(27 days)
Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures. Abutments can be used in single tooth replacements and multiple tooth restorations.
The Straumann Dental Implant System is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, permanent and temporary abutments and surgical and prosthetic parts and instruments. The device covered in this submission is an abutment.
The coronal portion of the abutment has an octagon design to interface with the final restoration. The abutment is seated in the implant with a screw that is mounted in the basal portion of the abutment. The abutment is used for cemented and screw-retained restorations.
This document is a 510(k) submission for a dental abutment, not an AI/ML medical device. Therefore, it does not contain the information requested about acceptance criteria or a study demonstrating the device meets those criteria, as these concepts are typically applied to the validation of AI/ML algorithms.
The document primarily focuses on establishing substantial equivalence to a predicate device based on similar intended use and technological characteristics.
Here's why the requested information cannot be extracted from the provided text:
- Acceptance Criteria & Device Performance Table: This submission is for a physical medical device (dental abutment). Its "performance" is assessed through material properties, fit, and intended function validation, not through metrics like sensitivity, specificity, or accuracy that would be relevant to an AI/ML algorithm. The document states "The proposed abutment is substantially equivalent to the currently marketed device. The intended use, basic design and fundamental operating principles are the same as the predicate device." This is the core "acceptance criteria" here – similarity to an already approved device.
- Sample Size for Test Set & Data Provenance: Not applicable for this type of device submission. There is no "test set" in the context of an algorithm.
- Number of Experts & Qualifications for Ground Truth: Not applicable. Ground truth, in the AI/ML context, refers to expertly labeled data. For a dental abutment, the "ground truth" would be established by engineering specifications, material standards, and clinical performance over time, not through labeling of data by experts in a diagnostic sense.
- Adjudication Method: Not applicable.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable, as this is a physical device, not a diagnostic algorithm.
- Standalone Performance: Not applicable.
- Type of Ground Truth Used: The "ground truth" for this device is its physical properties, material compatibility, and structural integrity under anticipated loads, which are confirmed through engineering tests and adherence to manufacturing standards, not through "expert consensus, pathology, or outcomes data" in the AI/ML sense.
- Sample Size for Training Set: Not applicable.
- How Ground Truth for Training Set Was Established: Not applicable.
In summary, this document describes a traditional medical device submission (a dental abutment) based on substantial equivalence. It does not provide information relevant to the validation of an AI/ML algorithm.
§ 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.)