(237 days)
The INFINITY Total Ankle System is indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. The INFINITY Total Ankle System is additionally indicated for patients with a failed previous ankle surgery. CAUTION: In the United States, the ankle prosthesis is intended for cement use only.
The subject INFINITY™ Total Ankle System is a fixed-bearing, bone-sparing ankle replacement prosthesis that restores mobility to a failing ankle joint. The system includes three components (i.e., tibial tray, poly insert, and talar dome) that are assembled together to create the two-piece prosthesis. The talar dome is manufactured using additive manufacturing technology.
The provided text is a 510(k) premarket notification for the INFINITY Total Ankle System. It outlines the regulatory review process and the basis for the FDA's substantial equivalence determination. However, it does not contain information about acceptance criteria for a device's performance (e.g., accuracy, sensitivity, specificity, or other performance metrics) nor details of a study proving the device meets those criteria, especially in the context of an AI/ML-based device.
The document states:
- "(b)(1). Substantial Equivalence- Non-Clinical Evidence" lists various bench performance tests (e.g., Chemical Analysis, Abrasion Resistance, Fatigue Testing, MRI Safety Analysis, DMLS Process Validation). These are engineering tests for the physical properties and manufacturing of the implant, not performance metrics of an AI/ML system.
- "(b)(2). Substantial Equivalence- Clinical Evidence" explicitly states: "Clinical Studies were not required to demonstrate substantial equivalence between the subject device and the predicate devices."
Therefore, I cannot provide the requested information as it is not present in the given text. The device described (an ankle prosthesis) is a physical implant, not a software device or an AI/ML-based system that would typically have performance criteria related to classification, diagnosis, or prediction, and associated test sets, ground truth establishment, or MRMC studies.
§ 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.