The PERFECTA® Femoral Stem with calcium sulfate coating 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:

non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
inflammatory degenerative joint disease such as rheumatoid arthritis;
correction of functional deformity;
revision procedures where other treatments or devices have failed; and,
treatment of fractures that are unmanageable using other techniques.

The PERFECTA® Femoral Stem with calcium sulfate coating is for single use only, and is intended for use in conjunction with existing Wright Medical Technology ceramic or metal femoral heads, acetabular liners and shells, as a part of an uncemented total hip arthroplasty.

Device Description

The design features and functions of the PERFECTA® Femoral Stem with calcium sulfate coating will be identical to the design features and functions of the currently available PERFECTA® Femoral Stem (510(k): K991123 and K004032), with the exception of the calcium sulfate coating.

The PERFECTA® Femoral Stem will be available in a range of sizes (9-22.5 mm) and will feature the Wright Medical Technology (SLT) 12/14 taper.

AI/ML Overview

This is a 510(k) premarket notification for a medical device, the PERFECTA® Femoral Stem with calcium sulfate coating. As such, the documentation focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed clinical study data with specific acceptance criteria and performance metrics typically found in clinical trials for novel devices.

Here's an analysis based on the provided text, addressing the requested points where possible, and noting where information is not available:

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

This document does not contain a table of acceptance criteria and reported device performance in the manner requested for efficacy or safety metrics. The basis for clearance is substantial equivalence to a previously cleared predicate device.

The "device performance" in this context is implicitly considered to be equivalent to the predicate device due to identical design features and functions, with the only specified difference being the calcium sulfate coating.

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

This information is not provided. As this is a 510(k) submission based on substantial equivalence, detailed clinical study data with test sets, sample sizes, and provenance are typically not included unless there are significant design or material changes that warrant new clinical testing. The submission states "The safety and effectiveness of the PERFECTA® Femoral Stem with calcium sulfate coating are adequately supported by the information provided in the Premarket Notification". This would refer to non-clinical testing (e.g., mechanical, biocompatibility) and comparison to the predicate.

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/not provided. Ground truth establishment by experts for a test set is relevant for studies evaluating diagnostic or predictive AI devices, or for clinical trials with subjective endpoints. This 510(k) submission is for an orthopedic implant, where "ground truth" and expert consensus for a "test set" in this context would typically relate to clinical outcomes and safety, which are not detailed in this type of submission focused on substantial equivalence.

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

This information is not applicable/not provided for the same reasons as point 3.

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/not provided. MRMC studies are used to evaluate the performance of diagnostic imaging devices or AI tools that assist human readers in tasks like detection or diagnosis. The PERFECTA® Femoral Stem is an orthopedic implant, not a diagnostic or AI-assisted imaging device.

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

This information is not applicable/not provided. This refers to AI algorithm performance in isolation. The PERFECTA® Femoral Stem is a physical medical device.

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

This information is not applicable/not provided in detail. For an orthopedic implant, "ground truth" for safety and effectiveness would ultimately involve long-term patient outcomes (e.g., pain reduction, improved function, revision rates, adverse events). However, in a 510(k) based on substantial equivalence, the primary "ground truth" is established by the successful clinical history and regulatory clearance of the predicate device. The submission relies on the predicate's established safety and effectiveness.

8. The sample size for the training set

This information is not applicable/not provided. Training sets are relevant for machine learning algorithms. The PERFECTA® Femoral Stem is a physical implant, not an AI/ML product.

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

This information is not applicable/not provided for the same reasons as point 8.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as per 510(k) process):

The "study" that proves the PERFECTA® Femoral Stem with calcium sulfate coating meets acceptance criteria is the demonstration of Substantial Equivalence to legally marketed predicate devices.

Predicate Devices: PERFECTA® Femoral Stem (510(k) numbers: K991123 and K004032).
Methodology: The submission asserts substantial equivalence based on:
- Identical Intended Use: The indications for use are the same as the predicate devices.
- Identical Design Features and Functions (with one exception): The design of the subject device is stated to be identical to the predicate, with the exception of the calcium sulfate coating.
- Identical Materials (implicitly, except for the coating): The statement mentions "material" in the context of substantial equivalence, implying that the core materials (e.g., for the stem itself) are the same as the predicate.
- Identical Type of Interface: The interface (e.g., with existing Wright Medical Technology ceramic or metal femoral heads, acetabular liners and shells) is stated to be identical.
"Proof": The FDA's clearance letter (NOV 22 2004) to Wright Medical Technology, Inc., explicitly states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This determination by the FDA serves as the regulatory "proof" that the device meets the acceptance criteria for market clearance under the 510(k) pathway.
Underlying Data: While not detailed in this summary, the "adequately supported by the information provided in the Premarket Notification" likely refers to non-clinical performance testing (e.g., mechanical strength, fatigue, biocompatibility, coating adhesion, and elution characteristics of the calcium sulfate) for the new coating, demonstrating that the addition of the calcium sulfate coating does not adversely affect the safety or effectiveness profile as established by the predicate devices.

