(128 days)
The Triathlon® All-Polyethylene Condylar Stabilizing (CS) and Posterior Stabilizing (PS) Tibial Implants are for cemented use in primary and revision Total Knee Arthroplasty.
General Total Knee Arthroplasty (TKR) Indications:
- Painful, disabling joint disease of the knee resulting from: non-inflammatory 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 General Total Knee Arthroplasty (TKR) Indications specific to the PS implant:
- 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 All Polyethylene tibial components are indicated for cemented use only.
The subject devices are a line extension to the Triathlon® Total Knee System (K063423, K050539, K042993 and K031729), providing an all-polyethylene tibial component in CS and PS designs. The All-Poly CS and PS Tibial implants are similar in intended use, design, materials, mechanical testing and operational priniciples as the predicate devices. These components are designed for cemented use only.
These implants are compatible for use with the Triathlon® PS, TS and CR Femoral Components (cemented and uncemented), Triathlon® PS and CR Femoral Components with PA (uncemented), Triathlon® Symmetrical Patellar Component [Conventional or X30 UHMWE] (cemented), Triathlon® Asymmetrical Patellar Component [Conventional or X3® UHMWPE] (cemented), Triathlon® Metal-Backed Patellar Component with PA (uncemented), Duracon® Symmetric Patellar Component (cemented). Duracon Asymmetric Patellar Component (cemented), and Duracon® Inset Patellar Component (cemented).
This submission, K123166, is for the Triathlon® All-Polyethylene Condylar Stabilizing (CS) and Posterior Stabilizing (PS) Tibial Implants. This device is a line extension to existing Triathlon® Total Knee System components.
This document describes a medical device, specifically a knee replacement implant, and does not involve AI/ML technology or clinical studies with human readers. Therefore, many of the requested categories related to AI performance, ground truth, and expert evaluation are not applicable.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with reported device performance in the manner typically seen for AI/ML device evaluations (e.g., sensitivity, specificity thresholds). Instead, the equivalence is established through material, design, and mechanical testing.
| Acceptance Criteria Category | Reported Device Performance/Conclusion |
|---|---|
| Intended Use | Acceptance: Device intended use matches predicate devices. |
| Performance: "The [subject] implants are similar in intended use... as the predicate devices." "Triathlon® All-Polyethylene Condylar Stabilizing (CS) and Posterior Stabilizing (PS) Tibial Implants are for cemented use in primary and revision Total Knee Arthroplasty." This matches the predicate devices. | |
| Design | Acceptance: Subject device's articular surface, periphery, and cement features are designed equivalently or with enhancements that maintain or improve performance compared to predicate devices. |
| Performance: "The Triathlon All-Poly Tibial Implant articular surface and periphery is designed equivalently to the existing Triathlon inserts. The bottom side... is designed with the Scorpio All-Poly Tibial Implant cement features to which was added a line to line boss with flat posterior section that ensures the cement mantle is even around the keel..." | |
| Materials | Acceptance: Materials are equivalent to predicate devices. |
| Performance: "The [subject] implants are similar in... materials... as the predicate devices." | |
| Mechanical Testing | Acceptance: Demonstrate equivalent or superior mechanical properties (deflection, micromotion) compared to predicate devices. |
| Performance (Deflection): "The deflection test was conducted to make sure that the stiffness (and strength) of the Triathlon All-Poly Tibial Implant component was equivalent or better then the Scorpio All-Poly Tibial Implant..." | |
| Performance (Micromotion): "Micromotion testing was conducted to show the difference in force/motion that the cement and bone interface would see in response to the change of articulation and periphery when utilizing the Scorpio cement features." | |
| Operational Principles | Acceptance: Operational principles are equivalent to predicate devices. |
| Performance: "The [subject] implants are similar in... operational principles as the predicate devices." | |
| Substantial Equivalence | Acceptance: Device is substantially equivalent to predicate devices. |
| Performance: "Device comparison showed that the proposed device is substantially equivalent in intended use, materials and performance characteristics to the predicate devices." "The Triathlon® All-Polyethylene Condylar Stabilizing (CS) and Posterior Stabilizing (PS) Tibial Implants are substantially equivalent to the predicate devices..." |
2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This submission relies on non-clinical (mechanical) testing for substantial equivalence, not a test set of patient data. Therefore, this section is not applicable in the context of an AI/ML device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. No human experts were used to establish a "ground truth" for a test set in the clinical evaluation sense, as this was a non-clinical submission based on mechanical testing and comparison to predicate devices.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as there was no test set requiring expert adjudication.
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 medical implant, not an AI-assisted diagnostic or interpretative device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the mechanical testing, the "ground truth" or reference points were established engineering specifications, established mechanical testing standards, and the performance characteristics of the predicate devices. For regulatory purposes, the "ground truth" for substantial equivalence is the set of characteristics (intended use, indications for use, technological characteristics, safety, and effectiveness) of the legally marketed predicate devices.
8. The sample size for the training set
Not applicable. This is a medical implant, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there is no ground truth establishment for it.
§ 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.