Intervertebral Body Fusion Device: The DiFUSION Technologies XIPHOS Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine, from L2 to Sl, 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 spondylolisthesis. 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.

Vertebral Body Replacement Device: The DiFUSION Technologies XIPHOS System of implants 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. These devices are intended to be used with autograft or allograft bone.

Device Description

The DiFUSION Technologies XIPHOS Interbody Fusion System is comprised of various sizes and configurations to accommodate individual patient anatomy. The configurations are designed to provide the surgeon with different surgical approach options. The XIPHOS System will be offered in two (2) configurations of various sizes. The configurations are designed based on indicated spinal implant level and surgical approach, and consist of: 1) XIPHOS PLIF, posterior lumbar approach and 2) XIPHOS TLIF, transforaminal lumbar approach. The XIPHOS System implants are manufactured from PEEK Zeniva ZA-500 (ASTM F-2026) with Tantalum alloy position markers (ASTM F-560).

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the DiFUSION Technologies XIPHOS Interbody Fusion System. It details the device description, indications for use, and a summary of technological characteristics, primarily focusing on non-clinical mechanical testing to demonstrate substantial equivalence to predicate devices.

However, the document does not describe acceptance criteria for an AI-powered device, nor does it detail a study involving human readers, ground truth establishment by experts, or any AI-specific performance metrics.

Therefore, I cannot provide the requested information about acceptance criteria and the study that proves an AI device meets acceptance criteria based on this document. The document describes a medical device (interbody fusion system), not an AI device.

If you intended to ask about the acceptance criteria and study for the medical device itself, I can extract information related to its mechanical testing.

Based on the provided document, here is what can be inferred about the medical device's performance criteria and evaluation:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" with numerical targets in a table format. Instead, it refers to demonstrating "substantially equivalent results" to predicate devices based on non-clinical mechanical testing standards. The reported performance is that the XIPHOS System meets these standards and shows similar characteristics to predicate devices.

Acceptance Criteria Category (Implied by testing)	Reference Standard / Basis	Reported Device Performance
Static and Dynamic Compression	ASTM F2077-03	Substantially equivalent to predicate devices
Static and Dynamic Compression-Shear	ASTM F2077-03	Substantially equivalent to predicate devices
Subsidence	ASTM F2267-04	Substantially equivalent to predicate devices
Expulsion	ASTM Draft Standard F-04.25.02.02	Substantially equivalent to predicate devices
Wear Debris Characterization	ASTM F1877	Studied (implies compliance with standard for characterization)
Material Equivalence	PEEK Zeniva ZA-500 (ASTM F-2026), Tantalum alloy (ASTM F-560)	Same material as predicate devices with similar characteristics
Intended Use	Predicate devices	Same intended use as predicate devices

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

Sample Size: The document does not specify the sample size (number of devices/implants) used for the non-clinical mechanical tests. These tests typically involve a defined number of samples to ensure statistical validity, but the exact count is not disclosed here.
Data Provenance: The tests are "non-clinical tests" conducted on the device components themselves, following ASTM standards. This implies laboratory testing rather than data from human or animal subjects. There is no country of origin for "data" in the sense of patient data, as this is a physical device test.

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

This question is not applicable to the type of premarket notification and testing described. "Ground truth" established by experts typically refers to clinical data interpretation or pathological findings for diagnostic/AI devices. For a physical interbody fusion system, performance is assessed through standardized mechanical tests, not expert consensus on diagnostic images or clinical outcomes.

4. Adjudication Method for the Test Set

Not applicable. As the "test set" refers to mechanical testing of physical implants, there is no adjudication method involving expert review as understood in clinical studies. Test results are compared against standard specifications or predicate device performance.

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 document is for a medical implant (DiFUSION Technologies XIPHOS Interbody Fusion System), not an AI device or a diagnostic tool that involves human readers. Therefore, an MRMC study related to AI assistance would not be part of this submission.

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

Not applicable. This relates to AI algorithms, which are not the subject of this document.

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

Not applicable in the context of clinical ground truth. For the mechanical testing, the "ground truth" or reference for performance is defined by the technical specifications within the ASTM standards (e.g., F2077-03, F2267-04, F1877) and the performance characteristics of legally marketed predicate devices. The goal is to demonstrate equivalence, not to achieve a "diagnosis" or "outcome" based on typical ground truth definitions.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI device where machine learning models are trained.

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

Not applicable. Same reason as above.

