(273 days)
The Destiknee™- 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, osteoarthritis, 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 consists of following components.
- . Femoral Component
- . Tibial Component which is available in following two designs
- o Metal Backed Tibial Component which consists of Tibial Base Plate and Tibial Articular Surface (viz. Tibial Liner)
- All Poly Tibial Component (viz. All Poly) and o
- All Poly Patella Component .
Each of these components are described below.
-
Femoral Component
Femoral Component is fabricated from Cobalt-Chromium-Molybdenum alloy and is intended for cemented application to replace the articulating surface of the distal femur in a measured resection technique.
The Femoral Component is available in two designs viz. Posterior Stabilized (PS) and Cruciate Retaining (CR).Each design is classified into Left and Right configurations. Each Left and Right configuration is available in eight different sizes. -
Tibial Component
Tibial Component is available in following two designs:
- a) Metal Backed (modular/two pieces)
- b) All Poly (non-modular/single piece)
Metal backed design of Tibial component is modular two piece design viz. Tibial Base Plate and Tibial Articular Surface (viz. Tibial Liner).
The Tibial Base Plate is fabricated from Cobalt-Chromium-Molybdenum alloy and is intended for use with the Tibial Liner for cemented application to replace the articulating surface of the proximal tibia in a measured resection.
Tibial Liner is fabricated from industry standard Ultra High Molecular Weight Polyethylene (UHMWPE) and is intended for use with the Tibial Base Plate to replace the articulating surface of the proximal tibia in a measured resection. It has a locking mechanism on the peripheral edges of the distal surface to lock into the Tibial Base Plate. The Tibial Liner is available in two designs viz. Posterior Stabilized (PS) and Cruciate Retaining (CR).Each PS and CR designs are available in 14 configurations. Each configuration is further available in four different thickness viz. 9mm, 11mm, 14mm and 17mm.
All poly design is a non modular single piece design viz. All Poly Tibial Component (viz. All Poly)fabricated from industry standard Ultra High Molecular Weight Polyethylene (UHMWPE) and is intended for cemented application to replace the articulating surface of the proximal tibia in a measured resection. All Poly is available in two designs viz. Posterior Stabilized (PS) and Cruciate Retaining (CR).
Each PS and CR designs are available in 12 configurations. Each configuration is available in five different thickness viz. 9mm, 11mm, 14mm, 17mm and 20mm.
All Poly Patella Component is fabricated from industry standard Ultra High Molecular Weight Polyethylene (UHMWPE). It is available in a symmetric single radius design. The symmetrical design is available in 4 diameters.
All materials used in Destiknee™ Total Knee System meet ASTM standards for implants, viz. ASTM F648 "Standard Specification for Ultra High Molecular Weight Polyethylene Powder and Fabricated Form for Surgical Implants" and ASTM F-75 "Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting alloy for Surgical Implants (UNS R30075)".
The provided text is a 510(k) premarket notification for a medical device called the "Destiknee Total Knee System." It describes the device, its indications for use, and a comparison to a predicate device. However, it does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria for an AI/machine learning medical device.
The document pertains to a traditional orthopedic implant, a knee replacement system, and the "performance data" mentioned refers to mechanical and material testing (endurance properties, stability, surface stress, kinematic range of motion) of the physical implant, not the performance of an AI algorithm.
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and reported device performance (for AI)
- Sample size for the test set and data provenance
- Number of experts and qualifications used for ground truth
- Adjudication method
- MRMC comparative effectiveness study results or effect size
- Standalone (algorithm only) performance
- Type of ground truth used (for AI)
- Sample size for the training set
- How ground truth for the training set was established
The document explicitly states: "All the necessary performance tests to determine the material and mechanical characteristics have been performed on predicate device viz. Freedom® Total Knee System." and "Destiknee™ Total Knee System is identical to the predicate device viz. Freedom® Total Knee System with respect to intended use, device design, materials, and method of sterilization." This indicates that the regulatory clearance for this physical device is based on its substantial equivalence to a previously cleared predicate device, and the "performance" discussed is physical and mechanical, not related to an AI/ML algorithm.
§ 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.