Indicated for use in total 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.
This device is intended for use with bone cement.

Device Description

The ADVANCE All Polyethylene Tibial Component, size 8mm, is manufactured from ultra high molecular weight polyethylene. The device features cement pockets on the underside of the component. The device is designed to be used with bone cement.

AI/ML Overview

The provided text describes a medical device submission (K974328) for the ADVANCE® Total Knee System, 8mm All Polyethylene Tibial Component. It outlines the device's description, intended use, and a summary of the testing conducted. However, the document does not present acceptance criteria in a structured table or a detailed study report that explicitly "proves the device meets the acceptance criteria" in the format typically associated with AI/ML model performance evaluation. Instead, it describes mechanical testing for a physical implant.

Therefore, many of the requested fields regarding AI/ML model evaluation, such as sample size for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment for training sets, are not applicable to the information provided.

Based on the available information, here is a breakdown of what can be extracted concerning acceptance criteria and device performance for this physical medical device:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Withstand a load of 450 lbs for at least 10 million cycles.	"Submitted testing indicates that the device should withstand a load of 450 lbs for at least 10 million cycles." (Implies it met this, but no numerical performance beyond "at least")
No areas of unacceptable high stress identified.	"Additional testing indicates that no areas of unacceptable high stress were identified." (Implies it met this)
Adequate constraint for expected physiological loads.	"Finally, testing provided indicates that the device provides adequate constraint for expected physiological loads." (Implies it met this)

Regarding the other information points, based on the provided text, the following apply:

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. This document describes mechanical testing of a physical implant, not a data-driven device where a "test set" in the context of AI/ML evaluation would be relevant. The testing would have involved physical specimens of the tibial component.

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. Ground truth in this context would refer to the physical and mechanical properties of the device, established through engineering testing, not expert consensus on data interpretation.

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

Not Applicable. Adjudication methods are relevant for human interpretation tasks, not for mechanical device testing.

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 physical orthopedic implant, not an AI/ML-driven diagnostic or assistive device.

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

Not Applicable. No algorithms or AI are mentioned in the context of this device's performance evaluation.

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

The ground truth for the mechanical testing would be established by
- Engineering specifications and standards: These would define the acceptable limits for load, stress, and constraint.
- Physical measurements and observations: Direct measurements from the testing (e.g., fatigue life, stress distribution visualizations, displacement under load) against predetermined thresholds.

8. The sample size for the training set

Not Applicable. No training set for an AI/ML model is mentioned.

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

Not Applicable. No training set for an AI/ML model is mentioned.

Summary

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JAN 30 1998

Image /page/0/Picture/1 description: The image shows the logo for Wright Medical Technology, Inc. The logo features a stylized "W" on the left, followed by the company name in bold, uppercase letters. Below the name is the company's address: 5677 Airline Road, Arlington, TN 38002, and their phone number: 901-867-9971. At the bottom of the image, the number K974328 is handwritten.

Kim Tompkins Contact Person: November 17, 1997 Date:

510(k) Summary

Trade Name:	ADVANCE® Total Knee System, All Polyethelene TibialComponent, size 8mm
Common Name:	Tibial Component
Classification:	Class II
Predicate Device:	ADVANCE® Total Knee System All Polyethylene TibialComponents manufactured by Wright Medical Technology, 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 knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions:

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.

Testing

Submitted testing indicates that the device should withstand a load of 450 lbs for at least 10 million cycles. Additional testing indicates that no areas of unacceptable high stress were identified. Finally, testing provided indicates that the device provides adequate constraint for expected physiological loads.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 30 1998

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

Re: K974328 ADVANCE® Total Knee System, 8mm All Polyethylene Tibial Component Requlatory Class: II Product Code: ਹੈਂ ਮ November 17, 1997 Dated: Received: November 18, 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). This decision is based on this device being equivalent only to similar devices labeled ... and intended to be fixed within bone with acrylic "bone cement." You may, therefore, market your device subject to the general controls provisions of the Act and the following limitations:

The thinnest tibial component available is the nominal 1. "8mm" sized component, which has a minimum polyethylene ... ా thickness under the condyles of 8.0mm.
1. This device may not be labeled or promoted for noncemented use.
All labeling for this device, including package label 3. and labeling included within the package, must prominently state that the device is intended for cemented use only.

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Page 2 - Ms. Kim Tompkins

Any non-cemented fixation of this device is considered 4 . investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulation under 21 CFR, Part 812. All users of the device for noncemented fixation must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) to conduct the investigation.
The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, 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. ਸ 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 In addition, FDA may publish further announcements action. 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 Regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and-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

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Page 3 - Ms. Kim Tompkins

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,

Celia M. Witten, Ph.D.

2Celia 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

Page 1 of 1

510(k) Number (if known):	K974328
---------------------------	---------

Device Name: ADVANCE Total Knee System, product line addition to include the 8mm thick all poly tibial component

Indications for Use:

Indicated for use in total knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions:

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 .--

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)

Prescription Use _____________________________________________________________________________________________________________________________________________________________

Or Over-the-Counter Use (Per 21 CFR 801.109)

(Optional Format 1-2-96)

(Division Sign-Off)
Division of General Restorative Devices

510(k) Number KG 7432

0000009

Regulation Number and Section

§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.