Patient conditions of non-inflammatory degenerative joint disease (NIDJD), e.g., 1. avascular necrosis, osteoarthritis and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
Those patients with failed previous surgery where pain, deformity, or dysfunction 2. persists.
Revision of previously failed arthroplasty. 3.

Device Description

The Precedent Revision Hip System is manufactured from either wrought or forged titanium alloy. The Precedent Revision Hip System features a threaded Sulzer 12/14 configured neck trunnion for attachment to Sulzer Orthopedics' currently marketed femoral heads, including Biolox and Zirconia heads, employing a Sulzer 12/14 configured bore. Precedent Revision Hip System is available in both a collared and collarless design to address surgeon preference. The entire length of the Precedent Revision Hip System, except the neck region and the distal tip, is roughened via the process of grit blasting. The grit blasted proximal surface of the stem is coated with hydroxylapatite (HA). The distal portion of the Precedent Revision Hip System employs flutes which cut into the distal cortices of the prepared femoral canal, thereby providing rotational stability to the hip stem. In addition, the Precedent Revision Hip System employs a coronal slot which potentially reduces bending stiffness of the distal stem and thigh pain. The distal tip of the Precedent Revision Hip System is polished to a machined finish to provide ease of insertion during surgery.

AI/ML Overview

This 510(k) summary for the Precedent Revision Hip System does not contain the kind of detailed study data, acceptance criteria, and specific performance metrics that would allow for a comprehensive answer to your request.

Medical device submissions from 1997, particularly for orthopedic implants like hip stems, typically did not include formal clinical studies or detailed performance data as would be expected for AI/software-as-a-medical-device (SaMD) products today. The clearance for such devices was primarily based on demonstrating substantial equivalence to already legally marketed predicate devices, focusing on material properties, design features, and intended use.

Here's a breakdown of why this document doesn't provide the requested information and what it does provide:

Acceptance Criteria and Reported Device Performance: This document does not list any specific quantitative acceptance criteria or provide reported device performance metrics in the way you've described (e.g., sensitivity, specificity, AUC). Instead, the "performance" demonstrated for this device is primarily its substantial equivalence to existing hip stems.
- Implicit Acceptance Criteria: The implicit acceptance criteria are that the device's design, materials, and indications for use are similar enough to predicate devices to not raise new questions of safety and effectiveness.
- "Reported Device Performance": The document states: "The data presented support equivalence with no additional claims over a conventional press-fit hip prosthesis (i.e., mechanical interlock, only)." This is the closest it comes to a "performance" statement, indicating its mechanical fixation is comparable to existing press-fit prostheses, but explicitly denying claims of "biological attachment, enhanced clinical or radiographic performance, enhanced fixation and/or long-term stable fixation."
Sample Size used for the test set and the data provenance: Not applicable. There was no "test set" in the context of an AI/SaMD study. The evaluation was a comparison to predicate devices, likely based on engineering principles (material science, biomechanics where applicable) and regulatory review of existing device performance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There was no "ground truth" to establish in the context of an AI/SaMD study. The "truth" in this submission is the established safety and effectiveness of the predicate devices.
Adjudication method: Not applicable. No clinical or performance adjudication process is described.
Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable. This is not a software or imaging device where human reader improvement with AI assistance would be relevant.
Standalone (i.e. algorithm only without human-in-the-loop performance) study: Not applicable. This is a physical orthopedic implant.
Type of ground truth used: Not applicable. No "ground truth" as typically understood in AI/SaMD studies was used.
Sample size for the training set: Not applicable. There was no AI model or "training set."
How the ground truth for the training set was established: Not applicable.

Summary of Information Provided in the Document Relevant to Device Evaluation (not directly answering your AI/SaMD specific questions):

Product Description: Details materials (titanium alloy), features (threaded neck trunnion, collared/collarless design, grit blasting, HA coating, flutes, coronal slot, polished distal tip).
Intended Use/Indications: Primarily for femoral bone deficiencies from failed primary arthroplasties, and for cementless application in total hip arthroplasty for NIDJD, IJD, failed previous surgery, and revision.
Substantial Equivalence: Lists five predicate devices:
- Restoration HA Hip Stem: Osteonics Corporation.
- Sentry Femoral Component: Howmedica Inc.
- S-ROM® Femoral Prosthesis: Joint Medical Product Corporation.
- Stability Hip Stem: DePuy Inc.
- Wagner Revision Stem: Protek Inc.

Conclusion:

This 510(k) pertains to a physical medical implant (a hip stem) from 1997. The regulatory process and documentation standards for such devices at that time were fundamentally different from those for AI/SaMD products, which your questions are tailored to. Therefore, the detailed performance study information, including acceptance criteria, sample sizes, expert ground truth, and AI-specific metrics, is not present in this document. The device's clearance was based on demonstrating substantial equivalence to pre-existing, legally marketed devices, primarily through comparison of design, materials, and intended use.

Summary

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OCT - 1 1997

K971523 1 of 2

510(k) SUMMARY

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807, this is to serve as a Summary of Safety and Effectiveness for the Precedent Revision Hip System.

