The Stryker Spine Aviator Anterior Cervical Plating (ACP) System is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation.

The Aviator Anterior Cervical Plating System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications:

Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
Trauma (including fractures)
Tumors
Deformities or curvatures (including kyphosis, lordosis, or scoliosis)
Pseudarthrosis
Failed previous fusion
Decompression of the spinal cord following total or partial cervical vertebrectomy
Spondylolisthesis
Spinal stenosis

WARNING: This device is not approved or intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Device Description

This Special 510(k) premarket notification is intended to introduce the following line extensions to the Reflex Hybrid Plates and Bone Screws approved under K062310 and K040261:

Aviator plates in 1-level, 2-level, 3-level, and 4-level configurations and in lengths ranging from 12mm through 96mm
Aviator 4.0 mm and 4.35mm diameter bone screws (variable angle self-drilling, variable angle self-tapping, fixed angle selfdrilling and fixed-angle self-tapping)

The Stryker Spine Aviator Anterior Cervical Plating (ACP) System is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation.

The intended use and materials of the subject anterior cervical plates are identical to those of the predicate anterior cervical plates. The predicate Reflex® Hybrid Anterior Cervical Plate (ACP) System consists of various size plates that are implanted and remain static. The subject system introduces various length plates that contain a new "spring bar" anti-backout mechanism similar to the existing Reflex Hybrid "locking ring" anti-backout mechanism. In addition to the new anti-backout mechanism introduced on the Aviator plate, new screws have been introduced with a modified head. Engineering analysis and performance testing verify that the subject device system is substantially equivalent in terms of performance characteristics to the predicate device systems.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Stryker Spine Aviator Anterior Cervical Plating (ACP) System:

Summary of Findings: The provided document is a 510(k) premarket notification for a line extension to an existing device. It focuses on demonstrating substantial equivalence to predicate devices, primarily through engineering analysis and performance testing, rather than extensive clinical studies with specific acceptance criteria related to a new AI or diagnostic device function. Therefore, many of the requested fields are not directly applicable or explicitly stated in this type of submission.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided document is a 510(k) premarket notification for a line extension to an existing medical device (spinal implant). This type of submission primarily focuses on demonstrating "substantial equivalence" to predicate devices through design comparisons, material equivalence, and non-clinical engineering testing. It does not typically include specific clinical acceptance criteria, detailed accuracy metrics (like sensitivity/specificity), or performance outcomes in the way one would see for a novel diagnostic or AI-powered device.

The document states: "Engineering analysis and performance testing verify that the subject device system is substantially equivalent in terms of performance characteristics to the predicate device systems." This is the overarching "acceptance criterion" for a 510(k) submission – to prove the new device is as safe and effective as a legally marketed predicate device.

Acceptance Criterion (Implicit)	Reported Device Performance (Summary)
Substantial equivalence in performance characteristics to predicate devices.	Engineering analysis and performance testing verified substantial equivalence. The new "spring bar" anti-backout mechanism is similar to the predicate's "locking ring" mechanism, and new screws have a modified head, but overall performance characteristics are equivalent.
Intended Use Match	The intended use for the Aviator ACP System is identical to that of the predicate anterior cervical plates.
Material Equivalence	The materials of the subject anterior cervical plates are identical to those of the predicate anterior cervical plates.

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

Sample Size for Test Set: Not explicitly stated in terms of a clinical patient sample size. The "test set" here refers to the components subjected to engineering and performance bench testing. The document implies sufficient testing was done to support the claim of substantial equivalence.
Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable in the context of clinical data for this type of 510(k) submission. The data would primarily be from internal laboratory engineering tests.

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

Number of Experts: Not explicitly stated or applicable in the way one would assess diagnostic accuracy. For engineering analysis and performance testing, the "experts" would be the design engineers, test engineers, and regulatory affairs personnel involved in the device design and testing, as well as the FDA reviewers.
Qualifications of Experts: The regulatory affairs consultant, Vikki O'Connor, is named. The design and testing would be handled by qualified engineers and scientists within Stryker Spine. FDA reviewers (e.g., Mark N. Melkerson, Director of the Division of General, Restorative and Neurological Devices) are experts in medical device regulation and evaluation.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. This refers to the process of resolving discrepancies among multiple human readers for ground truth establishment. For engineering tests, the "ground truth" is defined by established test methods, specifications, and observed results, which are then analyzed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

Was an MRMC study done? No. This submission does not involve an AI component or a diagnostic interpretation task that would necessitate an MRMC study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

Was a standalone study done? Not applicable. This device is a physical implant, not a software algorithm. The "standalone performance" refers to the device's mechanical and material properties as tested in a lab setting.

7. The Type of Ground Truth Used

Type of Ground Truth: The "ground truth" for this device's performance is established through engineering specifications, material standards, and validated mechanical and physical performance testing methods. This ensures the device meets design requirements and performs comparably to the predicate devices under simulated physiological conditions. Examples include tests for strength, fatigue, material compatibility, and anti-backout mechanism effectiveness.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This device does not use an AI algorithm that requires a "training set" of data.

