The Triathlon® X3™ UHMWPE Posterior Stabilized and Cruciate Retaining tibial inserts and the Triathlon® X3™ UHMWPE Patellar components are intended to be used with the cemented Triathlon® PS and CR femoral components and cemented Triathlon® Primary Cemented Tibial Tray in primary or revision total knee arthroplasty. The Triathlon® X3™ UHMWPE Patellar components are intended to be used with the femoral components of the previously released Duracon® Total Knee System The Triathlon® PS Total Knee System is intended to be used in situations where the posterior cruciate ligament is absent, or cannot be preserved. The Triathlon CR Total Knee System is intended to accommodate the posterior cruciate ligament (PCL) if it is present. The all polyethylene Triathlon® X3™ UHMWPE Patellar components are intended for implantation with bone cement only.

Indications:

· Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or, theumatoid arthritis.
· Post-traumatic loss of knee joint configuration and function.
· Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
· Revision of previous unsuccessful knee replacement or other procedure.
· Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture management techniques.

Additional Indications for Posterior Stabilized Components:

· Ligamentous instability requiring implant bearing surface geometries with increased constraint.
· Absent or non-functioning posterior cruciate ligament.

Device Description

The device includes tibial and patellar components of a total knee system. These components are used for the replacement of the bearing and/or articulating surfaces of the proximal tibia and patella. Tibial inserts will be made in Cruciate Retaining and Posterior Stabilized designs. Patellar components will be made in both Asymmetric and Symmetric designs.

AI/ML Overview

The provided text describes the 510(k) Premarket Notification for the Triathlon® X3™ UHMWPE Tibial and Patellar Components, an orthopedic medical device. The information details the device, its indications, contraindications, and a summary of the data supporting its substantial equivalence to predicate devices. However, the document does not contain the typical structure of a study report for an AI/ML device, which would include specific acceptance criteria, performance metrics, and details about clinical study methodology (e.g., sample size, expert ground truth, adjudication).

Based on the provided text, here's an analysis of the requested information:

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

This information is not explicitly provided in the given document. The document states "A risk analysis and research and development testing have been performed to demonstrate equivalence of the subject products to the predicate devices." It lists types of tests but does not define specific acceptance criteria or report quantified performance against such criteria in a tabular format. The goal of this 510(k) submission is to demonstrate "substantial equivalence" to a predicate device, rather than meeting pre-defined performance thresholds for a novel AI system.

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. The document mentions various types of engineering tests (material properties, wear, fatigue, etc.) but does not describe the use of a "test set" in the context of clinical data for an AI/ML device. There is no mention of human subject data, let alone its provenance or study design.

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 information is not provided. The device is an orthopedic implant, and its evaluation relies on engineering tests and comparison to a predicate device, not on expert-adjudicated ground truth from medical imaging or clinical diagnostic data.

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

This information is not provided. As there is no mention of a "test set" requiring expert adjudication, this detail is absent.

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

There is no indication that an MRMC comparative effectiveness study was done. This type of study is relevant for AI-assisted diagnostic or interpretative devices, not for orthopedic implants whose evaluation is based on mechanical and material properties.

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

This information is not applicable/not provided. The device is a physical orthopedic implant. There is no "algorithm only" component to evaluate in isolation.

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

This information is not applicable/not provided in the context of AI/ML. The "ground truth" for evaluating this device would revolve around measurements from mechanical testing and material science, and ultimately, clinical outcomes in patients receiving the implant (though not explicitly detailed in this short 510(k) summary). The submission focuses on demonstrating "substantial equivalence" based on these engineering tests, which is inherently a comparison to the predicate device's established performance parameters.

8. The sample size for the training set

This information is not applicable/not provided. There is no mention of an algorithm or a "training set" in the context of an AI/ML device.

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

This information is not applicable/not provided. There is no "training set" for this type of medical device.

Summary regarding AI/ML device criteria:

The provided document (K051146) is a 510(k) Premarket Notification for orthopedic implants (knee components). It details the device's physical attributes, indications for use, and the types of engineering tests performed to demonstrate its substantial equivalence to previously approved predicate devices. This type of submission predates the widespread regulatory frameworks for AI/ML in medical devices and, therefore, does not contain any of the requested information pertinent to the evaluation of an AI-powered diagnostic or therapeutic system. The "study" mentioned refers to engineering and R&D testing, not clinical trials or AI performance evaluations with human data.

