The StaXx® XD System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace and restore height of a collapsed, damaged, or unstable vertebral body or portion thereof, due to tumor or trauma (i.e., fracture). The system is to be placed bilaterally and used with autograft or allograft and supplemental spinal fixation. The supplemental fixation system that is intended to be used with the StaXx® XD System is the CapSure® PS Spine System.

Device Description

The StaXx® XD System is composed of wafers that are stacked into an expandable implant to adjust the height of the implant components are manufactured from PEEK-OPTIMA with 6% Barium Sulfate. The system also includes a delivery device to both implant and expand the system.

The purpose of this submission is to gain clearance for the addition of tantalum markers to the implants for added visualization under fluoroscopy.

AI/ML Overview

The provided text describes a 510(k) submission for the Spine Wave StaXx® XD System, a vertebral body replacement device. The assessment of acceptance criteria and device performance is based on mechanical testing rather than a clinical study involving human patients or imaging analysis.

Here's a breakdown of the requested information based on the provided text:

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

Acceptance Criteria	Reported Device Performance
Mechanical Testing:
Dynamic axial compression per ASTM F 2077	Results indicated that all acceptance criteria were met.
Dynamic torsion per ASTM F 2077	Results indicated that all acceptance criteria were met.
Substantial Equivalence to Predicate Device	Demonstrated; minor differences do not raise new questions of safety or effectiveness.

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

The study described is mechanical testing, not a test set involving human data. Therefore:

Sample size: Not applicable in the context of human or imaging data. It would refer to the number of physical devices tested. The specific number of devices tested mechanically is not provided in the text; it only states "mechanical testing" was performed.
Data provenance: Not applicable in the context of human or imaging data. It's mechanical test data from product testing.

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 mechanical testing is established by engineering standards (ASTM F 2077) and the physical properties of the device, not by expert consensus on clinical data.

4. Adjudication method for the test set

Not applicable. This concept applies to the interpretation of clinical or imaging data, not mechanical testing against engineering standards.

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 surgical implant, and the submission is for the addition of tantalum markers for visualization under fluoroscopy, not an AI-powered diagnostic tool. The assessment is purely mechanical.

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 algorithm.

7. The type of ground truth used

For the mechanical testing, the "ground truth" is defined by the acceptance criteria specified in ASTM F 2077 for dynamic axial compression and dynamic torsion, which are established engineering standards for spinal implant testing.

8. The sample size for the training set

Not applicable. There is no training set mentioned or implied as this is not a machine learning or AI-driven device.

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

Not applicable. There is no training set involved. The evaluation of this device is based on compliance with established mechanical testing standards.

Summary

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SPINE WAVE

K1D/288

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510(k) Summary StaXx® XD System

Submitter Information

Spine Wave, Inc. Three Enterprise Drive Suite 210 Shelton, CT 06484 Telephone: 203-712-1839 Telefax: 203-944-9493

Contact: Date Prepared: Roaida Rizkallah May 6, 2010

Device Information

Trade Name:	StaXx® XD System
Common Name:	Vertebral Body Replacement
Classification:	Class II per 21 CFR 888.3060
Classification Name:	Spinal Intervertebral Body Fixation Orthosis
Product Code:	MOP

Device Description

The purpose of this submission is to gain clearance for the addition of tantalum markers to the implants for added visualization under fluoroscopy.

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K101288
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Intended Use

Substantial equivalence

The StaXx® XD System described in this submission is substantially equivalent in terms of design, technological characteristics, and intended use, to the following device:

Predicate Device	Manufacturer	510(k) No.
StaXx® XD System	Spine Wave, Inc.	K090315

The mechanical testing performed on the modified StaXx® XD System included dynamic axial compression and dynamic torsion per ASTM F 2077. Results of mechanical testing indicated that all acceptance criteria were met, demonstrating the StaXx® XD System's substantial equivalence to predicate device. The minor differences between the StaXx® XD System and the predicate device do not raise any new questions of safety or effectiveness. Thus, the StaXx® XD System is substantially equivalent to its predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

Public Health Service

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

Spine Wave, Inc. % Ms. Roaida Rizkallah Three Enterprise Drive, Suite 210 Shelton, Connecticut 06484

Re: K101288

Trade/Device Name: StaXx® XD System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: August 30, 2010 Received: August 31, 2010

Dear Ms. Rizkallah:

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

SEP 1 0 2010

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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/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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Barbara Buelhm

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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510(k) Number (if known): KIDL288

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StaXx® XD System Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

The StaXx® XD System is a vertebral body replacement device intended for use in the thoracolumbar spine (TI-L5) to replace and restore height of a collapsed, damaged, or unstable vertebral body or portion thereof, due to tumor or trauma (i.e., fracture). The system is to be placed bilaterally and used with autograft or allograft and supplemental spinal fixation. The supplemental fixation system that is intended to be used with the StaXx® XD System is the CapSure® PS Spine System.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Division of

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

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KI01288 510(k) Number.

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.