The CONSERVE® Plus Revision Shell and CONSERVE® Plus Thick Shell are 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; and,
revision procedures where other treatments or devices have failed
The CONSERVE® Plus Revision Shell and CONSERVE® Plus Thick Shell are intended for single patient use only.

Device Description

The design features of the CONSERVE® Plus Revision Shell are summarized below:

Manufactured from cast cobalt-chromium-molybdenum .
Porous coated with CoCrMo sintered beads
The articulating surface of the implants will be superfinished .
Offered in inner diameters ranging from 36mm-56mm .
Increased eccentricity and offset and screw holes .
Fins for enhanced fixation .

The design features of the CONSERVE® Plus Thick Shell are summarized below:

Manufactured from cast cobalt-chromium-molybdenum .
Porous coated with CoCrMo sintered beads .
The articulating surface of the implants will be superfinished .
Offered in inner diameters ranging from 36mm-56mm .
Minimum wall thickness: 5.5mm .

AI/ML Overview

The provided document is a 510(k) summary for a medical device (CONSERVE® Plus Revision Shell and CONSERVE® Plus Thick Shell), which focuses on demonstrating substantial equivalence to a predicate device rather than providing a new study with explicit acceptance criteria and performance data in the typical AI/software sense. Therefore, many of the requested data points (like sample sizes for training/test sets, ground truth establishment, MRMC studies, etc.) are not applicable to this type of submission.

However, I can extract the information that is present concerning the device's characteristics and the basis for its safety and effectiveness.

Here's the breakdown based on the provided text, with clarifications where the information is not present or not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, "acceptance criteria" and "reported device performance" are typically framed around substantial equivalence to a predicate device based on design features, intended use, and materials. Explicit performance metrics like sensitivity, specificity, or AUC are not usually presented in this context unless the device has an active diagnostic function that would typically be evaluated this way.

Feature/Criterion	Acceptance for CONSERVE® Plus Revision/Thick Shell	Reported Device Performance/Rationale
Intended Use	Identical to predicate device (CONSERVE® Plus Spiked Shell)	Indicated for use in total hip arthroplasty for reduction/relief of pain and/or improved hip function in skeletally mature patients with specified conditions (non-inflammatory degenerative joint disease, inflammatory degenerative joint disease, correction of functional deformity, revision procedures). Intended for single patient use only.
Material	Identical to predicate device (CONSERVE® Plus Spiked Shell)	Manufactured from cast cobalt-chromium-molybdenum. Porous coated with CoCrMo sintered beads.
Type of Interface	Identical to predicate device (CONSERVE® Plus Spiked Shell)	Not explicitly detailed beyond "type of interface," but implies consistency with the predicate device's mechanism of integration (e.g., uncemented).
Design Features (Revision Shell)	Substantially equivalent to predicate device (CONSERVE® Plus Spiked Shell)	Superfinished articulating surface, inner diameters 36mm-56mm, increased eccentricity and offset, screw holes, fins for enhanced fixation.
Design Features (Thick Shell)	Substantially equivalent to predicate device (CONSERVE® Plus Spiked Shell)	Superfinished articulating surface, inner diameters 36mm-56mm, minimum wall thickness: 5.5mm.
Safety and Effectiveness Demonstration	Adequately supported by substantial equivalence information, materials data, and testing results provided within the Premarket Notification.	Based on the comparison of intended use, material, and type of interface being identical, and design features being substantially equivalent to the CONSERVE® Plus Spiked Shell.

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 in the 510(k) summary. Given the nature of a 510(k) for an orthopedic implant, "test sets" typically refer to mechanical and material testing, not human subject data in the way an AI/diagnostic device would. The document refers to "materials data, and testing results" but does not detail the nature or sample size of these tests.

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 is not applicable to this 510(k) submission. "Ground truth" in this context (an orthopedic implant) would relate to clinical outcomes or mechanical performance, which are not established by expert consensus in the same way as an image-based diagnostic AI.

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

This is not applicable to this 510(k) submission. Adjudication methods are typically used for expert consensus on ground truth in studies involving subjective interpretation, which is not the primary focus here.

