The ATH Femoral Stem 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 discase such as 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.

Device Description

The design features for Wright Medical Technology's ATH Femoral Stem are as follows:

Sizes range from 4mm to 13mm .
Wright Medical Technology's standard 12/14 SLT taper .
. Grit blast surface finish
Proximal body with double wedge shape .
Proximal body has rounded off rectangular cross-section .
Tapered distal stem with rounded off rectangular cross-section .
Dimple on lateral shoulder .

AI/ML Overview

This document is a 510(k) summary for the ATH Femoral Stem, submitted by Wright Medical Technology, Inc. It describes the device, its intended use, and states that it is substantially equivalent to predicate devices. This type of regulatory submission does not typically include a detailed study proving device meets acceptance criteria in the manner you've outlined for performance studies (e.g., specific acceptance criteria, sample sizes, expert ground truth).

Instead, "acceptance criteria" in this context refers to the FDA's regulatory requirements for demonstrating substantial equivalence to a legally marketed predicate device. This is achieved through comparisons of technological characteristics, intended use, and performance data from internal testing or literature, rather than a clinical study with an AI device.

Therefore, for the provided document, I cannot fill out the requested table regarding acceptance criteria and device performance as if it were an AI performance study. However, I can extract information relevant to the substantial equivalence determination.

Here's an analysis of the provided text in the context of your request:

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

The document does not present acceptance criteria and device performance in the format of a clinical or AI performance study. Instead, it relies on demonstrating substantial equivalence to predicate devices. This regulatory pathway means that the device is considered safe and effective if its intended use and technological characteristics are similar to those of a legally marketed predicate device, and any differences do not raise new questions of safety or effectiveness.

The "device performance" in this context is implied by its similarity to existing, approved devices. The summary states:

"The safety and effectiveness of the ATH Femoral Stem is established by the substantial equivalent information, materials data, and testing results provided within this Premarket Notification."

The specific "acceptance criteria" are not quantitative thresholds like sensitivity or specificity. Instead, they are the qualitative and quantitative similarities to the predicate device in terms of:

Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance (as per document)
Intended Use (Must be the same as or very similar to predicate)	The ATH Femoral Stem is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with conditions such as: 1) non-inflammatory degenerative joint disease (e.g., osteoarthritis, avascular necrosis); 2) inflammatory degenerative joint disease (e.g., rheumatoid arthritis); 3) correction of functional deformity; 4) revision procedures; and 5) treatment of unmanageable fractures.
Technological Characteristics (Must be similar to predicate)	- Sizes range from 4mm to 13mm.- Wright Medical Technology's standard 12/14 SLT taper.- Grit blast surface finish.- Proximal body with double wedge shape.- Proximal body has rounded off rectangular cross-section.- Tapered distal stem with rounded off rectangular cross-section.- Dimple on lateral shoulder.- Classification: 21 CFR 888.3358 Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented- Class II; 21 CFR 888.3350 Prosthesis, hip, semi-constrained, metal/polymer, cemented- Class II.
Performance Data (Must demonstrate equivalent safety and effectiveness; typically non-clinical for 510(k), e.g., material testing, mechanical testing)	The document explicitly states: "The safety and effectiveness... is established by the substantial equivalent information, materials data, and testing results provided within this Premarket Notification." (Specific types or results of these tests are not detailed in this summary, but would have been part of the full 510(k) submission.)

2. Sample size used for the test set and the data provenance

The document does not describe a "test set" in the context of an AI performance study, nor does it mention a specific sample size of patients or images. The "testing results" mentioned in the summary refer to non-clinical tests (e.g., mechanical, material) that demonstrate the device's characteristics are comparable to the predicate. The FDA letter confirms the device is "substantially equivalent... to legally marketed predicate devices."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is a medical device 510(k) submission, not an AI performance study involving expert ground truth labeling.

4. Adjudication method for the test set

Not applicable. This is a medical device 510(k) submission, not an AI performance study involving adjudication of expert opinions.

