(216 days)
The Vantage ™ Total Ankle System is indicated for patients with ankle joints damaged by severe rheumatoid, post- traumatic, or degenerative arthritis. It is also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.
The Vantage ™ Total Ankle System is indicated for cemented use only.
Exactech Vantage Total Ankle System is a fixed-bearing total ankle replacement device that is comprised of four sub-components, a tibial plate, a tibial insert, a locking component, and a highly polished talar component that are assembled to create the subject total ankle replacement system. The tibial plate is manufactured from titanium alloy (Ti-6Al-4V ELI) with commercially pure titanium coating on the bone-contacting surface. The tibial insert is made of ultra-high molecular weight polyethylene. The highly polished talar component is manufactured from cobalt-chromium alloy (Co-28Cr-6Mo) with commercially pure titanium coating on the bone-contacting surface. The locking component is made of titanium alloy (Ti-6Al-4V ELI). Each of the four sub-components is offered in multiple sizes to accommodate the various anatomical needs of a patient's ankle joint. With the exception of the locking component, all components are anatomically designed and offered in left and right implant components. The overall design goals of the Exactech Vantage Total Ankle System are to maximize bony support while allowing impingement-free range of motion, and provide anterior/posterior, medial/lateral, and rotational stability when implanted in the resected/prepared distal tibia and proximal talus. Exactech Vantage Total Ankle System device is indicated for cemented use only.
The Exactech Vantage Total Ankle System is accompanied by a complete instrumentation set including trial and rasp/cutting block system to assist surgeons in implantation of the device.
This FDA 510(k) summary describes a new medical device, the Exactech® Vantage™ Total Ankle System, and establishes its substantial equivalence to previously cleared predicate devices. The document does not describe a study conducted to prove the device meets acceptance criteria related to AI or algorithm performance; rather, it details non-clinical testing to demonstrate mechanical and design equivalence for a physical orthopedic implant.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, ground truth, adjudication methods, and MRMC/standalone studies is not present in the provided text, as these are typically associated with performance evaluations of AI/ML or diagnostic devices.
The document focuses on:
- Device Description: A fixed-bearing total ankle replacement system made of specific materials (titanium alloy, ultra-high molecular weight polyethylene, cobalt-chromium alloy).
- Indications for Use: Patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis, and for revision of failed previous reconstructions. Indicated for cemented use only.
- Substantial Equivalence: Claimed based on similar indications for use, materials, design features, dimensions, sterilization, and conformity to recognized performance standards compared to predicate devices (Salto Talaris™ Total Ankle Prosthesis and INFINITY® Total Ankle System).
- Non-Clinical Testing: A list of mechanical and engineering tests performed to support substantial equivalence (e.g., sizing studies, locking integrity testing, fatigue analysis, wear evaluation, contact area/stress, constraint evaluation, bone stability, range of motion study, finite element analysis).
In summary, none of the requested information about acceptance criteria for AI/ML device performance validation is available in the provided text. The document pertains to a traditional orthopedic implant's 510(k) submission, where the "acceptance criteria" are implied by conformity to recognized standards and successful completion of the listed non-clinical mechanical tests, demonstrating equivalence to predicates.
§ 888.3110 Ankle joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. An ankle joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an ankle joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces and has no linkage across-the-joint. This generic type of device includes prostheses that have a talar resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a tibial resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.