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The Triathlon® All-Polyethylene Condylar Stabilizing (CS) and Posterior Stabilizing (PS) Tibial Implants are for cemented use in primary and revision Total Knee Arthroplasty.

General Total Knee Arthroplasty (TKR) Indications:

• Painful, disabling joint disease of the knee resulting from: non-inflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis), rheumatoid arthritis or post-traumatic 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 General Total Knee Arthroplasty (TKR) Indications specific to the PS implant:

• Ligamentous instability requiring implant bearing surface geometries with increased constraint.
• Absent or non-functioning posterior cruciate ligament.
• Severe anteroposterior instability of the knee joint.

The Triathlon All Polyethylene tibial components are indicated for cemented use only.

The subject devices are a line extension to the Triathlon® Total Knee System (K063423, K050539, K042993 and K031729), providing an all-polyethylene tibial component in CS and PS designs. The All-Poly CS and PS Tibial implants are similar in intended use, design, materials, mechanical testing and operational priniciples as the predicate devices. These components are designed for cemented use only.

These implants are compatible for use with the Triathlon® PS, TS and CR Femoral Components (cemented and uncemented), Triathlon® PS and CR Femoral Components with PA (uncemented), Triathlon® Symmetrical Patellar Component [Conventional or X30 UHMWE] (cemented), Triathlon® Asymmetrical Patellar Component [Conventional or X3® UHMWPE] (cemented), Triathlon® Metal-Backed Patellar Component with PA (uncemented), Duracon® Symmetric Patellar Component (cemented). Duracon Asymmetric Patellar Component (cemented), and Duracon® Inset Patellar Component (cemented).

This submission, K123166, is for the Triathlon® All-Polyethylene Condylar Stabilizing (CS) and Posterior Stabilizing (PS) Tibial Implants. This device is a line extension to existing Triathlon® Total Knee System components.

This document describes a medical device, specifically a knee replacement implant, and does not involve AI/ML technology or clinical studies with human readers. Therefore, many of the requested categories related to AI performance, ground truth, and expert evaluation are not applicable.

Here's an analysis based on the provided text:

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

The document does not explicitly present a table of acceptance criteria with reported device performance in the manner typically seen for AI/ML device evaluations (e.g., sensitivity, specificity thresholds). Instead, the equivalence is established through material, design, and mechanical testing.

2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This submission relies on non-clinical (mechanical) testing for substantial equivalence, not a test set of patient data. Therefore, this section is not applicable in the context of an AI/ML device.

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 human experts were used to establish a "ground truth" for a test set in the clinical evaluation sense, as this was a non-clinical submission based on mechanical testing and comparison to predicate devices.

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

Not applicable, as there was no test set requiring expert adjudication.

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 implant, not an AI-assisted diagnostic or interpretative device.

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

Not applicable. This is a medical implant, not an algorithm.

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

For the mechanical testing, the "ground truth" or reference points were established engineering specifications, established mechanical testing standards, and the performance characteristics of the predicate devices. For regulatory purposes, the "ground truth" for substantial equivalence is the set of characteristics (intended use, indications for use, technological characteristics, safety, and effectiveness) of the legally marketed predicate devices.

8. The sample size for the training set

Not applicable. This is a medical implant, not an AI/ML model that requires a training set.

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

Not applicable. As there is no training set, there is no ground truth establishment for it.

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The Triathlon® CS (Condylar Stabilizing) Lipped Insert is intended for use in primary and revision total knee arthroplasty to alleviate pain and restore function. The Triathlon® CS (Condylar Stabilizing) Lipped Inserts will be provided sterile and are for single use only.

Indications For Use:

• Painful, disabling joint disease of the knee resulting from: noninflammatory . degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis), or rheumatoid 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

The Triathlon® CS (Condylar Stabilizing) Lipped Insert is compatible with the standard Triathlon® CR (Cruciate Retaining) and Triathlon® PS (Posterior Stabilizing) femoral components as well as the Triathlon® Primary Cemented, Triathlon® Beaded Baseplates, the Triathlon® Universal Baseplate and the Triathlon® Low-Profile Baseplate. The Triathlon® CS Lipped Insert features a similar anterior constraint to the Triathlon® CR insert which allows the surgeon to retain or sacrifice the Posterior Cruciate Ligament (PCL).

The provided document is a 510(k) Summary for a medical device called the Triathlon® CS (Condylar Stabilizing) Lipped Insert. This document is related to a knee implant component, not an AI/ML-driven diagnostic or prognostic device. Therefore, much of the information requested in your prompt regarding AI/ML study design (such as sample sizes for test/training sets, data provenance, expert adjudication, MRMC studies, standalone performance, and ground truth establishment) is not applicable.

The document focuses on establishing substantial equivalence to existing legally marketed predicate devices, which is the regulatory pathway for this type of medical device.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

For this specific device (a knee implant component), the "acceptance criteria" are demonstrated through substantial equivalence to predicate devices, focusing on design, materials, and operational principles, rather than performance metrics typically seen in AI/ML studies (like sensitivity, specificity, or AUC). The reported "performance" relates to its physical characteristics and how they compare to established implants.

2. Sample Size for Test Set and Data Provenance

Not applicable for this type of submission. This is a medical device (implant) and its equivalence isn't typically demonstrated through a "test set" of patient data in the way an AI/ML algorithm would be. The "test" for this device involves engineering analysis, material testing, and potentially bench testing, not clinical data sets for performance evaluation against a ground truth.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. There is no "ground truth" establishment in the context of clinical images or data for this engineering-focused substantial equivalence. The "experts" involved would be engineers, materials scientists, and regulatory specialists evaluating the design and testing of the implant.

4. Adjudication Method for the Test Set

Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is not an AI/ML device that assists human readers.

6. Standalone Performance Study

While the device undergoes extensive standalone engineering and material testing (e.g., fatigue testing, wear testing, range of motion, contact stress analysis), these are not presented as "standalone performance" in the context of an algorithm's output. The summary explicitly states: "Range of Constraint and Contact Area/Peak Stress was presented to compare to other tibial inserts on the market." This indicates engineering performance testing was conducted, but specific details or test results are not provided in this regulatory summary.

7. Type of Ground Truth Used

The "ground truth" in this context is the established performance and safety of the predicate devices and fundamental engineering and biomechanical principles for knee implants. Compliance with these established standards and the demonstrated equivalence to existing safe and effective devices serve as the basis for regulatory acceptance.

8. Sample Size for the Training Set

Not applicable.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary Conclusion for this Specific Device:

This 510(k) summary demonstrates the substantial equivalence of the Triathlon® CS (Condylar Stabilizing) Lipped Insert to predicate devices, thereby establishing its safety and effectiveness without needing extensive new clinical trials or AI-specific performance metrics. The "study" here refers to the comparative analysis of its design, materials, and biomechanical properties against legally marketed knee implant components, conforming to engineering standards and principles rather than statistical performance on patient data.

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