The GSO GS1 Spacer is intended for use in the thoracolumbar spine (i.e., T1 - L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The GS1 Spine Spacer System is also indicated for treating fractures of the thoracic and lumbar spine. The GS1 Spacer is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period of time. Supplemental internal fixation is required to properly utilize this system.

Device Description

The GSO GS1 Spacer is a slightly curved, hollow spacer with pyramidal teeth on the superior and inferior ends to resist expulsion. The device contains openings to allow the surgeon to pack the device with bone graft (autograft or allograft) prior to insertion. Openings in the anterior-posterior direction permit bone growth through the device. The GSO GS1 Spacer is intended for use with supplemental internal fixation.

The GSO GS1 Spacer is fabricated from medical grade titanium alloy.

AI/ML Overview

Here's an analysis of the GSO GS1 Spacer's acceptance criteria and the study that proves it meets those criteria, based on the provided text:

Important Note: The provided document is a 510(k) summary for a medical device (spinal spacer), not a research paper on an AI/machine learning device. Therefore, many of the requested categories like "Adjudication method," "MRMC comparative effectiveness study," "Training set sample size," and "Ground truth for training set" are not applicable. The device is a physical implant, and its "performance" is assessed through biomechanical testing, not diagnostic accuracy.

Acceptance Criteria and Reported Device Performance for GSO GS1 Spacer

Category	Acceptance Criteria	Reported Device Performance
Mechanical Performance	Meets or exceeds the performance requirements published for the ROI Spacer.	The GSO GS1 Spacer meets its functional requirements (based on static axial compression, dynamic compression, static torsion, dynamic torsion, and expulsion testing).
Substantial Equivalence (Design)	Similar design to predicate devices (Radiotransparent Open Implant (ROI) LDR Spine USA (K043349) and CAS Spine Spacer System - EBI, L.P. (K042268)).	The GSO GS1 Spacer has a similar design to the predicate CAS Spine Spacer System devices.
Substantial Equivalence (Sizes)	Offered in similar sizes to predicate devices.	The GSO GS1 Spacer is offered in similar sizes to the predicate CAS Spine Spacer System devices.
Substantial Equivalence (Material)	Manufactured from the same material as predicate devices.	The GSO GS1 Spacer is fabricated from medical grade titanium alloy, the same material as the predicate CAS Spine Spacer System devices.
Substantial Equivalence (Indications for Use)	Has the same indications for use as predicate devices.	The GSO GS1 Spacer has the same indications for use as the predicate CAS Spine Spacer System devices. Its intended use includes partial replacement in the thoracolumbar spine (T1 - L5) for tumors or fractures, to achieve anterior decompression, restore height, and restore biomechanical integrity with supplemental internal fixation.
Safety and Efficacy Differences	No significant differences that could affect safety or efficacy.	There are no significant differences between the GSO GS1 Spacer and the predicate devices that could affect the safety or efficacy of the device.

Study Details

Sample Size Used for the Test Set and the Data Provenance:
- Sample Size: Not explicitly stated as a "sample size" in the context of human data. For mechanical testing, the number of units tested for each type of test (static axial compression, dynamic compression, static torsion, dynamic torsion, and expulsion) is not provided.
- Data Provenance: The testing was non-clinical mechanical testing, performed in a lab setting to established ASTM standards. No geographical or retrospective/prospective human data provenance is applicable.
Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- Not applicable. The ground truth for this device (a physical implant) is based on engineering and material science principles, and adherence to established mechanical testing standards (ASTM F2077). Expert medical opinion would be involved in defining the clinical context and predicate devices, but not in establishing "ground truth" for the mechanical performance of the test set in the way it's understood for diagnostic AI.
Adjudication Method for the Test Set:
- Not applicable. This is not an AI/diagnostic study requiring adjudication of interpretations. The "adjudication" would be based on whether the physical device passed the mechanical tests according to predefined thresholds.
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, an MRMC study was not done. This type of study is relevant for evaluating the impact of an AI system on human reader performance for diagnostic tasks, which is not applicable to a physical spinal implant.
If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Not applicable. There is no algorithm or AI component to this device. The "standalone" performance refers to the device's mechanical integrity as measured by physical tests.
The Type of Ground Truth Used:
- Ground Truth: Mechanical performance standards (e.g., ASTM F2077) and the established performance of legally marketed predicate devices (ROI Spacer and CAS Spine Spacer System). The "ground truth" is that the device must withstand certain forces and loads as defined by these standards and comparative data.
The Sample Size for the Training Set:
- Not applicable. This is not an AI/machine learning device that requires a training set.
How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set for this physical medical device.

