ZERO PROFILE ANTERIOR CERVICAL PLATE (ACP) SYSTEM by STRYKER SPINE

The Zero Profile Anterior Cervical Plating (ACP) 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 to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Device Description

The Zero Profile ACP System includes anterior cervical plates in one-level and two-level configurations, and in lengths from 12mm to 42mm, depending on the configuration. The subject plates are intended for use with the predicate Reflex HybridTM ACP bone screws. The components of the Zero Profile ACP system are manufactured from Ti6Al4V alloy per ASTM F-136 and will be provided non-sterile. The intended use and materials of the subject anterior cervical plates are identical to those of the predicate anterior cervical plates. The new plates feature a lower profile design than the predicate Reflex HybridTM Anterior Cervical Plates, but are used with the predicate Reflex Hybrid™ ACP System screw.

AI/ML Overview

The provided text describes a medical device, the "Zero Profile Anterior Cervical Plate System," and its submission for a 510(k) premarket notification. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical studies to prove effectiveness or meeting specific performance acceptance criteria from a study.

Therefore, many of the requested categories related to clinical study design, acceptance criteria, sample sizes, expert ground truth, and AI performance do not apply to this specific document or the type of regulatory submission it represents.

Here's a breakdown of the information as it relates to your request, noting where information is not present or not applicable:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for a study. The acceptance criterion for this 510(k) submission is to demonstrate "substantial equivalence" to predicate devices.
Reported Device Performance: 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." Specific quantitative performance results from these tests are not provided in this summary. Instead, the assertion of substantial equivalence is the "performance reported."

Acceptance Criteria (for Substantial Equivalence)	Reported Device Performance
Demonstrates substantial equivalence in performance characteristics to predicate devices.	"Engineering analysis and performance testing verify that the subject device system is substantially equivalent in terms of performance characteristics to the predicate device systems."

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

Not Applicable: This 510(k) summary does not describe a clinical study with a "test set" in the context of evaluating a diagnostic or AI device. The statement "Engineering analysis and performance testing" refers to bench testing and mechanical properties, not patient data.

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)

Not Applicable: No clinical "test set" with ground truth established by experts is described for this type of device and submission.

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

Not Applicable: No clinical "test set" with expert adjudication is described.

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 an anterior cervical plate system (a mechanical implant), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance would not be relevant.

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 algorithm.

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

Not Applicable: For demonstrating substantial equivalence of a mechanical device, ground truth in the clinical sense (e.g., pathology) is not typically established. Performance is evaluated through engineering analyses, mechanical testing (e.g., fatigue strength, pull-out strength), and material properties compared to predicate devices.

8. The sample size for the training set

Not Applicable: No "training set" in the context of AI or clinical data is described. The "engineering analysis and performance testing" would involve a sample size of physical devices tested, but that is not referred to as a "training set."

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

Not Applicable: As there is no training set described in this context, no ground truth establishment method for it is applicable.

Summary

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Line Extension to the Stryker Spine Reflex ™ Hybrid ACP System

Special 510(k) Summary: Special 510(k) Sv.mary:

Zero Profile Anterior Cervical Plate System, MAR 2 2 2007 Line Extension to the Stryker Spine Reflex™ Hybrid ACP System

Proprietary Name:	Zero Profile Anterior Cervical Plate (ACP) System
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:	Simona Voic
	Regulatory Affairs Project Manager
	Stryker Spine
	2 Pearl Court
	Allendale, NJ 07401Telephone: (201) 760-8145Fax: (201) 760-8345Email: Simona.Voic@stryker.com
Date Summary Prepared:	February 28, 2007
Predicate Device	Reflex™ Hybrid ACP System (K062310, K040261)Synthes Cervical Spine Locking Plate System(K000536 and K000742)

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Device Description

Intended Use

Summary of the Technological Characteristics

ACP system are manufactured from Ti6Al4V alloy per

ASTM F-136 and will be provided non-sterile.

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

WARNING: This device is not approved or intended for screw attachment 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 new plates feature a lower

profile design than the predicate Reflex HybridTM

Anterior Cervical Plates, but are used with the

predicate Reflex Hybrid™ ACP System screw.

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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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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 eagle or bird-like symbol with flowing lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the symbol. The logo is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

MAR 2 2 2007

Re: K063430

Trade/Device Name: Zero Profile Anterior Cervical Plate System Regulation Number: 21 CFR §888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: November 10, 2006 Received: November 13, 2006

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.

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Page 2 - Ms. Simona Voic

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 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 (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Barbara Boehm

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): _K063430

Device Name: Zero Profile Anterior Cervical Plate System

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

WARNING: This device is not approved or intended for screw attachment 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 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Verbere Buelld

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

Page of

510(k) Number K063430

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.