HYBRID ANTERIOR CERVICAL PLATE SYSTEM by DEPUY SPINE, INC.

The Hybrid Anterior Cervical Plate System is indicated for stabilization of the cervical spine from C2 to C7 employing unicortical screw fixation at the anterior face of the vertebral bodies. Specific clinical indications for anterior plating include: instability caused by trauma; instability associated with correction of cervical lordosis and kyphosis deformity; instability associated with pseudoarthosis as a result of previously failed cervical spine surgery; instability associated with major reconstructive surgery for primary tumors or metastatic malignant tumors of the cervical spine; instability associated with single or multiple level corpectomy in advanced degenerative disc disease, spinal canal stenosis and cervical myleopathy.

Device Description

The Hybrid Anterior Cervical Plate System consists of an assortment of plate and screws. The Hybrid Anterior Cervical Plate System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.

AI/ML Overview

This is a 510(k) premarket notification for a medical device (Hybrid Anterior Cervical Plate System), not an AI/ML device. Therefore, the majority of the requested information (e.g., acceptance criteria for AI performance, sample sizes for AI training/test sets, expert adjudication, MRMC studies, standalone AI performance) is not applicable.

However, I can extract information related to the device's performance data and indications for use, which are analogous to acceptance criteria in the context of a 510(k) submission for a non-AI device.

Here's the relevant information:

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

For a 510(k) device like this, "acceptance criteria" are generally demonstrated through material properties, mechanical testing, and comparisons to a legally marketed predicate device to establish substantial equivalence. The document states that "Performance data were submitted to characterize the Hybrid Anterior Cervical Plate System components." This implies that the device underwent testing to ensure its mechanical integrity and functional performance.

Acceptance Criteria (Demonstrated through comparison to predicate and mechanical testing)	Reported Device Performance
Biocompatibility	Manufactured from ASTM F-136 implant grade titanium alloy (established biocompatibility)
Mechanical Strength and Stability (e.g., flexion, extension, lateral bending, axial rotation, pull-out strength of screws)	Performance data were submitted to characterize the Hybrid Anterior Cervical Plate System components. This data demonstrated it is substantially equivalent to the SLIM-LOC™ Anterior Cervical Plate System (K013877).
Fit and Function	The system consists of an assortment of plate and screws, designed for unicortical screw fixation at the anterior face of the vertebral bodies from C2 to C7, similar to the predicate.

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

This information is typically not detailed in a 510(k) summary for mechanical devices, as the "test set" refers to mechanical test samples, not patient data. The document does not specify the number of test samples used for material or mechanical testing. Data provenance in the sense of patient data is not applicable here.

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)

This is not applicable to a 510(k) submission for a mechanical device. Ground truth, in this context, would be established through engineering specifications and objective mechanical testing.

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

Not applicable to a conventional mechanical device 510(k). Mechanical testing results are typically evaluated against pre-defined engineering standards.

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, as this is not an AI/ML device.

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

Not applicable, as this is not an AI/ML device.

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

For this mechanical device, the "ground truth" for performance would be established through:

Engineering specifications and material standards: Ensuring the materials meet ASTM F-136 implant grade titanium alloy.
Mechanical test results: Demonstrating the device's strength, stability, and integrity under simulated physiological conditions, showing substantial equivalence to the predicate device.

8. The sample size for the training set

Not applicable, as this is not an AI/ML device.

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

Not applicable, as this is not an AI/ML device.

Summary

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OCT 2 5 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Sharon Starowicz Director, Regulatory Affairs Depuy Spine, A Johnson & Johnson Company 325 Paramount Drive Raynham, MA 02767-0350

Re: K052552

Trade Name: Hybrid Anterior Cervical Plate Systme Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation System Regulatory Class: II Product Code: KWQ Dated: September 15, 2005 Received: September 16, 2005

Dear Ms. Starowicz:

This letter corrects our substantially equivalent letter of October 13, 2005.

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 (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 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. Sharon Starowicz

This letter will allow you to continue 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Signature

Mark N. Melkerson Acting 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: K052552

Device Name: Hybrid Anterior Cervical Plate System

Indications For Use:

Prescription Use X = AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Us (21 CFR 801 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_Kos 255-

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510(k) Summary

SUBMITTER:	DePuy Spine, Inc.325 Paramount DriveRaynham, MA 02780
CONTACT PERSON:	Liz Lavelle
DATE PREPARED:	September 15, 2005
CLASSIFICATION NAME:	Spinal Intervertebral Body Fixation Orthosis§888.3060
PROPRIETARY NAME:	Hybrid Anterior Cervical Plate System
PREDICATE DEVICE:	SLIM-LOC™ Anterior Cervical Plate System, K013877
DEVICE DESCRIPTION:	The Hybrid Anterior Cervical Plate System consists of anassortment of plate and screws.
	The Hybrid Anterior Cervical Plate System also containsClass 1 manual surgical instruments and cases that areconsidered exempt from premarket notification.
INTENDED USE:	The Hybrid Anterior Cervical Plate System is indicated forstabilization of the cervical spine from C2 to C7 employingunicortical screw fixation at the anterior face of the vertebralbodies. Specific clinical indications for anterior platinginclude: instability caused by trauma; instability associatedwith correction of cervical lordosis and kyphosis deformity;instability associated with pseudoarthosis as a result ofpreviously failed cervical spine surgery; instabilityassociated with major reconstructive surgery for primarytumors or metastatic malignant tumors of the cervical spine;instability associated with single or multiple levelcorpectomy in advanced degenerative disc disease, spinalcanal stenosis and cervical myleopathy.
MATERIALS:	Manufactured from ASTM F-136 implant grade titaniumalloy.
PERFORMANCEDATA:	Performance data were submitted to characterize theHybrid Anterior Cervical Plate System components.

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.