REFLEX HYBRID ACP SYSTEM by STRYKER SPINE

The Reflex™ Hybrid 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 thefollowing indications:

· Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)

· Trauma (including fractures)
· Tumors

· Deformities or curvatures (including kyphosis, lordosis or scoliosis)

· Pseudoarthrosis
· Failed previous fusion

· Decompression of the spinal cord following total or partial cervical vertebrectomy.

· Spondylolisthesis
· Spinal Stenosis

Device Description

The Reflex™ Hybrid ACP System includes plates (1level, 2-level, 3-level, and 4-level), 4.0 mm and 4.5mm diameter bone screws (variable angle self-drilling, variable angle self-tapping, fixed angle self-drilling, and fixed-angle self-tapping), and a locking ring component. This submission adds three new 4-level plate lengths to the Reflex™ Hybrid ACP System.

AI/ML Overview

This document is a 510(k) summary for a line extension to an existing medical device, the Stryker Spine Reflex™ Hybrid ACP System. The submission is for adding three new 4-level plate lengths to the system.

Here's the analysis based on the provided text, addressing your questions:

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

Based on the provided text, there are no explicit acceptance criteria or reported device performance metrics in the format you've requested. This document is a 510(k) summary, which primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting detailed performance data against specific acceptance criteria.

The submission states:

"The intended use and materials of the subject devices are identical to those of the predicate device system."
"Engineering analysis demonstrated that the subject device system is substantially equivalent in terms of performance characteristics to the predicate device system."

This indicates that the acceptance criterion is substantial equivalence to the predicate device, demonstrated through engineering analysis. However, the specific metrics or thresholds used in that engineering analysis are not detailed in this summary.

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

The document does not mention any test set, sample size, or data provenance because it relies on an "engineering analysis" to demonstrate equivalence rather than clinical or performance testing on a specific "test set" of data or patients. This is typical for a line extension of a device where the core design and materials are unchanged, and the modification (new plate lengths) is assessed through design verification and validation (engineering analysis) rather than new clinical trials or extensive human-data-based testing.

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)

No information about experts, ground truth establishment, or test sets is provided, as the submission relies on engineering analysis for substantial equivalence.

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

No information about an adjudication method is provided, as no clinical test set or human evaluation 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

No MRMC study was conducted or mentioned. This device is a surgical implant (anterior cervical plate system), not an AI-driven diagnostic or interpretative tool.

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

Not applicable, as this is a physical medical device, not an algorithm.

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

No explicit "ground truth" in the clinical or image analysis sense is mentioned. The "ground truth" for demonstrating equivalence would have been the established performance and safety of the predicate device, against which the engineering analysis of the new plate lengths was compared.

8. The sample size for the training set

Not applicable, as this is a physical medical device, not an algorithm that requires a training set.

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

Not applicable for the same reason as above.

In summary:

This 510(k) summary is for a line extension of an existing, already cleared physical medical device (Reflex™ Hybrid ACP System). The primary method for demonstrating safety and effectiveness for such a submission is to show substantial equivalence to the predicate device through engineering analysis, rather than presenting new clinical study data or performance metrics from human-based testing with ground truth. The change is limited to adding new lengths to existing plates, suggesting that the core performance characteristics are expected to be the same as the predicate devices, as verified by engineering methods.

Summary

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Special 510(k) Summary of Safety and Effectiveness: Line Extension to the Stryker Spine Reflex™ Hybrid ACP System

Proprietary Name:	Reflex™ Hybrid ACP SystemAUG 1 8 2006
Common Name:	Anterior Cervical Plate System
Proposed Regulatory Class:	Class IISpinal Intervertebral Body Fixation Orthosis,21 CFR 888.3060
Device Product Code:	KWQ
Sponsor:	Stryker Spine
For Information contact:	Simona VoicRegulatory Affairs Project ManagerStryker Spine2 Pearl CourtAllendale, NJ 07401Telephone: (201) 760-8145Fax: (201) 760-8345Email: Simona.Voic@stryker.com
Date Summary Prepared:	August 7, 2006
Predicate Device	Reflex™ Hybrid ACP System (K040261)Synthes Cervical Spine Locking Plate System(K000536 and K000742)

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Intended Use

Device Description

· Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)

· Trauma (including fractures)
· Tumors

· Deformities or curvatures (including kyphosis, lordosis or scoliosis)

· Pseudoarthrosis
· Failed previous fusion

· Decompression of the spinal cord following total or partial cervical vertebrectomy.

· Spondylolisthesis
· Spinal Stenosis

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Summary of the Technological Characteristics

The intended use and materials of the subject devices are identical to those of the predicate device system. Engineering analysis demonstrated that the subject device system is substantially equivalent in terms of performance characteristics to the predicate device system.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS) of the United States. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of four human figures in profile, arranged in a row and connected by a continuous line.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 8 2006

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

Re: K062310

Trade/Device Name: Stryker Spine™ Reflex Hybrid ACP System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: August 07, 2006 Received: August 8, 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, and 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. Simona Voic

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,

Charles Bullworth

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

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Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Stryker Spine Reflex™ Hybrid ACP System

Indications for Use:

· Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)

· Trauma (including fractures)
· Tumors

· Deformities or curvatures (including kyphosis, lordosis or scoliosis)

· Pseudoarthrosis
· Failed previous fusion

· Decompression of the spinal cord following total or partial cervical vertebrectomy.

· Spondylolisthesis

· Spinal Stenosis

WARNING: This device is not approved 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)

Senbare michim

(Division Sign-Off)

Division of General, Restorative,

and Neurological Devices

510(k) Number K062310

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.