The PATHWAY ELIF device(s) is intended for spinal fusion procedure at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative Disc Diseases (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spiral surgery at the involved spinal level(s).

The PATHWAY ELIF device is intended to be used with supplemental spinal fixation systems that have been cleared for lumbosacral spine (i.e. posterior pedicle screws and rod systems, and anterior screw and rod systems. The device(s) is intended to be used with autogenous bone graft.

Patients must have undergone a regiment of at least (6) months of non-operative treatment prior to being treated with the PATHWAY ELIF device(s).

The PATHWAY ELIF device can be used in one of two methods:

Transforaminal Lumbar Interbody Fusion (TLIF)

Used as a TLIF, a single device is implanted in the appropriate location to provide support for a transforaminal approached surgery.

Posterior Lumbar Interbody Fusion (PLIF)

Used as a PLIF, two devices are implanted in the appropriate locations to provide support to the spine for a posterior surgery.

Device Description

The PATHWAY ELIF implant features three prescribed lordotic angle / height positions and is available in two lengths for posterior lumbar fusion. It allows lordotic adaptability and height restoration to meet patient anatomy. It is comprised of upper and lower expandable surfaces preassembled with a posterior height maintenance component. The device can be expanded to fixed configurations of 0°, 8°, and 16° positions. Each position after 0° provides approximately 2mm of additional mid-body height increase. The superior and inferior surfaces of all components are coated with plasma sprayed titanium to provide a roughened finish.

AI/ML Overview

This document describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the PATHWAY ELIF device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly present a table of acceptance criteria with specific numerical targets. Instead, it refers to compliance with established ASTM standards for intervertebral body fusion devices. The reported device performance is that the PATHWAY ELIF System demonstrated "equivalent performance to the predicate" by successfully passing these tests.

Acceptance Criterion (Implied)	Reported Device Performance
Mechanical Performance (Static Axial Compression)	Demonstrated equivalent performance to the predicate per ASTM F2077.
Mechanical Performance (Dynamic Axial Compression Shear)	Demonstrated equivalent performance to the predicate per ASTM F2077.
Subsidence Resistance	Successful subsidence testing per ASTM F2267.
Expulsion Resistance	Successful expulsion testing per ASTM Draft F04.25.02.02.
Usability and Functionality	Demonstrated in a cadaver study.
Material Properties (Titanium Alloy)	Ti-6AI-4V ELI according to ISO 5832-3 and ASTM F136.
Coating Properties (Plasma Spray Titanium)	Conformity to ASTM F1580, F1854, F1044, F1147, F1160, F1978 (implied by listing standards).

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

The document does not specify the exact sample sizes used for each mechanical test (static/dynamic compression, subsidence, expulsion). Instead, it states that "Testing was performed in accordance with the following standard(s):" and lists several ASTM standards. These standards typically define minimum sample sizes for such tests.

The document mentions a "cadaver study" for usability and functionality, but the sample size for this study is not provided.

The provenance of the data is retrospective, as it describes tests conducted to demonstrate the device's characteristics. No information on the country of origin for the data is provided, but given the US FDA submission, it's presumed to be from tests conducted by or on behalf of Custom Spine, Incorporated.

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

This information is not applicable to the supplied document. The "ground truth" for this medical device submission is established through objective engineering and material testing standards (ASTM standards), rather than expert consensus on medical images or clinical outcomes. The evaluation is based on whether the device meets pre-defined mechanical and material specifications.

4. Adjudication Method for the Test Set:

This information is not applicable. The assessment is based on quantifiable engineering test results and adherence to material specifications, not on human interpretation that would require an adjudication method.

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:

This information is not applicable. The PATHWAY ELIF is an intervertebral body fusion device (an implant), not an AI-powered diagnostic or assistive technology that would involve human readers or AI assistance.

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

This information is not applicable for the same reason as point 5. The device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

The ground truth used for this device is based on:

Engineering Standards: Compliance with recognized ASTM standards (e.g., F2077, F2267) for mechanical performance (static/dynamic compression, subsidence, expulsion).
Material Specifications: Adherence to defined material standards for Titanium alloy (ISO 5832-3, ASTM F136) and coating properties (e.g., ASTM F1580, F1854).
Cadaveric Demonstration: For usability and functionality, a cadaver study provided empirical evidence.

8. The Sample Size for the Training Set:

This information is not applicable. The device is a physical implant, not an AI model that requires a "training set." The development would involve engineering design, finite element analysis, and physical prototyping, but not a data training set in the AI sense.

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

This information is not applicable, as there is no "training set" in the context of this physical medical device.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three faces in profile, stacked on top of each other. The faces are facing to the right. The image is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it.

