(59 days)
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 stabilized by standard fracture-management techniques.
Additional Indications for Posterior Stabilized (PS) 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.
The Triathlon® Pro PS Femoral Components are intended for cemented use only.
The subject Triathlon® Pro PS Femoral Component is a line extension to the existing Triathlon® Total Knee System and will be a modified version of the predicate Triathlon® PS Femoral Components. The subject component is sterile, single use, and available in sizes 1-8 and in right and left configurations. The femoral component is manufactured from Cobalt-Chromium alloy, which meets ASTM material standard F2886-17 as well as F75-18 standard requirements in its final finished form. It is intended for cemented use only.
This document describes the 510(k) premarket notification for the "Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral Component". It focuses on establishing substantial equivalence to previously cleared devices rather than defining new acceptance criteria or conducting a study proving the device meets new acceptance criteria.
Therefore, the information you requested about acceptance criteria and a study proving the device meets them, particularly regarding AI assistance, multi-reader multi-case studies, and detailed ground truth methodologies, is not applicable to this submission. This is a medical device clearance based on substantial equivalence, not a performance study of a diagnostic AI algorithm.
Here's a breakdown of why many of your questions cannot be answered from the provided text:
- No specific "acceptance criteria" are provided in the context of device performance metrics, as this is a comparison to established predicates. The acceptance is based on demonstrating substantial equivalence in design, materials, and non-clinical performance characteristics.
- No "study that proves the device meets the acceptance criteria" in terms of clinical outcomes or diagnostic performance is present. Instead, the sponsor performed non-clinical lab testing and engineering analysis to demonstrate that the new device performs similarly to predicate devices.
- The device is a knee implant (femoral component), not an AI diagnostic tool. Therefore, questions related to AI effects, human reader improvement, and expert ground truth for diagnostic accuracy are not relevant.
However, I can extract information related to the non-clinical testing performed to support substantial equivalence:
1. A table of acceptance criteria and the reported device performance
Since specific numerical acceptance criteria (e.g., "sensitivity > 90%") for AI performance are not defined or applicable here, I will instead list the types of non-clinical tests performed and the conclusion drawn.
| Acceptance Criteria Type (as demonstrated via non-clinical testing for substantial equivalence) | Reported Device Performance / Conclusion |
|---|---|
| Material Characterization (CoCr per ASTM F2886-17 and ASTM F75-18) | Demonstrated compliance with specified material standards. |
| Femoral Component Fatigue Testing | Performance data supports substantial equivalence (specific values not provided in this summary, but implied acceptable from conclusion). |
| Wear Testing (per ISO 14243-3:2014) | Performance data supports substantial equivalence (implied acceptable from conclusion). |
| Characterization of Tibiofemoral Contact Area/Contact Stress | Performance data supports substantial equivalence (implied acceptable from conclusion). |
| Characterization of Patellofemoral Contact Area/Contact Stress | Performance data supports substantial equivalence (implied acceptable from conclusion). |
| Characterization of Articulating/Bearing Surface Finish | Performance data supports substantial equivalence (implied acceptable from conclusion). |
| Characterization of Range of Motion and Constraint | Performance data supports substantial equivalence (implied acceptable from conclusion). |
| Biocompatibility (evaluated per ISO 10993-1:2018) | Demonstrated compliance with biocompatibility standards. |
| Shelf-life (validated per ISO 11607-1:2019, ISO 11607-2:2019, ASTM F1980-21) | Demonstrated compliance with shelf-life validation standards. |
| Bacterial endotoxin testing (BET) (ANSVAAMI ST72:2019 for pyrogenicity, endotoxin limit |
§ 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.