The Stryker Spine Oasys Bone Screw is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. The Stryker Spine Oasys Bone Screw is indicated for bilateral fixation, with or without bone graft, at single or multiple levels, from C2 to T3. The Stryker Spine Oasys Bone Screw is indicated for treating any or all of the following:

Trauma, including fractures and/or dislocations
Spondylolisthesis
Spondylolysis
Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity
Degenerative disc disease (DDD) as defined by neck and back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies
Degenerative disease of the facets with instability

Device Description

The Stryker Spine Oasys Bone Screw is available in 3.5 and 4.0 mm diameters and a variety of lengths in order to accommodate patient anatomy. The components are fabricated from titanium alloy. The implants will be provided non-sterile.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for the Stryker Spine Oasys Bone Screw. This document does not describe a software or AI/ML device that would have acceptance criteria and a study design as typically associated with such technologies (e.g., diagnostic accuracy, performance metrics like sensitivity/specificity). Instead, it's for a physical medical device (bone screw).

Therefore, I cannot extract the requested information regarding acceptance criteria and study particulars in the context of an AI/ML device. The document states:

Substantial Equivalence: "Equivalency of this device is based on similarities in intended use, materials, and design to other currently marketed transfacetpedicular screws. Mechanical testing demonstrated comparable mechanical properties to the predicate device."

This indicates that the "study" for this device involved mechanical testing to show its performance was comparable to existing predicate devices, rather than a clinical study with human readers or AI algorithms.

To answer your specific points, based on the provided text, here’s how they relate to this physical device:

A table of acceptance criteria and the reported device performance: This document does not provide a table of acceptance criteria or specific performance metrics in the format you'd expect for an AI/ML device. The "performance" is stated as "comparable mechanical properties to the predicate device."
Sample sized used for the test set and the data provenance: Not applicable. There's no "test set" in the context of diagnostic accuracy. The testing was mechanical.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic accuracy is not relevant to mechanical testing of a bone screw.
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-assisted device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm.
The type of ground truth used: For a physical device like a bone screw, "ground truth" would relate to material properties, strength, fatigue life, etc., established through engineering standards and laboratory testing, not medical expert consensus or pathology in the diagnostic sense.
The sample size for the training set: Not applicable. There is no training set for a bone screw in the AI/ML context.
How the ground truth for the training set was established: Not applicable.

In summary, the provided document pertains to a physical medical device (bone screw) and its clearance based on substantial equivalence, primarily supported by mechanical testing, not a clinical performance study with AI/ML components or human review of diagnostic images. Therefore, the requested information elements are not applicable to this submission.

Summary

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K031 657 PG: 1/2

Stryker Spine Oasys Bone Screw

AUG 2 2 2003

510(k) Premarket Notification

Proprietary Name:	Stryker Spine Oasys Bone Screw
Common Name:	Transfacetpedicular Screw Fixation System
Proposed Regulatory Class:	Unclassified
Device Product Code:	87 MRW: System, Facet Screw Spinal Device
For Information contact:	Karen AriemmaRegulatory Affairs SpecialistHowmedica Osteonics Corp.59 Route 17Allendale, NJ 07401-1677Telephone: (201) 831-5718Fax: (201) 831-6038Email: kariemma@howost.com
Date Summary Prepared:	May 27, 2003

510(k) Summary for Stryker Spine Oasys Bone Screw

Device Description

Indications for Use

Trauma, including fractures and/or dislocations
Spondylolisthesis
. Spondylolysis
Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause . secondary instability or deformity

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K031657 P101 2/2

510(k) Premarket Notification

Degenerative disc disease (DDD) as defined by neck and back pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies
. Degenerative disease of the facets with instability

Substantial Equivalence

Equivalency of this device is based on similarities in intended use, materials, and design to other currently marketed transfacetpedicular screws. Mechanical testing demonstrated comparable mechanical properties to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure with three heads, representing health, services, and people.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 2 2003

Ms. Karen Ariemma Regulatory Affairs Specialist Howmedica Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677

K031657 · Re:

Trade Name: Stryker Spine Oasys Bone Screw Regulatory Class: Unclassified Product Code: MR W Dated: May 27, 2003 Received: May 28, 2003

Dear Ms. Ariemma:

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. Iisting 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- Ms. Karen Ariemma

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 Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely vours.

L. Mark N. Milliken

elia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Device Name: Stryker Spine Oasys Bone Screw

Trauma, including fractures and/or dislocations .
Spondylolisthesis .
Spondylolysis ●
Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause ● secondary instability or deformity
Degenerative disc disease (DDD) as defined by neck and back pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies
Degenerative disease of the facets with instability ●

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use OR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

for Mark A. Millam

510(k) Number K031657

Regulation Number and Section

N/A