(90 days)
The Triathlon™ CR Total Knee System consists of a femoral component, tibial insert, and allpolyethylene patellar components that are intended to be used with the previously cleared Triathlon™ Primary Cemented Tibial Tray in primary or revision total knee arthroplasty. The Triathlon™ All Polyethylene Patellar components are intended to be used with the femoral components of the previously released Duracon® Total Knee System, as well as the previously released Triathlon™ PS Femoral component in situations where replacement of the articular surface of the patella is required. The Triathlon™ CR Total Knee System is intended to accommodate the posterior cruciate ligament (PCL) if it is present. Specific indications and contraindications are listed below:
Indications:
- · Painful, disabling joint disease of the knee resulting from: nonintlammatory degenerative joint discass: (including osteoarthritis, traumatic arthritis or avascular necrosis) or, theumatoid arthrius
- · 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.
Contraindications
- · Any active or suspected latent infection in or about the knee joint.
- · Distant foci of infection which may cause hematogenous spread to the implant site
- · Any mental or neuromuscular disorder which would create an unacceptable risk of prostlyesis instability, prosthesis fixation failure, or complications in postoperative care,
- · Bone stock compromised by disease, infection or prior implantation that cannot provide adequate support and/or fixation to the prosthesis.
- Skeletal immaturity. .
- Severe instability of the knec joint secondary to the absence of collateral ligament integrity and . function.
- Obesity. An overweight or obesc patient can produce loads on the prosthesis that can lead to failure of the fixation of the device or to failure of the device itself.
The Triathlon™ Cruciate Retaining (CR) Total Knee System consists of three primary components: Triathlon™ Cruciate Retaining (CR) Femoral Component, Triathlon™ Cruciate Retaining (CR) Tibial Insert, and Triathlon™ Patellar components (available in two styles – symmetric and asymmetric). These components are intended to be used with the previously cleared Triathlon™ Primary Cemented Tibial Tray in primary or revision total knee arthroplasty. The Triathlon™ Patellar components are intended to be used with both the Triathlon™ CR Femoral component, the previously cleared Triathlon™ PS Femoral component, or the femoral components of the Duracon® Total Knee System. Duracon® patellar components may be used with both the Triathlon™ PS and Triathlon™ CR femoral components. The use of a patellar component is optional. The Triathlon™ CR components are described below:
The Triathlon" Total Knec Cruciate Retaining (CR) Femoral Component is fabricated from cast cobalt-chromium-molybdenum alloy, and is intended for cemented application to replace the articulating surface of the distal femur. This cruciate retaining femoral component is utilized when total knee replacement is indicated, and accommodates the posterior cruciate ligament if it is present.
The Triathlon"" Total Knee Cruciate Retaining (CR) Femoral Component is available in right and left configurations, and eight proportional sizes (sizes 1 to 8) to accommodate differences in patient anatomy. The interior surface of the component is grit-blasted to increase surface roughness - this is intended to promote interdigitation of the polymethylmethacrylate (PMMA) bone cement with the surface texture and the apposing bone. This femoral component features cast-in pegs to help in femoral component placement, and to provide rotational stability.
The Triathlon" Cruciate Retaining (CR) Tibial Insert is neutral in configuration, and is available in seven proportional sizes (sizes 2 to 8) and varying thicknesses (9mm, 11mm, 13mm, 16mm, and 19mm). The insert is fabricated from ultra high molecular weight polyethylene and cobalt-chromium alloy. The minimum thickness of the tibial insert on the bearing surface is 6mm. The tibial inscrt is designed to accommodate the posterior cruciate ligament if it is present. There is a relief on the anterior aspect of the tibial insert to accommodate the patellar tendon and patellar fat pad.
The Triathlon™ CR Tibial Inscrt incorporates a locking wire feature on the anterior aspect of the insert. This locking wire is fabricated from cobalt-chromium alloy, and engages under tabs on the anterior rim of the Triathlon" " Primary Tibial Baseplate. This wire-tab locking mechanism secures the insert into the baseplate. This insert-baseplate locking mechanism is identical to the locking mechanism utilized on the Triathlon™ PS Total Knee System.
Triathlon™ Patellar components are available in two styles: symmetric and asymmetric. Both are fabricated from ultra high molecular weight polyethylene. The symmetric design is available in six diameters (27mm, 31mm, 31mm, 36mm, 36mm, and 39mm) and four thicknesses (8mm, 9mm, 10mm, and 11mm). The symmetric design features a central cement recess, and three pegs on the bone interface surface. The Triathlon™ Symmetric patellar component is intended to be implanted via a resurfacing or inset surgical technique. The asymmetric design is available in five superior/inferior dimensions (29mm, 32mm, 35mm, 38mm, and 40mm) and three thicknesses (9mm, 10mm, and 11mm). The asymmetric design features a flare on the latcral aspect of the component. The asymmetric patcllar component also has a central recess with three pegs for cement fixation. The Triathlon™ Asymmetric patellar component is intended to be implanted using a resurfacing surgical technique.
The provided text is a 510(k) Premarket Notification for the Triathlon™ Cruciate Retaining (CR) Total Knee System. This document focuses on demonstrating the substantial equivalence of a new medical device to existing predicate devices. It does not contain information about the acceptance criteria and a study proving the device meets those criteria, as typically seen in performance studies for AI/ML devices.
Here's why the requested information cannot be extracted and why the structure of the prompt is not applicable to this document:
- No AI/ML Device: The Triathlon™ Cruciate Retaining (CR) Total Knee System is a mechanical orthopedic implant (knee replacement system), not an AI/ML powered medical device. Therefore, concepts like "acceptance criteria" related to AI performance metrics (sensitivity, specificity), "sample size for test set," "number of experts for ground truth," "adjudication method," "MRMC comparative effectiveness study," or "standalone performance" are not relevant to this type of device submission.
- Substantial Equivalence: The document's purpose is to demonstrate "substantial equivalence" to legally marketed predicate devices, not to prove performance against specific acceptance criteria in a clinical or AI-specific study. This means the submission emphasizes material composition, design, and intended use being similar to already approved devices.
- Testing for Equivalence: The text states, "Testing was presented to support a claim of substantial equivalence to the predicate devices." However, it does not describe the nature of this "testing" in detail. For orthopedic implants, this typically involves bench testing (e.g., wear testing, fatigue testing, mechanical strength) and comparison of geometric dimensions, materials, and manufacturing processes to predicates, rather than clinical efficacy studies with human subjects against acceptance criteria for diagnostic or prognostic performance.
Therefore, I cannot populate the table or provide answers to the specific questions regarding acceptance criteria and performance studies because the provided document is a 510(k) summary for a mechanical orthopedic device and does not contain the type of information outlined in your request for an AI/ML 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.