as in the predicate devices.

PERFORMANCE DATA – Summary of Non-Clinical Test Conducted for Determination of Substantial Equivalence

There have been no design changes made to CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System, and Cervical Stand Alone System implants. The purpose of this 510(k) submission is to obtain clearance to use allograft bone comprised of cancellous and/or corticocancellous bone graft as a substitute to autograft bone. No mechanical testing was performed to help determine substantial equivalence.

PERFORMANCE DATA – Summary of Clinical Test Conducted for Determination of Substantial Equivalence

Published retrospective clinical data for the cervical interbody fusion devices similar to the CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System, and Cervical Stand Alone System implants was provided in support of this application. The published clinical outcomes demonstrated that the use of allograft (cancellous and/or

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Image /page/7/Picture/0 description: The image shows the word "ORTHOFIX" in bold, black letters. To the left of the word is a blue, abstract shape. The registered trademark symbol is located to the right of the word.

corticocancellous bone graft) in anterior cervical interbody fusion procedures to treat patients diagnosed with cervical disc disease as defined above poses no new risks to patients. No changes were made to the existing devices, nor were any new components added to the system. Therefore, no additional testing was required or performed.

Basis of Substantial Equivalence

The CONSTRUX Mini PEEK Spacer system, CONSTRUX Mini PEEK Ti Spacer system and Cervical Stand Alone system have the same intended use, similar indications for use, the similar technological characteristics and design, same materials and the same principles of operation as the to the Medtronic ANATOMIC PEEK™ CERVICAL FUSION SYSTEM (K130177) and Medtronic ANATOMIC PEEK PTC Cervical Fusion System (K133653).

The minor differences between CONSTRUX Mini PEEK Spacer system, CONSTRUX Mini PEEK Ti Spacer system and Cervical Stand Alone system implant design and the Medtronic ANATOMIC PEEK™ CERVICAL FUSION SYSTEM (K130177) and Medtronic ANATOMIC PEEK PTC Cervical Fusion System (K133653) predicates does not introduce any additional patient risk.

There have been no design changes made to CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System, and Cervical Stand Alone System implants since their last 510(k) clearance. The purpose of this 510(k) submission is to obtain clearance to use allograft bone comprised of cancellous and/or corticocancellous bone graft as a substitute / addition to autograft bone.

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.