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 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 autograft and/or allograft comprised of cancellous bone graft material, and is to be used with three titanium alloy screws included as part of the system.

Hyperlordotic implants >20° are intended for use with supplemental fixation (e.g. facet screws or posterior fixation).

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 boxed shaped with teeth on the superior and inferior faces of the device. The IRIX-A™ implant is manufactured from both titanium alloy (Ti6AI4V) in accordance with ASTM F136 and Invibio PEEK Optima LT1 in accordance with ASTM F2026, or from Ti6Al4V 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 spacers of the IRIX-A™ System are supplied clean and STERILE. The screws and accompanying instruments of the IRIX™-A System are provided clean and non-sterile.

The system does not contain software/firmware or electrical equipment.

AI/ML Overview

The provided document is a 510(k) Pre-market Notification from the FDA for a medical device called the IRIX-A™ Lumbar Integrated Fusion System. This submission focuses on establishing substantial equivalence to existing predicate devices, rather than a clinical study evaluating the device's diagnostic performance against specific acceptance criteria for AI/software-based devices. Therefore, much of the requested information regarding acceptance criteria for device performance in a clinical context, sample sizes for test and training sets, expert qualifications, and ground truth establishment, is not applicable or not present in this type of regulatory document.

However, I can extract information related to the performance data provided within this 510(k) summary for non-clinical testing.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (from testing standards)	Reported Device Performance
ASTM F2077: Static and dynamic compression testing (specific values not provided in this document)	Meets or exceeds the performance of the predicate device.
ASTM F2267: Subsidence (specific values not provided in this document)	Meets or exceeds the performance of the predicate device.
Expulsion as recommended by FDA (specific methodology/values not provided in this document)	Meets or exceeds the performance of the predicate device.

Note: The document states the device "meets or exceeds the performance of the predicate device" for these tests, implying that the acceptance criteria are based on the performance of the predicate device as established through the same ASTM standards and FDA recommendations.

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

Test set sample size: Not applicable. This document describes non-clinical mechanical testing, not a clinical study involving a test set of data.
Data provenance: Not applicable. The testing is described as "Nonclinical testing" and performed on the device itself.

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

Not applicable. Ground truth for clinical data is not relevant to this non-clinical mechanical testing.

4. Adjudication method for the test set:

Not applicable.

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/software-based diagnostic device, nor a comparative effectiveness study involving human readers.

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

Not applicable. This is not an algorithm-only device.

7. The type of ground truth used:

For the non-clinical performance data: The "ground truth" or reference for performance is the established performance characteristics of the predicate device under the specified ASTM standards and FDA recommendations for static and dynamic compression, subsidence, and expulsion.

8. The sample size for the training set:

Not applicable. This product does not involve machine learning or a "training set."

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

Not applicable.

Summary based on the provided document:

The IRIX-A™ Lumbar Integrated Fusion System is a physical medical device (intervertebral body fusion device), not an AI/software-based diagnostic tool. The regulatory submission (510(k)) aims to demonstrate substantial equivalence to legally marketed predicate devices. This is achieved through non-clinical performance testing (mechanical/physical tests) rather than clinical studies involving patient data and diagnostic performance metrics like sensitivity, specificity, or reader studies.

The performance data supplied focuses on:

ASTM F2077: Static and dynamic compression testing
ASTM F2267: Subsidence
Expulsion testing as recommended by FDA

The conclusion is that the subject device "meets or exceeds the performance of the predicate device" for these tests, indicating that its mechanical integrity and function are comparable or superior, and it "does not introduce any new risks." The predicate device itself acts as the benchmark for establishing acceptable performance under these tests.

Summary

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Public Health Service

Image /page/0/Picture/12 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus-like symbol with three human profiles facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

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

August 28, 2017

X-Spine Systems, Inc. Charlene Brumbaugh Regulatory Affairs Manager 452 Alexanderville Rd. Miamisburg, Ohio 45342

Re: K171567

Trade/Device Name: IRIX-A™ Lumbar Integrated Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD Dated: May 26, 2017 Received: May 30, 2017

Dear Ms. Brumbaugh:

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

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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/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,

Katherine D. Kavlock -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

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

510(k) Number (if known) K171567

Device Name

IRIX-ATM Lumbar Integrated Fusion System

Indications for Use (Describe)

Hyperlordotic implants >20° are intended for use with supplemental fixation (e.g. facet screws or posterior fixation).

