The GSO GS1 Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. It is intended to be used as a temporary construct that assists normal healing and is not intended to replace normal body structures. The GSO GS1 Spinal System should be removed after fusion.

As a pedicle screw system, the GSO GS1 Spinal System is intended for patients: (a) having severe spondylolisthesis (Grade 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); (c) who are receiving fusions using autogenous bone graft only; and (d) who are having the device removed after the development of a solid fusion mass.

In addition, when used as a pedicle screw system, the GSO GS1 Spinal System is indicated for the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

When used as a posterior, non-cervical, non-pedicle screw and/or hook fixation system, the GSO GS1 Spinal System is indicated for:

Degenerative disc disease (as defined by chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
Idiopathic scoliosis
Kyphotic deformities of the spine
Paralytic scoliosis and/or pelvis obliquity
Vertebral fracture or dislocation
Neuromuscular scoliosis associated with pelvic obliquity
Vertebral fracture or dislocation
Tumors
Spondylolisthesis
Stenosis
Pseudarthrosis
Unsuccessful previous attempts at spinal fusion

For posterior, non-pedicle, screw use, the GSO GS1 screws are intended for sacral/iliac attachment only and the GSO GS1 hooks and crosslinks are intended for thoracic and/or lumbar use only.

In all cases, instrumentation must be at least 1 cm from any major vessel.

Device Description

The GSO GS1 Spinal System consists of rods, screws, hooks, and adjustable crosslink that can be locked rigidly into various configurations to build a spinal construct specific to the needs of each individual patient. The implants are a vophed to the spine posteriorly by means of screws and/or hooks joined with rods. Crosslink components are used to attach two rods in parallel. The GSO GS1 Spinal System can be installed with any suitable instrumentation.

The GSO GS1 Spinal System components are manufactured from CP Titanium conforming to ASTM F67 and Ti-6A1-4V Titanium alloy conforming to ASTM F136. Devices are available in various diameters, lengths and sizes.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the GSO GS1 Spinal System:

This document is a 510(k) summary for a spinal implant system, and as such, it focuses on demonstrating substantial equivalence to already legally marketed devices, rather than establishing de novo performance criteria through extensive clinical trials for new medical devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria (from predicate devices)	Reported Device Performance (GSO GS1 Spinal System)
Mechanical Performance	Failure loads meet or exceed those of the predicate devices (CD Horizon Spinal System and Synergy Spinal System). (Implicit, as "substantial equivalence" means performing at least as well as the predicates).	Failure loads for the GSO GS1 Spinal System are greater than published failure loads for the Synergy Spinal System (one of the predicate devices).
Indications for Use (Pedicle Screw System)	Same as predicate devices:	The GSO GS1 Spinal System has the same indications as both predicate devices (CD Horizon and Synergy) when used as a pedicle screw system.
	- Severe spondylolisthesis (Grade 3 and 4) of L5-S1 vertebral joint
	- Fixed or attached to lumbar and sacral spine (L3 and below)
	- Fusions using autogenous bone graft only
	- Device removed after solid fusion mass
	- Treatment of acute/chronic instabilities/deformities of thoracic, lumbar, sacral spine: degenerative spondylolisthesis with neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, failed previous fusion (pseudarthrosis).
Indications for Use (Posterior, non-cervical, non-pedicle screw and/or hook fixation system)	Same as predicate device (Synergy Spinal System):	The GSO GS1 Spinal System has the same indications as the Synergy Spinal System. (Implied, as Synergy is the relevant predicate for this usage).
	- Degenerative disc disease
	- Idiopathic scoliosis
	- Kyphotic deformities of the spine
	- Paralytic scoliosis and/or pelvis obliquity
	- Vertebral fracture or dislocation (listed twice)
	- Neuromuscular scoliosis associated with pelvic obliquity
	- Tumors
	- Spondylolisthesis
	- Stenosis
	- Pseudarthrosis
	- Unsuccessful previous attempts at spinal fusion
Material Composition	Made from CP Titanium conforming to ASTM F67 and Ti-6A1-4V Titanium alloy conforming to ASTM F136. (This is a characteristic, not a performance criterion for substantial equivalence, but it's part of the substantial equivalence claim, implicitly matching or being equivalent to predicate materials).	GSO GS1 Spinal System components are manufactured from CP Titanium conforming to ASTM F67 and Ti-6A1-4V Titanium alloy conforming to ASTM F136 (stated explicitly as a characteristic of the device). The predicates are "manufactured from the same materials."
Design	Similar design to predicate devices. (This is a characteristic, not a performance criterion, but a requirement for substantial equivalence).	The GSO GS1 Spinal System has a "similar design" to the predicate devices.

