degenerative, post-traumatic or rheumatoid arthritis; .
avascular necrosis of the femoral condyle; .
post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, . dysfunction or prior patellectomy;
moderate valgus, varus or flexion deformities; .
treatment of fractures that are unmanageable using other techniques. .
This device may also be indicated in the salvage of previously failed surgical attempts. The device is intended for cemented applications.

Device Description

The change that is the subject of this 510(k) is to add a coating of Titanium Nitride (TiNbN) to the entire surface of the above listed femoral components. Additionally, the porous coating has been removed from the Foundation Knee Femoral Component. There is no change to the fundamental scientific technology of the referenced knee systems with the modifications in this 510(k) submission. This includes no changes to materials, design, sterilization, packaging, or method of manufacture.

AI/ML Overview

The provided document is a 510(k) summary for a medical device modification, specifically adding a Titanium Nitride (TiNbN) coating to existing femoral components of the Foundation® Knee System. This type of submission focuses on demonstrating substantial equivalence to previously cleared devices through non-clinical testing, rather than establishing efficacy or accuracy through clinical studies.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, ground truth establishment, adjudication methods, and MRMC effectiveness studies is not applicable to this document.

Here's why and a summary of what the document does provide:

Device Type: This is a knee joint prosthesis, a mechanical implant. The evaluation for such devices often relies heavily on biomechanical testing, material characterization, and manufacturing process validation rather than AI performance metrics.
510(k) Purpose: The 510(k) submission seeks to clear a modification (adding a coating) to already cleared devices. The primary goal is to show that the modified device is "substantially equivalent" to predicate devices, meaning it is as safe and effective. This is typically achieved through non-clinical bench testing rather than clinical trials involving human subjects, especially for material changes.
"Clinical Testing: None provided": The document explicitly states "Clinical Testing: None provided," confirming that no human clinical trials were conducted to evaluate this specific modification.

Summary of Information from the Document (Addressing the spirit of the request where applicable):

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

Not Applicable. This document does not present acceptance criteria or reported device performance in the context of diagnostic accuracy, sensitivity, or specificity, as it's not a diagnostic AI device. Instead, it lists non-clinical tests performed to demonstrate safety and performance of the material modification.
Non-Clinical Tests Performed:
- Accute System Toxicity Study
- Bone Implantation Study
- Cytotoxicity Study
- GC/MS Fingerprint Study
- Irritation Study
- 28 Day Muscle Implantation Study
- 90 Day Muscle Implantation Study
- Sensitisation Study
- Coating Chemical Composition
- Coating Thickness
- Coating Hardness
- Adhesion Strength
- Roughness
- Wear Resistance
The document implies that these non-clinical tests were successful in demonstrating substantial equivalence, but specific pass/fail criteria or quantitative results are not detailed in this summary.

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 test sets or patient data were used for this 510(k) submission, as "Clinical Testing: None provided." The sample sizes for the non-clinical tests (e.g., number of test specimens for wear, number of animals for toxicity/implantation) are not specified in this summary.

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. No clinical test set or ground truth in the context of diagnostic performance was established for this submission.

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

Not Applicable. No clinical test set or adjudication was performed.

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 mechanical implant, not an AI software device. No MRMC study was conducted.

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

Not Applicable. This is a mechanical implant, not an AI algorithm.

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

Not Applicable. The "ground truth" for this device's safety and performance comes from the established scientific understanding of biomaterials and biomechanics, as validated by the non-clinical tests listed.

8. The sample size for the training set

Not Applicable. No training set was used, as this is not an AI/machine learning device.

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

Not Applicable. No training set or associated ground truth was established.

In summary: The provided document is a regulatory submission for a material modification to existing knee prostheses. Its focus is on non-clinical substantiation of equivalent safety and performance, not on clinical performance metrics typically associated with AI or diagnostic devices.

Summary

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510(k) Summary

Date: April 9, 2013

Manufacturer:

DJO Surgical (Legal Name: Encore Medical, L.P.) 9800 Metric Blvd Austin, TX 78758

Contact Person: Teffany Hutto Manager, Regulatory Affairs Phone: (512) 834-6255 Fax: (760) 597-3466 Email: teffany.hutto@djoglobal.com

Product	Original 510(k) Number, Clearance Date/ Classification	Product Code	Product Code	Regulation and Classification Name
Foundation® Knee System	K923277, February 9, 1993 / Class II	JWH	JWH	Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis per 21CFR 888.3560
Foundation® PS Knee System	K933539, November 8, 1994 / Class II	JWH
3DKnee™ System	K020114, July 12, 2002 / Class II	JWH

Description: The change that is the subject of this 510(k) is to add a coating of Titanium Nitride (TiNbN) to the entire surface of the above listed femoral components. Additionally, the porous coating has been removed from the Foundation Knee Femoral Component. There is no change to the fundamental scientific technology of the referenced knee systems with the modifications in this 510(k) submission. This includes no changes to materials, design, sterilization, packaging, or method of manufacture.

Indications for Use:

Joint replacement is indicated for patients suffering from disability due to:

degenerative, post-traumatic or rheumatoid arthritis; .
avascular necrosis of the femoral condyle; .
post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, . dysfunction or prior patellectomy;
moderate valgus, varus or flexion deformities; .
treatment of fractures that are unmanageable using other techniques. .

This device may also be indicated in the salvage of previously failed surgical attempts. The device is intended for cemented applications.

Predicate Devices:

DJO Surgical, Foundation® Knee System, K923277 .
DJO Surgical, Foundation® PS Knee System, K933593 .
DJO Surgical, 3DKnee™ System, K020114 .
. DJO Surgical, Movation Knee System, K100900
DJO Surgical, Foundation® Plasma Coated Femur, K964008 .

Comparable Features to Predicate Device(s): Features comparable to predicate devices include the same indications, dimensions, materials, packaging, sterilization, surgical implantation technique, and intended use.

Non-Clinical Testing: Accute System Toxicity Study, Bone Implantation Study, Cytotoxicity Study, GC/MS Fingerprint Study, Irritation Study, 28 Day Muscle Implantation Study, 90 Day Muscle Implantation Study, Sensitisation Study, Coating Chemical Composition, Coating Thickness, Coating Hardness, Adhesion Strength, Roughness, Wear Resistance

Clinical Testing: None provided.

APR 1 1 2013

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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Letter dated: April 11, 2013

Encore Medical, L.P. % Ms. Teffany Hutto Manager, Regulatory Affairs 9800 Metric Boulevard Austin, Texas 78758

Re: K122239

Trade/Device Name: Foundation®, Foundation® PS, and 3DKnee™ Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Codes: JWH Dated: March 7, 2013 Received: March 8, 2013

Dear Ms. Hutto:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical

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Page 2 -- Ms. Teffany Hutto

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark Nighterson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K122239 510(k) Number (if known):

Device Name: Foundation®, Foundation® PS, and 3DKnee™

Indications for Use:

Foundation®, Foundation® PS, and 3DKnee™ Indications for Use

Joint replacement is indicated for patients suffering from disability due to:

degenerative, post-traumatic or rheumatoid arthritis; .
avascular necrosis of the femoral condyle; .
post-traumatic loss of joint configuration, particularly when there is patellofemoral . erosion, dysfunction or prior patellectomy;
. moderate valgus, varus or flexion deformities;
treatment of fractures that are unmanageable using other techniques. .

This device may also be indicated in the salvage of previously failed surgical attempts.

The device is intended for cemented applications.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Casey L. Hanley Ph.D.

Division of Orthopaedic Devices

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.