The GSO PCT 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 PCT Spinal System should be removed after fusion.

The GSO PCT Spinal System is intended to promote fusion of the cervical spine and cervico-thoracic junction (C1-T3), and is indicated for the following:

Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
Spondylolisthesis
Spinal stenosis
Fracture or dislocation
Revision of previous cervical or cervico-throracic spine surgery
Tumors

The use of multi-axial pedicle screws is limited to placement in the upper thoracic spine (T1-T3) for the purpose of anchoring the construct. The multi-axial pedicle screws are not intended to be placed in the cervical spine.

Device Description

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

The GSO PCT 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

This appears to be a 510(k) premarket notification document for a spinal implant system, not an AI/ML medical device. Therefore, many of the requested categories related to AI/ML device performance and testing (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable.

However, I can extract information related to the acceptance criteria and the study performed to demonstrate "device meets acceptance criteria" in the context of a traditional medical device (spinal implant).

Acceptance Criteria and Reported Device Performance for GSO PCT Spinal System

1. Acceptance Criteria	2. Reported Device Performance
Sufficient strength for intended use (as demonstrated by mechanical testing according to ASTM F1717).	Mechanical testing conducted according to ASTM F1717 demonstrates that the GSO PCT Spinal System has sufficient strength for its intended use.
Similar indications, design, and materials to legally marketed predicate devices.	The GSO PCT Spinal System has a similar indications and design and is manufactured from the same materials as the Mountaineer OCT Spinal System - Depuy Spine, Inc. (K080828), the Altius OCT System - Interpore Cross International (K033961), and the OASYS System - Stryker Spine (K080143, K032394).

Study Details (Non-AI/ML Medical Device)

Sample sized used for the test set and the data provenance: Not applicable. For this type of device, mechanical testing is done on device samples, not patient data sets.
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 testing is based on engineering standards and measurements, not expert clinician consensus.
Adjudication method for the test set: Not applicable.
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.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI/ML device.
The type of ground truth used:
- For mechanical strength: Engineering standards (ASTM F1717) and physical measurements.
- For substantial equivalence: Comparison against legally marketed predicate devices based on indications, design, and materials.
The sample size for the training set: Not applicable. This is not an AI/ML device.
How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

Summary of the Study:

The primary study conducted for the GSO PCT Spinal System was non-clinical mechanical testing.

Study Type: Mechanical performance testing.
Methodology: The testing was conducted according to ASTM F1717. ASTM F1717, "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model," typically evaluates the static and fatigue strength of spinal implant constructs under various loading conditions (e.g., compression, torsion, bending) to ensure they can withstand the anticipated physiological stresses without failure.
Results: The mechanical testing demonstrated that the GSO PCT Spinal System possesses "sufficient strength for its intended use."

Additionally, the submission relies on demonstrating substantial equivalence to existing legally marketed devices (Mountaineer OCT Spinal System, Altius OCT System, and OASYS System). This comparison serves as a form of "study" to support the safety and effectiveness by showing similarity in:

Indications for Use
Design
Materials of construction (CP Titanium conforming to ASTM F67 and Ti-6A1-4V Titanium alloy conforming to ASTM F136).

Clinical Testing: The document explicitly states: "Clinical testing was not necessary to demonstrate the substantial equivalence of the GSO PCT Spinal System to the predicate devices." This is common for 510(k) submissions where substantial equivalence can be established through non-clinical data and direct comparison to predicates.

Summary

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K091359

1.	Applicant/Sponsor:	Gold Standard Orthopaedics, LLC.1226 Rowan St.Louisville, KY 40203
2.	Contact Person:	David BaughmanPresidentDavid06@Baughmangroup.comPhone (502) 581-8770
3.	Proprietary Name:	GSO PCT Spinal System
4.	Common Name:	Posterior Spinal Implants
5.	Classification Names:	21 CFR 888.3050 - Spinal interlaminal fixationorthosis

510/K) SIIMMARY

SFP - 2 2009

Legally Marketed Devices to which Substantial Equivalence is claimed: 6.

. Mountaineer OCT Spinal System - Depuy Spine, Inc. (14080828)
. Altius OCT System - Interpore Cross International (K033961)
. OASYS System - Stryker Spine (K080143, K032394)
. GS1 Spinal System - Gold Standard Orthopaedics, LLC (K070966)

7. . Device Description:

8-Intended Use:

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

ੇ. Indications:
The GSO PCT Spinal System is intended to promote fusion of the cervical spine and cervico-thoracic junction (C1-T3), and is indicated for the following:
Degenerative disc disease (as defined by neck pain of discogenic origin with 1 degeneration of the disc confirmed by history and radiographic studies)
1. Spondylolisthesis
1. Spinal stenosis
1. Fracture or dislocation
1. Revision of previous cervical or cervico-throracic spine surgery
1. Tumors

1. Summary of Technologies/Substantial Equivalence:
  The GSO PCT Spinal System has a similar indications and design and is manufactured from the same materials as the Mountaineer OCT Spinal System -Depuy Spine, Inc. (K080828), the Altius OCT System - Interpore Cross International (K033961), and the OASYS System -- Stryker Spine (K080143, K032394)

11. Non-Clinical Testing:

Mechanical testing conducted according to ASTM F1717 demonstrates that the GSO PCT Spinal System has sufficient strength for its intended use.

12. Clinical Testing:

র্বা

Clinical testing was not necessary to demonstrate the substantial equivalence of the GSO PCT Spinal System to the predicate devices.

page 2 of 2

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Gold Standard Orthopaedics; LLC % Mr. David Baughman President 1226 Rowan Street Louisville, Kentucky 40203

SEP - 2 2009

Re: K091359

Trade/Device Name: GSO PCT Spinal System

Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: KWP Dated: August 23, 2009 Received: August 27, 2009

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 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 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. J

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Page 2 - Mr. David Baughman

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 (240) 276-3150 or at its Internet address

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

Sincerely yours,

Barbara Buehrig

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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2. INDICATIONS FOR USE

510(k) Number (if known): K091359

Device Name: GSO PCT Spinal System

Indications for Use:

The GSO PCT Spinal System is intended to promote fusion of the cervical spine and cervico-thoracic junction (C1-T3), and is indicated for the following:

1. Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
Spondylolisthesis ri
1. Spinal stenosis
Fracture or dislocation 4.
Revision of previous cervical or cervico-throracic spine surgery 5.
(. Tumors

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)

Karen S. Bury for AKS MXM
(Division Sign-Off)
Division of Surgical

Page _ 1 of _ 1

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

510(k) Number K091359

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.