When used as an intervertebral body fusion device, the DiFUSION Technologies XIPHOS Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondvlolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

When used as a vertebral body replacement device, the DiFUSION Technologies XIPHOS System is indicated for use to replace a vertebral body that has been resected or excised (i.e. partial or total vertebrectomy) due to tumor or trauma/fracture. The XIPHOS System is intended for use in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental fixation. These devices are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. The DiFUSION Technologies XIPHOS System is intended to be used with autograft or allograft bone.

Device Description

The XIPHOSTM ALIF is a lumbar PEEK interbody fusion device. These implants can be described as an oval structural column having a central strut. The superior and inferior surfaces are open with parallel serrations. The implants are available in an assortment of height, depth, width and anteroposterior angulation combinations to accommodate a variety of anatomic requirements.

AI/ML Overview

The provided text is a 510(k) Summary for a medical device called XIPHOSTM ALIF, an intervertebral body fusion and vertebral body replacement device. It details the device's description, intended use, materials, and a declaration of substantial equivalence to predicate devices based on mechanical performance.

Here's an analysis of the acceptance criteria and study information based on the provided document:

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

Acceptance Criteria (Standard)	Reported Device Performance
Static and Dynamic Compression (ASTM F2077)	Met, demonstrates substantial equivalence to predicate devices.
Static and Dynamic Torsion (ASTM F2077)	Met, demonstrates substantial equivalence to predicate devices.
Subsidence Properties (ASTM F2267)	Met, demonstrates substantial equivalence to predicate devices.

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

The document mentions "Mechanical testing of the worst case XIPHOS™ ALIF." However, it does not specify the sample size used for these mechanical tests. The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective/prospective, but it's generated internally by the manufacturer for regulatory 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)

This product is a physical medical device (spinal implant), not an AI/software device that requires human expert interpretation for "ground truth" establishment in a test set. The "ground truth" for its performance is its physical and mechanical properties, assessed through standardized ASTM tests. Therefore, these sections are not applicable in their usual sense for this type of device.

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

Not applicable. As noted above, this is a physical device being evaluated by mechanical testing against established ASTM standards, not an AI/software requiring human adjudication of results.

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-assisted diagnostic or imaging interpretation device.

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

Not applicable. This is not an AI/software device with an algorithm.

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

The "ground truth" for this device's performance is derived from established mechanical testing standards (ASTM F2077 and ASTM F2267) and the comparison of its properties to predicate devices that have already been cleared by the FDA. The performance is assessed against these known standards and characteristics of existing safe and effective devices.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/machine learning model that requires a training set.

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

Not applicable. As established above, there is no "training set" for this type of medical device submission.

Summary

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FEB 0 7 2013

Section 8 - 510(k) Summary

・

Date:	21 December 2012
Sponsor:	DiFusion Technologies111 Cooperative WayGeorgetown, TX 78626Phone: 512-863-7777Facsimile: 512-628-3084
Contact Person:	Jami Hafiz, Ph.D., Vice-President Development
Trade Names:	XIPHOSTM ALIF
Device Classification	Class II
Classification Name:	Spinal vertebral body replacement device; Intervertebral fusiondevice with bone graft, lumbar
Regulation:	888.3060; 888.3080
Device ProductCode:	MQP; MAX
Device Description:	The XIPHOSTM ALIF is a lumbar PEEK interbody fusion device.These implants can be described as an oval structural column havinga central strut. The superior and inferior surfaces are open withparallel serrations. The implants are available in an assortment ofheight, depth, width and anteroposterior angulation combinations toaccommodate a variety of anatomic requirements.
Intended Use:	When used as an intervertebral body fusion device, the DiFUSIONTechnologies XIPHOS Interbody Fusion System is indicated forintervertebral body fusion of the lumbar spine, from L2 to SI, inskeletally mature patients who have had six months of non-operativetreatment. The device is intended for use at either one level or twocontiguous levels for the treatment of degenerative disc disease(DDD) with up to Grade I spondylolisthesis. DDD is defined as backpain of discogenic origin with degeneration of the disc confirmed byhistory and radiographic studies. The device system is designed foruse with supplemental fixation and with autograft to facilitate fusion.
	When used as a vertebral body replacement device, the DiFUSIONTechnologies XIPHOS System is indicated for use to replace avertebral body that has been resected or excised (i.e. partial or totalvertebrectomy) due to tumor or trauma/fracture. The XIPHOSSystem is intended for use in the thoracolumbar spine (from T1 toL5) and is intended for use with supplemental fixation. These devicesare designed to restore the biomechanical integrity of the anterior,middle and posterior spinal column even in the absence of fusion fora prolonged period. The DiFUSION Technologies XIPHOS System isintended to be used with autograft or allograft bone.
Materials:	The XIPHOSTM ALIF is manufactured from polyetheretherketone(PEEK) per ASTM F2026 (VESTAKEEP® i4 R, Evonik PolymersTechnologies GmbH). Integral marker pins are manufactured fromtantalum according to ASTM F560.

and the comments of the comments of

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Predicate Devices:

Performance Data:

Technological Characteristics:

Conclusion:

DiFusion Technologies (K100042) Eminent Spine LLC (K090064) Theken Spine (K080822)

Mechanical testing of the worst case XIPHOS™ ALIF was performed according to ASTM F2077 and included static and dynamic compression and static and dynamic torsion. The subsidence properties were evaluated according to ASTM F2267.

The mechanical test results demonstrate that the XIPHOS™ ALIF device performance is substantially equivalent to the predicate devices.

The XIPHOS™ ALIF device possesses the same technological characteristics as the predicate devices. These include:

. performance (as described above),
. basic design (hollow structural frame),
material (PEEK polymer and tantalum), and .
sizes (widths, lengths and heights are within the range(s) . offered by the predicate).

Therefore the fundamental scientific technology of the XIPHOS™ ALIF device is the same as previously cleared devices.

The XIPHOS™ ALIF devices possess the same intended use and technological characteristics as the predicate devices. Therefore the XIPHOS™ ALIF is substantially equivalent for its intended use. ·

Page 16

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Image /page/2/Picture/0 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its wings and tail. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES .

Public Health Service

Letter dated: February 7, 2013

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

Difusion Technologies % Backroads Consulting, Inc. Karen E. Warden, PhD PO BOX 566 Chesterland, Ohio 44026

Re: K123969

Trade/Device Name: XIPHOS™ ALIF Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, MQP Dated: December 21, 2012 Received: December 26, 2012

Dear Dr. Warden:

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

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Page 2 - Karen E. Warden. PhD

forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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,

Mark N. Melkerson

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 7 - Indications for Use Statement

510(k) Number:_K123969

Device Name: XIPHOS™ ALIF

Indications for Use:

OR Prescription Use _ X Over-the-Counter Use_ (Per 21 CFR 801.109)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Stephanie Bechtold -S 2013.02.07 -02.00 37 -05'00'

(Division Sign-Off) Division of Orthopedic Devices 510 (k) Number: K123969

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.