(60 days)
The Opulent 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 join contcularly 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 and soft tissue integrity are present.
The Opulent TiNbN Coated Knee is intended for cemented use only. This device is for single use only.
The Opulent 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.
5.7.1 Femoral Component
The Femoral Component is fabricated from Cobalt-Chromium-Molybdenum (Co-Cr-Mo), coated with Titanium Niobium Nitride (TiNbN). The Femoral Component is available in two designs: Cruciate Retaining (CR) and Posterior Stabilized (PS). Each of these designs is further classified into Left and Right configurations. Each Left and Right configuration is available in eight different sizes (A to H) based on Anterior/Posterior (A/P) and Medial/Lateral (M/L) dimensions. Thus, a total of thirty two (32) models are available for the Femoral Component.
5.7.2 Tibial Component (Tibial Base Plate)
The Tibial Base Plate is fabricated from Cobalt-Chromium-Molybdenum coated with TiNbN. The tibial base plate is available in eight different sizes from 1 to 8 based on Anterior/Posterior (A/P) and Medial/Lateral (M/L) dimensions.
The provided text describes a medical device, the "Opulent TiNbN Coated Knee," and its submission for FDA clearance (K222816). However, the document does not contain information related to acceptance criteria, device performance metrics, sample sizes for test sets, data provenance, expert adjudication, MRMC studies, standalone performance, or ground truth establishment.
Instead, the document primarily focuses on:
- FDA Clearance Letter: Confirming the device's substantial equivalence to a predicate device.
- Indications for Use: Listing the medical conditions for which the device is intended.
- 510(k) Summary: Detailing the device information, predicate device comparison, manufacturing process, material, and non-clinical performance data (e.g., coating characteristics, wear resistance, biocompatibility testing).
The non-clinical performance data section lists the types of tests conducted (e.g., coating thickness, hardness, wear resistance, various biocompatibility tests), but does not provide specific acceptance criteria or the reported performance outcomes for these tests. Therefore, I cannot construct the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, or ground truth.
The document states:
"The subject device was subjected to following non clinical performance testing to evaluate device function and mechanical performance." (Page 6)
and lists tests like "Coating characteristics of TiNbN Coating," "Wear resistance," and "Biocompatibility testing." While these indicate the areas of evaluation, they do not provide the results or the criteria for acceptance.
In summary, the information required to answer your request is not present in the provided text.
§ 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.