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The Triathlon® Tritanium® Cone Augment is intended for use in primary or revision total knee arthroplasty where there is a femoral and/or tibial metaphyseal defect secondary to trauma, failed previous prosthesis, or severe degeneration. The Triathlon Cone Augment is intended to be affixed to the mating femoral and/or tibial component using bone cement. The cones are intended for fixation as an assembled construct in the distal femur and/or proximal tibia, with or without bone cement.

Device Description

The Triathlon® Tritanium® Cone Augment is an extension of the Triathlon® Total Knee System product line intended to be used as an optional accessory component in primary or revision Total Knee Arthroplasty. It is a sterile, single-use device that is compatible for use with other Triathlon® Total Knee System components. The Tritanium® Cone Augment is composed of commercially pure titanium (raw material per ASTM F1580, processed material per ASTM F67).

The subject device is designed to be used with the Triathlon® TS femoral components and Triathlon® Universal baseplates and is compatible with other Triathlon® Total Knee System components. The cones are intended to be cemented to the respective Triathlon femoral and/or tibial component, and are intended for fixation within the proximal tibia or distal femur with or without bone cement. Tritanium Femoral and Tibial Cones are intended to be used where there is a femoral and/or tibial metaphyseal defect secondary to trauma, failed previous prosthesis, or severe degeneration.

There are three designs of Triathlon Tritanium Cone Augments:

Femoral Cone Augments
Symmetric Tibial Cone Augments
Asymmetric Tibial Cone Augments

AI/ML Overview

The provided FDA 510(k) summary for the Triathlon® Tritanium® Cone Augments indicates that no clinical studies were performed or required to establish substantial equivalence. Instead, the determination was based on non-clinical (laboratory) testing, a comparison of technological characteristics, intended use, and materials to predicate devices.

Therefore, the requested information regarding acceptance criteria, device performance from a clinical study, sample size for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details cannot be provided from this document as no such clinical studies were conducted or reported.

However, I can extract the non-clinical acceptance criteria and the reported performance from the laboratory testing:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical Testing):

Test Type	Acceptance Criteria	Reported Device Performance
Cantilever Fatigue Testing (ASTM F1800)	Survive ten million cycles of clinically relevant loading without failure.	Cone augments survived ten million cycles of clinically relevant loading without failure.
Torque Testing	Able to withstand clinically relevant torque loads.	Established that the cone augments are able to withstand clinically relevant torque loads.
Plastic Deformation of Cone Augments (Post-Impaction)	Porous surface must withstand impaction without loss of coating integrity.	Cones were metallographically examined in the post-impacted condition and indicated the porous surface can withstand impaction without loss of coating integrity.
Micromotion of Triathlon Tibial Cone Augments	Initial stability of the Triathlon Tibial Cone construct within the simulated tibial cavity during a simulated stair descent activity must be at least equivalent to the predicate Zimmer Trabecular metal cone constructs.	Testing indicates that the Triathlon Tibial Cone Augments are at least equivalent to the Zimmer Trabecular Metal Cones in their ability to resist micromotion.
Triathlon Tritanium Femoral Cone Augment Micromotion	Initial stability of the Triathlon Femoral Cone construct within the simulated femoral cavity during a normal walking profile must be at least equivalent to the predicate Zimmer Femoral Cone Augment.	Testing indicates that the Triathlon Femoral Cone Augment is at least equivalent to the Zimmer Femoral Cone Augment in the ability to resist micromotion.
Characterization of Physical Properties of Porous Coating	Meets requirements outlined in FDA guidance documents: "Guidance Document for Testing Orthopedic Implants With Modified Metallic Surfaces Apposing Bone Or Bone Cement", April 28, 1994, and "Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses, Guidance for Industry and FDA", January 16, 2003.	This testing established that the porous coating meets the requirements outlined in the specified FDA guidance documents.
Characterization of Material Chemistry (ASTM F67)	Material meets the requirements set forth in ASTM F67 for Grade 4 unalloyed titanium material, and is similar to a reference device.	The results of the chemical analysis illustrate that the material meets the requirements set forth in ASTM F67 for Grade 4 unalloyed titanium material, and is similar to a reference device.
Characterization of Mechanical Properties of Cone Augments	Meets or exceeds pre-established performance criteria, and is similar to the reference device in terms of performance criteria.	The subject devices met or exceeded the pre-established performance criteria, and are similar to the reference device in terms of performance criteria (using surface-treated test coupons).

The following information cannot be provided from this document as no clinical studies were performed:

Sample size used for the test set and the data provenance: Not applicable, as no clinical test set was used. The non-clinical tests involved various laboratory setups and simulated environments, often comparing against predicate devices or regulatory standards.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical test set requiring expert ground truth was used.
Adjudication method for the test set: Not applicable, as no clinical test set was used.
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, as this device is a physical implant and not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this device is a physical implant and not an algorithm.
The type of ground truth used: Not applicable for clinical ground truth. For non-clinical tests, the "ground truth" was established by engineering standards, material specifications (e.g., ASTM F67, ASTM F1800), and compliance with FDA guidance documents.
The sample size for the training set: Not applicable, as no machine learning algorithm was involved, hence no training set.
How the ground truth for the training set was established: Not applicable, as no machine learning algorithm was involved.

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