HOWMEDICA AND HOWMEDICA LEIBINGER BONE SCREW WASHERS by HOWMEDICA CORP.

The washers are intended to be used to provide additional surface area contact between the screw head and bone surface, when used in combination with bone screws between the occord froution of the mandible, hand, foot and the midfacial skeleton where there exists a condition of a thin cortex or osteoporotic bone.

Device Description

The Howmedica® and Howmedica® Leibinger Bone Screw Washers consist of sizes ranging from .8 mm internal diameter to 3.5 mm internal diameter. The washers are used in conjunction with screws, of like or similar material, currently available in Luhr® and Leibinger®-Luhr® plating systems, which were cleared under various 510(k) notifications (K761228, K854886, K862482, K862534, K882454, K901941, K913355, K923861, K935448, K950595, K951415, K961485, K961497, K963739, K963740, K970912,) and any future styles of Howmedica® and Howmedica Leibinger® screws found substantially equivalent.

AI/ML Overview

This document is a 510(k) summary for medical devices, specifically bone screw washers. It details the device's intended use, materials, and establishes substantial equivalence to previously cleared devices. However, it does not contain the kind of performance study data, acceptance criteria, ground truth establishment, or sample size details that would typically be found in a clinical study report or a more detailed technical submission for a diagnostic AI/ML device.

Therefore, many of the requested points cannot be answered from the provided text.

Here is what can be inferred or explicitly stated from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics (e.g., sensitivity, specificity, accuracy). The acceptance for this type of device (bone screw washers) is based on substantial equivalence to predicate devices in terms of intended use, materials, design, and operational principles.
Reported Device Performance: Not applicable in the context of diagnostic performance metrics. The document asserts that the device is substantially equivalent to predicate devices.

Acceptance Criterion	Reported Device Performance
Intended Use	Equivalent
Materials	Equivalent
Design	Equivalent
Operational Principles	Equivalent

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

Sample Size (Test Set): Not applicable. There was no "test set" in the sense of a dataset of patient cases used to evaluate diagnostic performance. The substantial equivalence argument relies on a comparison of device characteristics rather than a performance study on a test set.
Data Provenance: Not applicable for a performance study. The "data" here refers to the specifications and characteristics of the bone screw washers and their predicate devices.

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 requiring ground truth establishment by experts for diagnostic performance.

4. Adjudication method for the test set:

Not applicable.

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/ML diagnostic 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 safety and effectiveness of the predicate devices. The device is deemed safe and effective because it is substantially equivalent to devices already cleared for market. This isn't "ground truth" in the diagnostic sense, but rather regulatory precedent.

8. The sample size for the training set:

Not applicable, as this is not an AI/ML device requiring a training set.

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

Not applicable.

Summary

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APR 2 9 1998

510(k) Summarv

Proprietary Name:

Common Name: Classification Name & Reference: Proposed Requlatory Class: Device Product Code:

Howmedica® and Howmedica® Leibinger Bone Screw Washers Washers Smooth or threaded metallic bone fixation fastener 21 CFR 888.3040 ﺍﻟﻤ HWC

For information contact:

Sean Luland Regulatory Affairs Associate Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 Phone: (201) 507-7437 Fax: (201) 507-6870

The washers are intended to be used to provide additional surface area contact between the screw head and bone surface, when used in combination with bone screws for small bone reconstruction of the mandible, hand, foot and the midfacial skeleton where there exists a condition of a thin cortex or osteoporotic bone.

The substantial equivalence of these components is based on an equivalence in intended use, materials, design, and operational principles to Howmedica's Large Cancellous Washer, Vitallium Washer, ICS Mini and Small Fregment Set Washer and Synthes® Mini Fragment Implant Set Washer and Schuhli Washer.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 9 1998

Mr. Sean Luland Requlatory Affairs Associate Howmedica Inc. Pfizer Hospital Products Group 359 Veterans Boulevard Rutherford, New Jersey 07070-2584

K980364 Re : Bone Screw Washers Trade Name: Requlatory Class : II Product Code: HWC Dated: January 28, 1998 Received: January 29,1998

Dear Mr. Luland:

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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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. ਜੋ 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 Failure to Administration (FDA) will verify such assumptions. 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.

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Page 2 - Mr. Sean Luland

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

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: The Howmedica® and Howmedica® Leibinger Bone Screw Washers

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)	X
OR
Over-The-Counter Use

(Division Sign-Off)
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Division of General Restorative Devices
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510(k) Number	4980364
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(Optional Format 1-2-96)

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.