(34 days)
SPI® ART Abutments are intended to be used in conjunction with SPI System dental implants in the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures.
SPI ART Abutments are contraindicated for free-end bridges with more than one intermediate pontic element.
Thommen SPI ART Abutments are zirconia dental implant abutments for use with the SPI Dental Implant System.
This document is a 510(k) summary for the Thommen Medical AG SPI® ART Abutment, an endosseous dental implant abutment. It seeks to demonstrate substantial equivalence to predicate devices and does not describe a study involving acceptance criteria and device performance in the context of AI or machine learning. Since the request is to "Describe the acceptance criteria and the study that proves the device meets the acceptance criteria" and mentions specifics like "Sample sized used for the test set," "Number of experts used," "Adjudication method," "MRMC comparative effectiveness study," "standalone ... performance," "ground truth," and "training set," these are all concepts related to performance evaluation of algorithms or AI/ML-driven devices, which is not applicable to the predicate device submission provided.
Therefore, based on the provided text, I cannot answer the questions related to acceptance criteria and study details for an AI/ML context because the document describes a traditional medical device submission, not an AI/ML product. The document focuses on demonstrating substantial equivalence in design principles and intended use to already marketed devices.
§ 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.)