DURATION STABILIZED UHMWPE by HOWMEDICA CORP.

The P.C.A.® System Inserts (previously cleared in K921384) are intended to be used with P.C.A.® Acetabular Shells, and Howmedica femoral stems and heads in cementless primary or cemented primary/revision total hip arthroplasty.

The Premise® Hip Acetabular Components (previously cleared in K912426) are intended to be used with Howmedica femoral stems and heads in comented primary or revision total hip arthroplasty.

The Osteolock™ Inserts (previously cleared in K903362), and the System 12® inserts (previously cleared in K951114 and K951115), when used with the Osteolock™ and Vitalock® Shells, are intended to be used with Howmedica femoral stems and heads in cemented primary of revision total hip arthroplasty.

SEE ADDITIONAL PAGE LABELED DURATION WEAR CLAIMS

Device Description

Duration™ Stabilized UHMWPE - Hip Components

AI/ML Overview

The provided document describes wear claims for Howmedica's Duration™ Stabilized UHMWPE hip components and does not present acceptance criteria or a study design in the typical format for medical device performance evaluation against specific metrics like sensitivity, specificity, or accuracy. Instead, it describes a series of in vitro wear simulation tests demonstrating a reduction in volumetric wear compared to conventionally gamma-sterilized components.

Therefore, the requested information cannot be fully provided as it pertains to a different type of performance evaluation (e.g., diagnostic accuracy of an AI device vs. material wear properties of an implant). However, I can extract and structure the information presented regarding the wear tests.

Here's an attempt to structure the available information, noting where specific requested fields are not applicable or estimable from the provided text:

Acceptance Criteria and Device Performance (Wear Claims)

Given the nature of the document detailing material wear claims, the "acceptance criteria" are implicitly a demonstrable reduction in volumetric wear compared to the conventionally sterilized counterpart. The reported device performance is the percentage reduction in volumetric wear.

Table of Acceptance Criteria and Reported Device Performance

Test Condition	Implicit Acceptance Criteria (Reduction in Volumetric Wear)	Reported Device Performance (Reduction in Volumetric Wear)
System 120, size P4, neutral acetabular inserts (32mm ID, 6.1mm thickness), aged 6 months in oxygen, vs. conventionally gamma sterilized and aged 6 months in oxygen.	> 0% reduction (implied)	36% reduction
Hemispherical cup of generic design (32mm ID, 8.4mm thickness), vs. conventionally gamma sterilized (no aging specified, "low calcium" lubricant).	> 0% reduction (implied)	40% reduction
System 12® Neutral Acetabular Insert, size P4 (32mm ID, 6.1mm thickness), vs. conventionally gamma sterilized ("high calcium" lubricant).	> 0% reduction (implied)	40% reduction
Hemispherical cup of generic design (32mm ID, 8.4mm thickness), 11 days heating in air (simulating 5 years aging), vs. conventionally gamma sterilized with 11 days heating in air (simulating 5 years aging). (Independent lab test, cited twice)	> 0% reduction (implied)	27% reduction

Note: The document explicitly states: "The results of in vitro tests have not been shown to correlate with clinical wear mechanisms." This is a crucial disclaimer for interpreting these results.

Study Details (as inferrable from the provided text):

Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact number of hip components (samples) used in each test (e.g., N=3 per group). It refers to "a hemispherical cup" or "neutral acetabular inserts," implying at least one test article for each condition, but standard practice usually involves multiple samples for statistical validity.
- Data Provenance: The data is from in vitro laboratory tests. The document mentions "Howmedica's" tests and an "independent laboratory test." This indicates the data is from manufacturer-sponsored and potentially third-party laboratory experiments, not from human patients or clinical trials.
- Retrospective or Prospective: These are prospective laboratory experiments designed to assess wear characteristics under controlled conditions.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For material wear testing, "ground truth" is typically established by direct measurement of material loss (e.g., gravimetric or profilometric methods) in a controlled laboratory setting, not by expert consensus or interpretation in the way one would assess clinical images or outcomes. The "ground truth" here is the measured volumetric wear.
Adjudication method for the test set:
- Not Applicable. Adjudication methods (like 2+1) are used for resolving disagreements among human readers or experts, which is not relevant to automated laboratory measurements of material wear.
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 document describes in vitro mechanical testing of a medical implant material, not a study involving human readers or AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm-based device. It's a physical implant, and the assessment is of its material properties in a simulator.
The type of ground truth used:
- The "ground truth" for these tests is the direct, quantifiable measurement of volumetric wear of the UHMWPE components under simulated physiological loading conditions. This is obtained through laboratory techniques (e.g., gravimetric analysis and density measurements to calculate volume loss).
The sample size for the training set:
- Not Applicable. This is not a machine learning or AI context where "training sets" are used. The material properties are inherent to the manufactured product, and performance is tested directly.
How the ground truth for the training set was established:
- Not Applicable. See point 7.

