Total hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; nonunion; femoral neck fracture and trochanteric fractures of the proximal femur with heads involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity.
The Zirconia Ceramic Femoral Head is designed for single use only.

Device Description

The Zirconia Ceramic Femoral Head designed for use with both titanium and cobalt chromium alloy femoral components with a 12/14 taper.

AI/ML Overview

The provided text describes a medical device submission (K013989) for a Zirconia Ceramic Femoral Head. This device is a component of a total hip replacement system. The document focuses on demonstrating substantial equivalence to existing, legally marketed devices.

Let's break down the requested information:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Mechanical Testing (Requirements for ceramic femoral head draft guidance document)	All test results indicate the Zirconia Ceramic Femoral Head is equivalent to devices currently on the market and capable of withstanding in vivo loading without failure.
Substantial Equivalence (to legally marketed predicate devices)	Similar in design and indicated for total hip replacement to the Zirconia Ceramic Femoral Head with a 14/16 taper distributed by Smith & Nephew, Inc. Also substantially equivalent to devices marketed prior to May 28, 1976.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state a sample size for a "test set" in the context of clinical performance or a specific study with patient data. The evaluation of this device is primarily based on mechanical testing and a demonstration of substantial equivalence to predicate devices, rather than a prospective clinical trial with a defined patient test set. The data provenance for the mechanical testing is not specified beyond being performed according to a "ceramic femoral head draft guidance document".

3. 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)

This information is not applicable or provided in the context of this submission. The "ground truth" for this device's acceptance is established through mechanical testing against engineering standards and comparison to predicate devices, not through expert review of clinical data from a test set.

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

This information is not applicable or provided. There is no mention of a human-reviewed test set or an adjudication process for clinical outcomes in this document.

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

This information is not applicable or provided. The Zirconia Ceramic Femoral Head is a medical implant, not an AI-assisted diagnostic tool.

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

This information is not applicable or provided. This device is a physical implant, not an algorithm.

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

The "ground truth" for this device's acceptance is based on:

Mechanical performance standards: The device passed mechanical tests according to relevant guidance documents.
Demonstrated equivalence to predicate devices: The device was shown to be similar in design and intended use to previously cleared devices which have an established safety and effectiveness profile.

8. The sample size for the training set

This information is not applicable or provided. This is a physical medical device, not a machine learning model that requires a training set.

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

This information is not applicable or provided. As above, there is no "training set" in the context of this device.

Summary

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K 0/3989

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Summary of Safety and Effectiveness Smith & Nephew, Inc. Zirconia Ceramic Femoral Head

Contact Person and Address

DEC 1 9 2001

Janet Johnson Green Manager, Clinical and Regulatory Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 East Brooks Road Memphis, TN 38116 (901) 396-2121

Device Description

The Zirconia Ceramic Femoral Head designed for use with both titanium and cobalt chromium alloy femoral components with a 12/14 taper.

Device Classification Name

Device Classification wetal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Class II

Indications for Use

The Zirconia Ceramic Femoral Head is designed for single use only.

Mechanical and Clinical Data

Mechanical testing was performed according to the requirements in the ceramic femoral head draft guidance document. All of the test results indicate that the Zirconia Ceramic Femoral Head is equivalent to devices currently on the market and capable of withstanding in vivo loading without failure.

Substantial Equivalence Information

The Zirconia Ceramic Femoral Head with a 12/14 taper is similar to the Zirconia Ceramic Femoral Head with a 14/16 taper distributed by Smith & Nephew, Inc. Both heads are indicated for total hip replacement and are similar in design.

CONFIDENTIAL

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Image /page/1/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 9 2001

Ms. Janet Johnson Green Manager, Clinical and Regulatory Affairs Smith & Nephew, Inc. 1450 East Brooks Road Memphis, Tennessee 38116

Re: K013989

Trade/Device Name: Zirconia Ceramic Femoral Head Regulation Number: 21 CFR 888.3353 Regulation Name: Hip Joint Metal/Ceramic/Polymer Semi-constrained Cemented or Nonporous Uncemented Prosthesis Regulatory Class: Class II Product Code: LZO Dated: November 26, 2001 Received: December 4, 2001

Dear Ms. Green:

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. Janet Johnson Green

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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

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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K013989

page 1 of 1

Zirconia Ceramic Femoral Head Indications Statement

Total hip components are indicated for individuals undergoing primary and revision Total mp Confoonchs are indicated in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses nonimalinitis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; Such as Useballunines, avascular incostrophic variant; old, remote osteomyelitis with an iused inip, fracture of the period; nonunion; femoral neck fracture and trochanteric fractures of the proximal femur with heads involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity.

Signature

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

510(k) Number K013989

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.