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 510(k) summary for the StaXx® XD System does not describe a study involving an AI/Machine Learning device or any software that processes diagnostic images. Instead, it describes a medical implant (vertebral body replacement) and its mechanical performance evaluation.

Therefore, many of the requested points related to acceptance criteria, ground truth, expert review, sample sizes for training/test sets, and MRMC studies, which are standard for AI/ML device descriptions, are not applicable to this submission.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Test	Reported Device Performance/Conclusion
Mechanical Performance	Substantial equivalence in mechanical performance to predicate devices for additional sizes.	Finite Element Analysis (FEA) was performed to demonstrate that the subject StaXx® XD System is substantially equivalent to the listed predicate devices. The submission concludes "does not present any new issues of safety or effectiveness."
Material Composition	Use of specified materials (PEEK-OPTIMA with Barium Sulfate, tantalum markers).	Device is composed of wafers manufactured from PEEK-OPTIMA with 6% Barium Sulfate and contains tantalum markers for visualization. This is consistent with predicate materials.
Intended Use	Consistency with predicate device's intended use.	The intended use for the expanded StaXx® XD System is consistent with the predicate device: vertebral body replacement in the thoracolumbar spine (T1-L5) for tumor or trauma, to be placed bilaterally with autograft/allograft and supplemental fixation.
Design Characteristics	Wafers stacked into an expandable implant for height adjustment.	The system design (stacked wafers for expansion) is consistent with the predicate (K101288, K102682).

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

Not applicable. This is a mechanical device, not an AI/ML diagnostic tool. Performance was demonstrated through Finite Element Analysis (FEA), a computational simulation method, rather than a clinical test set with data provenance in the context of AI/ML.

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 performance from FEA typically involves engineering standards and simulation validity, not expert medical consensus on a diagnostic outcome.

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

Not applicable. This concept applies to human expert review in diagnostic studies, not mechanical testing or FEA.

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/ML device.

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

Not applicable. This is not an AI/ML device.

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

The "ground truth" for the mechanical performance of this device would be based on established engineering principles, material properties, biomechanical standards, and validated simulation models used in Finite Element Analysis. This is not a biological or diagnostic ground truth.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no "training set." Finite Element Analysis involves creating a model and performing simulations, not training on data.

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

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

Summary

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510(k) Summary StaXx® XD System

1. Submitter Information

Submitter:	Spine Wave, Inc.
Address:	Three Enterprise Drive
	Suite 210
	Shelton, CT 06484
Telephone:	203-712-1839
Telefax:	203-944-9493
Contact:	Roaida Rizkallah
Date Prepared:	November 1, 2011

2. Device Information

Trade Name: Common Name: Classification Name: Classification/Code:

StaXx® XD System Vertebral Body Replacement Spinal Intervertebral Body Fixation Orthosis 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 predicates:

Predicate Device	Manufacturer	510(k) No.
StaXx® XD System	Spine Wave, Inc.	K101288
StaXx® XD System	Spine Wave, Inc.	K102682

5. Device Description

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6. Intended 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.

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

Finite Element Analysis was performed to demonstrate that the subject StaXx XD System is substantially equivalent to the listed predicate devices.

9. Conclusion

Based on the indications for use, technological characteristics, performance testing and comparison to predicates, 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

DEC 1 3 2011

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

Re: K111418

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: November 01, 2011 Received: November 02, 2011

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

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Page 2 - Ms. Roaida Rizkallah

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,
Erinl Keith

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): _杉川 418

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)

Rishabh Shah, MD

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

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KI11418 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.