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.
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.