Summary

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

DURATION™ WEAR CLAIMS - HIP COMPONENTS K963612 רפפו, ווי ב

Howmedica's Duration™ Stabilized UHMWPE, System 120, size P4, neutral acetabular inserts, with an inner diameter of 32mm, a bearing thickness of 6.1 mm and aged for 6 months in an oxygen environment, showed a 36% reduction in volumetric wear versus the same cup conventionally gamma sterilized and aged for 6 months in an oxygen environment. Testing was performed in a multlaxial hip joint simulator for over 10 million cycles, using a 32mm CoCr Head articulating counterface and bovine calf serum as a lubricant. The results of in vitro tests have not been shown to correlate with clinical wear mechanisms.

Howmedica's Duration™ Stabilized UHMWPE, a hemispherical cup of generic design for hip simulator testing, with an inner diameter of 32 mm, and a bearing thickness of 8.4 mm, showed a 40% reduction in volumetric wear versus the same cup conventionally gamma sterilized. Testing was performed in a multiaxial hip joint wear simulator for over 5 million cycles, using a 32 mm diameter CoCr Head articulating counterface and "low calcium" containing bovine calf serum as a lubricant. The results of in vitro tests have not been shown to correlate with clinical wear mechanisms.

Howmedica's Duration™ Stabilized UHMWPE, System 12® Neutral Acetabular Insert, size P4, with an inner diameter of 32mm, and a bearing thickness of 6.1 mm, showed a 40% reduction in volumetric wear versus the same cup conventionally gamma sterilized. Testing was performed in a hip joint wear simulator for over 5 million cycles, 32 mm CoCr Head articulating counterface and "high calcium" containing a using a bovine calf serum as a lubricant. The results of these in vitro tests have not been shown to correlate with clinical wear mechanisms or in vitro third body wear mechanisms involving fragments of bone, bone cement, UHMWPE , metal, ceramic, etc.

In an independent laboratory test on Howmedica's Duration™ Stabilized UHMWPE, a hemispherical cup of generic design for hip simulator testing, with an inner diameter of 32 mm, a bearing thickness of 8.4 mm, and having undergone 11 days of healing in air to simulate 5 years "aging", showed a 27% reduction in volumetric wear versus the same cup conventionally gamma sterilized, having undergone 11 days of heating in air to simulate 5 years "aging". Testing was performed in a multiaxial hip joint wear simulator over 10 million cycles, using a 32 mm CoCr Head articulating counterface and bovine calf serum as a lubricant. The results of in vitro tests have not been shown to correlate with clinical wear mechanisms.

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

In an independent laboratory test on Howmedica's Duration™ Stabilized UHMWPE, a hemispherical cup of generic design for hip simulator testing, with an inner diameter of 32 mm, a bearing thickness of 8.4 mm, and having undergone 11 days of heating in air to simulate 5 years "aging", showed a 27% reduction in volumetric wear versus the same cup conventionally gamma sterilized, having undergone 11 days of heating in air to simulate 5 years "aging". Testing was performed in a multiaxial hip joint wear simulator over 10 million cycles, using a 32 mm CoCr Head articulating counterface and bovine calf serum as a lubricant. The results of in vitro tests have not been shown to correlate with clinical wear mechanisms.

For information, contact:

John Dichiara Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Ruthertord, NJ 07070 (201) 507-7386 - Phone (201) 507-6870 - Fax

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - (USA)" written around the top half of the circle. Inside the circle is an abstract image of an eagle or bird-like figure with outstretched wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN | | 1997

Mr. John F. Dichiara Manager, Regulatory Affairs Howmedica Inc... ... . --------Pfizer Hospital Products Group 359 Veterans Boulevard 07070-2584 Rutherford, New Jersey

સંદ

Re : K963612 Duration™ Stabilized UHMWPE - Hip Components K965173 Duration™ Stabilized UHMWPE - Knee Components Regulatory Class: II Product Codes: JDI, LPH, JWH, and HRY March 21, 1997 Dated: Received: March 25, 1997

Dear Mr. Dichiara:

We have reviewed your Section 510(k) notification 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 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 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP 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 devices in the Federal Register. Please note: this response to your premarket notification submission does not affect any

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

Page 2 - Mr. John F. Dichiara

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.

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.

ff you desire specific advice for your devices 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 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,

Ascolefa

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

Enclosures

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

Indications for Use

510(k) Number (if known): K963612

Device Name: Duration™ Stabilized UHMWPE (Wear Data - Hip Components)

Indications for Use:----------------------------------------------------------------------------------------------------------------------------------------------------------

The Premise® Hip Acetabular Components (previously cleared in K912426) are intended to be used with Howmedica femoral stems and heads in comented primary or revision total hip arthroplasty.

SEE ADDITIONAL PAGE LABELED DURATION WEAR CLAIMS

(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
---------------------------------------	---

Over-The-Counter Use
----------------------	--

(Optional Format 1-2-96)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	K963612

Regulation Number and Section

§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip 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 an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.