The DePuy OrthoTech Spiked Washer is intended for use with a 6.5mm cancellous thread or a 4.5mm cortical thread low profile head screw for fixation of soft tissue, such as tendon and ligaments, to bone in orthopaedic procedures.

Device Description

The DePuy OrthoTech Spiked Washer is a circular device with eight inferior (fixative surface) spikes and a central hole for screw insertion. The DePuy OrthoTech Spiked Washer is manufactured from polyacetal polymer and is available in two outer diameters, 8mm and 13.5mm.

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device called the DePuy OrthoTech Spiked Washer. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with acceptance criteria for device performance. Therefore, many of the requested categories related to clinical study design and performance metrics are not applicable to the information contained in this document.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not specify "acceptance criteria" in the sense of predefined thresholds for performance metrics from a clinical study. Instead, the "acceptance criteria" for this 510(k) submission are based on demonstrating substantial equivalence to predicate devices. The "reported device performance" is a comparison of its design, material, and intended use with the predicate devices.

Feature	Acceptance Criteria (based on predicate devices)	Reported Device Performance (DePuy OrthoTech Spiked Washer)
Material	Polyacetal Polymer (as per Acufex® Tibial Anchor Screw & Spiked Washer and Synthes Spiked Washer)	Polyacetal Polymer
Intended Use	Soft Tissue Fixation (similar to Acufex®) or Ligament Fixation (similar to Synthes®)	Soft Tissue Fixation
Product Code	HWC or HTN (consistent with predicate devices)	HTN, HWC
Use with Screws	Yes (consistent with predicate devices)	Yes
Washer Design	Circular with Spikes (consistent with predicate devices)	Circular with Spikes
Washer Outer Diameter	Within a range comparable to predicate devices (Acufex 14-20mm, Synthes 13.5mm)	8mm, 13.5mm
Labeling (Sterility/Reuse)	Not explicitly stated as an "acceptance criterion," but the predicate devices are Sterile, Single Use. The proposed device is Non-Sterile, Single Use. This difference is noted but not presented as a barrier to substantial equivalence.	Non-Sterile, Single Use

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

Sample Size: Not applicable. This submission is not based on a clinical test set with human or animal subjects that would have a "sample size." It relies on a comparison of device characteristics.
Data Provenance: Not applicable. The data primarily consists of design specifications and regulatory information for the proposed device and its predicates.

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

Not applicable. There was no "test set" in the traditional sense of a dataset requiring expert interpretation. The ground truth is established by the design specifications and technical characteristics of the devices themselves.

4. Adjudication method for the test set

Not applicable. No adjudication method was used as there was no test set requiring interpretation or consensus among experts.

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 is not an AI-assisted device and no MRMC study was conducted.

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

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

7. The type of ground truth used

The "ground truth" in this context is the design specifications, material composition, and stated intended use of the DePuy OrthoTech Spiked Washer and its identified predicate devices (Smith-Nephew Acufex® Tibial Anchor Screw & Spiked Washer and Synthes® Spiked Washer). Substantial equivalence is established by comparing these fundamental attributes.

8. The sample size for the training set

Not applicable. There is no training set in the context of this 510(k) submission.

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

Not applicable. There is no training set for which ground truth would need to be established.

Summary

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DEC 18 1998

K983906

SUMMARY OF SAFETY AND EFFECTIVENESS

NAME OF FIRM:	DePuy Orthopaedics, Inc.700 Orthopaedic Drive; P.O. Box 988Warsaw, Indiana 46581-0988
510(k) CONTACT:	Sally FoustSr. Regulatory Submissions AssociateDePuy Orthopaedics, Inc.(219) 372-7455; FAX 1 (219) 267-7098E-mail: Sally_Foust@ccgate.depuy.com
TRADE NAME:	DePuy OrthoTech Spiked Washer
COMMON NAME:	Spiked Washer
CLASSIFICATION:	888.03030 - Single/multiple component, metallicbone fixation appliances and accessories
DEVICE PRODUCT CODE:	87 HTN, HWC

SUBSTANTIALLY

EQUIVALENT DEVICES:

Smith-Nephew Acufex® Tibial Anchor Screw & Spiked Washer (K961649) Synthes® Spiked Washer (K914472)

DEVICE DESCRIPTION AND INTENDED USE:

BASIS OF SUBSTANTIAL EQUIVALENCE:

The DePuy OrthoTech Spiked Washer is substantially equivalent to both the Smith & Nephew Acufex Spiked Washer and the Synthes Spiked Washer in that all are circular washers designed with fixative surface spikes, are manufactured from polyacetal polymer, and are intended for use with screws for fixation of soft tissue, such as tendon and ligaments, to bone in orthopaedic procedures.

Based on similarities of design, materials and intended use, DePuy believes that the subject spiked washer is substantially equivalent to the previously cleared Smith & Nephew Acufex Tibial Spiked Washer and Synthes Spiked Washer.

The table on the following page summarizes the similarities:

OK
TI

000003

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	DePuy OrthoTechSpiked Washer	Acufex® TibialAnchor Screw &Spiked Washer	Synthes (USA)Spiked Washer
	(Current)	(K961649)	(K914472)
MATERIAL	Polyacetal Polymer	Polyacetal Polymer	Polyacetal Polymer
IINTENDEDUSE	Soft Tissue Fixation	Soft Tissue Fixation	Ligament Fixation
PRODUCTCODE	HTNHWC	HWC	HTN
USE WITHSCREWS	Yes	Yes	Yes
WASHERDESIGN	CircularWith Spikes	CircularWith Spikes	CircularWith Spikes
WASHEROUTERDIAMETER	8mm13.5mm	14-20mm	13.5mm
LABELING	Non-Sterile,Single Use	Sterile,Single Use	Sterile,Single Use

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and head. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 18 1998

Ms. Sally Foust Senior Regulatory Submissions Associate DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive 46581-0988 Warsaw, Indiana

K983906 Re: DePuy OrthoTech Spiked Washer Trade Name: Regulatory Class: II Product Code: HWC Dated: November 2, 1998 November 3, 1998 Received:

Dear Ms. Foust:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਕੇ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (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 action. In addition, FDA may publish further announcements 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.

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Page 2 - Ms. Sally Foust

This letter will allow you to begin marketing your device as described in your 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 requlation (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,

[signature]

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known) _ k 983906_

Device Name DePuy OrthoTech Spiked Washer

Indications for Use:

Concurrence of CDRH, Office of Device Evaluation

==============================================================================================================================================================================

Prescription Use _ X

Over-The Counter Use __

(Per 21 CFR 801.109)

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(Division Sign-Off) Division of General Restorative Devices

510(k) Number

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.