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Indications for Use:

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 with Per-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 additional components being added to the Triathlon Total Knee System are:

• Size 0 Cruciate Retaining Femoral Component (cemented use) .
• o Size 0 Primary Cemented Tibial Baseplate
• Size 0 Tritanium Tibial Baseplate for cemented/cementless use ●
• Size 0 CR, CS, and PS Tibial Inserts in X3 ETO and N2Vac ●
• New PS Femoral Component with modified intercondylar PS box (cemented use) ●
• o New PSR (Posterior Stabilizing Rotation ) tibial insert in sizes 0-8 in X3 ETO

Additionally, engineering analyses and finite element analyses were presented to document the range of motion available with the Triathlon Total Knee System.

This document is a 510(k) summary, which is a premarket notification to the FDA to demonstrate that a device is at least as safe and effective as a legally marketed predicate device. It is not a clinical study report that would typically include detailed acceptance criteria and performance data for an AI/ML device.

Therefore, the provided text does not contain the information needed to describe acceptance criteria and a study proving a device meets them, especially for an AI-based medical device. The document concerns modifications to an existing total knee system (implants), not an AI/ML device.

The questions you've asked are highly relevant for the regulatory approval of AI/ML medical devices. If this document were for an AI/ML device, here's how I would break down why the requested information is missing:

Reasoning for Missing Information (Applicable if this were an AI/ML device submission):

The provided text is a 510(k) summary for a "Triathlon Total Knee System - Additional Components." This is a premarket notification for an orthopedic implant (knee replacement components), not an AI/ML (Artificial Intelligence/Machine Learning) device.

The questions posed are specifically for describing the regulatory submission and study design for an AI/ML medical device, which often requires:

• Demonstrating performance metrics (e.g., sensitivity, specificity, AUC) against established acceptance criteria.
• Detailing the ground truth establishment process (expert consensus, pathology, etc.).
• Describing the size and provenance of training and test datasets.
• Explaining human-in-the-loop studies (multi-reader multi-case studies).

Since the device under review is a physical medical implant (knee components), these types of studies and acceptance criteria are not applicable. The sponsor instead provides:

• Engineering analyses and finite element analyses: To document range of motion.
• Non-clinical testing: Fatigue testing, static shear testing, contact area/stress analysis, range of constraint, sterilization validation, and MR Conditional status.
• Bacterial endotoxin testing.

The document explicitly states: "Clinical Testing: Clinical testing was not required as a basis for substantial equivalence." This further confirms that the type of performance evaluation relevant to AI/ML devices was not conducted or required for this orthopedic implant.

In summary, none of the requested information regarding acceptance criteria, study design for AI/ML device performance, sample sizes for training/test sets, ground truth establishment, or human expert involvement is present in this 510(k) summary because it pertains to a mechanical orthopedic implant, not an AI/ML software device.

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