DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATION by HOWMEDICA CORP.

The Intended use of this additional style of Duracon® Condylar and A-P lipped tibial inserts is identical to that of previously released Duracon® tibial inserts: they are intended to be used with Duracon® femoral and patellar components, and tibial baseplates in primary or revision cemented total knee arthroplasty.

Device Description

The purpose of this submission is to describe an additional style of Duracon® Condylar and A-P lipped tibial inserts which are stabilized/sterilized using a process called and A-1 "Ilpped tible incorro the Duration® II process is to crosslink all of the free radicals found in the UHMWPE rod stock by exposure to gamma radiation this froo radio lound lount in a heated oven. During this radiation/stabilization period, the UHMWPE is exposed to a very low oxygen concentration. The stabilized periou, the United to its final configuration. The tibial insert is packaged in air, and terminally sterilized by the ethylene oxide sterilization process. The Duracon® and terminally ottomized by this method conform to the requirements for Ultra High Molecular Weight Polyethylene specified in ASTM Specification F-648, for Okla Figh Molocation on UHMWPE used in Bearing Surfaces for Orthopedic Devices.

These Duracon® Condylar and A-P lipped inserts are identical to those previously released. They are available in peripheral sizes extra-small through extra-large in thicknesses from 6mm to 25mm. These inserts have a three point locking in thisklesson from on on on one Duracon® inserts which have been previously released.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (Duration® II Duracon® Tibial Inserts) and does not describe artificial intelligence performance or a study comparing AI to human readers. Therefore, I cannot extract the requested information about AI acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader, multi-case studies.

The document focuses on demonstrating substantial equivalence of a new style of tibial inserts to previously marketed versions, primarily through material property testing and comparison of intended use.

Here's a breakdown of what the document does provide, although it doesn't align with the AI-centric questions:

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

Acceptance Criteria	Reported Device Performance
Products meet all ASTM F 648 specified standards.	Duration® II products meet all ASTM F 648 specified standards.
No detectable oxidation as measured by FTIR up to 30 days of accelerated aging at 80° C in air.	Duration® II products have no detectable oxidation as measured by FTIR up to 30 days of accelerated aging at 80° C in air.
Higher gel content (cross-linking) than air irradiated UHMWPE measured in accordance with modified ASTM D2765-90 standard.	Duration® II products have a higher gel content (cross-linking) than air irradiated UHMWPE measured in accordance with modified ASTM D2765-90 standard.
Lower tensile modulus than air irradiated UHMWPE, increasing contact area and decreasing contact stress.	Duration® II has a lower tensile modulus than air irradiated UHMWPE. This would increase in contact area and a decrease in contact stress.
No free radicals detected in the final product when analyzed by the ESR technique.	No free radicals are detected in the Duration® II material when analyzed by the ESR technique of the final product.

2. Sample sized used for the test set and the data provenance: Not applicable. The document discusses material testing, not a dataset for an AI model.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" here is defined by material standards (ASTM F-648, ASTM D2765-90) and analytical methods (FTIR, ESR) for which expert consensus in the AI sense is not relevant.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Material testing results are objective measurements against defined 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. This is not an AI device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.

7. The type of ground truth used: Material property standards (ASTM F-648, ASTM D2765-90) and analytical measurements (FTIR, ESR).

8. The sample size for the training set: Not applicable. There is no training set for an AI model.

9. How the ground truth for the training set was established: Not applicable. There is no training set for an AI model.

Summary

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K980925

DEC 16 1998

510(k) Summary

Device:

Duration® II Duracon® Tibial Inserts - Ethylene Oxide Sterilization

The intended use of this additional style of Duracon® Condylar and A-P lipped tibial inserts is identical to that of previously released Duracon® tibial inserts: they are intended to be used with Duracon® femoral and patellar components, and tibial baseplates in primary or revision cemented total knee arthroplasty.

These inserts are substantially equivalent to the other Duracon® Condylar and A-P lipped tibial Inserts which are already in distribution by Howmedica.

Testing was performed in accordance with the draft FDA guidance on UHMWPE.

The following marketing claims will be made for the product:

Duration® II products meet all ASTM F 648 specified standards. 1.
Duration® II products have no detectable oxidation as measured by FTIR up to 2. 30 days of accelerated aging at 80° C in air.
Duration® II products have a higher gel content (cross-linking) than air irradiated న. UHMWPE measured in accordance with modified ASTM D2765-90 standard.

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Duration® II has a lower tensile modulus than air irradiated UHMVE. This 4. Duranone if had a lower tonelle would increase in contact area and a decrease in contact stress.
No free radicals are detected in the Duration® II material when analyzed by ട്. the ESR technique of the final product.

Frank Maas For information contact: Manager, Regulatory Affairs Howmedica Osteonics 359 Veterans Boulevard Rutherford, NJ 07070 (201) 507-7875

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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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized, curved lines representing its wings or body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 16 1998

Ms. Margaret Crowe Manager, Regulatory Affairs Howmedica Inc. Pfizer Medical Technology Group 359 Veterans Boulevard Rutherford, New Jersey 07070-2584

Re : K980925 Duration® II Tibial Inserts - EtO Trade Name: Sterilization K980926 Duration® II Acetabular Components - EtO Trade Name: Sterilization Regulatory Class: II Product Codes: JWH and JDI October 7, 1998 Dated: Received: October 8, 1998

Dear Ms. Crowe:

We have reviewed your Section 510(k) notifications of intent to market the devices referenced above and we have determined these devices are substantially equivalent (for the indications for use stated in the enclosures) 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A 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.

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Page 2 - Ms. Margaret Crowe

In addition, FDA may publish further announcements action. concerning your devices 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 requlations.

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

If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your devices, 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,

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

Enclosures

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Indications for Use

510(k) Number (if known): K980925

Device Name: Duration® II Duracon® Tibial Inserts - Ethylene Oxide Sterilization

Indications for Use:

The Intended use of this additional style of Duracon® Condylar and A-P lipped tibial
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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use OR (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

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Regulation Number and Section

§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.