The Irix-C Cervical Integrated Fusion System is a stand-alone cervical fusion device intended for spinal fusion procedures at one level (C2 – T1 inclusive) in skeletally mature patients for treatment of degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radies).

Implants are to be implanted via an open, anterior approach and packed with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft.

Patients should receive at least six (6) weeks of non-operative treatment with a cervical intervertebral fusion device.

Device Description

The Irix-C Cervical Integrated Fusion System is a stand-alone intervertebral fusion device designed to restore biomechanical height and act as an aid in fusion of the cervical spine in anterior discectomy procedures. The device is generally boxed shaped with teeth on the superior and inferior faces of the device. The Irix-C implant will be manufactured in either a composite construction of 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 intervertebral fusion device is intended to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. The device is then secured in location through the use of bone screws, also manufactured from titanium alloy (Ti6AI4V) per ASTM F136.

The devices are available in various sizes, and screws are offered in multiple lengths to adjust for variations in patient anatomy. The single-use implants are provided clean and non-sterile. These devices are intended 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.

A series of manual surgical instruments, provided clean and non-sterile, intended to assist with the insertion and placement of the implants, is included in an instrument tray, which is used for instrument sterilization and storage.

The system does not contain software/firmware.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "Irix-C Cervical Integrated Fusion System." It is a submission to the FDA seeking clearance to market the device.

Based on the provided text, the device is an intervertebral body fusion device intended for spinal fusion procedures. It is classified as a Class II device with product code OVE.

Crucially, this document states: "No substantial technological changes were made to the existing Irix-C System, nor were any new components added to the Irix-C System. The only change is the expanded Indications for Use. Therefore, no additional testing was required or performed."

This means there is NO EVIDENCE OF A STUDY to prove the device meets acceptance criteria related to its performance for this particular 510(k) submission. Instead, the submission relies on the substantial equivalence principle, arguing that the device is equivalent to previously cleared predicate devices for its expanded indications for use.

Therefore, I cannot provide a table of acceptance criteria or details of a study proving the device meets those criteria, as no such study is described in this document for the current submission.

However, I can extract the proposed Indications for Use (the acceptance criteria in terms of clinical application) for the device and clarify why no performance study was conducted.

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

As stated above, this 510(k) submission did not involve new performance testing. The "acceptance criteria" for this submission are essentially the expanded "Indications for Use," which are compared to predicate devices for substantial equivalence, rather than being demonstrated through new performance data.

Acceptance Criteria (Expanded Indications for Use)	Reported Device Performance (as demonstrated by substantial equivalence)
Intended Use: Stand-alone cervical fusion device for spinal fusion.	Substantially equivalent to predicate devices (K131951, K161280, and other reference devices).
Level: One level (C2 – T1 inclusive)	Substantially equivalent to predicate devices for cervical levels, with an expansion from C3-T1 to C2-T1 deemed non-unique based on other cleared devices.
Patient Population: Skeletally mature patients.	Substantially equivalent to predicate devices.
Condition: Treatment of degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).	Substantially equivalent to predicate devices.
Implantation Method: Open, anterior approach.	Substantially equivalent to predicate devices.
Graft Material: Packed with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft.	This is the primary expansion of the indication from the previous clearance, which presumably only included autograft. The inclusion of allograft is deemed substantially equivalent based on predicate devices from Orthofix and other reference devices that already have this indication.
Pre-operative Treatment: Patients should receive at least six (6) weeks of non-operative treatment with a cervical intervertebral fusion device prior to treatment.	Substantially equivalent to predicate devices.

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

Not applicable. No new performance study (test set) was conducted for this 510(k) submission.

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 new performance study requiring expert ground truth establishment was conducted.

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

Not applicable. No new performance study requiring adjudication was conducted.

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 device is a physical implant, not an AI/software device. The submission explicitly states "The system does not contain software/firmware."

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

Not applicable. This device is a physical implant, not an AI/software device.

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

Not applicable. No new performance study requiring ground truth was conducted. The ground for substantial equivalence is based on comparisons of design, materials, and established indications for use of predicate devices.

8. The sample size for the training set

Not applicable. No new performance study (training set) was conducted as there is no algorithm or AI component.

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

Not applicable. No new performance study (training set) was conducted.

Summary of the document's approach:

The manufacturer, X-Spine Systems, Inc., submitted a 510(k) for their Irix-C Cervical Integrated Fusion System. The core of this submission is substantial equivalence to existing predicate devices. They are seeking to expand the device's "Indications for Use" to include:

The use of allograft (in addition to autograft) as bone graft material.
An expanded anatomical region for use, specifically including level C2 (whereas the previous clearance was for C3-T1 inclusive).

The document explicitly states that no new performance data or testing was required or performed because "No substantial technological changes were made to the existing Irix-C System, nor were any new components added to the Irix-C System. The only change is the expanded Indications for Use."

They argue that the expanded indications are not "unique" and are already covered by other legally marketed devices, thus demonstrating substantial equivalence.

Summary

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

November 7, 2016

X-Spine Systems, Inc. Kriss Anderson Director, Regulatory Affairs 452 Alexandersville Rd. Miamisburg, Ohio 45342

Re: K162944

Trade/Device Name: Irix-C Cervical Integrated Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE Dated: October 20, 2016 Received: October 24, 2016

Dear Kriss Anderson:

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 (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.

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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,

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.

K162944

Page 1 of 1

510(k) Number (if known)

K162944

Device Name

Irix-C Cervical Integrated Fusion System

Indications for Use (Describe)

Implants are to be implanted via an open, anterior approach and packed with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft.