Submitter:	Sulzer Orthopedics Inc.9900 Spectrum DriveAustin, Texas 78717(512) 432-9900
Date:	July 17, 1997
Contact Person:	Jacquelyn HughesManager, Regulatory Affairs
Classification Name:	Hip Joint metal/ceramic/polymer semi-constrained cemented ornonporous uncemented prosthesis - 21CFR 888.3353 (87LZO).
Common/Usual Name:	Femoral hip prosthesis
Trade/Proprietary Name:	Precedent Revision Hip System

PRODUCT DESCRIPTION

The Precedent Revision Hip System is manufactured from either wrought or forged titanium The Precedent Revision Hip System features a threaded Sulzer 12/14 configured neck allov. trunnion for attachment to Sulzer Orthopedics' currently marketed femoral heads, including Biolox and Zirconia heads, employing a Sulzer 12/14 configured bore. Precedent Revision Hip System is available in both a collared and collarless design to address surgeon preference. The entire length of the Precedent Revision Hip System, except the neck region and the distal tip, is roughened via the process of grit blasting. The grit blasted proximal surface of the stem is coated with hydroxylapatite (HA). The distal portion of the Precedent Revision Hip System employs flutes which cut into the distal cortices of the prepared femoral canal, thereby providing rotational stability to the hip stem. In addition, the Precedent Revision Hip System employs a coronal slot which potentially reduces bending stiffness of the distal stem and thigh The distal tip of the Precedent Revision Hip System is polished to a machined finish to pain. provide ease of insertion during surgery.

This device is intended for use with the following previously cleared devices:

Sulzer Orthopedics metallic femoral bearing heads 일
Sulzer Orthopedics Biolox Bearing Heads 제
그 Sulzer Orthopedics Zirconia Bearing Heads
발 Sulzer Orthopedics bipolar components
Sulzer Orthopedics unipolar components 발
Sulzer Orthopedics acetabular components

SPECIFIC DIAGNOSTIC INDICATIONS

The Precedent Revision Hip System is primarily intended to address femoral bone deficiencies associated with failure of primary total or hemi-hip arthroplasties. In addition, the Precedent Revision Hip System, like the predicate competitive hip stems, is intended for cementless application.

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The general indications associated with the use of the Precedent Revision Hip System in total hip arthroplasty include:

Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., 1. avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
Those patients with failed previous surgery where pain, deformity, or dysfunction 2. persists.
Revision of previously failed hip arthroplasty 3.

Total hip replacements may be considered for younger patients if any unequivocal indication outweighs the risks associated with the age of the patient, and modified demands regarding activity and hip joint loading are assured. This includes severely crippled patients with multiple joint involvement, for whom an immediate need of hip mobility leads to an expectation of significant improvement in the quality of their lives.

The Precedent Revision Hip System is intended only for use without bone cement in the United States. This device is intended for single use only.

SUBSTANTIAL EQUIVALENCE

The Precedent Revision Hip System is substantially equivalent to the following legally marketed predicate competitive devices:

Restoration HA Hip Stem: Osteonics Corporation. 1
비 Sentry Femoral Component: Howmedica Inc.
프 S-ROM® Femoral Prosthesis: Joint Medical Product Corporation.
월 Stability Hip Stem: DePuy Inc.
189 Wagner Revision Stem: Protek Inc.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Lori K. Holder, RAC ·Regulatory Affairs Specialist Sulzer Orthopedics, Inc. 9900 Spectrum Drive Austin, Texas 78717

OCT - I

Re : K971523 Precedent Revision Hip System Requlatory Class: II Product Code: MEH Dated: July 25, 1997 Received: July 28, 1997

Dear Ms. Holder:

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). This decision is based on consideration of the specific design of stem and coating composition detailed in this application. You may, therefore, market the device, subject to the general controls provisions of the Act and the following limitation:

You may not label or in any way promote these devices for "biological attachment, enhanced clinical or radiographic performance, enhanced fixation and/or long-term stable fixation." The data presented support equivalence with no additional claims over a conventional press-fit hip prosthesis (i.e., mechanical interlock, only).

Additional limitations for more specific claims of safety and effectiveness may be forthcominq. Should additional limitations be applied you will be contacted in writing to inform you of the additional labeling limitations.

The general controls provisions of the Act include requirements for annual reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

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Page 2 - Lori K. Holder, RAC

You may market your device under the above limitations as class II devices. These devices would be considered not substantially equivalent to a legally marketed predicate device if labeled with other intended uses and/or claims of safety or effectiveness. Any other intended uses or claims may cause the device to be classified into Class III under Section 513 (f) of the Act. Class III devices are required to have an approved premarket approval (PMA) application prior to marketing.

Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to A substantially equivalent determination assumes 895. compliance with the current Good Manufacturing Practice reguirement, 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. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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 - Lori K. Holder, RAC

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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Page 1 of 1

510(k) Number (if known): K971523

Device Name: Distally Fixed Hip Stem RENANED; PRECEDENT REVISION HIP SYSTEM

Indications For Use:

Patient conditions of non-inflammatory degenerative joint disease (NIDJD), e.g., 1. avascular necrosis, osteoarthritis and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
Those patients with failed previous surgery where pain, deformity, or dysfunction 2. persists.
Revision of previously failed arthroplasty. 3.

(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

Prescription Use X

Over-The-Counter Use

(Optional Format 1-2-96)

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.