The DePuy Motech PEAK Polyaxial Anterior Cervical Plate System is intended for anterior cervical screw fixation in the treatment of anterior cervical spine instability as a result of fractures (dislocations and subluxations), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), or a failed previous cervical spine surgery.

Device Description

The DePuy Motech PEAK Polyaxial Anterior Cervical Plate System consists of 30 different Ti-6Al-4V ELI plates. The plates are available in 4 design segments (1, 2, 3 or 4 "I shaped" segments), each being available in a variety of lengths. The system also includes 3 different Ti-6Al-4V ELI cancellous screws. The 4.0mm screw is utilized in the plate holes which are located around the periphery of the plate and are intended for fixation between the plate and vertebral bodies that have been spanned by the construct. The 4.35mm screws are intended for use in the same manner as the 4.0mm screws. The 4.35mm bone screw is intended to be used in the event that the surgeon must remove and reinsert a 4.0mm bone screw. The 4.35mm bone screw is larger and therefore would allow a surgeon to regain purchase in the previous screw hole. The graft screw is optionally used in the case of a corpectomy and subsequent replacement with a strut graft, to obtain fixation between the graft and plate.

AI/ML Overview

The provided 510(k) summary for the DePuy Motech PEAK™ Polyaxial Anterior Cervical Plate System focuses on demonstrating substantial equivalence through material, design, and intended use comparison to a predicate device, as well as mechanical fatigue testing. It does not include information about a study involving performance metrics like accuracy, sensitivity, or specificity for a software-driven device, nor does it describe human reader studies.

Therefore, many of the requested sections below cannot be populated from the provided text.

Here's a breakdown based on the information available:

Acceptance Criteria and Device Performance Study for DePuy Motech PEAK™ Polyaxial Anterior Cervical Plate System

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Mechanical Testing: Fatigue Strength (specifically, in comparison to the predicate device)	The fatigue strength of the DePuy Motech PEAK Polyaxial Anterior Cervical Plate System is equivalent or better than that of the predicate device (DePuy Motech PEAK Anterior Compression Plate System).

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

The document describes mechanical testing, not a test set for an AI or imaging device. Therefore, typical sample size and data provenance (country of origin, retrospective/prospective) for clinical data are not applicable here. The "sample size" would refer to the number of devices or constructs tested in the mechanical fatigue study. This specific number is not provided in the summary.

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

This section is not applicable as the document describes mechanical testing of a medical device, not a study requiring expert-established ground truth for a test set (e.g., for diagnostic accuracy).

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

This section is not applicable as the document describes mechanical testing. Adjudication methods are relevant for studies involving human interpretation or clinical outcomes, not device mechanics.

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

There is no mention of an MRMC comparative effectiveness study, nor any AI component in this device. The device described is a physical anterior cervical plate system.

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

This section is not applicable as the device is a physical implant, not an algorithm or software.

7. The type of ground truth used

For the mechanical testing, the "ground truth" would be the physical properties and performance of the predicate device under specific test conditions, as established through standard mechanical testing protocols.

8. The sample size for the training set

This section is not applicable as there is no AI or algorithm that would require a training set.

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

This section is not applicable as there is no AI or algorithm that would require a training set.

Summary

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

x971430

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

NAME OF FIRM:	DePuy, Inc.
	700 Orthopaedic Drive
	Warsaw, Indiana 46581-0988
510(K) CONTACT:	Arlene C. Saull, RAC
	Manager, Medical Device Submissions
	DePuy Orthopaedics, Inc.
	700 Orthopaedic Drive
	Warsaw, IN 46581-0988
TRADE NAME:	DePuy Motech PEAK™ Polyaxial AnteriorCervical Plate System
COMMON NAME:	Anterior Cervical Plate
CLASSIFICATION:	888.3060: Spinal intervertebral body fixationorthosis
DEVICE PRODUCT CODE:	87 KWQ
SUBSTANTIALLYEQUIVALENT DEVICES:	DePuy Motech PEAK Anterior Compression PlateSystem

DEVICE DESCRIPTION AND INTENDED USE:

The 4.0mm screw is utilized in the plate holes which are located around the periphery of the plate and are intended for fixation between the plate and vertebral bodies that have been spanned by the construct. The 4.35mm screws are intended for use in the same manner as the 4.0mm screws. The 4.35mm bone screw is intended to be used in the event that the surgeon must remove and reinsert a 4.0mm bone screw. The 4.35mm bone screw is larger and therefore would allow a surgeon to regain purchase in the previous screw hole.

