The S-ROM Zirconia Ceramic Femoral Head is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, traumatic and non-union of femoral fractures. Use of the prosthesis is also indicated for revision of previous hip arthroplasty and for patients with congenital hip dysplasia, protrusio acetabuli, slipped femoral epiphysis, and disability due to previous fusion.

Device Description

The S-ROM Zirconia Ceramic hip head is manufactured of Yttrium Stabilized Zirconium Oxide (Zirconia), also known as PROZYR®. The S-ROM ceramic hip heads are designed to be used with the S-ROM Total Hip System femoral stems.

AI/ML Overview

Here's an analysis of the provided text regarding the S-ROM Zirconia Ceramic Femoral Head:

This document is a 510(k) premarket notification for a medical device and therefore, is a request for substantial equivalence. It does not typically contain detailed acceptance criteria and study data in the way a clinical trial report or a PMA (Premarket Approval) submission would for a novel device. The primary goal of a 510(k) is to demonstrate that the new device is as safe and effective as a legally marketed predicate device.

Given this, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies. These elements are not typically part of a 510(k) summary for a device seeking substantial equivalence based on material and design similarity to already cleared devices.

However, I can extract the information that is present in the document.

Acceptance Criteria and Study Information for the S-ROM Zirconia Ceramic Femoral Head

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable for a 510(k) substantial equivalence submission. This type of regulatory filing demonstrates equivalence to a predicate device rather than presenting novel performance criteria against specific benchmarks.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. The submission focuses on equivalence to predicate devices, not on a new clinical study with a test set. The data provenance would be from the predicate device's existing clearance.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

Not applicable. Ground truth establishment with experts is typical for diagnostic algorithms, not for orthopedic implants in a 510(k) submission.

4. Adjudication Method for the Test Set

Not applicable. No new test set for performance on diagnostic tasks is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

Not applicable. MRMC studies are used for diagnostic imaging devices to assess human reader performance with and without AI assistance. This document is for a hip prosthesis.

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

Not applicable. This device is a physical hip implant, not an algorithm.

7. The Type of Ground Truth Used

Not applicable in the context of diagnostic performance evaluation. The "ground truth" for this device's safety and effectiveness is established by its substantial equivalence in material properties, design, and intended use to previously cleared devices.

8. The Sample Size for the Training Set

Not applicable. This device is a physical product, not an AI algorithm requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This device is a physical product, not an AI algorithm.

Summary of Device Equivalence (from the provided text, as this is the "study" context for a 510(k)):

The "study" presented here is a demonstration of substantial equivalence to predicate devices already on the market.

Predicate Devices:
- P.F.C. Zirconia Ceramic Hip Head (K# 962248, K# 933275)
- S-ROM Zirconia Ceramic Hip Head (K# 921111)
Basis for Equivalence:
- Material: Identical in material (PROZYR® Yttrium Stabilized Zirconium Oxide) to the P.F.C. Zirconia Ceramic Hip Head.
- Function/Indicated Use: Identical to the P.F.C. Zirconia Ceramic Hip Head and the S-ROM Zirconia Ceramic Hip Head (K# 921111).
- Design: Identical in design (drawing specifications) to the S-ROM Zirconia Ceramic Hip Head (K# 921111).
- Packaging and Sterilization: Same as the predicate device.
Limitation Noted by FDA: The S-ROM Zirconia Ceramic Femoral Hip Heads are to be used only with titanium alloy (Ti6Al4V) hip stems with the 11/13 Morse taper trunnions.

In essence, the "study" for this 510(k) is a comparison of the new device's specifications against those of previously cleared devices, asserting that because they are sufficiently similar, the new device is also safe and effective.

Summary

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K973307

arti nesser in

NOV 2 0 1997

Summary of Safety and Effectiveness Data for the S-ROM® Zirconia Ceramic Femoral Head

Johnson & Johnson Professional, Inc. 325 Paramount Drive Raynham, MA 02767-0350

Contact Person_

Mary E. Gray Associate Regulatory Affairs Specialist Phone: (508) 828-3545 Fax: (508) 828-3212

Name of Device

Proprietary Name:	S-ROM Zirconia Ceramic Femoral Head
Common Name:	Hip Prosthesis
Classification Name:	Hip joint metal/ceramic/polymer semi-constrainedcemented or nonporous uncemented prosthesis.
Regulatory Class:	Class II by 21 CFR 888.3353
Product Code:	87 LZO
Owner/Operator No.:	9001269

Device Classification_

This device has been placed in Class II for Hip joint metal/ ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis per 21 CFR § 888.3353.

Statement of Substantial Equivalence_

The S-ROM Zirconia Ceramic Hip Head is identical in material (PROZYR®) and in function (indicated use) to the P.F.C. Zirconia Ceramic Hip Head cleared for marketing under premarket notifications K# 962248 (August 29, 1996)/ K# 933275 (September 28, 1994).

The S-ROM Zirconia Ceramic Hip Head is identical in design (drawing specifications) and function (indicated use) to the S-ROM Zirconia Ceramic Hip Head cleared for marketing under premarket notification K# 921111.

The subject device is composed of similar materials to the predicate device mentioned above (P.F.C. Zirconia Ceramic Hip Head). Further, the intended use and the manufacture of the S-ROM Ziconia Ceramic Hip Head are substantially equivalent to those already cleared for domestic commercial distribution.

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Additionally, the packaging and method of sterilization utilized for the S-ROM Zirconia Ceramic Hip Head are the same as those used for the previously mentioned predicate device.

Indications for Use

The S-ROM Zirconia Ceramic Hip Head is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, posttraumatic arthritis, collagen disorders, avascular necrosis, traumatic and nonunion of femoral fractures. Use of the prosthesis is also indicated for revision of previous hip arthroplasty and for patients with congenital hip dysplasia, protrusio acetabuli, slipped femoral epiphysis, and disability due to previous fusion.

Physical Description_

The ceramic femoral heads are contraindicated for use with any acetabular components other than an UHMWPE cup or metal backed UHMWPE cup.

S-ROM® Zirconia Ceramic Femoral Heads

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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 with three human profiles incorporated into its design. The eagle is facing right, and the profiles are arranged in a way that they form the body of the eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 20 1997

Ms. Mary E. Gray Associate Regulatory Affairs Specialist Johnson & Johnson Professional, Inc. 325 Paramount Drive 02767-0350 Raynham, Massachusetts

Re: K973307 S-ROM® Zirconia Ceramic Femoral Hip Head for Use with the S-ROM® Total Hip System Regulatory Class: II Product Code: Code: TLLO Trip Dated: September 2, 1997 Received: September 3, 1997

Dear Ms. Gray:

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 S-ROM Zirconia Ceramic Femoral Hip Heads are to be used only with titanium alloy (Ti6Al4V) hip stems with the 11/13 Morse taper 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.

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 requlations affecting your device can be found in the Code of Federal Requlations, Title 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 requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to

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Page 2 - Ms. Mary E. Gray

comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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 Requlations.

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 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,

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 for the S-ROM® Zirconia Ceramic Femoral Head

Johnson & Johnson Professional, Inc. 325 Paramount Drive Raynham, MA 02767-0350

Indications of Use

Prescription Use
(Per 21 CFR 801.109)

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S-ROM® Zirconia Ceramic Femoral Heads

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.