The DePuy Ceramic Femoral Heads are indicated for use as the femoral head component in total hip arthroplasty procedures. Total hip arthroplasty is intended to provide increased patient mobility and to reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions:

I. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
1. Avascular necrosis of the femoral head.
1. Acute traumatic fracture of the femoral head or neck.
1. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
1. Certain cases of ankylosis.

Device Description

The DePuy Ceramic Femoral Heads are composed of an alumina composite material and are available in head diameters of 32mm and 36mm sizes with various offset options. The internal bore of the ceramic femoral head, which is designed to interlock with the external taper on the femoral hip stem, is available in two variations (11/13 SROM and 12/14 Articul/eze taper options). The ceramic heads are designed to mate with a corresponding DePuy femoral hip stem and provide the femoral articular surface of a total hip replacement.

AI/ML Overview

This document describes a 510(k) premarket notification for the DePuy Ceramic Femoral Heads. The basis for substantial equivalence is primarily through comparison to a predicate device (DePuy Femoral Heads submitted in K011533), rather than through a study proving specific acceptance criteria related to a device's performance characteristics.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for studies assessing the accuracy or effectiveness of a diagnostic or therapeutic medical device, cannot be found in this document.

This document focuses on regulatory approval based on demonstrating substantial equivalence to a previously cleared device. It asserts similarity in design, material composition, sterilization and packaging methods, intended use/indications for use, and labeling between the new device and its predicate.

To directly answer your request based on the provided text:

A table of acceptance criteria and the reported device performance
- Not Applicable. The document does not define specific performance acceptance criteria (e.g., accuracy, sensitivity, specificity, or mechanical thresholds) for the DePuy Ceramic Femoral Heads with associated reported device performance data from a clinical or technical study. The "performance" is implicitly tied to the previous clearance of the predicate device (K011533).
- Basis of Substantial Equivalence (Implicit "Acceptance Criteria"):
  - Similarities in design
  - Same material composition
  - Same sterilization and packaging methods
  - Same intended use/indications for use
  - Similar labels
- Reported Device "Performance": The device is considered "substantially equivalent" to K011533 based on meeting the above similarities.
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not Applicable. No test set or related data (clinical or in vitro) is described in this document. Substantial equivalence is claimed based on design and material comparison to a predicate device, not through a new performance study with a test set.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not Applicable. No test set or ground truth establishment process is described. This document is a regulatory submission, not a study report.
Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. No test set or adjudication method is described.
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 device is a ceramic femoral head (joint component), not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study related to human readers and AI assistance is entirely irrelevant and not mentioned.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is a physical medical device (implant), not an algorithm or software. Standalone algorithm performance is not relevant.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable. No ground truth is established for the device itself in this submission. The "truth" for regulatory purposes here is the established safety and effectiveness of the predicate device (K011533) to which the new device is compared.
The sample size for the training set
- Not Applicable. No training set is mentioned or relevant to this type of regulatory submission for a physical implantable device.
How the ground truth for the training set was established
- Not Applicable. No training set or associated ground truth establishment process is described.

Summary

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Image /page/0/Picture/0 description: The image shows handwritten text that appears to be a combination of alphanumeric characters. The primary text is "K031803", with the numbers being clearly written. Below this, there's another line of text that reads "10F2", which is smaller in size compared to the first line. The handwriting is somewhat rough, but the characters are still legible.

NAME OF FIRM:	DePuy Orthopaedics, Inc.P.O. Box 988700 Orthopaedic DriveWarsaw, IN 46581-0988
510(k) CONTACT:	Karla HamSr. Regulatory Affairs Associate
TRADE NAME:	DePuy Ceramic Femoral Heads
COMMON NAME:	Ceramic Femoral Ball Prosthesis
CLASSIFICATION:	888.3353: Hip joint femoral metal/ceramic/polymersemi-constrained cemented or nonporous,uncemented prosthesis;Class II
DEVICE PRODUCT CODE:	87 LZO

2003

DEVICE DESCRIPTION AND INTENDED USE:

DePuy Femoral Heads, K011533

The ceramic heads are designed to mate with a corresponding DePuy femoral hip stem and provide the femoral articular surface of a total hip replacement.

INDICATIONS FOR USE:

DEVICE:

I. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
1. Avascular necrosis of the femoral head.
1. Acute traumatic fracture of the femoral head or neck.
1. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
1. Certain cases of ankylosis.

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K031803
2 OF 2

BASIS OF SUBSTANTIAL EQUIVALENCE:

DePuy considers the Ceramic Femoral Heads to be substantially equivalent to the DePuy Femoral Heads submitted in K011533 based on similarities in design, same material composition, same sterilization and packaging methods, same intended use/indications for use, and similar labels.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with three curved lines above them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 2003

Ms. Karla A. Ham Senior Regulatory Associate DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthpaedic Drive Warsaw. Indiana 46581-0988

Re: K031803 Trade/Device Name: DePuy Ceramic 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: June 10, 2003 Received: June 11, 2003

Dear Ms. Ham:

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

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Page 2 - Ms. Karla A. Ham

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 (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

for Mark A. Milliken

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

Enclosure

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510(k) Number (if known): KO31803

Device Name: DePuy Ceramic Femoral Heads

Indications for Use:

The DePuy Ceramic Femoral Heads are indicated for use as the femoral head component in total hip arthroplasty procedures.

Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, rheumatoid arthritis, or congenital hip dysplasia.
1. Avascular necrosis of the femoral head.
1. Acute traumatic fracture of the femoral head or neck.
1. Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
1. Certain cases of ankylosis.

Concurrence of CDRH, Office of Device Evaluation

Mark N. Millkern

Division Sign-Off Division of General, Restorative and Neurological Devices

510(k) Number K031803

Prescription Use OR (Per 21 CFR 801.109)

Over-The-Counter Use

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Regulation Number and Section

§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.