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.

The StaXx® XDL 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 used with autograft or allograft and supplemental spinal fixation.

The StaXx® IB System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The StaXx® IB System is to be used with autogenous bone graft and with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device.

The StaXx® IBL System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-L5. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The StaXx® IBL System is to be used with autogenous bone graft and with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device.

Device Description

The StaXx® Systems are composed of expandable implants and interlocking wafers, which are implanted through a delivery system that includes a Cartridge and a Surgical Gun. The Cartridge is inserted into the Surgical Gun which, when activated, sequentially delivers locking wafers from the Cartridge to the expandable implant. The wafers are designed to be inserted incrementally to form a stack and therefore attain the desired height.

The StaXx® XD and XDL Systems are vertebral body replacement devices intended for use in the thoracolumbar spine (TI-L5). They are composed of wafers that are stacked into an expandable implant 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 implant components are manufactured from PEEK-OPTIMA with 6% Barium Sulfate and contain tantalum markets for additional visualization under fluoroscopy. The StaXx® XD System is to be placed bilaterally while the StaXx® XDL System is to be placed unilaterally and both are to be 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.

The StaXx® IB and IBL Systems are intervertebral body fusion devices composed of wafers that are stacked into an expandable implant to adjust the height of the implant. The implants are to be used with autogenous bone graft material. The StaXx® IB implant components are manufactured from both PEEK-OPTIMA and PEEK-OPTIMA with 6% Barium Sulfate while the StaXx® IBL implant components are manufactured from PEEK-OPTIMA with 6% Barium Sulfate and tantalum markers.

AI/ML Overview

The provided text is a 510(k) Summary for the StaXx® System, specifically focusing on clearance for a new Surgical Gun. This type of submission is for medical devices and primarily demonstrates substantial equivalence to existing predicate devices, rather than establishing de novo performance criteria against a set of acceptance criteria in the way AI/software devices often do.

Therefore, the document does not contain the specific information requested about acceptance criteria and a study proving a device meets those criteria in the context of an AI/software evaluation.

Here's a breakdown of why this information is not present and what is included instead:

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

Not present. This document discusses "Performance Data" in section 8, stating that "non-clinical tests were performed to demonstrate that the subject StaXx® Systems are substantially equivalent to the listed predicate devices." However, it does not provide a table of acceptance criteria or specific reported performance metrics. Substantial equivalence in this context means proving the new device is as safe and effective as a legally marketed predicate device, not necessarily meeting a predefined numerical performance target.

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

Not present. The document mentions "Simulated Use Testing," "Insertion Testing," and "Cadaveric Testing" but does not detail sample sizes for these tests or data provenance. These are physical and mechanical tests demonstrating the device's functionality and safety, not statistical performance studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not present. This is not relevant for the type of device (spinal fusion system and surgical gun) and the type of submission (510(k) for substantial equivalence). Ground truth establishment by experts is typically relevant for diagnostic or AI-powered devices where human expert interpretation is the standard for comparison.

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

Not present. See point 3.

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 present. This is specific to AI-assisted diagnostic or interpretation devices and is not applicable to a spinal fusion system and surgical gun.

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

Not present. See point 5.

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

Not present. See point 3.

8. The sample size for the training set:

Not present. Training sets are relevant for AI/machine learning models. This document describes a physical medical device.

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

Not present. See point 8.

In summary, the provided document is a regulatory submission demonstrating substantial equivalence for a physical medical device (spinal fusion system and surgical gun) based on mechanical and functional testing, not a detailed performance study for an AI/software device against specific acceptance criteria.

Summary

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DEC 0 6 2013

SpineWAVE

510(k) Summary StaXx® System

1. Submitter Information

Submitter: Address:

Spine Wave, Inc. Three Enterprise Drive Suite 210 Shelton, CT 06484 Telephone: 203-712-1847 203-944-9493 Telefax:

Contact:

Joseph Mercado

Date Prepared: December 3, 2013

1. Device Information Trade Name:
  StaXx® System

Fusion Device

Common Name(s):

Classification Name(s):

Spinal Intervertebral Body Fixation Orthosis; Intervertebral Fusion Device with Bone Graft, Lumbar

Vertebral Body Replacement; Intervertebral Body

Classification(s)/Code(s):

Class II per 21 CFR 888.3060/MQP; Class II (special controls) per 21 CFR 888.3080/MAX

3. Purpose of Submission

The purpose of this submission is to gain clearance for a new Surgical Gun to be used with the StaXx® Systems.

4. Predicate Device Information

The StaXx® Systems described in this submission are substantially equivalent to the following predicates:

Predicate Device	Manufacturer	Most recent510(k) No.
StaXx® XD System	Spine Wave, Inc.	K121889
StaXx® XDL System	Spine Wave, Inc.	K102315
StaXx® IB System	Spine Wave, Inc.	K123461
StaXx® IBL System	Spine Wave, Inc.	K132719

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5. Device Description

6. Intended Use

The StaXx® Systems have the following indications:

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 allografi 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.

The StaXx® XDL 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 used with autograft or allograft and supplemental spinal fixation.

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7. Comparison of Technological Characteristics

The substantial equivalence of the StaXx® Systems to the predicates is shown by similarity in intended use, indications for use, materials and performance.

8. Performance Data

The following non-clinical tests were performed to demonstrate that the subject StaXx® Systems are substantially equivalent to the listed predicate devices:

Simulated Use Testing .
. Insertion Testing
. Cadaveric Testing

9. Conclusion

Based on the indications for use, technological characteristics and comparison to the predicates, the subject StaXx® Systems have been shown to be substantially equivalent to the predicate devices identified in this submission, and do not present any new issues of safety or effectiveness.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

December 6, 2013

Spine Wave, Incorporated Mr. Joseph Mercado Regulatory Affairs Specialist 3 Enterprise Drive, Suite 210 Shelton, Connecticut 06484

Re: K133207

Trade/Device Name: StaXx * Surgical Gun Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MOP, MAX Dated: November 5. 2013 Received: November 6, 2013

Dear Mr. Mercado:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH docs 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 cither 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 - Mr. Joseph Mercado

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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,

Lori A. Wiqqins

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K133207

Device Name StaXx(R) Surgical Gun

Indications for Use (Describe)

The StaXx® Systems have the following indications:

The StaXx® XD System is a vertebral body replacement device intended for use in the thoracolumbar spine (TI-LS) to replace and restore height of a collapsed, 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 fixation. The supplemental fixation system that is intended to be used with the StaXx® XD System is the CapSure® PS Spine System:

The StaXx® XDL System is a vertebral body replacement device in the thoracolumbar spine (TI-LS) to replace and restore height of a collapsed, damaged, or unstable vertebral body or portion thereof. due to turnor or trauma (i.e., fracture), The system is to be used with autograft or allograft and supplemental spinal fixation.

The StaXx® IB System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The StaXx® IB System is to be used with and with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral body fusion device.

The StaXx® IBL System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-L5. Degenerative disc discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The StaXx® IBL System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral body fusion device.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

	----------------	Company Concessful Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Ch	ANNO FOR A LA B
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Concurrence of t	Center for I	*or Devices and Radiological Health (CDRH) i

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

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.