The ADVANCE® HA Coated Components are indicated for use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions:

noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
inflammatory degenerative joint disease including 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 ADVANCE® HA Coated Components are for use without bone cement and are single use devices.

Device Description

The ADVANCE® HA Coated Components are an HA Coated Spiked Tibial Base and an ADVANCE® HA Coated Modular Keel. The design features of the components are described below.
ADVANCE® HA Coated Spiked Tibial Base

4 spikes on the distal surface .
Manufactured from titanium alloy .
Titanium sintered bead porous coated .
HA coated ●
ADVANCE® HA Coated Modular Keel
2 small anterior fins .
2 posterior fins .
Manufactured from titanium alloy .
HA coated .

AI/ML Overview

The provided text is a 510(k) summary for a medical device called "ADVANCE® HA Coated Spiked Tibial Base and ADVANCE® HA Coated Modular Keel." This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing acceptance criteria or reporting performance from a de novo study.

Therefore, the requested information cannot be fully extracted as such a study was not performed. The document explicitly states:

"The safety and effectiveness of ADVANCE® HA Coated Components are adequately supported by the substantial equivalence information, materials data, and testing results provided within the Premarket Notification."

This means that Wright Medical Technology, Inc. is claiming their device is as safe and effective as devices already on the market, based on similarities in materials, design, and intended use, and supported by various testing (likely mechanical, material characterization, biocompatibility, etc.) rather than a unique clinical study with specific acceptance criteria as you've outlined.

Here's what can be gathered, and why other parts of your request are not applicable:

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

Not Applicable. This document does not establish new acceptance criteria as it is a 510(k) submission based on substantial equivalence. Performance is implied to be equivalent to predicate devices. A typical 510(k) submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than proving performance against novel, pre-defined acceptance criteria in a clinical study.

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

Not Applicable. No human-subject clinical test set, in the sense of a prospective or retrospective study to measure a particular performance metric against acceptance criteria, is described. The "testing results" mentioned in the document likely refer to bench testing (e.g., mechanical properties, material characterization) rather than a clinical dataset.

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):

Not Applicable. As no clinical test set for algorithmic performance or human assessment is mentioned, there's no ground truth established by experts.

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

Not Applicable. No human-based test set or adjudication process is described.

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:

Not Applicable. This device is a knee arthroplasty component (implant), not an AI-assisted diagnostic or assistive device for human readers. Therefore, an MRMC study is not relevant to its regulatory submission.

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

Not Applicable. This is a physical medical device (implant), not an algorithm or software-as-a-medical-device (SaMD).

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

Not Applicable. No "ground truth" in the context of diagnostic or algorithmic performance is used. For this type of device, ground truth would typically be related to the device's physical properties (e.g., material strength, wear characteristics, biocompatibility) demonstrated through bench testing and often compared to known values of predicate devices.

8. The sample size for the training set:

Not Applicable. This is a physical medical device, not a machine learning model. Therefore, there is no "training set" in the context of AI.

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

Not Applicable. As there's no training set, this question is not relevant.

Summary of what we do know from the document (focused on Substantial Equivalence):

Device Name: ADVANCE® HA Coated Spiked Tibial Base and the ADVANCE® HA Coated Modular Keel
Intended Use: Knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with conditions like noninflammatory/inflammatory degenerative joint disease, correction of functional deformity, revision procedures, and treatment of fractures. For use without bone cement and are single-use devices.
Basis of Approval: Substantial Equivalence to previously cleared predicate devices.
Evidence for Substantial Equivalence: "substantial equivalence information, materials data, and testing results." (Specific details of these tests are not provided in this 510(k) summary, but would be in the full submission).
Key Features for Substantial Equivalence: Intended use, material, and design features are stated to be substantially equivalent to predicate devices.
Device Materials:
- ADVANCE® HA Coated Spiked Tibial Base: Manufactured from titanium alloy, titanium sintered bead porous coated, HA coated.
- ADVANCE® HA Coated Modular Keel: Manufactured from titanium alloy, HA coated.

Summary

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Image /page/0/Picture/0 description: The image shows the text 'K043083 (pg 1 of)'. The text appears to be handwritten in black ink on a white background. The text likely represents a document identifier or page number.

Image /page/0/Picture/1 description: The image shows the word "WRIGHT." in a bold, sans-serif font. Below the word is a stylized graphic consisting of three parallel lines that are angled downwards and slightly overlap each other, creating a sense of depth. The letters are large and prominent, and the graphic is positioned to complement the text.

APR 1 8 2005

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 1 000 and in conformance with 21 CRF 807, this information serves as a Moural Dovies Ave of 1998 and is a for the ADVANCE® HA Coated Spiked Tibial Base and the ADVANCE® HA Coated Modular Keel.