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

Test Set: The primary "test set" for this submission was the mechanical testing of the GSO GS1 Spinal System components. The document does not specify a numerical sample size for the mechanical tests (e.g., number of rods, screws tested), but it states that testing was "conducted according to ASTM I-1717." ASTM standards typically specify sample size requirements for such tests.
Data Provenance: The mechanical testing data was generated prospectively by Gold Standard Orthopaedics, LLC. The location of the testing is not specified, but it would have been conducted in a qualified lab for such ASTM standards. There is no mention of "country of origin of data" in the context of clinical data for this 510(k).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Not applicable. This submission relies on non-clinical mechanical testing and comparison to predicate device characteristics/indications. It does not involve human interpretation of medical images or clinical outcomes that would require "experts to establish ground truth" in the way a diagnostic AI device would. The "ground truth" for mechanical testing is derived from the established ASTM standard and the measured failure loads compared to published data from predicate devices.

4. Adjudication Method for the Test Set

Not applicable. As above, this is a mechanical testing and substantial equivalence submission, not a study requiring adjudication of expert opinions on clinical cases.

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

No, an MRMC comparative effectiveness study was not done. This 510(k) is for a spinal implant, which is a physical medical device, not an AI-powered diagnostic tool. Clinical testing (including MRMC studies) was explicitly stated as "not necessary to demonstrate the substantial equivalence of the GSO GS1 Spinal System to the predicate devices."

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

Not applicable. This is a spinal implant, not an algorithm or AI device.

7. The Type of Ground Truth Used

For mechanical performance: The "ground truth" was established by standardized mechanical testing (ASTM I-1717), which measures physical properties like failure loads. The acceptance criterion was based on the "published failure loads" of predicate devices, essentially using their established performance as a benchmark.
For indications for use, materials, and design: The "ground truth" for substantial equivalence was the characteristics and indications of the legally marketed predicate devices (CD Horizon Spinal System Medtronic Sofamor Danek, Inc. (K031833) and Synergy Spinal System Interpore Cross International (K010515)).

8. The Sample Size for the Training Set

Not applicable. This submission is for a physical medical device, not a machine learning or AI algorithm. Therefore, there is no "training set" in the context of AI development.

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

Not applicable. (See point 8).

Summary

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K070966

510(K) SUMMARY

1.	Applicant/Sponsor:	Gold Standard Orthopaedics, LLC.1226 Rowan St.Louisville, KY 40203
2.	Contact Person:	David Baughman, PresidentDavid06@Baughmangroup.comPhone (502) 581-8770
3.	Proprietary Name:	GSO GS1 Spinal System
4.	Common Name:	Spinal Implants
5.	Classification Names:	Pedicle screw spinal system, 21 CFR 888.3070Spinal interlaminal fixation orthosis, 21 CFR 888.3050

Product Codes: MNI, KWP, MNH

Legally Marketed Devices to which Substantial Equivalence is claimed: 6.
- CD Horizon Spinal System Medtronic Sofamor Danek, Inc. (K031833) .
- Synergy Spinal System Interpore Cross International (K010515) .