The graft screw is optionally used in the case of a corpectomy and subsequent replacement with a strut graft, to obtain fixation between the graft and plate.

The DePuy Motech PEAK Polyaxial Anterior Cervical Plate System is intended for anterior cervical screw fixation in the treatment of anterior cervical spine instability as a

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

result of fractures (dislocations and subluxations), turnor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), or a failed previous cervical spine surgery.

BASIS OF SUBSTANTIAL EQUIVALENCE:

The DePuy Motech PEAK Polyaxial Anterior Cervical Plate System is similar in material, design and intended use to the DePuy Motech PEAK Anterior Compression Plate System. Both of these systems consist of Ti-6Al-4V ELI bone plates and screws intended for use in anterior stabilization of various cervical spine instabilities. Mechanical testing indicates that the fatigue strength of the DePuy Motech PEAK Polyaxial Anterior Cervical Plate System is equivalent or better than that of the DePuy Motech PEAK Anterior Compression Plate System..

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

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three heads, representing service to individuals and families. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 3 1997

Arlene C. Saull, RAC Senior Submissions Associate DePuy, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

Re: K971730 DePuy Motech PEAK™ Polyaxial Anterior Cervical Plate System Regulatory Class: II Product Code: KWQ Dated: August 20, 1997 Received: August 21, 1997

Dear Ms. Saull:

We have reviewed your Section 510(k) notification of intent to market the device system referenced above and we have determined the device system is substantially equivalent (for the indications for use stated in the enclosure) to device systems marketed in interstate commerce prior to May 28, 1976 or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market your device system subject to the general controls provisions of the Act and the limitations identified below.

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. Note that labeling or otherwise promoting this device system for pedicular screw fixation/attachment would cause the device system to be adulterated under 501(f) (1) of the Act.

FDA identifies that any device system, if intended for use in pedicular screw fixation/attachment, except for some limited indications, would be found not substantially equivalent and would be a class III device under Section 513(f) of the Act. Class III devices are required to have an approved premarket approval (PMA) application prior to marketing. Accordingly:

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

Page 2 - Arlene C. Saull, RAC

You may not label or in any way promote this device 1. system for pedicular screw attachment to, or fixation of the cervical, thoracic or lumbar vertebral column. Therefore, in order to prevent off-label promotion, the package insert must include the following statement, This device system is not approved for screw "WARNING: attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.";
All labeling for this device system, including the 2. package label, must state that there are labeling The package insert must prominently state limitations. that the device system is intended for the specific use(s) described in the enclosure only; and
Pedicular screw fixation/attachment to the cervical, 3. thoracic or lumbar vertebral column, except for limited indications, of any device system is considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulations under 21 CFR, Part 812. All users of the device system for pedicular screw fixation/attachment must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) prior to conducting an investigation.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. ಗೆ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.

FDA advises that the use of the subject device system and/or device components with any other device components but those identified in this 510(k) would require submission of a new

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

Page 3 - Arlene C. Saull, RAC

510(k) providing documentation of design, material, and labeling compatibility between the device components. Mechanical testing of a spinal system consisting of the subject device components and other device components, whether yours or other manufacturers', may also be required.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.
Director

Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

INDICATIONS

510(k) Number (if known) K971730

DePuy Motech PEAK™ Polyaxial Anterior Cervical Plate System Device Name

Indications for Use:

Concurrence of CDRH, Office of Device Evaluation

Apede

510(k) Numb

Prescription Use
OR

Over-The Counter Use ____(Per 21 CFR 801.109)

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.