(226 days)
The Freedom® - TiNbN Coated Knee is indicated for the following:
· Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, traumatic arthritis, and polyarthritis.
· Correction of functional deformities.
· Post-traumatic loss of knee joint contour, when there is patellofemoral erosion, dysfunction, and/or prior patellectomy.
· Moderate valgus, varus, or flexion trauma.
- · Knee fractures untreatable by other methods.
· Revision surgery where sufficient bone stock and soft tissue integrity are present.
The Freedom® - TiNbN Coated Knee is intended for cemented use only. This device is for single use only.
The Freedom® - TiNbN Coated Knee comprises of Femoral Component and Tibial Component as described below,
- Femoral Knee Component CR and PS (Left and Right)
- Tibial Component (Tibial Base Plate)
Each of these components is described below.
The provided text does not describe a study involving an AI/ML powered medical device or a diagnostic device that would require the establishment of ground truth by experts or a comparative effectiveness study with human readers.
Instead, the document is a 510(k) premarket notification for the Freedom® - TiNbN Coated Knee, which is a knee joint prosthesis. The acceptance criteria and the "study" (referred to as "Non clinical Performance data") described in the document relate to the physical and material properties of this medical implant, not to a diagnostic or AI-driven system.
Therefore, I cannot answer your request based on the provided text, as the information you've asked for (such as ground truth establishment by experts, adjudication methods, multi-reader multi-case studies, and AI effect size) is irrelevant to the type of device described in the document.
The document discusses:
- Device Type: Knee joint prosthesis (mechanical implant).
- Purpose of Submission: Demonstrating substantial equivalence to legally marketed predicate devices for the purpose of market clearance.
- "Acceptance Criteria" / Performance Testing: Physical and material tests to ensure the implant meets safety and performance standards (e.g., wear resistance, coating adhesion, fatigue testing). This is not about diagnostic accuracy or AI performance.
- "Study" Data: Non-clinical (laboratory) performance data on the mechanical properties and coating characteristics of the knee implant.
If you have a document describing an AI/ML medical device, I would be happy to analyze it according to your criteria.
§ 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.