Summary

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3. 510(K) SUMMARY
1. Applicant/Sponsor:	Gold Standard Orthopaedics, LLC.1226 Rowan St.Louisville, KY 40203	AUG 2 4 200
2. Contact Person:	David BaughmanPresidentDavid06@Baughmangroup.comPhone (502) 581-8770
3. Proprietary Name:	GSO GS1 Spacer
4. Common Name:	Vertebral Body Replacement
5. Classification Name:	Spinal Intervertebral Body Fixation Orthosis(21 CFR 888.3060)

1. Legally Marketed Devices to which Substantial Equivalence is claimed:
- Radiotransparent Open Implant (ROI) LDR Spine USA (K043349) .
- . CAS Spine Spacer System - EBI, L.P. (K042268)
1. Device Description:

The GSO GS1 Spacer is fabricated from medical grade titanium alloy.

8. Intended Use:

The GSO GS1 Spacer is intended for use in the thoracolumbar spine (i.e., T1 - L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of turnors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The GS1 Spine Spacer System is also indicated for treating fractures of the thoracic and lumbar spine. The GST Spine Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period of time. Supplemental internal fixation is required to properly utilize this system.

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KU71274

1. Summary of Technologies/Substantial Equivalence:
  The GSO GS1 Spacer has a similar design, is offered in similar sizes, is manufactured from the same material and has the same indications for use as the predicate CAS Spine Spacer System devices. Mechanical testing demonstrates that the GSO GS1 Spacer meets or exceeds the performance requirements published for the ROI Spacer. There are no significant differences between the GSO GS1 Spacer and the predicate devices that could affect the safety or efficacy of the device.
1. Non-Clinical Testing:
  Mechanical testing included static axial compression, dynamic compression, static torsion, dynamic torsion, and expulsion testing. Where applicable, this testing conformed to ASTM F2077. These tests demonstrate that the GS1 Spacer meets its functional requirements and is substantially equivalent to one of the predicate devices.

11. Clinical Testing:

Clinical testing was not necessary to demonstrate substantial equivalence between the GSO GS1 Spacer and the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Gold Standards Orthopaedics, LLC % Mr. David Baughman President 1226 Rowan St. Louisville, Kentucky 40203

AUG 2 4 2007

Re: K071274

Trade/Device Name: GSO GS1 Spacer Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: July 10, 2007 Received: July 12, 2007

Dear Mr. Baughman:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 - Mr. David Baughman

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Mcdical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 3 –

cc: HFZ-401 DMC HFZ-404 510(k) Staff HFZ- Division D.O.

OC Numbers:

Division of Enforcement A	240-276-0115
Dental, ENT and Ophthalmic Devices Branch	240-276-0115
OB/GYN, Gastro. & Urology Devices Branch	240-276-0115
General Hospital Devices Branch	240-276-0115
General Surgery Devices Branch	240-276-0115
Division of Enforcement B	240-276-0120
Cardiovascular & Neurological Devices Branch	240-276-0120
Orthopedic, Physical Medicine & Anesthesiology Devices andRadiological Devices	240-276-0120

Last Updated: Brandi Stuart – 7/9/07

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6071274

INDICATIONS FOR USE 2.

510(k) Number (if known): N/A (unknown)

Device Name: GSO GS1 Spacer

Indications for Use:

The GSO GS1 Spacer is intended for use in the thoracolumbar spine (i.e., TI - L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The GS1 Spine Spacer System is also indicated for treating fractures of the thoracic and lumbar spine. The GS1 Spacer is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period of time. Supplemental internal fixation is required to properly utilize this system.

Prescription Use __ X (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of _1

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Division Sign-Off

Division of General, Restorative, and Neurological Devices

510(k) Number K071274

Regulation Number and Section

N/A