STGC-Lordotic is indicated for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e. fracture). STGC-Lordotic is intended to be used with autograft in combination with supplemental fixation indicated for use in the thoracolumbar spine.

Device Description

STGC-Lordotic is a vertebral body replacement device manufactured from titanium allov (Ti-6Al-4V), and is available in a variety of sizes to suit the individual anatomic and clinical circumstances of each patient. STGC-Lordotic is a single-piece device manufactured using electrical discharge machining, having a trapezoidal cross section with a hollow interior to accommodate the placement of autograft or allograft bone. Intended for placement via an anterior approach, STGC-Lordotic is to be used in combination with supplemental fixation indicated for use in the thoracolumbar spine. STGC-Lordotic is provided with 8.2° to 11.5° of endplate angulation (lordosis). STGC-Lordotic is provided non-sterile to the end user.

AI/ML Overview

This document describes a 510(k) premarket notification for the STGC-Lordotic device, a vertebral body replacement. The focus is on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria in a clinical setting. Therefore, many of the requested details about acceptance criteria, study design, and ground truth are not directly available from this document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of explicit acceptance criteria or detailed performance metrics against those criteria. Instead, it states that "performance testing to demonstrate substantial equivalence included methods described in the standards ASTM F2077 Test Methods for Intervertebral Body Fusion Devices (static compression, dynamic compression, static torsion, dynamic torsion) and ASTM F2267 Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression (subsidence). Static expulsion testing also was performed."

The conclusion is that "The performance data included in this submission demonstrate substantial equivalence to the predicate device K121176 and K003043." This implies that the device performed comparably to, or within acceptable ranges of, the predicate devices for these mechanical tests. Specific numerical performance values or defined acceptance thresholds are not presented in this document.

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

This document describes non-clinical performance testing (mechanical testing), not a clinical study involving human patients or data. Therefore:

Sample size for test set: Not applicable in the context of human data. For mechanical testing, the sample size would refer to the number of device units tested, which is not specified in this summary.
Data provenance: Not applicable in the context of human data. The data originates from laboratory mechanical testing.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable as no clinical study involving human assessment of ground truth is described. The "ground truth" here is the physical performance of the device against established mechanical standards.

4. Adjudication Method

This is not applicable as no clinical study with human readers/assessors or their adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not done or reported in this document. The device is a physical implant, not an AI-assisted diagnostic tool.

6. Standalone Performance Study

Yes, a form of standalone performance was done in the sense of non-clinical bench testing of the device's mechanical properties (static compression, dynamic compression, torsion, subsidence, expulsion). This testing was against recognized ASTM standards. However, this is "algorithm only" performance, given the device is mechanical.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical performance evaluation was the established mechanical testing standards (ASTM F2077 and ASTM F2267) and the performance of the predicate devices. The device's performance was compared against these standards and the known performance of the predicate devices to establish substantial equivalence.

8. Sample Size for the Training Set

This is not applicable. The device is a physical implant assessed through mechanical testing; there is no "training set" in the context of an algorithm or AI.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the reasons stated above.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of three human profiles facing right, arranged in a way that they appear to be interconnected. The profiles are black and are set against a white background. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.

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

January 23, 2015

Cardinal Spine, LLC % Kevin Thomas, Ph.D. Vice President and Director of Regulatory Affairs PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130

Re: K142030

Trade/Device Name: STGC-Lordotic Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: December 22, 2014 Received: December 23, 2014

Dear Dr. Thomas:

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 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 - Kevin Thomas, Ph.D.

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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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 vours.

Mark N. Melkerson -S

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

Enclosure

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Indications for Use

510(k) Number (if known) K142030

Device Name STGC-Lordotic

Indications for Use (Describe)

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

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary Cardinal Spine, LLC STGC-Lordotic K142030

December 22, 2014

ADMINISTRATIVE INFORMATION

Manufacturer Name	Cardinal Spine, LLC12307 Old LaGrange Road, Suite 105Louisville, KY 40245
Telephone:	+1 (502) 777-4788
Fax:	+1 (502) 245-5768
Official Contact	Natasha LonnonVice President

Representative/Consultant Kevin A. Thomas, PhD Floyd G. Larson PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, CA 92130 Telephone: +1 (858) 792-1235 +1 (858) 792-1236 Fax: Email: kthomas@paxmed.com flarson@paxmed.com

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name:	STGC-Lordotic
Common Name:	Vertebral body replacement device
Classification Name:	Spinal Intervertebral Body Fixation Orthosis
Classification Regulations:Product Code:	21 CFR 888.3060, Class IIMQP
Classification PanelReviewing Branch	Orthopedic and Rehabilitation Devices PanelAnterior Spine Devices Branch (ASDB)

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INDICATIONS FOR USE

STGC-Lordotic is indicated for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e. fracture). STGC-Lordotic is intended to be used with autograft or allograft in combination with supplemental fixation indicated for use in the thoracolumbar spine.

DEVICE DESCRIPTION

PERFORMANCE DATA

Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence included: performance testing, engineering analysis and dimensional analysis. Performance testing to demonstrate substantial equivalence included methods described in the standards ASTM F2077 Test Methods for Intervertebral Body Fusion Devices (static compression, dynamic compression, static torsion, dynamic torsion) and ASTM F2267 Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression (subsidence). Static expulsion testing also was performed. The performance data included in this submission demonstrate substantial equivalence to the predicate device K121176 and K003043.

Clinical data were not submitted in this premarket notification.

EQUIVALENCE TO MARKETED DEVICE

Cardinal Spine, LLC has submitted information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, STGC-Lordotic is substantially equivalent in indications and design principles to the following legally marketed predicate devices:

STGC, Cardinal Spine LLC, K121176,

MaxFuse VBR System. Pioneer Surgical Technology, Inc., K131724, and

Surgical Titanium Mesh System, DePuy AcroMed, K003043.

The primary predicate device is K121176.

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The intended use, design, materials, and functional characteristics of the STGC-Lordotic and the predicate device STGC are substantially the same. The subject device and the predicate device STGC encompass a similar range of physical dimensions, and have similar design characteristics. The subject device and the predicate device MaxFuse VBR System also encompass a similar range of physical dimensions including the lordosis intrinsic to the devices. Any differences in the technological characteristics between the subject and predicate devices do not raise different questions of safety or effectiveness.

The subject and predicate devices all are intended to be used to provide support after resection or removal of a damaged, collapsed, or unstable vertebral body due to tumor, fracture, or other disease. The subject device and predicate devices are placed within the area of removed or resected spine and are functionally complemental internal fixation. The subject device and the predicate devices are intended to be used with bone graft.

CONCLUSION

The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.

Overall, STGC-Lordotic has the following similarities to the predicate devices:

has the same intended use, ●
uses the same operating principle,
incorporates the same basic design,
incorporates the same or very similar materials, and ●
is to be sterilized using the same processes. ●

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.