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 is not applicable to this 510(k) submission. MRMC studies are used for evaluating diagnostic performance of systems that produce outputs interpreted by human readers, typically in imaging diagnostics. This device is an orthopedic implant, not a diagnostic tool that assists human readers.

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

This is not applicable to this 510(k) submission. This device is an orthopedic implant, not a standalone algorithm.

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

For this type of device, "ground truth" would implicitly refer to established biomechanical properties, material standards, and potentially clinical outcomes of the predicate device. However, the document does not explicitly define or provide details on the "ground truth" for its "testing results." It primarily relies on the concept of substantial equivalence to a legally marketed predicate device.

8. The sample size for the training set

This is not applicable to this 510(k) submission. Machine learning "training sets" are not part of the evaluation for this type of medical implant.

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

This is not applicable to this 510(k) submission. As above, training sets and ground truth for them are not relevant to this traditional medical device submission.

Summary

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JUN 2 5 2004

Image /page/0/Picture/1 description: The image shows the text "K041425" on the top left corner and "p.1/2" on the top right corner. In the center of the image is the word "WRIGHT." in bold, uppercase letters. Below the word is a black graphic design element that looks like a stylized wing or chevron, and below that is the trademark symbol.

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

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 CRF 807, this information serves as a Mouren Dovies For of 1990 and Effectiveness for the CONSERVE® Plus Revision Shell and CONSERVE® Plus Thick Shell.

Submitted By:	Wright Medical Technology, Inc.
Date:	May 27, 2004
Contact Person:	Katie LogerotRegulatory Affairs Specialist II
Proprietary Name:	CONSERVE® Plus Revision Shell andCONSERVE® Plus Thick Shell
Common Name:	Acetabular Shell
Classification Name and Reference:	21 CFR 888.3320 Hip joint metal/ metal semi-constrained, with a cemented acetabular componentprosthesis - Class III21 CFR 888.3330 Hip joint metal/ metal semi-constrained, with an uncemented acetabularcomponent prosthesis - Class III
Device Product Code and Panel Code:	Orthopedics/87/JDLOrthopedics/87/KWA

DEVICE INFORMATION

A. INTENDED USE

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;
correction of functional deformity; and, 3.
1. revision procedures where other treatments or devices have failed

The CONSERVE® Plus Revision Shell and CONSERVE® Plus Thick Shell are intended for single patient use only.

headquarters
Wright Medical Technology, Inc.	5677 Airline Road	Arlington, TN 38002	901.867.9971 phone	www.wmt.com
international subsidiaries
011.32.2.378.3905 Belgium	905.826.1600 Canada	011.33.1.45.13.24.40 France	011.49.4161.745130 Germany
011.39.0250.678.227 Italy	011.81.3.3538.0474 Japan	011.44.1483.721.404 UK

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p.2/2

B. DEVICE DESCRIPTION

The design features of the CONSERVE® Plus Revision Shell are summarized bclow:

Manufactured from cast cobalt-chromium-molybdenum .
Porous coated with CoCrMo sintered beads �
The articulating surface of the implants will be superfinished .
Offered in inner diameters ranging from 36mm-56mm .
Increased eccentricity and offset and screw holes .
Fins for enhanced fixation .

The design features of the CONSERVE® Plus Thick Shell are summarized below:

Manufactured from cast cobalt-chromium-molybdenum .
Porous coated with CoCrMo sintered beads .
The articulating surface of the implants will be superfinished .
Offered in inner diameters ranging from 36mm-56mm .
Minimum wall thickness: 5.5mm .

C. SUBSTANTIAL EQUIVALENCE INFORMATION

The intended use, material, and type of interface of the CONSERVE® Plus Revision Shell and CONSERVE® Plus Thick Shell are identical to the CONSERVE® Plus Spiked Shell. The design features are substantially equivalent to the CONSERVE® Plus Spiked The safety and effectiveness of this device are adequately supported by the Shell. substantial equivalence information, materials data, and testing results, provided within this Premarket Notification.

