PARTNERSHIP CALCAR FEMORAL COMPONENTS by HOWMEDICA, INC.

The Partnership Calcar Femoral Components consist of a series of Titanium femoral stems with Titanium plasma spray coating that are intended to be used with Howmedica V40™ femoral heads, Howmedica Unipolar and Bipolar components, and Howmedica acetabular components in primary and revision total hip arthroplasty. These femoral stems are designed to be press fit into the proximal femur. They do not achieve fixation by biological ingrowth.

Device Description

The Partnership Calcar Femoral Components consist of a family of Titanium femoral stems with Titanium plasma spray coating. The stems are intended to be used with Howmedica V40™ femoral heads, Howmedica Unipolar and Bipolar components, and Howmedica acetabular components in primary and revision total hip arthroplasty. These femoral stems are designed to be press fit into the proximal femur. They do not achieve fixation by biological ingrowth. These femoral components are manufactured from Titanium alloy, Ti-6Al-4V, which meets the requirements of ASTM specification F 136. The Titanium plasma spray coating is CP titanium, which conforms to ASTM specification F 1580.

AI/ML Overview

This document is a 510(k) summary for a medical device called "Partnership Calcar Femoral Components." It describes the device, its intended use, and its substantial equivalence to other legally marketed devices. However, it does not contain a study proving the device meets specific acceptance criteria in the manner requested (e.g., performance metrics, sample sizes, expert ground truth).

Instead, the document states: "Testing has demonstrated that the fatigue load carrying capacity of the Partnership Calcar Femoral stems exceeds the minimum ISO load requirements." This indicates that a mechanical performance test was conducted, and the acceptance criterion was "exceeds the minimum ISO load requirements" for fatigue load carrying capacity.

Therefore, most of the requested information regarding sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment for a diagnostic or AI-driven device is not applicable to this document, as it pertains to a mechanical medical implant, not a diagnostic or AI device.

Here's how we can extract what is present:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Exceeds minimum ISO load requirements	Fatigue load carrying capacity exceeds minimum ISO load requirements

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

Sample Size: Not specified (refers to "Testing" in general, not a specific number of components or a clinical study).
Data Provenance: Not specified (implied to be laboratory testing of the device itself).

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

Not Applicable. This is a mechanical device, not one requiring expert interpretation for ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not Applicable. Mechanical testing typically relies on predefined test procedures and measurements against standards, not expert adjudication.

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 a mechanical implant, not an AI or diagnostic device that would involve human readers.

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

Not Applicable. This is a mechanical implant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For the fatigue test, the "ground truth" or standard is the minimum ISO load requirements for hip prostheses. This is a technical standard, not a clinical ground truth.

8. The sample size for the training set:

Not Applicable. This is a mechanical device, not an AI model requiring a training set.

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

Not Applicable. No training set is involved.

Summary

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APR 1 6 1998

Image /page/0/Picture/1 description: The image shows the text "K9800239" on the top line and "510(k) Summary" on the second line. The top line appears to be handwritten, while the second line is typed. The text is black and the background is white.

Proprietary Name: Partnership Calcar Femoral Components

Common Name: Hip Prosthesis

21 CFR 888.3353 Classification Name and Reference: Hip Joint Metal/Ceramic/Polymer semi-constrained cemented or nonporous uncemented prosthesis.

Proposed Regulatory Class: Class II

Device Product Code: LZO

Frank Maas For information contact:

Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 Telephone: (201) 507-7875 (201) 507-6870 Fax: Date Summary Prepared: 1-22-98

These femoral components are manufactured from Titanium alloy, Ti-6Al-4V, which meets the requirements of ASTM specification F 136. The Titanium plasma spray coating is CP titanium, which conforms to ASTM specification F 1580.

The substantial equivalence of the Partnership Calcar Femoral stems is based on an equivalence in intended use, materials, design, and relative indications and contraindications to Howmedica's Partnership Revision Femoral Components (K972893). Biomet's Mallory-Head Revision System (K945115) and Osteonics' Restoration Monolithic Calcar Replacement Hip Stems (K951932).

Testing has demonstrated that the fatigue load carrying capacity of the Partnership Calcar Femoral stems exceeds the minimum ISO load requirements.

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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract design of a stylized eagle or bird-like figure with three human profiles incorporated into its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 16 1998

Mr. Frank Maas Manager, Requlatory Affairs Howmedica, Inc. Pfizer Hospital Products Group 359 Veterans Boulevard Rutherford, New Jersey 07070-2584

Re: K980239 Partnership Calcar Femoral Components Trade Name: Requlatory Class: II Product Code: LZO and LPH Dated: January 22, 1998 Received: January 23, 1998

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 Requlations, 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 General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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.

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

Sincerely yours,

for

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): K980239

Device Name: Partnership Calcar Femoral Components

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 X OR (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Stepten Rhode

(Division Sign-Off) Division of General Restorative Devices 5980239 510(k) Number _

Regulation Number and Section

N/A