When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput-T3), the Stryker Spine OASYS® System is intended for: Degenerative Disc Disease (as defined by neck or back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); Spondylolisthesis; Spinal Stenosis; Fracture/Dislocation; Atlanto/axial fracture with instability; Occipitocervical dislocation; Revision of previous cervical spine surgery; Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity; and Tumors.

When used with the occipital plate, the bone screws are limited to occipital fixation only. The bone screws are not intended to be used in the cervical spine.

The use of the polyaxial screws is limited to placement in the upper thoracic spine (T1-T3). They are not intended to be placed in the cervical spine.

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

The Stryker Spine OASYS® System can also be linked to the Xia® System, SR90D System and Xia® 4.5 Spinal System via the rod-to-rod connectors and polyaxial screws of Xia® II and Xia® 3 Systems via the saddle connector.

Device Description

The Stryker Spine OASYS® System is comprised of rods, polyaxial screws, bone screws, hooks, connectors, and occiput plates. The components are available in a variety of lengths in order to accommodate patient anatomy. The components are fabricated from Titanium alloy and CP Titanium and are provided non-sterile. The subject system also offers Vitallium® rods. The Stryker Spine OASYS® System can be linked to the Stryker Spine Xia® Spinal System, Xia 4.5 System and SR90D System.

This Special 510(k) submission is intended to introduce a line extension to the predicate OASYSTM System, which consists of the addition of the saddle connector.

AI/ML Overview

This document focuses on a Special 510(k) Premarket Notification for a line extension to the Stryker Spine OASYS® System, specifically the addition of a saddle connector. As such, the acceptance criteria and study described are for the mechanical performance of the device and its components, not for an AI/software device or a comparative effectiveness study in a clinical setting.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance and Study Description
Mechanical Performance	Substantial equivalence to predicate devices in terms of material, design, mechanical performance, and indications for use. Specific tests include: - Static Compression Bending - Dynamic Compression Bending - Static Torsion - Dynamic Torsion	"Documentation is provided which demonstrates that the new component of the Stryker Spine Oasys System to be substantially equivalent to the predicate devices in terms of material, design, mechanical performance and indications for use. Static Compression Bending testing, Dynamic Compression Bending testing, Static Torsion testing and Dynamic Torsion testing per ASTM F 1717 were conducted on the Oasys System components. The results obtained from these tests were compared to those of a predicate system to demonstrate substantial equivalence, as recommended by the "Guidance for Industry & FDA Staff Spinal System 510(k)s, May 3, 2004."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size: The document does not specify exact sample sizes (e.g., number of saddle connectors or spinal constructs tested). It notes "Oasys System components" were tested. Mechanical performance testing typically involves multiple samples for statistical validity, but the precise numbers are not provided.
Data Provenance: The data is generated from in vitro laboratory mechanical testing, conducted in compliance with ASTM F1717. The country of origin of the data is not explicitly stated but would likely be where Stryker Spine conducts its R&D and testing, presumably in the US based on the submission to the FDA. The data is prospective in the sense that the testing was performed specifically to support this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This question is not applicable to this type of submission. "Ground truth" in this context refers to the defined mechanical properties and performance standards established by ASTM F1717 and the FDA's guidance document for spinal systems. The "experts" are the engineers and technicians who conduct the tests and compare the results to established benchmarks and predicate device performance. Explicit numbers or qualifications of such experts are not details typically included in a 510(k) summary for mechanical testing.

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

This question is not applicable to a mechanical performance study. Adjudication methods like "2+1" typically refer to reconciling expert opinions in clinical or image-based studies. For mechanical testing, the "adjudication" is based on objective measurements and comparison against pre-defined acceptance criteria (e.g., within a certain percentage of predicate device performance, or exceeding minimum strength requirements).

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

This question is not applicable. This 510(k) is for a physical medical device (surgical implant component) and its mechanical performance, not a software/AI device or a diagnostic tool involving human readers.

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

This question is not applicable. This 510(k) is for a physical medical device and its mechanical performance, not an algorithm or AI.

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

The "ground truth" for this study is defined by:

ASTM F1717 Standard: This standard specifies the methodology and parameters for testing spinal implant constructs. Adherence to this standard ensures a defined benchmark for testing.
Predicate Device Performance: The performance of the predicate device serves as the direct comparative "ground truth" for demonstrating substantial equivalence. The new component's mechanical performance is considered acceptable if it is substantially equivalent to that of the already-marketed predicate device.
FDA Guidance: The "Guidance for Industry & FDA Staff Spinal System 510(k)s, May 3, 2004" provides the regulatory framework and recommendations for demonstrating substantial equivalence for spinal systems.