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)
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CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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510(K) SUMMARY

IRIX-A™ Lumbar Integrated Fusion System

I.	SUBMITTER/MANUFACTURER:	X-spine Systems, Inc.452 Alexandersville Rd.Miamisburg, OH 45342
		Telephone (937) 847-8400FAX (937) 847-8410
		Establishment Registration Number: 3005031160
	Official Contact:	Charlene BrumbaughRegulatory Affairs ManagerEmail: cbrumbaugh@X-spine.comTelephone (937) 847-8400, ext. 2192
II.	DATE PREPARED:	August 28, 2017
III.	OWNER/OPERATOR:	Xtant Medical Inc.604 Cruiser LaneBelgrade, MT 59714
	Owner/Operator Number:	10028385
	Official Correspondent:	Stephen Smith, Vice PresidentRegulatory Assurance/ Quality AssuranceXtant Medical, Inc.Telephone (406) 388-0480
IV.	DEVICE
	Trade/Proprietary Name:Device Common Name:Regulation Number:Product Code:	IRIX-A™ Lumbar Integrated Fusion SystemIntervertebral Body Fusion Device21 CFR §888.3080OVD -- Intervertebral Fusion Device withIntegrated Fixation, Lumbar[disc spacer, holds bone graft]
	Regulatory Class:Review Panel:	Class IIOrthopedic

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K171567 Page 2 of 3

V. PURPOSE OF THE SUBMISSION

The purpose for this submission is to add hyperlordotic angle options and to expand the Indications for Use to include the use of allograft comprised of cancellous and/or corticancellous bone graft material.

VI. PREDICATE DEVICES

Primary: X-spine, Inc.: IRIX-A™ Lumbar Integrated Fusion System - K133947
Additional: Globus Medical, Inc.: INDEPENDENCE® Spacers -- K152022

VII. REFERENCE DEVICES

· NuVasive, BASE Interfixated Titanium System (K170592)
· Synthes, T-PAL Spacer System (K162358)
SeaSpine, Vu A Pod™ Prime NanoMetalene® Intervertebral Body Fusion Device (K162351)

VIII. 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) 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 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 autograft and/or allograft comprised of cancellous and/or corticancellous bone graft material, and is to be used with three titanium alloy screws included as part of the system.

Hyperlordotic implants >20° are intended for use with supplemental fixation (e.g. facet screws or posterior fixation).

DEVICE DESCRIPTION IX.

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The system does not contain software/firmware or electrical equipment.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES X.

The technological principle for both the subject and primary predicate device is fixation in the lumbar spine for skeletally mature patients with degenerative disc disease.

As was established in this submission, the subject device, IRIX-A™ Lumbar Integrated Fusion System, is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent and have the same technological characteristics to its predicate devices through comparison in areas including design, intended use, material composition, and function.

XI. PERFORMANCE DATA

Nonclinical testing was performed to demonstrate that the subject IRIX-A™ Lumbar Integrated Fusion System is substantially equivalent to its primary predicate device. The following testing was performed:

ASTM F2077: Static and dynamic compression testing
ASTM F 2267: Subsidence ●
. Expulsion as recommended by FDA

The results of these studies show that the subject device meets or exceeds the performance of the predicate device and does not introduce any new risks; therefore, the system is substantially equivalent to the predicate device.

XII. CONCLUSION

The subject device, IRIX-A™ Lumbar Integrated Fusion System, has been modified to expand the Indications for Use and to expand the implant offerings to include three additional lordotic angles. Based on the indications for use, technological characteristics, performance testing, and comparison to predicate and reference devices, the subject IRIX-A™ Lumbar Integrated Fusion System has been shown to be substantially equivalent to legally marketed 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.