The Zirconia Ceramic Femoral Head is designed to be implanted into the human hip as a component in total hip arthroplasty and is indicated for the following: Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur; patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis; patients suffering from disability due to previous fusion; patients with previously failed endoprostheses and/or total hip components in the operative extremity; and patients with acute neck fractures.

Device Description

The Zirconia Ceramic Femoral Head (12/14 taper) is made from yttria stabilized zirconium oxide (ZrO2) ceramic and provides an alternative to cobalt-chrome alloy femoral heads. The Zirconia Ceramic Femoral Head is intended for mating with either a Tivanium® Ti-6Al-4V Alloy or Zimaloy® Cobalt-Chrome-Molybdenum Alloy modular femoral stem equipped with a tapered neck of identical dimensions. The Zirconia Ceramic Femoral Head is designed to articulate upon the UHMWPE-bearing surface of an acetabular component. The prosthesis is supplied in 26, 28, and 32 mm diameters and a variety of neck lengths.

AI/ML Overview

The provided document is a 510(k) summary for a medical device, the Zirconia Ceramic Femoral Head (12/14 Taper). It outlines the device's description, intended use, and comparison to predicate devices, but does not contain any information about acceptance criteria or specific studies proving the device meets those criteria in the context of performance metrics like sensitivity, specificity, accuracy, or similar measures typically associated with AI/software devices.

This document describes a physical implantable medical device and its substantial equivalence to existing predicate devices based on material, design, and intended use, rather than a diagnostic or AI-powered device that would typically have acceptance criteria presented in the requested format.

Therefore, I cannot provide the requested information from the provided text. To clarify:

No acceptance criteria (e.g., sensitivity, specificity, workflow metrics) are mentioned. The document focuses on regulatory clearance through substantial equivalence.
No "study" in the sense of a clinical trial or performance evaluation with a test set, ground truth, or expert readers is described. The "Clinical and Nonclinical Data" section merely states that "The yttria stabilized zirconium oxide from which the Zirconia Ceramic Femoral Head is made has a limited clinical history" and that "Clinical investigation of the zirconium oxide ceramic prosthesis is ongoing." This indicates a lack of completed, reported studies, not the description of one.
No information on sample size (for test or training sets), data provenance, number/qualifications of experts, adjudication methods, MRMC studies, or standalone algorithm performance is present.
The "ground truth" referenced in the document relates to the long-term biological effects of particulates, which are stated as "unknown" at the time of submission. This is not a ground truth for evaluating device performance in the context of the prompt.

Essentially, this document is a regulatory submission demonstrating substantial equivalence for a physical medical device, not a performance study for an AI or software device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Zimmer Biomet. The logo consists of a stylized letter "Z" inside of a circle, with the word "zimmer" written in lowercase letters below it. The letter "Z" is bold and black, and the circle is a thin line. The word "zimmer" is also black and in a sans-serif font.

X97175J

Warsaw, IN 46581-0708 219 267-613

Summary of Safety and Effectiveness Zirconia Ceramic Femoral Head (12/14 Taper)

. Submitted By:
Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581-0708 219-267-6131

JUL 30

. Contact Person:

Karen Cain, Regulatory Affairs Specialist Telephone: 219-372-4219 Fax: 219-372-4605

. Date:
May 8, 1997
Trade Name: .
Zirconia Ceramic Femoral Head

. Common Name:

Femoral head for total hip joint prosthesis

. Classification Name:

Hip joint metal/ceramic/polymer semiconstrained cemented or nonporous uncemented prosthesis, 21 CFR 888.3353

. Predicate Devices:

Zimmer® Zirconia Ceramic Femoral Head, K944601 and K955877, cleared . January 12, 1995, and October 8, 1996, respectively.
. Astel Cobalt-Chrome Femoral Heads, manufactured by Zimmer, K901480 and K901594, cleared June 12, 1990, and August 3, 1990, respectively.