8. The sample size for the training set

This question is not applicable. This is not an AI/ML study that uses training sets. The "training" in mechanical testing refers to the established testing methodologies and standards (ASTM F1717).

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

This question is not applicable as there is no "training set" in the context of this mechanical performance study. The standards (ASTM F1717) and regulatory guidance (FDA) serve as the established benchmarks against which the device's performance is measured, ensuring safety and effectiveness through substantial equivalence to predicate devices.

Summary

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Special 510(k) Premarket Notification

Special 510(k) Summary Line Extension to the OASYS® System

NOV - 9 2010

Proprietary Name:	Stryker Spine OASYST™ System
Common Name:	Spinal Fixation Appliances
Proposed Regulatory Class:	Class II
	21 CFR 888.3050: Spinal Interlaminal Fixation Orthosis
Device Product Code:	87 KWP: Appliance, Fixation, Spinal Interlaminal
For Information contact:	Curtis D. Truesdale
	Regulatory Affairs Project Manager
	2 Pearl Court
	Allendale, NJ 07401
	Telephone: (201) 760-8296
	Fax: (201) 760-8496
	Email: Curtis.Truesdale@Styker.com
Date Summary Prepared:	November 4, 2010

Stryker Spine OASYS® System: K032394, K052317, Predicate Device Identification K062853, K072568. K080143, K093670

Predicate Device Description

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Description of Device Modification

This Special 510(k) submission is intended to introduce a line extension to the predicate OASYSTM System, which consists of the addition of the saddle connector.

Intended Use:

When used with the occipital plate, the bone screws are limited to occipital fixation only. The bone screws are not intended to be used in the cervical spine.

The use of the polyaxial screws is limited to placement in the upper thoracic spine (T1-T3). They are not intended to be placed in the cervical spine.

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

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K101182

. 5/2

Statement of Technological Comparison:

Documentation is provided which demonstrates that the new component of the Stryker Spine Oasys System to be substantially equivalent to the predicate devices in terms of material, design, mechanical performance and indications for use. Static Compression Bending testing, Dynamic Compression Bending testing, Static Torsion testing and Dynamic Torsion testing per ASTM F 1717 were conducted on the Oasys System components. The results obtained from these tests were compared to those of a predicate system to demonstrate substantial equivalence, as recommended by the "Guidance for Industry & FDA Staff Spinal System 510(k)s, May 3, 2004."

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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 with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Stryker Spine % Mr. Curtis D. Truesdale Regulatory Affairs Project Manager 2 Pearl Court Allendale, New Jersey 07401

NOV - 9 2010

Re: K101183

Trade/Device Name: Line Extension to the Stryker Spine OASYS® System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP Dated: October 13, 2010 Received: October 14, 2010

Dear Mr. Truesdale:

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, Orve 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

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Page 2 - Mr. Curtis D. Truesdale

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.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Barbara Buehrs
Sgt.

Mark N. Melk Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K101183

2010

Device Name: Line Extension to the Stryker Spine OASYS® System

Indications for Use:

When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput-T3), the STRYKER Spine Oasys System is intended for:

Degenerative Disc Disease (as defined by neck and back pain of discogenic origin with degeneration of the . disc confirmed by history and radiographic studies)
t Spondylolisthesis
. Spinal Stenosis
. Fracture/Dislocation
Atlanto/axial fracture with instability .
Occipitocervical dislocation .
Revision of previous cervical spine surgery .
Tumors .

When used with the occipital plate, the bone screws are limited to occipital fixation only. The bone screws are not intended to be used in the cervical spine.

The use of the polyaxial screws is limited to placement in the upper thoracic spine (TI-T3). They are not intended to be placed in the cervical spine.

The hooks and rods are also intended to provide stabilization following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

The Stryker Spine OASYS® System can also be linked to the Xia® System and Xia® 4.5 Spinal System.

The Stryker Spine OASYS® System can also be linked to the Xia® System, SR90D System and Xia® 4.5 System via the rod-to-rod connectors and polyaxial screws of Xia® 11 and Xia® 3 Systems via the saddle connector.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign=Off) Division of Surgical, Orthopedic, and Restorative Devices

Page 1 of l

	510(k) Number_________________________________________________________________________________________________________________________________________________________________------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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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.