(180 days)
The LW Implant System - Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
The LW Implant System - Abutment consists of the LW Solid, LW Angled, and LW Vis Abutment. The abutments have s-Line type and cuff type. The abutments are made of Ti-6AI-4V-ELI (ASTM F136), and they are provided non-sterile, which are required to be sterilized by the end-user before use.
The LW Implant System – Abutment is compatible with the LW Fixture and LW Abutment Screw in the LW Implant System, K223924.
The provided text is an FDA 510(k) clearance letter for a dental implant abutment system. It focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a performance study with acceptance criteria for a new, AI-driven or novel device.
Therefore, the document does not contain the information requested regarding acceptance criteria for a device's performance, a study proving it meets those criteria, sample sizes for test sets, data provenance, expert involvement, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment.
The "Non-Clinical Test Data" section lists various engineering and material tests (surface modification, sterilization, biocompatibility, fatigue, MRI safety) that were performed to demonstrate the device's safety and effectiveness in comparison to the predicate devices, but these are not performance metrics that would be evaluated against specific acceptance criteria for a new and complex medical device with an AI component or a diagnostic function.
In summary, none of the requested information to describe acceptance criteria and the study proving the device meets those criteria is present in this FDA 510(k) document because it's for a dental implant abutment, not a device with the type of performance metrics implied by your query.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)