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

Degenerative Disc Disease (as defined by neck and back pain of discogenic origin with t 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
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) in treating thoracic conditions only. 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.

Device Description

This 510(k) adds new polyaxial screw components (non-biased and cancellous styles) to the existing OASYSTM System. The new polyaxial screws of the Stryker Spine OASYSTM System are identical to the existing polyaxial screws of the OASYS™ System with regard to materials, intended use, and basic operating principles. The new polyaxial screws differ from the existing OASYS™ polyaxial screws with regard to specific design features; however, mechanical testing has demonstrated that OASYS™ Systems constructed with the new screws perform equivalently to one or more of the cited predicate device systems.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for a line extension to the Stryker Spine OASYS™ System. This document focuses on the substantial equivalence of device modifications (new polyaxial screw components) to existing predicate devices, demonstrating equivalence through mechanical testing.

Therefore, this type of submission (a 510(k) for a device modification) does not typically involve the kinds of studies and data points (such as AI performance metrics, expert adjudication, ground truth establishment, or multi-reader multi-case studies) that would be relevant for a new diagnostic or AI-powered medical device.

The study described here is mechanical testing to demonstrate the equivalence of the modified components to the predicate devices.

Here's an attempt to answer your questions based on the provided text, while acknowledging its limitations for an AI-focused detailed response:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical equivalence to predicate devices (OASYS™ System)	"mechanical testing has demonstrated that OASYS™ Systems constructed with the new screws perform equivalently to one or more of the cited predicate device systems."
Materials equivalence to predicate devices (OASYS™ System)	"identical to the existing polyaxial screws of the OASYS™ System with regard to materials"
Intended Use equivalence to predicate devices (OASYS™ System)	"identical to the existing polyaxial screws of the OASYS™ System with regard to... intended use"
Basic operating principles equivalence to predicate devices (OASYS™ System)	"identical to the existing polyaxial screws of the OASYS™ System with regard to... basic operating principles."

2. Sample size used for the test set and the data provenance

Sample Size: The document does not specify the sample size for the mechanical testing.
Data Provenance: Not specified. Mechanical testing is typically laboratory-based, not reliant on human clinical data provenance (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not applicable. Mechanical testing for medical devices relies on engineering standards and measurements, not expert consensus for "ground truth" in the clinical sense.
Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

Adjudication Method: Not applicable. Mechanical testing involves objective measurements rather than subjective adjudication.

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

MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted interpretation, not for mechanical device components.
Effect Size: Not applicable.

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

Standalone Performance: Not applicable. This document concerns a physical device, not an algorithm.

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

Ground Truth Type: For mechanical testing, the "ground truth" is defined by established engineering standards, material properties, and biomechanical performance specifications. These are objective and measurable, not derived from clinical expert consensus, pathology, or outcomes data.

8. The sample size for the training set

Training Set Sample Size: Not applicable. This submission describes mechanical testing for device modification, not a machine learning model.

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

Training Set Ground Truth: Not applicable.

Summary

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OCT 5 " 2007

Line Extension to the Stryker Spine OASYS™ System

Special 510(k) Premarket Notification

072568

Special 510(k) Summary: Line Extension to the Stryker Spine OASYSTM System

Proprietary Name:	OASYST™ System
Common Name:	Spinal Fixation Appliances
Proposed Regulatory Class:	Class II21 CFR 888.3070 (b)(1): Pedicle Screw Spinal Syster21 CFR 888.3050: Spinal Interlaminal FixationOrthosis
Device Product Code:	MNI: Orthosis, Spinal Pedicle FixationKWP: Appliance, Fixation, Spinal Interlaminal
For Information contact:	Simona VoicRegulatory Affairs Project Manager2 Pearl CourtAllendale, NJ 07401Telephone: (201) 760-8145Fax: (201) 760-8345Email: Simona.Voic@stryker.com
Date Summary Prepared:	September 11, 2007
Predicate Devices	Stryker Spine's OASYST™ System - 510(k)#:K032394, K052317, & K062853DePuy Spine, Inc. Summit OCT Spinal System -510(k)#: K030103 & K041203

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Intended Use

Special 510(k) Premarket Notification

This 510(k) adds new polyaxial screw components Description of Device Modification (non-biased and cancellous styles) to the existing OASYSTM System.

When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput -T3), the Stryker Spine OASYSTM 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)
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 (T1-T3) in treating thoracic conditions only. 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

{2}------------------------------------------------

Line Extension to the Stryker Spine OASYS™ System

Special 510(k) Premarket Notification

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.

Summary of the Technological Characteristics

The new polyaxial screws of the Stryker Spine OASYSTM System are identical to the existing polyaxial screws of the OASYS™ System with regard to materials, intended use, and basic operating principles. The new polyaxial screws differ from the existing OASYS™ polyaxial screws with regard to specific design features; however, mechanical testing has demonstrated that OASYS™ Systems constructed with the new screws perform equivalently to one or more of the cited predicate device systems.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Stryker Spine % Ms. Simona Voic Regulatory Affairs Project Manager 2 Pearl Court Allendale, New Jersey 07401

OCT 5 2007

Re: K072568

Trade/Device Name: OASYS™ System Regulation Number: 21 CFR §888.3070 Regulation Name: Pedicle Screw Spinal System Regulatory Class: Class II Product Code: KWP. MNI Dated: September 11, 2007 Received: September 12, 2007

Dear Ms. Voic:

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. 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

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Page 2 - Ms. Simona Voic

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 its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Barbara Buchno

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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Line Extension to the Stryker Spine OASYSTM System

Special 510(k) Premarket Notification

Indications for Use

K0725b8 510(k) Number (if known):

Device Name: Line Extension to the Stryker Spine OASYSTM System

Indications for Use:

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

Degenerative Disc Disease (as defined by neck and back pain of discogenic origin with t 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
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) in treating thoracic conditions only. 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.

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)

harbare Buchm

Division of Gener and Neurological Devices

510(k) Number K072568

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.