The Irix-A Lumbar Integrated Fusion System is a stand-alone intervertebral body fusion device intended for use in patients with degenerative disc disease (DDD) at one (1) or two (2) contiguous levels of the lumbosacral spine (L2-S1 inclusive). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and at least six (6) months of non-operative treatment. In addition, these patients may have had a previous non-fusion spinal surgery at the involved level(s) and may have had up to a Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Irix-A System is intended to be used with autogenous bone graft material, and is to be used with three titanium alloy bone screws included as part of the system.

Device Description

The Irix-A Lumbar Integrated Fusion System is a stand-alone intervertebral fusion device to restore biomechanical height and act as an aid in fusion of the lumbar spine in anterior discectomy procedures. The device is generally box-shaped with teeth on the superior and inferior faces of the drix-A implant is manufactured from both titanium alloy (Ti6Al4V) in accordance with ASTM F136 and Invibio PEEK-Optima LT1 in accordance with ASTM F2026, or from Ti6AMV titanium alloy alone. The device will be supplied with the option of having the superior and inferior surfaces of the device plasma coated with medical-grade commercially pure titanium (CP Ti) per ASTM F1580. The device is secured in location through the use of bone screws, also manufactured from titanium alloy (Ti6Al4V) per ASTM F136. The devices are provided in various sizes and screws are offered in multiple lengths to adjust for variations in patient anatomy.

The CP-Ti coated devices will be sterile packed with the balance of system components being provided clean and non-sterile. The non-sterile components are to be sterilized by a healthcare professional using a steam autoclave in accordance with the instructions for use provided by X-spine Systems Inc., as well as the instructions provided by the manufacturer of the autoclave.

AI/ML Overview

The information provided describes the Irix-A™ Lumbar Integrated Fusion System, which is an intervertebral body fusion device, not a device that relies on AI algorithms or machine learning. Therefore, many of the requested categories related to acceptance criteria for AI/ML performance, such as sample sizes for test/training sets, ground truth establishment by experts, adjudication methods, and MRMC studies, are not applicable.

The acceptance criteria and supporting study for this device are based on mechanical performance testing to demonstrate substantial equivalence to existing predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Standard	Acceptance Criteria	Reported Device Performance
Mechanical Performance	ASTM F2077	Must meet the requirements for intervertebral body fusion devices, including static and dynamic compression, and static and dynamic compression-shear.	"Substantially equivalent to predicate device performance and is capable of performing in accordance with its intended use." (Specific quantitative values not provided in summary).
	ASTM F2267	Must meet the standard for measuring load-induced subsidence of an intervertebral body fusion device under static axial compression.	"Substantially equivalent to predicate device performance and is capable of performing in accordance with its intended use." (Specific quantitative values not provided in summary).
	Expulsion Testing	There is no cited standard, but the device must demonstrate acceptable resistance to expulsion.	Performed as part of the submission, and results contributed to the overall finding of substantial equivalence. (Specific quantitative values not provided in summary).
Material Qualification	FDA Guidance & ASTM F1580	For plasma coating (CP-Ti), full material performance qualification and characterization.	Performed, and results contributed to the overall finding of substantial equivalence. (Specific details not provided in summary).
	Wear Debris Analysis	For plasma coating, wear debris particulate analysis from dynamic compression-shear testing.	Performed, and results contributed to the overall finding of substantial equivalence. (Specific details not provided in summary).

2. Sample size used for the test set and the data provenance
This is a medical device (spinal implant) and not an AI/ML device relying on a test set of data in the common sense. The "test set" refers to the physical devices and materials tested. The summary does not specify the exact number of units or samples tested for each mechanical test, but implies sufficient testing was conducted to meet the ASTM standards and satisfy FDA requirements for substantial equivalence.
Data provenance: The testing was conducted by X-spine Systems, Inc. in Miamisburg, OH, USA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The "ground truth" for this type of device is established by meeting engineering and mechanical standards, not by expert consensus on data interpretation. Performance is objectively measured against specified limits in the ASTM standards.

4. Adjudication method for the test set
Not applicable. Mechanical testing results are objective measurements against pre-defined engineering standards, not subjective interpretations requiring adjudication.

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 not an AI/ML device, and thus no MRMC study involving human readers and AI assistance was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical spinal implant, not an algorithm.

