(124 days)
This device is indicated for patients with severe knee pain and disability due to:
- Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
- Collagen disorders, and/or avascular necrosis of the femoral condyle.
- Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
- Moderate valgus, varus, or flexion deformities.
- The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
Porous coated components may be used cemented (biological fixation). All other femoral, tibial baseplate, and all-polyethylene (UHMWPE and VEXLPE) patella components are indicated for cemented use only.
The Zimmer Persona Personalized Knee System is a semi-constrained modular knee prosthesis designed to resurface the articulating surface of the femoral, tibial and patellar bones. The Persona Knee System utilizes a modular design between the tibial plates and articular surfaces. With this submission, Medial Congruent (MC) Vivacit-E® articular surface components are being added to the system. The subject components articulate against, the existing Cruciate Retaining (CR) femoral component, and lock onto the existing tibial baseplate components using a dovetail mechanism. The subject articular surface components, when used with the CR femoral, can accommodate a maximum active flexion of 155°. The MC articular surfaces provide greater medial conformity, similar anterior lateral conformity, and less posterior lateral conformity when compared to the predicate Persona UC articular surface design. In addition, the subject articular surface can be implanted with or without a functioning PCL. The components are single use and are provided sterile to the healthcare facility/hospital. MC articular surfaces are for use with both cemented and uncemented femoral and tibial baseplate components.
The provided text describes a 510(k) premarket notification for a medical device, the Zimmer® Persona® Personalized Knee System. It details the device's indications for use, its comparison to a predicate device, and the non-clinical performance data used to demonstrate substantial equivalence.
However, the provided document does not contain information related to software or AI-driven medical devices. Therefore, it is not possible to describe acceptance criteria or a study proving that an AI-enhanced device meets those criteria based on this document.
The document discusses acceptance criteria and performance data for a physical medical device (a knee prosthesis), which involves mechanical and material properties rather than AI-related metrics like accuracy, sensitivity, or specificity.
Specifically, the document lists "Property or Characteristics" and "Analysis/Test Results" for the knee system, which include:
- Biocompatibility testing
- Evaluation of wear performance
- Tibiofemoral Constraint Evaluation
- Tibiofemoral Contact Area and Contact Pressure Evaluation
- Anterior and Posterior Liftoff Testing
- Evaluation of Interactions with Magnetic Fields (MRI compatibility)
- Posterior Crush Evaluation
These are all physical tests for a physical implant. The document explicitly states: "Clinical data and conclusions were not needed for this device." This further confirms that the assessment did not involve human-in-the-loop studies or standalone algorithm performance, as these would be relevant for software or AI.
Therefore, I cannot fulfill the request to describe the acceptance criteria and study for an AI-driven device based on the provided text. The information requested (sample sizes, ground truth establishment, expert qualifications, MRMC studies, etc.) is specific to AI/software validation studies and is not present in this document.
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.