Image /page/1/Picture/18 description: The image shows the logo for Wright Medical Technology, Inc. The logo consists of the word "WRIGHT" in a bold, sans-serif font, with a stylized "W" symbol above it. Below the word "WRIGHT" are the words "MEDICAL TECHNOLOGY, INC." in a smaller, sans-serif font. The logo is simple and modern, and it conveys a sense of professionalism and innovation.

Image /page/1/Picture/19 description: The image shows a black and white drawing of a globe. The globe is tilted and shows the continents of Asia, Europe, and Africa. There is a small object below the globe, which is difficult to identify due to the image quality. The image is simple and lacks detail.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows a circular logo for the Department of Health & Human Services - USA. The logo features the department's name encircling a stylized symbol. The symbol consists of three curved lines that resemble a person's profile, with the lines representing different aspects of health and human services.

Public Health Service

JUN 2 5 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Katie Logerot Regulatory Affairs Specialist II Wright Medical Technology, Inc. 5677 Airline Road, Arlington, Tennessee 38002

Re: K041425

K041423
Trade/Device Name: CONSERVE® Plus Revision Shell and CONSERVE® Plus Thick Shell

Regulation Number: 21 CFR 888.3320 and 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with a cemented acetabular
Regulation Name: Hip joint metal/metal semi-constrained, with a cements in a Trip John metal senia Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis

Regulatory Class: III Product Code: KWA and JDL Dated: May 27, 2004 Received: May 28, 2004

Dear Ms. Logerot:

We have reviewed your Section 510(k) premarket notification of intent to market the indication we nave reviewed your bection of the device is substantially equivalent (for the indications referenced above and nave acteringedly marketed predicate devices marketed in interstate for use stated in the enclosury to regary to regard to the Medical Device American so to to commerce provide to May 20, 1976, the enature with the provisions of the Federal Food. Drug, devices that have been recassmen in asses approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval appl You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, therefore, mance the art include requirements for annual registration, listing of general controls provisions of the 120 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 If your device is elassified (500 abor of the Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulation FDA may be subject to such additional controller ... Title 21, Parts 800 to 898. In addition, FDA may be found in the Outs ocements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Prease be advised that I DA 3 issualled of a substition.
that FDA has made a determination that your device complies with other requirements of the Act that I DA has made a acterimisered by other Federal agencies. You must br any it cach statutes and regularents and adding, but not limited to: registration and listing (21 Comply with an the Act STequirements) and manufacturing practice requirements as set

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Page 2 – Ms. Katie Logerot

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 100-1050.
product radiation control provisions (Sections 531-542 of the Action Section S product radiation control provisions (Doctors 301 cevice as described in your Section 510(k)
This letter will allow you to begin marketing your device of your daying to legal I his letter will anow you to ocgin manomig of substantial equivalence of your device to a legally premarket nothication. The PDA miding of backandar organ
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), please If you desire specific advice for your active of the carner on one note the regulation entitled, contact the Office of Compliation at (301) of Cations (21CFR Part 807.97). You may obtain " Misbranding by reference to premarket notifical on the Act from the Division of Small other general Information on your responsion.com its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at in the manage attral Manufacturers, michiational and Oblisantety://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark A. McMahon

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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K041425

Indications for Use

510(k) Number (if known):

Device Name: _CONSERVE® Plus Revision Shell and CONSERVE® Plus Thick Shell

Indications For Use:

The CONSERVE® Plus Revision Shell and CONSERVE® Plus Thick Shell are indicated for The CONSERVE® Plus Revision Silen and OOT&BA. De 2011-2017 and/or improved hip function in use in total mp artises with the following conditions:

skorean matory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
ankylosis, protrusio accusein, a.a. pass such as rheumatoid arthritis;
1. correction of functional deformity; and,
1. confection of functional developments or devices have failed

The CONSERVE® Plus Revision Shell and CONSERVE® Plus Thick Shell are intended for single patient use only.

Prescription Use × (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)
Mark N. Melker

Division of General, Restorative, and Neurological Devices

510(k) Number K041425

Page 1 of

Regulation Number and Section

§ 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.

(a)
Identification. A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part 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 consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).(b)
Classification. Class III.(c)
Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.