7. The type of ground truth used
The "ground truth" in this context is based on established engineering principles, materials science, and biomechanical performance standards (e.g., ASTM F2077, ASTM F2267). The device's performance is objectively measured against the requirements of these standards and compared to the performance of predicate devices.

8. The sample size for the training set
Not applicable. This is not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established
Not applicable.

Summary

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K133947 Page 1 of 2

510(k) Summary

JUL 2 9 2014

ADMINISTRATIVE INFORMATION

Manufacturer Name:	X-spine Systems, Inc.452 Alexandersville Rd.Miamisburg, OH 45342
	Telephone (937) 847-8400FAX (937) 847-8410
Official Contact:	David Kirschman, M.D.Chief Medical Officer
Date Prepared:	July 29, 2014
DEVICE NAME
Trade/Proprietary Name:	Irix-A™ Lumbar Integrated Fusion System
Classification Name:	Intervertebral Fusion Device with Integrated Fixation, Lumbar
Regulation Description:	Intervertebral body fusion device
Device Class:	Class II
Product Code:	OVD
Regulation Number:	§888.3080

ESTABLISHMENT REGISTRATION NUMBER

The X-spine Systems, Inc. establishment registration number is 3005031160. The owner/operator number for X-spine Systems, Inc. is 9063903.

INDICATIONS FOR USE

The Irix-A Lumbar Integrated Fusion System is a stand-alone intervertebral body fusion device intended for use in patients with degenerative disc disease (DDD) at one (1) contiguous levels of the lumbosacral spine (L2-S1 inclusive). DDD is defined as back pain of discogenic origin 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 had a previous non-fusion spinal surgery at the involved level(s) and may have had up to a Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Irix-A System is intended to be used with autogenous bone graft material, and is to be used with three titanium alloy screws included as part of the system.

DEVICE DESCRIPTION

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medical-grade commercially pure titanium (CP Ti) per ASTM F1580. The device is secured in location through the use of bone screws, also manufactured from titanium alloy (Ti6Al4V) per ASTM F136. The devices are provided in various sizes and screws are offered in multiple lengths to adjust for variations in patient anatomy.

PREDICATE DEVICES

Surgicraft Limited STALIF-TT Intervertebral Body Fusion System (K073109) .
Globus Medical, Inc. INDEPENDENCE Spacer (K082252) .
Spinal Elements, Inc. LUCENT OR LUCENT MAGNUM (K110632) .

EQUIVALENCE TO MARKETED PRODUCT

X-spine Systems, Inc. has submitted information to demonstrate that, for the purposes of FDA's regulation of medical devices, the Irix-A Lumbar Integrated Fusion System is substantially equivalent to predicate devices based on a comparison including the following characteristics:

. FDA Product Code
. Indications for Use
Surgical Approach .

Anatomical Region ●
. Implant Materials
Product Dimensions .
Mechanical Performance .

PERFORMANCE DATA

The implant components were tested using the following standards:

ASTM F2077 – Test Methods for Intervertebral Body Fusion Devices

Static and dynamic compression ●
Static and dynamic compression-shear .

ASTM F2267 – Standard Test Method for Measuring Load Induced Subsidence of an Intervertebral Body Fusion Device under Static Axial Compression

In addition to the above standard testing, expulsion testing was performed as part of this submission. There is no cited standard for this test.

For validation of the plasma coating, a full material performance qualification and characterization was performed per published FDA guidance, as well as wear debris particulate analysis from dynamic compression-shear testing.

In summary, the mechanical testing results indicate that the Irix-A Lumbar Integrated Fusion System is substantially equivalent to predicate device performance and is capable of performing in accordance with its intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

July 29, 2014

X-spine Systems. Incorporated David Kirschman, M.D. Chief Medical Officer 452 Alexandersville Road Miamisburg, Ohio 45342

Re: K133947

Trade/Device Name: Irix-ATM Lumbar Integrated Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: July 3. 2014 Received: July 3. 2014

Dear Dr. Kirschman:

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

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Page 2 - David Kirschman, M.D.

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/Safetv/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.

Ronald P. Jean -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

510(k) Number (if known) K133947

Device Name

Irix-ATM Lumbar Integrated Fusion System

Indications for Use (Describe)

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)

Katherine D. Kavlock, PhD

Division of Orthopedic Devices

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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.