DURATION IV STERILIZATION PROCESS (ACETABULAR INSERTS) by HOWMEDICA OSTEONICS CORP.

The intended use of the additional styles of the System 12®, Omnifit®, & Trident™ acetabular inserts is identical to that of previously released inserts: they are intended to be used with their respective acetabular shells in primary or revision total hip arthroplasty.

Device Description

The purpose of this submission is to describe additional styles of System 120 Acetabular, Omnifit® and Trident™ Acetabular Inserts which are sterilized/ stabilized using a process called Duration® IV Stabilization. The purpose of the Duration® IV process is to minimize (through crosslinking) the free radicals found in the UHMWPE rod stock by exposure to gamma radiation followed by a stabilization process in a heated oven. The stabilized rod stock is then machined to its final configuration. The components are packaged in air, and terminally sterilized by either Gas Plasma or Ethylene Oxide sterilization. The components produced by this method conform to the requirements for Ultra High Molecular Weight Polyethylene specified in ASTM Specification F-648, and the FDA guidance document on UHMWPE used in Bearing Surfaces for Orthopedic Devices.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Duration® IV Sterilization/Stabilization Process, based on the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Claim	Reported Device Performance
1. Duration® IV products meet all ASTM F-648 specified standards.	The components produced by this method conform to the requirements for Ultra High Molecular Weight Polyethylene specified in ASTM Specification F-648.
2. Duration® IV products have no detectable oxidation as measured by FTIR up to 23 days of accelerated aging at 80℃ in air.	No specific reported device performance value is given, but the claim explicitly states "no detectable oxidation."
3. Duration® IV products have a higher cross-linking density than air irradiated UHMWPE measured in accordance with modified ASTM D2765-90 standard.	No specific reported device performance value is given, but the claim explicitly states "higher cross-linking density."
4. Duration® IV has a lower tensile modulus than air irradiated UHMWPE. This lower stiffness has demonstrated an increase in contact area and a decrease in contact stress.	No specific reported device performance value is given, but the claim explicitly states "lower tensile modulus," "increase in contact area," and "decrease in contact stress."
5. No free radicals are detected in the Duration® IV material when analyzed by the ESR technique of the final product.	No specific reported device performance value is given, but the claim explicitly states "No free radicals are detected."
6. Duration® IV has a 91% lower wear rate, as measured by hip wear simulation testing under non-abrasive conditions, than UHMWPE that is gamma sterilized in an inert atmosphere.	Average total wear of 22.8 ± 13.7 mm³ for Duration® IV compared to 258.8 ± 39.7 mm³ for control UHMWPE (gamma sterilized in inert atmosphere). This represents a 91% lower wear rate for Duration® IV. Testing was performed in a multiaxial hip joint simulator for 5.0 million cycles using a 32 mm CoCr head articulating counterface against a 4.8 mm thickness polyethylene insert with bovine calf serum as lubricant.
7. Duration® IV has a 98% lower wear rate, as measured by hip wear simulation testing under abrasive conditions, than UHMWPE that is gamma sterilized in an inert atmosphere.	Average total wear of 2.2 ± 2.2 mm³ for Duration® IV compared to 89.9 ± 4.0 mm³ for control UHMWPE (gamma sterilized in inert atmosphere). This represents a 98% lower wear rate for Duration® IV. Testing was performed in a multiaxial hip joint simulator for 3.5 million cycles using a 32 mm CoCr head articulating counterface against a 4.8 mm thickness polyethylene insert with bovine calf serum as lubricant and PMMA bone cement particles as the abrasive media.

Study Details:

The provided document describes physical and mechanical testing of the Duration® IV Sterilization/Stabilization Process and its resultant products (Acetabular Inserts). It does not describe a clinical study involving human patients or the evaluation of an AI-powered device. Therefore, many of the requested fields are not applicable to the provided information.

