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The subject and predicate devices are sterile, single use tibial tray knee components intended to be used in total knee arthroplasty (TKA). The indications for use for the Triathlon® Low Profile Tibial Tray are provided below.

Indications for Use:

• Painful, disabling joint disease of the knee resulting from: degenerative . arthritis, 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.

The Triathlon® Low Profile Tibial Tray is intended to be used with commercially available Triathlon® femoral components and associated patellar components, and tibial bearing inserts in primary cemented total knee arthroplasty. The indications/contraindications for the Triathlon® Low Profile Tibial Tray are outlined below:

Indications for Use:

• · Painful, disabling joint disease of the knee resulting from: degenerative arthritis, 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.

This Special 510(k) submission is a line extension intended to add a low profile tibial tray to the Triathlon® Primary System.

The provided text describes a 510(k) premarket notification for a medical device called the Triathlon® Low Profile Tibial Tray. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with specific acceptance criteria as you might see for novel high-risk devices.

Therefore, many of the requested categories for acceptance criteria and study details are not directly applicable or available in this document. The primary "study" is a mechanical test for substantial equivalence.

Here's an attempt to answer based on the provided text, highlighting where information is not available:

Acceptance Criteria and Device Performance

Study Details:

1. Sample sizes used for the test set and the data provenance:

   • Test Set Sample Size: Not specified. The document mentions "mechanical testing" but does not give sample sizes for these tests.
   • Data Provenance: Not specified, but generally, such mechanical testing is conducted in a laboratory setting by the manufacturer.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable/Not specified. "Ground truth" in this context refers to clinical outcomes or expert consensus in evaluating patient data. For a 510(k) based on mechanical testing for substantial equivalence, clinical ground truth establishment is not typically part of the submission. The "ground truth" for mechanical properties would be established by industry standards and comparison to predicate device performance.

3. Adjudication method for the test set:

   • Not applicable/Not specified. Adjudication methods like 2+1 or 3+1 are used in clinical studies involving human interpretation or subjective assessments. This document describes mechanical testing.

4. 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:

   • No. This is a medical device (tibial tray), not an AI diagnostic or image interpretation tool. Therefore, an MRMC study and AI-related effect size are not relevant.

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

   • No. This is a physical implant, not an algorithm.

6. The type of ground truth used:

   • For the purpose of this 510(k), the "ground truth" for substantial equivalence was based on mechanical properties and design concepts being comparable to legally marketed predicate devices. This is established through laboratory biomechanical testing rather than clinical patient outcomes or expert pathology review which would be more relevant for higher-risk or novel devices.

7. The sample size for the training set:

   • Not applicable/Not specified. This is not an AI model requiring a training set. The "training" for such a device would be its design, manufacturing processes, and material selection, informed by years of orthopedic implant knowledge.

8. How the ground truth for the training set was established:

   • Not applicable. As this is not an AI model, there is no "training set ground truth" in the traditional sense. The design and manufacturing are based on existing engineering principles and medical understanding of orthopedic implants, ensuring the device meets established standards for safety and performance in a knee replacement.

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