(59 days)
The r3 Tibial Implants of the Kinos Total Ankle System are indicated for revision total ankle arthroplasty. The Kinos Total Ankle System is intended for cement use only.
The subject line extension to the Kinos Total Ankle System are implant and instrument components designed to preserve motion in patients with ankle arthritis or previously failed ankle surgery. The device is a fixed bearing and semi-constrained implant construct, intended for replacement of the articulating surfaces of the ankle that have been affected by a disease state or injury. The subject device provides limited mobility to a patient by restoring alignment of the articulating surfaces, reducing pain, and providing flexion-extension movement within the ankle joint. The tibial and talar implants are intended to be used with bone cement. The subject Kinos Total Ankle System consists of three implant components - a tibial implant affixed to the tibia, a bearing implant assembled to the tibial implant and a talar implant affixed to the talus. The tibial implant and bearing implant, assembled intraoperatively, function together and articulate with the talar implant to create a fixed bearing prosthesis, replacing the articulating surface of the tibiotalar joint. The extension includes tibial segments which are assembled intraoperatively to the tibial base plate to enhance tibial fixation height in the tibia.
The provided document is an FDA 510(k) clearance letter for the Kinos Total Ankle System. This document focuses on the substantial equivalence of a new device (a line extension) to a previously cleared predicate device, rather than the performance of an AI/ML device.
Therefore, the information required to answer the prompt (acceptance criteria, study details for AI/ML device performance, sample sizes, expert involvement, ground truth, etc.) is not present in this document.
The document details the device's classification, indications for use, and a summary of performance testing primarily related to mechanical properties of the implant (e.g., fatigue testing, bone stability, assembly tests, porous surface characterization). This is typical for a medical device clearance that is a physical implant, not a software or AI/ML diagnostic tool.
In summary, this document does not contain the information requested in your prompt regarding AI/ML device acceptance criteria and performance study details.
§ 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.