The subject femoral heads are single-use devices intended for use in cemented or cementless total hip arthroplasty with various Howmedica Osteonics hip stems featuring the PCA® taper (2° 52') that are manufactured from CoCr alloy. They are not intended for use with any stem manufactured from Stainless Steel or Titanium alloy. They are also intended for use with any compatible, currently available Howmedica Osteonics acetabular component featuring a polyethylene bearing surface.

Indications for Use:

noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis:
rheumatoid arthritis (excepting the Osteolock" HA Acetabular Cup and Peri-Apatite coated prostheses):
correction of functional deformity:
revision procedures where other treatments or devices have failed; and,
treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

The Peri-Apatite coated prostheses are indicated only for primary uncemented total hip arthroplasty for items 1, 3, & 5 above when offered for sale in the USA.

Femoral head prostheses are indicated for use in cementless total hip arthroplasty, depending upon the indications of the acetabular and femoral stem components chosen.

Device Description

PCA® taper (2° 52') femoral heads manufactured from Alumina ceramic (ASTM F603) with a Ti-6Al-4V alloy sleeves (ASTM F136) will be available in 32mm diameters. The femoral heads will be available with 0 (standard) and +5 offsets. The PCA® taper femoral heads are compatible with a range of CoCr alloy Howmedica Osteonics PCA® taper femoral stems. The subject components are also compatible for use with a wide range of acetabular components (shells and polyethylene inserts).

AI/ML Overview

The provided text is a 510(k) summary for a medical device, specifically PCA® Alumina 32mm Femoral Heads. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria through a study with performance metrics in the way a diagnostic AI device would.

Therefore, the information requested in your prompt regarding acceptance criteria, reported device performance, sample sizes, ground truth establishment, expert involvement, adjudication methods, and MRMC/standalone studies is not present in this document. This document describes a physical orthopedic implant, not an AI or diagnostic software.

Here's why the requested information isn't available and what the document does provide:

Acceptance Criteria and Reported Device Performance (Table): This document does not present quantitative performance metrics for the device. Instead, it asserts substantial equivalence based on material composition, design principles, and intended use as compared to existing devices.
Sample size for the test set and data provenance: Not applicable. This is a physical device, not an algorithm tested on a dataset of patient information.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This device does not have "ground truth" established by experts in the context of diagnostic interpretation.
Adjudication method for the test set: Not applicable.
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 diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

What the document does describe and implies about how the device meets requirements:

The document focuses on demonstrating substantial equivalence to predicate devices already on the market. This is the primary "proof" for a 510(k) submission for this type of device.

Substantial Equivalence Section:
The PCA® Alumina Femoral Heads are deemed substantially equivalent to:

Alumina V40™ Femoral Heads (K023901)
PCA Total Hip System - Cementless Use (K920831)
V40™/C-Taper Adapter Sleeve (K003379)

The inference is that because the new device is substantially equivalent in terms of materials (Alumina ceramic with Ti-6Al-4V alloy sleeves, 32mm diameter, 0 and +5 offsets for PCA® taper), intended use, and indications for use to these already cleared devices, it meets the safety and effectiveness requirements without the need for a new clinical trial generating performance data against specific acceptance criteria. The materials (ASTM F603 for Alumina, ASTM F136 for Ti-6Al-4V alloy) imply adherence to established material standards, which are a form of "acceptance criteria" for material properties.

In summary, for medical devices like the PCA® Alumina Femoral Heads, the "study that proves the device meets the acceptance criteria" is the comparison to legally marketed predicate devices under the 510(k) pathway, demonstrating that its features, intended use, and performance characteristics are similar to those already deemed safe and effective by the FDA.

Summary

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K063816 pg 1 of 2

510(k) Summary of Safety and Effectiveness for the PCA® Alumina 32mm Femoral Heads

Proprietary Name:	FEB - 2 2007PCA® Alumina Femoral Heads
Common Name:	Artificial Hip Components
Classification Name and Reference	Hip joint metal/ceramic/polymer semi-constrainedcemented or nonporous uncemented prosthesis:Section 21 CFR 888.3353.
Regulatory Class:	Class II
Device Product Code(s):	LZO - prosthesis, hip, semi-constrained,metal/ceramic/polymer, cemented or non-porous,uncemented.
For Information contact:	Patricia Setti-LaPerchRegulatory Affairs AssociateStryker Orthopaedics325 Corporate DriveMahwah, New Jersey 07430Phone: (201) 831-5938Fax: (201) 831-4938E-Mail: Patricia.LaPerch@stryker.com
Date Summary Prepared:	January 31, 2007

Device Description

Intended Use:

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KU3816 pg 2 of 2

compatible, currently available Howmedica Osteonics acetabular component featuring a polyethylene bearing surface.

Indications for Use

1. noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis:
rheumatoid arthritis (excepting the Osteolock" HA Acetabular Cup and Peri-2) Apatite coated prostheses):
1. correction of functional deformity:
1. revision procedures where other treatments or devices have failed; and,
ર) treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

The Peri-Apatite coated prostheses are indicated only for primary uncemented total hip arthroplasty for items 1, 3, & 5 above when offered for sale in the USA.

Femoral head prostheses are indicated for use in cementless total hip arthroplasty, depending upon the indications of the acetabular and femoral stem components chosen.

Substantial Equivalence:

The PCA® Alumina Femoral Heads are substantially equivalent to the Alumina V40™ Femoral Heads (K023901), cleared by Howmedica Osteonics Corp., PCA Total Hip System - Cementless Use (K920831), cleared by Pfizer Hospital Products Group, Inc., and the V40™/C-Taper Adapter Sleeve (K003379), cleared by Howmedica Osteonics Corp.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Stryker Orthopaedics % Ms. Patricia Setti-LaPerch Regulatory Affairs Associate 325 Corporate Drive Mahwah, New Jersey 07430

FEB - 2 2007

Re: K063816 Trade/Device Name: PCA® Alumina 32 mm Femoral Heads Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis. Regulatory Class: II Product Code: LZO Dated: December 21, 2006 Received: December 22, 2006

Dear Ms. Setti-LaPerch:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation

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Page 2 - Ms. Patricia Setti-LaPerch

(21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Barbara Priehus

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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325 Corporate Drive Mahwah, NJ 07430 t: 201 831 5000 www.stryker.com

Image /page/4/Picture/18 description: The image shows the word "stryker" in a bold, sans-serif font. The letters are all lowercase except for the "S", which is uppercase. There is a small, superscripted circle with the letters "DC" inside it to the right of the word. The word is likely a logo or brand name.

Orthopaedics

510(k) Number (if known): K063816

Device Name: PCA® Alumina Femoral Heads

Indications for Use

noninflammatory degenerative joint disease including osteoarthritis and avascular 1) necrosis:
rheumatoid arthritis (excepting the Osteolock" HA Acetabular Cup and Peri-2) Apatite coated prostheses);
1. correction of functional deformity;
1. revision procedures where other treatments or devices have failed; and,
treatment of nonunion, femoral neck and trochanteric fractures of the proximal ર) femur with head involvement that are unmanageable using other techniques.

The Peri-Apatite coated prostheses are indicated only for primary uncemented total hip arthroplasty for items 1, 3, & 5 above when offered for sale in the USA.

Femoral head prostheses are indicated for use in cementless total hip arthroplasty. depending upon the indications of the acetabular and femoral stem components chosen.

Prescription Use

OR Over-the-Counter Use (Per 21 CFR 801.109)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

fortare Puchar for MOM
(Division Sign Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number K043816

Regulation Number and Section

N/A