Summary

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DiFUSION Technologies XIPHOS Interbody Fusion System

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Premarket Notification

SUBMITTED BY	DIFUSION Technologies701 Brazos Street, Suite 500Austin, TX 78701
ESTABLISHMENTREGISTRATION NUMBER	Pending
OWNER/OPERATORNUMBER	PendingOCT 1 2010
CONTACT PERSON	PrimaryJami HafizDirector of DevelopmentPhone: 612-804-4180Fax: 512-628-3084
SUBMISSION PREPARED BY	Lisa PetersonQA Consulting, Inc.Phone: 512-507-0746
DATE PREPARED	January 6, 2010
CLASSIFICATION NAME	Intervertebral Fusion Device with Bone Graft, LumbarSpinal Intervertebral Body Fixation Orthosis
DEVICE CLASS	Class II
REGULATION NUMBER	888.3080 (Product Code: MAX)888.3060 (Product Code: MQP)
COMMON NAME	Intervertebral Body Fusion Device (MAX)Spinal Vertebral Body Replacement Device (MQP)
PROPRIETARY NAME	DIFUSION Technologies XIPHOS Interbody Fusion System
IDENTIFICATION OF PREDICATEDEVICE(S)	Predicate devices include several recently down classifiedcages, as well as various cleared VBR systems:- LT-CAGE® Peek Lumbar Tapered Fusion Device (P970015,Medtronic Sofamor Danek, Approved 9/10/03)- BAK® Cage (P950002, Zimmer Spine, Approved 7/8/03)- RAY® Threaded Fusion Cage (P950019, Stryker, Approved9/4/03)- Lumbar I/F Cage (P960025, DePuy, Approved 3/4/05)- MC+ Partial VBR (K043479, LDR Spine, Cleared 6/30/05)

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DEVICE DESCRIPTION

The XIPHOS System will be offered in two (2) configurations of various sizes. The configurations are designed based on indicated spinal implant level and surgical approach, and consist of: 1) XIPHOS PLIF, posterior lumbar approach and 2) XIPHOS TLIF, transforaminal lumbar approach.

INDICATIONS

Intervertebral Body Fusion Device:

The DiFUSION Technologies XIPHOS Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine, from L2 to Sl, 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 spondylolisthesis. 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.

Vertebral Body Replacement Device:

The DiFUSION Technologies XIPHOS System of implants 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. These devices are intended to be used with autograft bone.

SUMMARY OF TECHNOLOGICAL CHARACTERISTICS

The purpose of this submission is to obtain clearance to market the XIPHOS System. The XIPHOS System implants are manufactured from PEEK Zeniva ZA-500 (ASTM F-2026) with Tantalum allov position markers (ASTM F-560). The subject XIPHOS device has similar technological characteristics as the predicate devices identified above. Specifically, the following characteristics support this conclusion:

Intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis.
Substantially equivalent results of non-clinical testing relative to static and dynamic testing . (per ASTM F2077-03), subsidence (per ASTM F2267-04), and expulsion (per ASTM Draft Standard F-04.25.02.02)

DISCUSSION OF NON-CLINICAL TESTING

The following non-clinical tests were conducted:

Static and dynamic compression testing, conducted in accordance with ASTM F2077-03 י
Static and dynamic compression-shear testing, conducted in accordance with ASTM F2077-. 03
Subsidence testing, conducted in accordance with ASTM F2267-04 -
Expulsion testing, conducted in accordance with ASTM Draft Standard F-04.25.02.02
Wear Debris Characterization, conducted in accordance to ASTM F1877 .

CONCLUSIONS

The subject and predicate device(s) share the same intended use, primary implant design and equivalent material of manufacture. The non-clinical mechanical test results demonstrate that any minor differences do not impact device performance as compared to the predicates and demonstrate that the XIPHOS System is substantially equivalent to the predicate device.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all caps and appears to be in a sans-serif font.

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

2010 DCI 1

DiFusion Technologies % Jami Hafiz Director of Development 701 Brazos Street, Suite 500 Austin, Texas 78701

Re: K100042

Trade/Device Name: DiFusion Technologies XIPHOS Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, MOP Dated: September 03, 2010 Received: September 07, 2010

Dear Jami Hafiz:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substanțially 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

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Page 2 - Jami Hafiz

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 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 go to http://www.fda.gov/AboutfDA/CentersOffices/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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Mark N. Melkerson

Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known):

K/00047

Device Name:

DiFUSION Technologies XIPHOS Interbody Fusion System

Indications for Use:

Intervertebral Body Fusion Device:

The DiFUSION Technologies XIPHOS Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine, from L2 to SI, 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 spondylolisthesis. 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.

Vertebral Body Replacement Device:

The DiFUSION Technologies XIPHOS System of implants 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. These devices are intended to be used with autograft or allograft bone.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

·· Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Surgical. Orthopedic, and Restorative Devices

K100042 510(k) Number_

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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.