This device is indicated in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
1 . Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
2. Inflammatory degenerative joint disease such as rheumatoid arthritis:
3. Correction of function deformity:
Revision procedures where other treatments or devices have 4. failed; and
5. Treatment of nonunion, femoral neck, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
This device is intended for use with bone cement.

Device Description

The Dual Offset PERFECTA® IMC Hip Stem is manufactured from cobalt chrome alloy (ASTM F 799). The stem is available in standard and long lengths and features a collar. The stem is designed to be used with bone cement.

AI/ML Overview

This document describes a medical device, the Dual Offset PERFECTA® IMC Hip Stem, and its testing. It is a 510(k) summary, which indicates it's a submission to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.

Here's the breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Required Performance)	Reported Device Performance	Unit
Withstand a load of 2300N for at least 5 million cycles	Withstood 2300N for at least 5 million cycles	N for cycles
At 10 hertz	Tested at 10 hertz	hertz

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

Sample Size: Not explicitly stated. The document mentions "Submitted testing indicates," implying that the testing was performed on at least one device, but the exact number of units tested is not provided.
Data Provenance: Not explicitly stated. This is a 510(k) submission from a manufacturer (Wright Medical Technology, Inc.), so the testing was presumably conducted by or for the manufacturer. The country of origin of the data is not specified, but the manufacturer is based in Arlington, Tennessee, USA. The study appears to be a prospective mechanical test, not reliant on patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This type of mechanical testing study does not involve "experts" establishing ground truth in the traditional sense of clinical studies. The ground truth is the physical properties and performance of the device under specific load conditions, measured by engineering protocols and equipment.
Therefore, the concept of "number of experts" and their qualifications as typically applied to medical image analysis or clinical diagnosis is not relevant here.

4. Adjudication Method for the Test Set

Not applicable. This is a mechanical engineering test, not a clinical study requiring adjudication of expert opinions. The outcome is determined by whether the device meets the specified physical performance criteria.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This document describes a mechanical test of a hip stem's durability, not a study involving human readers or AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone algorithm performance study was not done. This document describes the mechanical testing of a physical medical device. The concept of an "algorithm" as applied in AI/software is not relevant here.

7. Type of Ground Truth Used

The ground truth used is based on engineering specifications and mechanical testing results. The "truth" is whether the device physically endured the specified load and cycles without failure.

8. Sample Size for the Training Set

Not applicable. This is a mechanical test of a physical device, not an AI/machine learning study that would involve a training set.

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

Not applicable, as there is no training set in this context.

Summary

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OCT - 9 1997

page 1 of 1

Image /page/0/Picture/3 description: The image shows a stylized letter "W" logo. The "W" is formed by three thick, black, triangular shapes that are arranged to create the letter's form. A registered trademark symbol is located to the bottom right of the "W".

Contact Person: Kim Tompkins July 14, 1997 Date:

510(k) Summary

Trade Name:	Dual Offset PERFECTA® IMC Hip Stem, product line extension tothe PERFECTA® IMC Hip System
Common Name:	Femoral Hip Stem
Classification:	Class II
Predicate Device:	PERFECTA® IMC Hip Stem manufactured by Wright MedicalTechnology, Inc.

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

Description/Intended Use

This device is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia:
1. inflammatory degenerative joint disease such as rheumatoid arthritis:
1. correction of functional deformity:
1. revision procedures where other treatments or devices have failed; and,
1. treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Testina

Submitted testing indicates that the device should withstand a load of 2300N for at least 5 million cycles at 10 hertz.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized eagle symbol. The eagle is depicted with three lines forming its body and wings, giving it a sense of motion. The overall design is simple and professional, reflecting the department's role in public health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 9 1997

Ms. Kim Tompkins Director, Clinical and Regulatory Affairs Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002

Re: K972641 Dual Offset PERFECTA® IMC Hip Stem Trade Name: Requlatory Class: II Product Code: JDI Dated: July 14, 1997 Received: July 15, 1997

Dear Ms. Tompkins:

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. 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 regulations affecting your device can be found in the Code of Federal Regulations, 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 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 requlations.

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Page 2 - Ms. Kim Tompkins

This letter will allow you to begin marketing your device as described in your 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 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,

C. Gale M. Whitten, Ph.D., M.

a 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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C. Indications for Use of the Device

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	510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________		K972641
			.

Device Name: Dual Offset PERFECTA® IMC Hip Stem

Indications for Use:

This device is indicated in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

1 . Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
1. Inflammatory degenerative joint disease such as rheumatoid arthritis:
1. Correction of function deformity:
Revision procedures where other treatments or devices have 4. failed; and
1. Treatment of nonunion, femoral neck, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

This device is intended for use with bone cement.

(Please do not write below this line-continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

t. ceele

(Division Sign-Off) (Division Signi-On)
Division of General Restorative Devices 510(k) Number_12322641

Prescription Use X (Per 21 CFR 801.109)

Over-the-Counter Use (Optional Format 1-2-96)

Regulation Number and Section

§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.