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

How Ground Truth for Training Set Was Established: Not applicable. As there is no AI algorithm, there is no training set or ground truth in this context.

Summary

{0}------------------------------------------------

MAR 2 5 2009

Line Extension to the Stryker Spine Reflex® Hybrid ACP System

Special 510(k) Premarket Notification

Special 510(k) Summary of Safety and Effectiveness: Aviator Anterior Cervical Plate System

Line Extension to the Stryker Spine Reflex® Hybrid ACP System

Proprietary Name:

Aviator ACP System

Common Name:

Proposed Regulatory Class:

Anterior Cervical Plate System Class II

Spinal Intervertebral Body Fixation Orthosis, 21 CFR 888.3060

Device Product Code:

KWQ

Sponsor: For Information contact:

Stryker Spine Vikki O'Connor Regulatory Affairs Consultant 2 Pearl Court Allendale, NJ 07401 Telephone: (201) 760-8215 Fax: (201) 760-8415 Email: vikki.o'connor@stryker.com

Date Summary Prepared:

March 24, 2009

Predicate Device

Stryker Spine Reflex® Hybrid ACP System (K062310, K040261) and Synthes Spine Cervical Spine Locking Plate System (K000536, K000742)

Device Description

This Special 510(k) premarket notification is intended to introduce the following line extensions to the Reflex Hybrid Plates and Bone Screws approved under K062310 and K040261: - Aviator plates in 1-level, 2-level, 3-level, and 4-level

{1}------------------------------------------------

Intended Use

Special 510(k) Premarket Notification

configurations and in lengths ranging from 12mm through 96mm

Aviator 4.0 mm and 4.35mm diameter bone screws (variable angle self-drilling, variable angle self-tapping, fixed angle selfdrilling and fixed-angle sclf-tapping)

The Stryker Spine Aviator Anterior Cervical Plating (ACP) System is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation.

트 Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
Trauma (including fractures) 트
트 Tumors
트 Deformities or curvatures (including kyphosis, lordosis, or scoliosis)
. Pseudarthrosis
Failed previous fusion
Decompression of the spinal cord following total or partial D cervical vertebrectomy
I Spondylolisthesis
. Spinal stenosis

WARNING: This device is not approved or intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Summary of the Technological Characteristics

Page 2 of 3

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

introduced on the Aviator plate, new screws have been introduced with a modified head. Engineering analysis and performance testing verify that the subject device system is substantially equivalent in terms of performance characteristics to the predicate device systems.

Page 3 of 3

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing strength and protection. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is simple and monochromatic.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 & 2009

Stryker Corp. % Ms. Vikki M. O'Connor 2 Pearl Court Allendale, NJ 07401

Re: K083562

Trade/Device Name: Aviator Anterior Cervical Plating (ACP) System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: March 11, 2009 Received: March 13, 2009

Dear Ms. O'Connor:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enoredary to regions of the Medical Device Amendments, or to commerce pror to May 20, 1970, are eccordance with the provisions of the Federal Food, Drug, devices that have been route approval of a premarket approval application (PMA). and Cosmetic (110-) that to novice, subject to the general controls provisions of the Act. The I ou may, merelore, market of the Act include requirements for annual registration, listing of general controls provisions of the rise labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), II your device is viassified (666 acre) arols. Existing major regulations affecting your device . EDA It inay be subject to such additional Regulations, Title 21, Parts 800 to 898. In addition, FDA ean be louits in the Outsuneements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Frease be advisou mate I DTT 3 loseanse over device complies with other requirements of the Act that I D'i has inder a determistions administered by other Federal agencies. You must of any I catal statutes and regaranents, including, but not limited to: registration and listing (21 Compry with an the riot 81 cFR Part 801); good manufacturing practice requirements as set Crit Fart 807), idocing (21 OFRT art 820), and if applicable, the electronic forth in the quality bybections (Sections 531-542 of the Act); 21 CFR 1000-1050.

{4}------------------------------------------------

Page 2 – Ms. Vikki M. O'Connor

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 yours,

Mark N. Mollenkamp

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Special 510(k) Premarket Notification

Indications for Use

510(k) Number (if known): K 083562

Device Name: Stryker Spine Aviator Anterior Cervical Plating (ACP) System

Indications For Use:

The Stryker Spine Aviator Anterior Cervical Plating (ACP) System is intended for use as an aid in cervical spinal fusion and is intended for unilatcral fixation.

Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
Trauma (including fractures)
Tumors
Deformities or curvatures (including kyphosis, lordosis, or scoliosis) 트
Pseudarthrosis ■
I Failed previous fusion
Decompression of the spinal cord following total or partial cervical vertebrectomy
Spondylolisthesis
I Spinal stenosis

WARNING: This device is not approved or intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR
--------

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number K083562

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.