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

The Reflex® Translational 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)
피 Trauma (including fractures)
Tumors
E Deformities or curvatures (including kyphosis, lordosis, or scoliosis)
트 Pseudarthrosis
트 Failed previous fusion
Decompression of the spinal cord following total or I partial cervical vertebrectomy
트 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 approved under K000742 and K000536: Translational plates in 1-level, 2-level, 3-level, and 4-level configurations and in lengths ranging from 14mm through 96mm.

The subject system consists of various length plates that have Titanium clips which hold the plate in the "fully open" position. After the plate is placed and secured, Titanium clips are removed allowing the plate to decrease in size up to 2mm per level treated. This translational plate design uses the same screws and locking mechanism used in the predicate Stryker Spine Reflex® Hybrid ACP System.

AI/ML Overview

The provided text describes a Special 510(k) premarket notification for a medical device, the Stryker Spine Reflex® Translational Anterior Cervical Plating System. This notification is for a line extension to an existing product and, therefore, focuses on demonstrating substantial equivalence to predicate devices through engineering analysis and performance testing, rather than a clinical study evaluating diagnostic or prognostic performance.

As such, the information typically requested for AI/diagnostic device studies (such as sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for training/test sets) is not applicable to this type of submission. This device is a mechanical implant, not an AI or diagnostic tool.

The document explicitly 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 indicates that the "study" proving the device meets acceptance criteria was based on engineering and performance benchmarks, rather than a clinical trial with human subjects.

Therefore, I cannot provide the requested table and details because the submission is not focused on an AI or diagnostic device that would involve such criteria and studies.

However, I can extract the acceptance criteria (implied by the substantial equivalence claim) and the general nature of the "study" reported:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Description (Implied)	Reported Device Performance
Functional Equivalence	The device must perform its intended function (e.g., aid in cervical spinal fusion, temporary stabilization) similarly to the predicate devices. This includes the translational mechanism allowing up to 2mm decrease in size per level.	The subject device features Titanium clips that allow the plate to decrease in size up to 2mm per level treated after removal of the clips. This translational plate design uses the same screws and locking mechanism as the predicate device.
Material Equivalence	The materials used in the device must be comparable to or the same as the predicate devices to ensure biocompatibility and mechanical integrity.	The intended use and materials of the subject anterior cervical plates are identical to those of the predicate anterior cervical plates.
Mechanical Performance	The device must withstand expected physiological loads and stresses without failure, similar to the predicate devices. This includes screw retention, plate integrity, and translational mechanism reliability.	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 implies satisfactory mechanical performance validated through testing).
Safety	The device must demonstrate a similar safety profile to the predicate devices, with no new safety concerns introduced by the translational design.	The successful 510(k) clearance indicates that the FDA found the device to be substantially equivalent in safety and effectiveness to the predicate devices, implying no new safety concerns were identified that would preclude market entry. The warning regarding posterior elements is consistent with predicate device limitations.
Indications for Use Equivalence	The device's indications for use must be the same as the predicate devices.	The indications for use match those listed for the predicate devices, including specific conditions like Degenerative Disc Disease, Trauma, Tumors, etc., and C2-T1 spinal levels.

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

Not applicable. This was an engineering and performance testing study, not a clinical study on human subjects where a "test set" and "data provenance" (e.g., country of origin, retrospective/prospective) would be relevant. The "test set" would refer to mechanical test specimens.

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

Not applicable. Ground truth, in the context of clinical expert consensus, is not relevant for this type of engineering and performance study. The "ground truth" here would be established by validated engineering standards and test methods.

4. Adjudication method for the test set

Not applicable. Adjudication methods are used in clinical studies or image interpretation, not in mechanical engineering verification.

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

Not applicable. This device is a surgical implant, not an AI tool.

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

Not applicable. This device is a surgical implant, not an AI algorithm.

7. The type of ground truth used

Engineering specifications and validated performance testing methods. The "ground truth" for this submission is based on established engineering and material science principles, biomechanical testing standards, and direct comparison to the performance characteristics of legally marketed predicate devices.

8. The sample size for the training set

Not applicable. This is not an AI or machine learning device; therefore, there is no "training set."

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

Not applicable. As there is no training set, this question is not applicable.

Summary

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Device Description

MAR 2 6 2009

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

Line Extension to the Stryker Spine Reflex® Hybrid ACP System

Reflex® Translational ACP System Proprietary Name: Common Name: Anterior Cervical Plate System Proposed Regulatory Class: Class II Spinal Intervertebral Body Fixation Orthosis, 21 CFR 888.3060 Device Product Code: KWQ Sponsor: Stryker Spine For Information contact: Kimberly Lane Regulatory Affairs Specialist 2 Pearl Court Allendale, NJ 07401 Telephone: (201) 760-8215 Fax: (201) 760-8415 Email: Kimberly.Lane(@stryker.com Date Summary Prepared: October 7, 2008 Predicate Device Stryker Spine Reflex® Hybrid ACP System (K062310,

K040261) and Synthes Spine Cervical Spine Locking Platc System (K000536, K000742)

page 1 of 3

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configurations and in lengths ranging from 14mm through

96mm

Intended Use

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

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

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 consists of various length plates that have Titanium clips which hold the plate in the "fully open" position. After the plate is placed and secured, Titanium clips are

Page 2 of 3

Summary of the Technological Characteristics

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removed allowing the plate to decrease in size up to 2mm per level treated. This translational plate design uses the same screws and locking mechanism used in the predicate Stryker Spine Reflex® Hybrid ACP System. Engineering analysis and performance testing verify that the subject device system is substantially equivalent in terms of performance characteristics to the 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 Department of Health & Human Services - USA. The logo consists of 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 with its wings spread.

Public Health Service

Stryker Spine % Ms. Kimberly Lane Regulatory Affairs Specialist 2 Pearl Court Allendale, New Jersey 07401

ood and Drug Administration 200 Corporate Boulevard Rockville MD 20850

MAR 2 6 2009

Re: K083020

Trade/Device Name: Stryker Spine Reflex® Translational Anterior Cervical Plating System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: February 23, 2009 Received: February 24, 2009

Dear Ms. Lane:

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.

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Page 2 - Ms. Kimberly Lane

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 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 vours,

ely yours,

for

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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Indications for Use

510(k) Number (if known): K 083020

Device Name: Stryker Spine Reflex® Translational Anterior Cervical Plating System

Indications For Use:

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

I Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
I Trauma (including fractures)
포 Tumors
프 Deformities or curvatures (including kyphosis, lordosis, or scoliosis)
트 Pseudarthrosis
צ Failed previous fusion
Decompression of the spinal cord following total or partial cervical vertebrectomy 트
트 Spondylolisthesis
트 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 AND/OR (Part 21 CFR 801 Subpart D)

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

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

Concurrence of CIRH, Office of Device Evaluation (ODE)
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Division Sign-Off)

Division of General, Restorative,

and Neurological Devices page 1 of 1

510(k) Number	1083020
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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.