(58 days)
The APEX 3D™ Total Ankle Replacement System is indicated as a total ankle replacement in primary surgery for patients with ankle joints damaged by severe rheumatoid, post traumatic, or degenerative arthritis. Revision surgery for these patients is also indicated for patients with sufficient bone stock present. In the United States, components are intended for cemented use only.
The APEX 3D Total Ankle Replacement System has been cleared under K192994. The purpose of this submission is to introduce a new diffusion bonded talar dome to the APEX 3D Total Ankle Replacement System. The APEX 3D Total Ankle Replacement System is a cemented, fixed-bearing device comprised of a tibial component, a talar component, and a UHMWPE component used for ankle joint replacement. Based on patient anatomy, a number of component sizes and design configurations can be selected for best fit.
The provided document is an FDA 510(k) clearance letter for the APEX 3D Total Ankle Replacement System. This document does not describe AI/ML-driven medical devices or related acceptance criteria studies.
The 510(k) summary explains that the submission is to introduce a new diffusion-bonded talar dome to an already cleared total ankle replacement system. The performance testing described is focused on the physical and mechanical properties of the implant materials and manufacturing processes, such as:
- Porous Structure Characterization
- Diffusion Bonded Tensile Strength
- Diffusion Bonded Static Shear Strength
- Diffusion Bonded Fatigue Shear Strength
- Diffusion Bonded Abrasion Resistance
- Metallurgical Analysis
- Accelerated Corrosion Soak
The document explicitly states: "Clinical data are not needed to support the safety and effectiveness of the subject device."
Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria and studies for an AI/ML-driven device, as this document pertains to a mechanical orthopedic implant, not an AI/ML product.
To answer your request, I would need a different source document that details the performance study of an AI/ML-driven medical device.
§ 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.