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General Total Knee Arthroplasty (TKR) Indications:

· Painful, disabling joint disease of the knee resulting from: noninflammatory 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 standard fracture -management techniques.

The Triathlon® Tritanium® Total Knee System components are indicated for both uncemented use.

The Triathlon® Total Knee System beaded and beaded with Peri-Apatite components are intended for uncemented use only.

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

Additional Indications for Posterior Stabilized (PS) and Total Stabilizer (TS) Components:

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

Additional Indications for Total Stabilizer (TS) Components:

• · Severe instability of the knee secondary to compromised collateral ligament integrity or function.
  Indications for Bone Augments:

• Painful, disabling joint disease of the knee secondary to: degenerative arthritis, rheumatoid arthritis, or post-traumatic arthritis, complicated by the presence of bone loss.

• · Salvage of previous unsuccessful total knee replacement or other surgical procedure, accompanied by bone loss.
  Additional Indications for Cone Augments:

• · Severe degeneration or trauma requiring extensive resection and replacement

• · Femoral and Tibial bone voids

• Metaphyseal reconstruction

The Triathlon TS Cone Augments are intended for cemented or cementless use.

The subject Triathlon Intermediate Tibial Inserts will be available in the following configurations:

• Cruciate Retaining (CR) intermediate thicknesses of inserts (10mm, 12m, 14mm) will . be added to the previously cleared size range of 9mm, 13mm, 16mm and 19mm
• Cruciate Substituting (CS) intermediate thicknesses of inserts (10mm, 12mm and ● 14mm) will be added to the previously cleared size range of 9mm, 11mm, 13mm, 16mm, 19mm, 22mm and 25mm
• Posterior Stabilizing (PS) intermediate thicknesses of inserts (10mm. 12mm and . 14mm) will be added to the previously cleared size range of 9mm, 11mm, 13mm, 16mm, 19mm, 22mm and 25mm

The design of these inserts are identical to the predicate devices in terms of condylar geometry. post dimensions (in PS design) and locking wire feature. The inserts will be available in X3 ETO, and N2Vac styles.

Additionally. MR Conditional labeling is being added for the subject intermediate thickness inserts as well as those X3 ETO tibial inserts and patellar components previously cleared in premarket notification K172634.

This document is a 510(k) premarket notification from the FDA for the Triathlon Total Knee System. It is a regulatory approval and not a detailed study report with acceptance criteria and performance metrics typically seen in AI/ML device submissions. Therefore, many of the requested fields cannot be filled.

However, I can extract the information related to the non-clinical testing performed to demonstrate substantial equivalence, which serves as a form of acceptance criteria and evidence of performance for this type of medical device.

Acceptance Criteria and Study for Triathlon Total Knee System (K173849)

This submission is for a Traditional 510(k) for an orthopedic implant (knee replacement system), not an AI/ML diagnostic device. As such, the concept of "acceptance criteria" and "device performance" relies on demonstrating substantial equivalence to already legally marketed devices through material characterization, mechanical testing, and biocompatibility, rather than evaluating diagnostic accuracy or clinical outcomes as would be done for AI/ML.

The "study" here refers to the non-clinical testing conducted to support the substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device, "acceptance criteria" are generally compliance with recognized standards and demonstration that new designs do not create a "new worst case" compared to predicate devices. "Reported device performance" is the manufacturer's conclusion that these criteria are met.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: Not specified in terms of traditional patient data sample size. The "test set" here refers to physical components and materials subjected to laboratory testing. The document states that the design of the new inserts was analyzed to determine if they created a "new worst case" for material thickness, contact area/stress, moments, and forces. The implication is that specific samples of the new intermediate thicknesses (10mm, 12mm, 14mm) were subjected to various mechanical and material tests, or that the previous test results from predicate devices were deemed representative for these new configurations. The exact number of physical samples tested is not disclosed in this summary.
• Data Provenance: Not applicable in the context of human data. The data provenance is from laboratory testing of medical device components and materials. It is neither retrospective nor prospective in the clinical sense.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. "Ground truth" in this context is established through recognized engineering standards, physical measurements, and material science principles, not expert medical opinion on diagnostic images or patient outcomes.

4. Adjudication Method for the Test Set

Not applicable. This concept applies to human-read data (e.g., radiologists reviewing images), not to laboratory testing of physical implants.

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 knee implant, not an AI/ML diagnostic device with human readers.

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

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

7. The Type of Ground Truth Used

• For Material and Mechanical Testing: The "ground truth" used is defined by internationally recognized standards (ASTM, ISO), FDA guidance, and established engineering principles for material properties, mechanical strength, wear, biocompatibility, and sterilization.
• For MR-Conditional Labeling: The ground truth is defined by ASTM standards for measuring magnetic displacement, torque, image artifact, and RF-induced heating.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of this device approval for an orthopedic implant. The design and manufacturing process are subject to quality systems, but there isn't a machine learning training phase.

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

Not applicable, as there is no training set.

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