Summary

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K031402

NOV 2 2 2004

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe in accordance with the room and in conformance with 21 CRF 807, this information serves as a Medical Dovices For of Serviveness for the use of the PERFECTA® Femoral Stem.

Submitted By:	Wright Medical Technology, Inc.
Date:	May 2, 2003
Contact Person:	Ehab M. EsmailSenior Manager, Regulatory Affairs
Proprietary Name:	PERFECTA® Femoral Stem
Common Name:	TOTAL HIP SYSTEM
Classification Name and Reference:	21CFR 888.3358 Hip joint metal/polymer/metal,semi-constrained porous coated uncementedprosthesis21CFR 888.3350 Hip joint metal/polymer, semi-constrained, cemented prosthesis - Class II
Device Product Code and Panel Code:	Orthopedics/87/ LPH, and JDI

DEVICE INFORMATION

A. INTENDED USE

non-inflammatory degenerative joint disease such as osteoarthritis, avascular 1 . necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
inflammatory degenerative joint disease such as rheumatoid arthritis; 2.
correction of functional deformity; 3.
revision procedures where other treatments or devices have failed; and, 4.
treatment of fractures that are unmanageable using other techniques. 5.

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B. DEVICE DESCRIPTION

DL VICE DEBOTED TIME .
The design features and functions of the first of the currently available The design features and functions of the Peter Petures of the currently available
coating will be identical to the 100 110 - 11 F000022, with the exception of the coating will be identical to the design features and railorions
PERFECTA® Femoral Stem (510(k): K991123 and K004032), with the exception of the calcium sulfate coating.

ourerally could be available in a range of sizes (9-22.5 mm) and will feature the All Tembral Dedical Technology (SLT) 12/14 taper.

C. SUBSTANTIAL EQUIVALENCE INFORMATION

The intended use, material, type of interface, and design features of the PERFECTA" The intended lise, malerial, type of microos, are substantially equivalent to the Femoral Stem with calciall suffato coating and control of the market (510(k): K991123 and K004032).

100 1052).
The safety and effectiveness of the PERFECTA® Femoral Stem with californation, marcrials The satety and effectiveness of the substial equivalence information materials
coating are adequatedy supported by the subscription Promarket Notification coating are adequately supported by the sabetainler of any and

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 2 2004

Mr. Ehab M. Esmail Senior Manager, Regulatory Affairs Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002

Re: K031402

Rosi402
Trade/Device Name: Calcium Sulfate Coated Perfecta® Femoral Stem Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: II Product Code: LPH Dated: August 20, 2004 Received: August 24, 2004

Dear Mr. Esmail:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roved your 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 for use surved in the excess, 1976, the enactment date of the Medical Device Amendments, or to commerce processified in accordance with the provisions of the Federal Food, Drug, de noos that hat t over wat 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 rou mayy arous 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 - Mr. Ehab M. Esmail

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter wif anow you've ough finding of substantial equivalence of your device to a legally prematics notification. The Processification 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), please If you desire specific acries in 1 240) 276-0120. Also, please note the regulation entitled, Connact the Office or Comment notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general miormational 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,

Cilia Wither

Celia M. Witten, PhD, MD Director Division of General, Restorative And Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/4/Picture/0 description: The image shows the word "WRIGHT." in all caps. Below the word is a graphic of three diagonal lines that are stacked on top of each other. Below the graphic is the letters "TM".

PERFECTA® Femoral Stem INDICATIONS STATEMENT

510(k) Number (if known):

Device Name: PERFECTA® Femoral Stem

Indications For Use:

The PERFECTA® Femoral Stem with calcium suffate coating 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:

non-inflammatory degenerative joint disease such as osteoarthritis, avascular 1. necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
inflammatory degenerative joint disease such as rheumatoid arthritis, 2.
1. correction of functional deformity;
revision procedures where other treatments or devices have failed; and, 4.
1. treatment of fractures that are unmanageable using other techniques.

The PERFECTA® Femoral Stem with calcium sulfate coating is for single use only, and is intended for use in conjunction with existing Wright Medical Technology cerainic or metal femoral heads, acetabular liners and shells, as a part of an uncemented total hip arthroplasty.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over. The-Counter Use (21 CFR 807 Subpart C)

(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, and Neurological Devices

headquartersWright Medical Technology, Inc.	5677 Airline Road Arlington, TN 38002
510(k) Number	K031402
Phone	901.867.9971
Website	www.wmt.com

International subsidiaries
011.32.2.378.3905 Belgium	905.826.1600 Canada
011.39.0250.678.227 Italy	011.81.3.9538.0474 Japan
	011.33.1.45.13.24.40 France
	011.44.1483.721.404 UK
	011.49.4161.745130 Germany

Regulation Number and Section

N/A