7. Device Description:

1. Intended Use:
  The GSO GS1 Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. It is intended to be used as a temporary construct that assists normal healing and is not intended to replace normal body structures. The GSO GS1 Spinal System should be removed after fusion.

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K070966

As a pedicle screw system, the GSO GS1 Spinal System is intended for patients: (a) having severe spondylolisthesis (Grade 3 and 4) of the fifth lumbar-first sacral (1.5-S1) vertebral joint; (b) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); (c) who are receiving fusions using autogenous bone graft only; and (d) who are having the device removed after the development of a solid fusion mass.

When used as a posterior, non-cervical, non-pedicle screw and/or hook fixation system, the GSO GS1 Spinal System is indicated for:

1. Degenerative disc disease (as defined by chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
1. Idiopathic scollosis
Kyphotic deformities of the spine 3.
1. Paralytic scoliosis and/or pelvis obliquity
1. Vertebral fracture or dislocation
1. Neuromuscular scoliosis associated with pelvic obliquity
1. Vertebral fracture or dislocation
1. Tumors
1. Spondylolisthesis
1. Stenosis
1. Pseudarthrosis
1. Unsuccessful previous attempts at spinal fusion

For posterior, non-pedicle, screw use, the GSO GS1 screws are intended for sacral/illac attachment only and the GSO GS1 hooks and crosslinks are intended for thoracic and/or lumbar use only.

In all cases, instrumentation must be at least 1 cm from any major vessel.

9. Summary of Technologies/Substantial Equivalence:

The GSO GS1 Spinal System has a similar design and is manufactured from the same materials as the CD Horizon Spinal System - Medtronic Sofamor Danek, Inc. (K031833) and the Synergy Spinal System – Interpore Cross International (K010515). When used as a pedicle screw system, the GSO GS1 Spinal System has the same indications as both of the predicate devices. When used as a posterior, non-

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K676966

cervical, non-pedicle screw and/or hook fixation system the GSO GS1 Spinal System has the same indications as the Synergy Spinal System.

10. Non-Clinical Testing:

Mechanical testing conducted according to ASTM I-1717 demonstrates that the failure loads for the GSO GS1 Spinal System are greater than published failure loads for the Synergy Spinal System.

1. Clinical Testing:
  Clinical testing was not necessary to demonstrate the substantial equivalence of the GSO GS1 Spinal System to the predicate devices.

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Image /page/3/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" written around the perimeter. Inside the circle is an image of an eagle with its wings spread, with three lines emanating from the eagle's head.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 U 2007

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

K070966 Re:

Trade/Device Name: GS0 GS1 Spinal System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP, MNI, MNH Dated: June 11, 2007 Received: June 13, 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 (Medical 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 the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Barbara Bonell

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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INDICATIONS FOR USE

510(k) Number (if known): KO70966

Device Name: GSO GS1 Spinal System

Indications for Use:

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)

nce of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of General, Restorative, and Neurological Devices

Page 1 of 2

Koznalage 8 510(k) Number_

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Ko70966

When used as a posterior, non-cervical, non-pedicle screw and/or hook fixation system, the GSO GS1 Spinal System is indicated for:

1. Degenerative disc disease (as defined by chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
1. Idiopathic scoliosis
1. Kyphotic deformities of the spine
1. Paralytic scoliosis and/or pelvis obliquity
1. Vertebral fracture or dislocation
1. Neuromuscular scoliosis associated with pelvic obliquity
1. Vertebral fracture or dislocation
1. Tumors
1. Spondylolisthesis
1. Stenosis
1. Pseudarthrosis
1. Unsuccessful previous attempts at spinal fusion

For posterior, non-pedicle, screw use, the GSO GS1 screws are intended for sacral/iliac attachment only and the GSO GS1 hooks and crosslinks are intended for thoracic and/or lumbar use only.

In all cases, instrumentation must be at least 1 cm from any major vessel.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 2 of 2

Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.