Summary

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K051146 (pg. 1 of 2)

Triathlon® X3™ UHMWPE Tibial and Patellar Components

510(k) Premarket Notification

JUL 1 3 2005

510(k) Summary of Safety and Effectiveness

Device:	Triathlon® X3™ UHMWPE Tibial Inserts and Patellar Components
Classification:	21 CFR 888.3560 - Knee joint, patellofemorotibial,polymer/metal/polymer semi-constrained cemented prosthesis
Product Code	87 JWH,
Predicate Devices:	Triathlon® Tibial Inserts and Patellar
Contact Person:	Karen AriemmaSenior Regulatory Affairs SpecialistHowmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430(201) 831-5718(201) 831-6038 (FAX)karen.ariemma@stryker.com

Date Summary Prepared: May 3, 2005

The Triathlon® X3TM UHMWPE Postcrior Stabilized and Cruciate Retaining tibial inserts and the Triathlon® X31™ UHMWPE Patellar components are intended to be used with the cemented Triathlon® PS and CR femoral components and cemented Triathlon® Primary Cemented Tibial Tray in primary or revision total knee arthroplasty. The Triathlon® X3™ UHMWPE Patellar components are intended to be used with the femoral components of the previously released Duracon® Total Knee System The Triathlon® PS Total Knee System is intended to be used in situations where the posterior cruciate ligament is absent, or cannot be preserved. The Triathlon® CR Total Knee System is intended to accommodate the posterior cruciate ligament (PCL) if is present. The all polyethylene Triathlon® X3™ UHMWPE Patellar components are intended for implantation with bone cement only.

Indications:

· Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or, rheumatoid artlritis.
· Post-traumatic loss of knee joint configuration and function.
· Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
· Revision of previous unsuccessful knee replacement or other procedure.
· Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture management techniques.

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K051146 (pg. 2 of 2)

Triathlon® X3™ UHMWPE Tibial and Patellar Components

Additional Indications for Posterior Stabilized Components:

· Ligamentous instability requiring implant bearing surface geometries with increased constraint.
· Absent or non-functioning posterior cruciate ligament.

Contraindications

Any active or suspected latent infection in or about the knee joint. .
· Distant foci of infection which may cause hematogenous spread to the implant site.
· Any mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care.
· Bone stock compromised by disease, infection or prior implantation that cannot provide adequate support and/or fixation to the prosthesis.
· Skeletal immaturity.
· Severe instability of the knee joint secondary to the absence of collateral ligament integrity and function.
Obesity. An overweight or obese patient can produce loads on the prosthesis that can lead to failure of the fixation of the device or to failure of the device itself.

Device Description

Summary of Data

A risk analysis and research and development testing have been performed to demonstrate equivalence of the subject products to the predicate devices. Testing and analysis includes material properties testing, wear testing, disassembly force evaluation, multi-axis fatigue testing, patella shear testing and finite element modeling of contact stresses.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract bird or a series of interconnected human figures.

JUL 1 3 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Karen Ariemma Senior Regulatory Affairs Specialist Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, New Jersey 07430

Re: K051146

Trade/Device Name: Triathlon® X3™ UHMWPE Tibial Inserts and Patellar Components Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial, polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: May 3, 2005 Received: May 4, 2005

Dear Ms. Ariemma:

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 north 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. Karen Ariemma

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 (240) 276-0210. 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/cdrl/industry/support/index.html.

Sincerely vours,

Sincerely yours,

Stypt Curda
Miriam C. Provost, Ph.D.

1 Miriam 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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K051146 (pg. 1 of 2)

510(k) Number (if known): _

Device Name: Triathlon® Knee System

Indications for Use:

Indications:

· Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or, theumatoid arthritis.
· Post-traumatic loss of knee joint configuration and function.
· Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
· Revision of previous unsuccessful knee replacement or other procedure.
· Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture management techniques.

Additional Indications for Posterior Stabilized Components:

· Ligamentous instability requiring implant bearing surface geometries with increased constraint.
· Absent or non-functioning posterior cruciate ligament.

Contraindications

· Any active or suspected latent infection in or about the knee joint.
· Distant foci of infection which may cause hematogenous spread to the implant site.
· Any mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care.
· Bone stock compromised by disease, infection or prior implantation that cannot provide adequate support and/or fixation to the prosthesis.

(Division Sign-Off)
Division of General, Restorative.
and Neurological Devices

Page 1 of 2

510(k) Number

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K051146 (pg. 2 of 2)

· Skeletal immaturity.
· Severe instability of the knee joint secondary to the absence of collateral ligament integrity and function.
· Obesity. An overweight or obese patient can produce loads on the prosthesis that can lead to failure of the fixation of the device or to failure of the device itself.

Prescription Use X (Per 21 CFR 801.109)

Over-the-Counter Use___

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Page of

Stye Rurde

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K051146

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.