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a numerical 'sample size' for each test. For wear simulation (Claims 6 & 7), the statistical reporting includes standard deviations (e.g., 22.8 ± 13.7 mm³), implying multiple test repetitions. However, the exact 'n' for these tests or for other criteria like FTIR, ESR, or tensile modulus is not provided.
- Data Provenance: The studies are retrospective in vitro laboratory bench tests on the material. The country of origin for the data is not specified, but the submission is to the US FDA by Howmedica Osteonics Corp., which has its contact in Rutherford, NJ, USA.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A: As this is a materials science and engineering study involving laboratory testing, "experts" in the context of clinical ground truth (e.g., radiologists) are not applicable. The measurements themselves serve as the 'ground truth' for the material properties.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A: Adjudication methods like 2+1 are relevant for clinical studies with subjective interpretations (e.g., imaging reads). This is a laboratory testing scenario where direct measurements are taken.
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:
- No: This is a materials science study, not a study evaluating human reader performance with or without AI.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- N/A: Not applicable, as this is not an algorithm or AI device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for the acceptance criteria are direct physical and chemical measurements of the material's properties (e.g., wear rate, oxidation detection, cross-linking density, tensile modulus, free radical detection) using established ASTM standards and laboratory techniques (FTIR, ESR, hip wear simulation).
The sample size for the training set:
- N/A: There is no "training set" as this is not a machine learning or AI algorithm.
How the ground truth for the training set was established:
- N/A: Not applicable, as there is no training set.

Summary

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DEC 20 1991

510(k) Summarv

Proprietary Name: Duration® IV Sterilization / Stabilization Process (System 12® Acetabular Inserts, Omnifit® and Trident™ Acetabular Inserts)

Common Name: Modular Acetabular Inserts

Classification Name and Reference: 21 CFR 888.3353 Hip Joint Metal/Ceramic/Polymer, Semi-Constrained Cemented or uncemented prosthesis

Proposed Regulatory Class: Class II

Device Product Code: JDI OR(87)

For information contact: Frank Maas Manager, Regulatory Affairs Howmedica Osteonics Corp. 359 Veterans Boulevard Rutherford, NJ 07070 Telephone: (201) 507-7875 (201) 507-6870 Fax: Date Summary Prepared: 3/12/99

The intended use of the additional styles of components referenced above is identical to that of the previously released components. The System 12®, Omnifit®, and Trident™ acetabular inserts are intended to be used with their respective acetabular shells in primary or revision total hip arthroplasty.

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

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The following marketing claims will be made for the products:

I. Duration® IV products meet all ASTM F-648 specified standards.
1. Duration® IV products have no detectable oxidation as measured by FTIR up to 23 days of accelerated aging at 80℃ in air.
1. Duration® IV products have a higher cross-linking density than air irradiated UHMWPE measured in accordance with modified ASTM D2765-90 standard.
1. Duration® IV has a lower tensile modulus than air irradiated UHMWPE. This lower stiffness has demonstrated an increase in contact area and a decrease in contact stress.
న. No free radicals are detected in the Duration® IV material when analyzed by the ESR technique of the final product.
રં. Duration® IV has a 91% lower wear rate, as measured by hip wear simulation testing under non-abrasive conditions, than UHMWPE that is gamma sterilized in an inert atmosphere (an average total wear of 22.8 ± 13.7mm² instead of 258.8 ± 39.7 mm3). Testing was performed in a multiaxial hip joint simulator for 5.0 million cycles using a 32 mm CoCr head articulating counterface against a 4.8 mm thickness polyethylene insert with bovine calf serum used as a lubricant. The results of in vitro tests have not been shown to correlate with clinical wear mechanisms.
1. Duration® IV has a 98% lower wear rate, as measured by hip wear simulation testing under abrasive conditions, than UHMWPE that is gamma sterilized in an inert atmosphere (an average total wear of 2.2 ± 2.2 mm² instead of 89.9 ± 4.0 mm' ). Testing was performed in a multiaxial hip joint simulator for 3.5 million cycles using a 32 mm CoCr head articulating counterface against a 4.8 mm thickness polyethylene insert with bovine calf serum used as a lubricant and PMMA bone cement particles as the abrasive media.. The results of in vitro tests have not been shown to correlate with clinical wear mechanisms.

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Image /page/2/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's logo, which is a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 0 1999

Mr. Frank Maas Manager, Regulatory Affairs Howmedica Osteonics Corporation 359 Veterans Blvd. Rutherford, New Jersey 07070

Re: K990849

Trade Name: Duration IV Sterilization Process (Acetabular Inserts) Regulatory Class: II Product Code: LPH and JDI Dated: September 13, 1999 Received: September 30, 1999

Dear Mr. Maas:

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 regulations affecting your device 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 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 - Mr. Frank Maas

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 at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely vours.

Neil R.P. Ogden for
James E. Dillard

Acting Division 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

K990849 510(k) Number (if known):

System 12®, Omnifit®, & Trident™ Acetabular Inserts Device Name:

Indications for Use:

(Division Sign-Off)

Division of General Restorative Devices K 990849 510(k) Number --

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ 2022 OR (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

N/A