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 is a medical device 510(k) submission for an implantable orthopedic device, not an AI diagnostic or assistive technology.

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

Not applicable. This is for a physical medical device.

7. The type of ground truth used

For a 510(k) submission for a physical implant, the "ground truth" for demonstrating safety and effectiveness relies on established engineering principles, material science, biomechanical testing standards, and the successful clinical history of the predicate device. It's not about expert consensus on an image or pathology from a dataset.

8. The sample size for the training set

Not applicable. This is a medical device 510(k) submission, not an AI development project.

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

Not applicable. This is a medical device 510(k) submission.

Summary

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Image /page/0/Picture/1 description: The image shows a document with the text "510(K) SUMMARY OF SAFETY AND EFFECTIVENESS" and the Wright Medical logo. The document also has the date "MAR 11 2004" and the handwritten text "K034028 page 1 of 2". The document appears to be a summary of safety and effectiveness for a medical device.

In accordance with the Food and Drug Administration Rule to implement provin Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information scrves as a Summary of Safety and Effectiveness for the ATH Femoral Stem.

510(K) SUMMARY

Submitted By:	Wright Medical Technology, Inc.
Date:	December 19, 2003
Contact Person:	Jeanine H. ReddenRegulatory Affairs Associate
Proprietary Name:	ATH Femoral Stem
Common Name:	HIP PROSTHESIS
Classification Name and Reference:	21 CFR 888.3358 Prosthesis, hip, semi-constrained,metal/polymer, porous uncemented- Class II
	21 CFR 888.3350 Prosthesis, hip, semi-constrained,metal/polymer, cemented- Class II
Device Product Code and Panel Code:	Orthopedics/87/LPH/JDI

DEVICE INFORMATION

A. INTENDED USE

The ATH Femoral Stem 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 discase such as 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.

B. DEVICE DESCRIPTION

The design features for Wright Medical Technology's ATH Femoral Stem are as follows:

Sizes range from 4mm to 13mm .
Wright Medical Technology's standard 12/14 SLT taper .
. Grit blast surface finish

headquarters

5677 Airline Boad Arlington, IN 38002 Wright Medical Technology, Inc.

901.867.9971 phone

www.wmt.com

international subsidianes 011.32.2.378.3905 Belgium 011.39.0250.678.227 Italy

905.826.1600 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

{1}------------------------------------------------

K034028
page 2 of 2

And Children Children Children

Proximal body with double wedge shape .
Proximal body has rounded off rectangular cross-section .
Tapered distal stem with rounded off rectangular cross-section .
Dimple on lateral shoulder .

C. SUBSTANTIAL EQUIVALENCE INFORMATION

Wright Medical Technology's ATH Femoral Stem is substantially cquivalent to the wing.it insured "Founded" "The safety and effectiveness of the ATH predicate actives provised by the substantial equivalent information, matcrials data, and testing results provided within this Premarket Notification.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three wings, representing health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

MAR 1 1 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Jeanine H. Redden Regulatory Affairs Specialist II Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002

Re: K034028

Trade/Device Name: ATH Femoral Stem Implant Regulation Numbers: 21 CFR 888.3350 and 21 CFR 888.3358 Regulation Names: Spinal interlaminal fixation orthosis, Hip joint metal/polymer/metal semi-constrained pouous-coated uncemented prosthesis Regulatory Class: II Product Codes: JDI and LPH Dated: February 20, 2004 Received: February 23, 2004

Dear Ms. Redden:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above 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 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) that 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 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 (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 - Ms. Jeanine H. Redden

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International 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,

Mark McMillan

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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Indications for Use

510(k) Number: K034028

ATH Femoral Stem Device Name:

Indications For Use:

The ATH Femoral Stem 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 fractures that are unmanageable using other techniques.

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 Milliman

Restorative and Neurological Devices

Page 1 of 1

510(k) Number K034028

Regulation Number and Section

N/A