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. The implant components are manufactured from PEEK-OPTIMA with 6% Barium Sulfate and contain tantalum markers for additional visualization under fluoroscopy. The system also includes the Surgical Gun, a delivery device to place and expand the system.

AI/ML Overview

The provided document is a 510(k) summary for the StaXx® XD System, which is a vertebral body replacement device. This summary describes the device and its intended use, but it does not contain information related to software or AI performance, nor does it present "acceptance criteria" or a "study that proves the device meets the acceptance criteria" in the context of device performance metrics often associated with AI/software-based medical devices (e.g., sensitivity, specificity, accuracy).

Instead, the "Performance Data" section (Section 8) indicates that the device's substantial equivalence to a predicate device was demonstrated through:

Dynamic axial compression testing according to ASTM F2077.

This type of testing is a standard mechanical engineering test for spinal implants to assess their structural integrity and performance under simulated physiological loads. Therefore, the "acceptance criteria" and "device performance" would relate to the results of these physical tests, compared against the predicate device or established standards.

Given the nature of the document, the following requested information cannot be fully provided, as it pertains to AI/software performance studies which are not relevant to this submission:

A table of acceptance criteria and the reported device performance: This would be specific to the mechanical testing (e.g., yield strength, stiffness, fatigue life). The document states "Dynamic axial compression testing according to ASTM F2077 was performed to demonstrate that the modified StaXx® XD System is substantially equivalent to the predicate StaXx® XD System." The specific numerical acceptance criteria and reported device performance values from this testing are not included in the provided summary.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as this is a physical device subject to mechanical testing, not a dataset for software evaluation.
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.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for a mechanical device is its physical properties and measured performance against engineering standards.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

In summary, the provided submission is for a physical medical device (vertebral body replacement) and focuses on demonstrating substantial equivalence to a predicate device through mechanical testing, not through AI/software performance evaluation.

Summary

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SPINE WAVE

AUG 2 9 2012

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510(k) Summary StaXx® XD System

1. Submitter Information

Submitter:	Spine Wave, Inc.
Address:	Three Enterprise DriveSuite 210Shelton, CT 06484
Telephone:	203-712-1839
Telefax:	203-944-9493
Contact:	Roaida Rizkallah

Date Prepared: August 16, 2012

2. Device Information

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

3. Purpose of Submission

The purpose of this submission is to gain clearance to expand the StaXx® XD System offering to include additional sizes.

4. Predicate Device Information

The StaXx® XD System described in this submission is substantially equivalent to the following predicate:

Predicate Device	Manufacturer	510(k) No.
StaXx ® XD System	Spine Wave, Inc.	K102682,K111418

Device Description 5.

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6. Intended Use

7. Comparison of Technological Characteristics

The substantial equivalence of the subject StaXx® XD System is shown by similarity in intended use, indications for use, materials and performance to the cited predicate device.

8. Performance Data

Dynamic axial compression testing according to ASTM F2077 was performed to demonstrate that the modified StaXx® XD System is substantially equivalent to the predicate StaXx® XD System.

9. Conclusion

Based on the indications for use, technological characteristics, performance testing and comparison to a predicate, the subject StaXx® XD System has been shown to be substantially equivalent to the predicate device identified in this submission, and does not present any new issues of safety or effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle.

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

Spinewave, Incorporporated % Ms. Roaida Rizkallah Regulatory Affairs Manager Three Enterprise Drive, Suite 210 Shelton, Connecticut 06484

Re: K121889

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 16, 2012 Received: August 17, 2012

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 comply with all the Act's requirements, including, but not limited to: registration and listing (21

AUG 2 9 2012

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Page 2 - Ms. Roaida Rizkallah

CFR Part 807): labeling (21 CFR Part 801): medical device 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,

Mark A. Mellema

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):

Device Name:

StaXx® XD System

Indications for Use:

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)

Carl-Ry

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

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510(k) Number K121889

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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.