(70 days)
The Triathlon® X3™ UHMWPE Posterior Stabilized and Cruciate Retaining tibial inserts and the Triathlon® X3™ UHMWPE Patellar components are intended to be used with the cemented Triathlon® PS and CR femoral components and cemented Triathlon® Primary Cemented Tibial Tray in primary or revision total knee arthroplasty. The Triathlon® X3™ UHMWPE Patellar components are intended to be used with the femoral components of the previously released Duracon® Total Knee System The Triathlon® PS Total Knee System is intended to be used in situations where the posterior cruciate ligament is absent, or cannot be preserved. The Triathlon CR Total Knee System is intended to accommodate the posterior cruciate ligament (PCL) if it is present. The all polyethylene Triathlon® X3™ UHMWPE Patellar components are intended for implantation with bone cement only.
Indications:
- · Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or, theumatoid 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 Components:
- · Ligamentous instability requiring implant bearing surface geometries with increased constraint.
- · Absent or non-functioning posterior cruciate ligament.
The device includes tibial and patellar components of a total knee system. These components are used for the replacement of the bearing and/or articulating surfaces of the proximal tibia and patella. Tibial inserts will be made in Cruciate Retaining and Posterior Stabilized designs. Patellar components will be made in both Asymmetric and Symmetric designs.
The provided text describes the 510(k) Premarket Notification for the Triathlon® X3™ UHMWPE Tibial and Patellar Components, an orthopedic medical device. The information details the device, its indications, contraindications, and a summary of the data supporting its substantial equivalence to predicate devices. However, the document does not contain the typical structure of a study report for an AI/ML device, which would include specific acceptance criteria, performance metrics, and details about clinical study methodology (e.g., sample size, expert ground truth, adjudication).
Based on the provided text, here's an analysis of the requested information:
1. A table of acceptance criteria and the reported device performance
This information is not explicitly provided in the given document. The document states "A risk analysis and research and development testing have been performed to demonstrate equivalence of the subject products to the predicate devices." It lists types of tests but does not define specific acceptance criteria or report quantified performance against such criteria in a tabular format. The goal of this 510(k) submission is to demonstrate "substantial equivalence" to a predicate device, rather than meeting pre-defined performance thresholds for a novel AI system.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The document mentions various types of engineering tests (material properties, wear, fatigue, etc.) but does not describe the use of a "test set" in the context of clinical data for an AI/ML device. There is no mention of human subject data, let alone its provenance or study design.
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)
This information is not provided. The device is an orthopedic implant, and its evaluation relies on engineering tests and comparison to a predicate device, not on expert-adjudicated ground truth from medical imaging or clinical diagnostic data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. As there is no mention of a "test set" requiring expert adjudication, this detail is absent.
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
There is no indication that an MRMC comparative effectiveness study was done. This type of study is relevant for AI-assisted diagnostic or interpretative devices, not for orthopedic implants whose evaluation is based on mechanical and material properties.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/not provided. The device is a physical orthopedic implant. There is no "algorithm only" component to evaluate in isolation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable/not provided in the context of AI/ML. The "ground truth" for evaluating this device would revolve around measurements from mechanical testing and material science, and ultimately, clinical outcomes in patients receiving the implant (though not explicitly detailed in this short 510(k) summary). The submission focuses on demonstrating "substantial equivalence" based on these engineering tests, which is inherently a comparison to the predicate device's established performance parameters.
8. The sample size for the training set
This information is not applicable/not provided. There is no mention of an algorithm or a "training set" in the context of an AI/ML device.
9. How the ground truth for the training set was established
This information is not applicable/not provided. There is no "training set" for this type of medical device.
Summary regarding AI/ML device criteria:
The provided document (K051146) is a 510(k) Premarket Notification for orthopedic implants (knee components). It details the device's physical attributes, indications for use, and the types of engineering tests performed to demonstrate its substantial equivalence to previously approved predicate devices. This type of submission predates the widespread regulatory frameworks for AI/ML in medical devices and, therefore, does not contain any of the requested information pertinent to the evaluation of an AI-powered diagnostic or therapeutic system. The "study" mentioned refers to engineering and R&D testing, not clinical trials or AI performance evaluations with human data.
§ 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.