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

July 22, 2015

Custom Spine, Incorporated Mr. Mahmoud Abdelgany Chief Executive Officer 9 Campus Drive Parsippany, New Jersey 07054

Re: K143143

Trade/Device Name: PATHWAY ELIF Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: June 15, 2015 Received: June 18, 2015

Dear Mr. Abdelgany:

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 Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Mahmoud Abdelgany

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 vours.

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.

K143143

Page 1 of 1

510(k) Number (if known) K143143

Device Name PATHWAY ELIF

Indications for Use (Describe)

Patients must have undergone a regiment of at least (6) months of non-operative treatment prior to being treated with the PATHWAY ELIF device(s).

The PATHWAY ELIF device can be used in one of two methods:

Transforaminal Lumbar Interbody Fusion (TLIF)

Used as a TLIF, a single device is implanted in the appropriate location to provide support for a transforaminal approached surgery.

Posterior Lumbar Interbody Fusion (PLIF)

Used as a PLIF, two devices are implanted in the appropriate locations to provide support to the spine for a posterior surgery.

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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Section VIII. 510(K) SUMMARY

Name of Firm

Custom Spine, Incorporated 9 Campus Dr. Parsippany, NJ 07054 Phone: (973) 808-0019 Fax: (877) 770-7746

Date Prepared

July 17, 2015

Official Correspondent

Mahmoud Abdelgany Chief Executive Officer 9 Campus Dr. Parsippany, NJ 07054 Phone: (973) 808-0019 Fax: (877) 770-7746 E-mail: mahmoud(@customspine.com

Establishment Number

3005129649

Device Name

Legally Marketed Trade Name: PATHWAY ELIF Common Name: INTERVERTEBRAL BODY FUSION DEVICE Device Classification: Class II Regulation Number: 21 CFR 888.3080 Device Product Codes: MAX

Predicate Devices

Custom Spine PATHWAY (K111774)

Device Description

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Indications for Use

The PATHWAY ELIF device(s) is intended for spinal fusion procedure at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative Disc Diseases (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD mav also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).

The PATHWAY ELIF device is intended to be used with supplemental spinal fixation systems that have been cleared for lumbosacral spine (i.e. posterior pedicle screws and rod systems, anterior plate systems, and anterior screw and rod systems. The device(s) is intended to be used with autogenous bone graft.

Patients must have undergone a regiment of at least (6) months of non-operative treatment prior to being treated with the PATHWAY ELIF device(s).

The PATHWAY ELIF device can be used in one of two methods:

Transforaminal Lumbar Interbody Fusion (TLIF) Used as a TLIF, a single device is implanted in the appropriate location to provide support for a transforaminal approached surgery.

Posterior Lumbar Interbody Fusion (PLIF)

Used as a PLIF, two devices are implanted in the appropriate locations to provide support to the spine for a posterior surgery.

Materials

Materials used in the PATHWAY ELIF device(s) are:

Titanium allov: Ti-6AI-4V ELI according to ISO 5832-3 and ASTM F136. and are coated with ● plasma spray titanium.

Performance Data

Testing was performed in accordance with the following standard(s):

ASTM F2077-11, "Test Methods for Intervertebral Body Fusion Devices" ●
o ASTM F2267-04(2011), "Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression"
. ASTM F04.25.02.02, Draft standard for implant expulsion
o ASTM F1580-07 Standard Specification for Titanium 6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical Implants
o ASTM F1854-09, Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants
o ASTM F1044-05, Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings
. ASTM F1147-05, Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings
ASTM F1160-05, Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic
o ASTM F1978-00, Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the TaberTM Abraser

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Non-Clinical Testing

The PATHWAY ELIF System demonstrated equivalent performance to the predicate through static and dynamic axial compression shear testing per ASTM F2077, subsidence testing per ASTM F2267, and expulsion testing per ASTM Draft F04.25.02.02. In addition, a cadaver study was conducted to demonstrate usability and functionality.

Technological Characteristics

The PATHWAY ELIF System consists of a series of Titanium alloy: Ti-6Al-4V ELI according to ISO 5832-3 and ASTM F136, and are coated with plasma spray titanium. The proposed devices are the same as the current predicate devices already on the market with minor differences in shapes and sizes.

Test data has shown that the proposed devices are equivalent to the predicate devices and the minor differences will not impact the devices safety and effectiveness.

Substantial Equivalence Statement

Documentation is provided to demonstrate that the PATHWAY ELIF System is substantially equivalent to its predicate devices in terms of its material, design, indications for use, and performance characteristics.

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.