Submitted By:	Wright Medical Technology, Inc.
Date:	November 5, 2004
Contact Person:	Ehab M. EsmailSr. Manager, Regulatory Affairs
Proprietary Name:	ADVANCE® HA Coated Spiked Tibial Base andthe ADVANCE® HA Coated Modular Keel
Common Name:	HA COATED COMPONENTS
Classification Name and Reference:	21 CFR 888.3565 Prosthesis, Knee,Patello/femorotibial, Semi-Constrained,Uncemented, Porous Coated,Polymer/Metal/Polymer - Class II
Device Product Code and Panel Code:	Orthopedics/87/ MBH

DEVICE INFORMATION

A. INTENDED USE

1. noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
1. inflammatory degenerative joint disease including rheumatoid arthritis;
1. correction of functional deformity;
1. revision procedures where other treatments or devices have failed; and
1. treatment of fractures that are unmanageable using other techniques.

headquarters Wright Medical Technology, Inc.

Arlington, TN 38002 901.867.9971 phone 5677 Airline Road

ww.wmt.com

international subsidiaries 011.32.2.378.3905 Belgium 011.39.0250.678.227 Italy

05.826.1600 Canada 011.81.3.3538.0474 Japan 011.33.1.45.13.24.40 France

011.44.1483.721.404 UK

011.49.4161.745130 Germany

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K043083 (pg 2 of 2)

The ADVANCE® HA Coated Components are for use without bone cement and are single use devices.

B. DEVICE DESCRIPTION

The ADVANCE® HA Coated Components are an HA Coated Spiked Tibial Base and an The ADVANCES In Feel. The design features of the components are described below.

ADVANCE® HA Coated Spiked Tibial Base

4 spikes on the distal surface .
Manufactured from titanium alloy .
Titanium sintered bead porous coated .
HA coated ●

ADVANCE® HA Coated Modular Keel

2 small anterior fins .
2 posterior fins .
Manufactured from titanium alloy .
HA coated .

The design features of ADVANCE® HA Coated Components are substantially equivalent to the design features of other devices previously cleared for market.

C. SUBSTANTIAL EQUIVALENCE INFORMATION

The intended use, material, and design features of ADVANCE® HA Coated Components are substantially equivalent to the predicate devices previously cleared for market. The safety and effectiveness of ADVANCE® HA Coated Components are adequately supported by the substantial equivalence information, materials data, and testing results provided within the Premarket Notification.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/12 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" written around it. Inside the circle is an abstract symbol that resembles an eagle or bird with three stylized lines forming its body and wings.

APR 1 8 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K043083

K043083
Trade/Device Name: ADVANCE® HA Coated Spiked Tibial Base and the ADVANCE® HA Coated Modular Keel Regulation Number: 21 CFR 888.3565 Regulation Number: 21 CFK 866.5503
Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prothesis Regulatory Class: II Product Code: MBH Dated: March 25, 2005 Received: March 28, 2005

Dear Mr. Esmail:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Security (10). "I substantially equivalent (for the indications
referenced above and have determined the device is substantial in interstate for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosule) to regary manced prought in the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior in May 28, 1970, the chance with the provisions of the Federal Food. Drug, devices that have been reciassified in accordance while approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act . The and Cosmetic Act (Act) that to hot require approvide on trols provisions of the Act. The You may, merelore, market the devree, becjocher to the one in annual registration, listing of
general controls provisions of the Act include requirements for any province and general controls provisions of the Feet neralies requires 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 classified (sec above) movement major regulations affecting your device can
may be subject to such additional controls. Existing major regulations EDA may may be subject to such additional controller Entrological of 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to Register be found in the Code of Pederal Registering your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualies of a subscription with other requirements of the Act
that FDA has made a determination that your device complies . You must that FDA nas made a delerimiation mac your as roos be species. You must of any list in or any Federal statutes and regulations daministered of registration and listing (21 l
eomply with all the Act's requirements, including, but not limited to set comply with all the Act S requirements, mercessed in the practice requirements as set CFR Part 807); labeling (21 CFR Party, good and 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Path, 21 CFR 1000 1050 forth in the quality systems (QD) regalantin (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000

{3}------------------------------------------------

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 will anow you to begin marketing your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivalias and thus, premarket notification. The FDA Inding of substanced by July 19, 2017 11:55
marketed predicate device results in a classification for your device and thus, permits your devic to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 81), please an If you desire specific advice for your active of the can and the regulation entitled, the regulation entitled, the international contact the Office of Compliance at (2 to 21 to a market notification the Division of Small "Misbranding by relerence to premarkst nothleadon (1) be Act from the Division of Small
other general information on your responsibilities under the Act from the (800) 638, 2 other general information on your responsion.com in toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-free warming on html Manufacturers, International and Consumer Fissionalite aroved childring stry/support/index.html.

Sincerely yours,

Stupt Plurde
S.E. Ph.D.

Airiam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K043083

Indications for Use

510(k) Number (if known):

Device Name: ADVANCE® HA Coated Spiked Tibial Base and ADVANCE® HA Coated Modular Keel

Indications For Use:

The ADVANCE® HA Coated Components are indicated for use in knee arthroplasty for The ADVANCE® HA Coated Components are mercion in skeletally mature patients with the following conditions:

1. noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
1. correction of functional deformity;
1. correction of functional deforming,

revision procedures where other treatments or devices have failed; and

1. Tevision procedures where of the read of the rechniques.

The ADVANCE® HA Coated Components are for use without bone cement and are single use devices.

X 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)

typt Purbe
(Division Sign-Off)

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Division of General, Restorative, and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis is a device intended to be implanted to replace a knee 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.