(65 days)
The DestikneeTM Total Knee System is indicated for patients with severe knee pain and disability due to:
· Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, traumatic arthritis, polyarthritis.
· Correction of functional deformities.
· Post-traumatic loss of knee joint contour, particularly when there is patellofemoral erosion, dysfunction, or prior patellectomy.
· Moderate valgus, varus, or flexion trauma.
· Knee fractures untreatable by other methods.
The Destiknee™ Total Knee System is intended for cemented use only. This device is for single use only.
The Destiknee™ Total Knee System is a system of components intended to replace the Femoral, Tibial and Patella articular surfaces of the knee joint. The components are available in many styles and sizes and are manufactured from metallic and non-metallic materials.
The Destiknee TM Total Knee System was originally cleared under 510(k): K160771. The purpose of current submission is to add Tibial Base Plate (size 7 and size 8) and All Poly Patella (size 37mm and 40mm) in Destiknee™ Total Knee System.
The provided text is a 510(k) summary for the Destiknee™ Total Knee System, a medical device. It describes the device, its indications for use, and a comparison to a predicate device. However, it does not contain information about formal acceptance criteria, studies proving the device meets those criteria, or details regarding Artificial Intelligence (AI) algorithms as requested in the prompt.
The document focuses on demonstrating substantial equivalence to a previously cleared device (K160771) based on non-clinical performance data which includes:
- Fatigue test of Tibial Base Plate (ASTM F1800-12; ISO 14879-1:2000)
- Endotoxin testing (to confirm manufacturing process does not introduce endotoxins)
- 14-day USP sterility testing
The document explicitly states that the purpose of the current submission is "to add Tibial Base Plate (size 7 and size 8) and All Poly Patella (size 37mm and 40mm) in Destiknee™ Total Knee System." This indicates a modification or expansion of an existing device rather than a new AI-powered diagnostic device.
Therefore, I cannot fulfill the request for information related to AI device acceptance criteria, study details (sample size, ground truth, expert qualifications, MRMC studies, standalone performance), or training set information, as this document does not describe such a device or studies. The information provided is for a total knee replacement system and its mechanical and biological safety performance.
§ 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.