Patients should receive at least six (6) weeks of non-operative treatment with a cervical intervertebral fusion device.

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 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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"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

Irix-C Cervical Integrated Fusion System November 2, 2016

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:	Mr. Kriss AndersonDirector, Regulatory AffairsEmail: kanderson@X-spine.comTelephone (937) 847-8400, ext. 2137
II.	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
III.	DEVICE
	Trade/Proprietary Name:	Irix-C Cervical Integrated Fusion System
	Device Common Name:	Intervertebral Body Fusion Device
	Regulation Number:	21 CFR §888.3080
	Product Code:	OVE -- Intervertebral body fusion device

Class II

Orthopedic

Regulatory Class:

Review Panel:

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IV. PREDICATE DEVICES

Primary: X-spine, Inc.: Irix-C Cervical Integrated Fusion System (K131951) ● o This predicate has not been subject to a design related recall.
. Additional: Orthofix, Inc.: Cervical Stand Alone System (K161280)
- o This predicate has not been subject to a design related recall.

V. REFERENCE DEVICES

The following devices have been 510k cleared with these same or similar technological elements: Indications for Use including autograft and/or allograft, anatomical region of one level (C2—T1 inclusive), OVE product code, and implant materials of PEEK and/or Titanium Alloy:

o Globus Medical: COALITION Spacer (K151939)
O Spinal Elements: Vertu/Vertu TI Bond (K153352)
Pioneer Surgical Unison (RTI Surgical) (K152793) O
Choice Spine: TomCat (K152515) O
o LDR Spine: ROI-C (K151934)
Centinel Spine: STALIF C/STALIF C-Ti (K150053) O

INDICATIONS FOR USE VI.

The Irix-C Cervical Integrated Fusion System is a stand-alone cervical intervertebral fusion device intended for spinal fusion procedures at one level (C2 – T1 inclusive) in skeletally mature patients for treatment of degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).

Implants are to be implanted via an open, anterior approach and packed with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft.

Patients should receive at least six (6) weeks of non-operative treatment prior to treatment with a cervical intervertebral fusion device.

VII. DEVICE DESCRIPTION

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surfaces of the device plasma coated with medical-grade commercially pure titanium (CP Ti) per ASTM F1580.

The system does not contain software/firmware.

VIII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES

The technological principle for both the subject and primary predicate device is anterior fixation at one level in the cervical spine for skeletally mature patients with degenerative disc disease.

The subject device, Irix-C Cervical Integrated Fusion System, and the primary predicate device, Irix-C Cervical Integrated Fusion System (K131951) are based on the following technological elements:

O Same FDA Product Code: OVE -- Intervertebral Body Fusion Device.
Same implant materials: PEEK/Titanium Alloy or All Titanium Alloy. O
O Equivalent Indications for Use
Identical multiple lengths, widths, and heights to account for variations in O patient anatomy.
o Equivalent anatomical region.
Same surgical approach. o
o No change to device specifications; therefore mechanical tests were not repeated.

The purpose of this 510(k) submission is to expand the Indications for Use to allow the Irix-C Interbody device to be used with allograft comprised of cancellous and/or corticocancellous bone graft, and to update the fusion level.

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The predicate Irix-C System is already cleared to be used with autogenous bone graft [autograft], and the predicate Irix-C System is intended to be used for procedures at one level (C3-T1 inclusive). The proposed indication for the Irix-C System is to include the use of allograft for procedures at one level (C2-T1 inclusive). With the exception of the proposed expanded indication adding the inclusion of allograft, and the slight change in vertebrae level, there has been no change to the subject device.

The additional predicate device, Orthofix Cervical Stand Alone System (K161280), is equivalent to the subject device in the following technological elements:

Same FDA Product Code: OVE -- Intervertebral Body Fusion Device. O
Equivalent implant materials: PEEK/Titanium Alloy. O
Equivalent Indications for Use only difference is the added indication of O allograft comprised of cancellous and/or corticocancellous bone graft and the anatomical region: C2-T1 inclusive instead of C3-T1 inclusive.
Equivalent multiple lengths, widths, and heights to account for variations in o patient anatomy.
Same surgical approach. O

Reference Devices:

In addition to the additional predicate device, Orthofix, numerous other 510k cleared devices have the same or similar technological elements:

Same FDA Product Code: OVE -- Intervertebral Body Fusion Device. O
Same implant materials: PEEK and/or Titanium Alloy. O
o Same Indications for Use –Autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft
Same anatomical region: C2 -- T1 inclusive o

For the years 2016 and 2015, there are at least six 510(k) summaries that include those same or similar technological elements stated above:

Globus Medical: COALITION Spacer (K151939) O
O Spinal Elements: Vertu/Vertu TI Bond (K153352)
O Pioneer Surgical Unison (RTI Surgical) (K152793)
Choice Spine: TomCat (K152515) O
LDR Spine: ROI-C (K151934) O
Centinel Spine: STALIF C/STALIF C-Ti (K150053) o

Therefore, the expansion of the Irix-C Indication for Use to include allograft at one level from C2 to T1 inclusive is not unique, and substantial equivalency of the use of both autograft and allograft at one level (C2 to T1 inclusive) is demonstrated.

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IX. PERFORMANCE DATA

No substantial technological changes were made to the existing Irix-C System, nor were any new components added to the Irix-C System. The only change is the expanded Indications for Use. Therefore, no additional testing was required or performed.

X. CONCLUSION

The subject device Irix-C Cervical Integrated Fusion System has been modified to expand the indications to use, and the 510k demonstrates substantial equivalence 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.