(85 days)
When a mechanical alignment approach is utilized, 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.
When a Personalized Alignment approach is utilized, 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.
- Moderate valgus, varus, or flexion deformities.
The Personalized Alignment (PA) surgical technique may only be used with Persona cemented and uncemented CR femoral components, Persona CR, Ultra Congruent (UC), and Medial Congruent (MC) articular surface components, the Persona Cemented Stemmed tibial components without a stem extension, and the Persona OsseoTi Keel Tibia and Cemented Keel Tibia.
Porous coated components may be used cemented (biological fixation), except for the Persona OsseoTi Keel Tibia and the Persona OsseoTi 3-peg Patella which are for uncemented use only. All other femoral, tibial baseplate and all-polyethylene (UHMWPE and VEHXPE) patella components are indicated for cemented use only.
The purpose of this submission is to add a new component to the Personalized Knee System. The component is the Persona OsseoTi 3-Peq Patella and the associated instruments. The addition of these components do not change the intended use or fundamental scientific technology of the device system.
The Personalized Knee System is a semiconstrained modular knee prosthesis designed to resurface of the femoral, tibial, and patellar bones. With this submission a new porous metal backed UHMWPE patella component will be added to the system. These patellar components articulate against femoral component as part of a total knee system. The new patellar components come in a variety of sizes to match the needs of a patient's anatomy when performing total knee arthroplasty. These components are provided sterile and single use. To aid the implantation of these devices several new reusable instruments are also introduced.
The provided text is an FDA 510(k) clearance letter for the "Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)". This document primarily addresses the substantial equivalence of a new medical device to existing legally marketed devices, rather than detailing the acceptance criteria and the rigorous study design typically associated with a de novo approval or a premarket approval (PMA) application that would involve extensive clinical trials with pre-defined acceptance criteria.
Therefore, the document does not contain the information requested in the prompt regarding:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for test sets.
- Number and qualifications of experts for ground truth.
- Adjudication methods.
- MRMC comparative effectiveness study details.
- Standalone algorithm performance.
- Specific type of ground truth used.
- Training set sample size or how its ground truth was established.
Instead, the FDA 510(k) process is about demonstrating that a new device is "substantially equivalent" to a predicate device already on the market. This often relies on non-clinical performance testing and a comparison of technological characteristics and indications for use.
The relevant section for performance data in this document is under "Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)". This section lists several mechanical and characterization tests performed on the device:
- Shear and Torsional Strength of the Persona Link OsseoTi Patella Polyethylene -Ti6Al4V Interface
- Fatigue Strength of the Persona OsseoTi Porous Patella in an Undersupported Bending Configuration and Manufactured Using PQ Process Parameters
- Shear Fatigue Strength of Persona OsseoTi Porous Patella Pegs Manufactured Using PQ Process Parameters
- Durability Testing, per ISO 14243-5, for the Persona OsseoTi 3- Peg Patella when Articulated with a Persona CR Femoral Component
- Expanded In Vivo RF-Induced Heating Simulations for the Persona Primary Knee System
- Characterization of As-Printed Four-Point Bend Fatigue Strength
- Evaluation of the Interfacial Motion Between the Persona OsseoTi Patella and a Bone Analog When Subjected to Physiologically Derived Patellofemoral Joint Kinetics and Kinematics
- Characterization of OsseoTi Lattice
However, the document states: "Clinical Testing Not Applicable". This explicitly indicates that human-in-the-loop performance studies, multi-reader multi-case studies, or standalone algorithm performance studies with human data (which would require establishing ground truth from expert consensus or pathology) were not conducted or deemed necessary for this 510(k) clearance.
The conclusion drawn by the applicant is that:
- "any differences [from the predicate] do not raise new questions of safety and effectiveness; and"
- "the proposed device is at least as safe and effective as the legally marketed predicate device(s)."
This illustrates that for a 510(k) submission, the "proof" often comes from extensive non-clinical testing demonstrating equivalence in mechanical properties, materials, and design features, rather than clinical efficacy trials involving patients or human readers interpreting diagnostic images.
§ 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.