Image /page/0/Picture/21 description: The image shows a geometric pattern. The pattern is made up of multiple triangles arranged in a circular fashion. Each triangle has a smaller triangle inside it, creating a nested effect. The overall design has a symmetrical and tessellated appearance.

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Summary of Safety and Effectiveness Zirconia Ceramic Femoral Head (12/14 Taper) (Continued)

Zimmer® Cobalt-Chrome Femoral Heads, described in the premarket . notification for the Beta System, K953337, cleared January 22, 1996.

Device Description: .

Intended Use: .

The Zirconia Ceramic Femoral Head is designed to be implanted into the human hip as a component in total hip arthroplasty and is indicated for the following:

Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur, patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis; patients suffering from disability due to previous fusion; patients with previously failed endoprostheses and/or total hip components in the operative extremity; and patients with acute neck fractures.

Comparison to Predicate Devices: .

The Zirconia Ceramic Femoral Head (12/14 taper) is substantially equivalent to the femoral heads listed above as predicate devices. Each is designed to function as the modular femoral head component of a total hip prosthesis, is impacted onto the proximal taper of a femoral stem at the time of surgery, and articulates upon the UHMWPE-bearing surface of an acetabular component.

Both the Zirconia Ceramic Femoral Head (12/14 taper) and the Zimmer Zirconia Ceramic Femoral Head are made from zirconium oxide ceramic. The size range for the Zirconia Ceramic Femoral Head (12/14 taper) includes 26, 28, and 32 mm

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Summary of Safety and Effectiveness Zirconia Ceramic Femoral Head (12/14 Taper) (Continued)

diameters. The Zimmer Zirconia Ceramic Femoral Head is provided in 22, 26, and 28 mm diameters and supports a different taper for impaction upon the femoral stem component.

Clinical and Nonclinical Data .

Ceramic materials have been successfully used in orthopaedic applications for approximately 20 years. These materials exhibit excellent resistance to corrosion and wear and are highly biocompatible. The yttria stabilized zirconium oxide from which the Zirconia Ceramic Femoral Head is made has a limited clinical history. Although mechanical testing demonstrates that when used with polyethylene acetabular cups, the zirconia ceramic femoral head produces a relatively low amount of particulates, the total amount of particulate produced remains undetermined. Because of limited clinical and preclinical experience, the long-term biological effects of these particulates are unknown. Clinical investigation of the zirconium oxide ceramic prosthesis is ongoing.

RA04702K.510

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. . . . . . . . . .

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 30 1997

Ms. Karen Cain Requlatory Affairs Specialist Global Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581-0708

Re : K971752 Zirconia Ceramic Femoral Head Regulatory Class: II Product Code: LZO Dated: May 8, 1997 Received: May 12, 1997

Dear Ms. Cain:

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 and the following limitation that the package insert must reflect that the Zirconia Ceramic Femoral Heads are to be used only with cobalt-chrome and Ti6Al4V alloy hip stems with the 12/14 male taper (5°40′00″±2′30″) trunnions.

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.

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Page 2 - Ms. Karen Cain

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, Titlé 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.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and 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

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Page 3 - Ms. Karen Cain

obtained from the Division of Small Manufacturers Assistance obeazied 220m or number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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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Exhibit K

Page __ I __ of ______________________________________________________________________________________________________________________________________________________________

510(k) Number (if known):

Device Name: Zirconia Ceramic Femoral Head, 12/14 Taper

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

The Zirconia Ceramic Femoral Head is designed to be implanted into the human hip as a component in total hip arthroplasty and is indicated for the following:

Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur; patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis; patients suffering from disability due to previous fusion; patients with previously failed endoprostheses and/or total hip components in the operative extremity; and patients with acute neck fractures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
--------------------------------------------------------	--

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	K971752

Prescription Use	X	OR	Over-The-Counter Use
(Per 21 CFR 801.109)

RA02650K.FM	(Optional Format 1-2-96)
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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.