(297 days)
The Multi-unit Abutment Plus is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.
The Multi-unit Abutment Plus are transmucosal abutments used for multiple unit screw retained restorations. The abutment family consists of straight and angled abutments in varying collar heights. The non-angled abutments have a built in screw and the angled abutments are co-packed with a separate abutment screw. The Multi-unit Abutment Plus is compatible with the Nobel Biocare dental implants that have the internal conical connection. The Multi-unit Abutment Plus is available for Internal Conical Connection implants with the Narrow Platform (NP), Regular Platform (RP) and Wide Platforms (WP). The Multi-unit Abutment Plus is available with collar heights of 1.5, 2.5, 3.5, and 4.5 mm and angulations of 0°, 17°, 30°.
The provided document is a 510(k) premarket notification decision letter from the FDA regarding a dental implant abutment, the "Multi-unit Abutment Plus." This type of document is for medical device clearance, not for AI/ML-based software. Therefore, the information requested regarding acceptance criteria and study details for an AI-based device is not applicable to this document. The document describes the mechanical and material equivalence of a physical dental device to a previously cleared predicate device.
Specifically, the document focuses on:
- Device Description: Multi-unit Abutment Plus (transmucosal abutments for multiple unit screw-retained restorations).
- Comparison to Predicate Device: The subject device is an "evolution" of the predicate (NobelActive Multi Unit Abutment - K072570) with the addition of a Wide Platform (WP) abutment and a "snap coping feature."
- Non-Clinical Testing Summary: The testing primarily involved leveraging data from the predicate device due to similar materials, sterilization methods, packaging, shelf life, and biocompatibility. The primary new test mentioned is fatigue limit testing using a modified ISO 14801 standard, where both the subject and predicate devices were tested under identical conditions.
Therefore, I cannot provide the requested information for an AI/ML device. The questions posed (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set size) are entirely designed for software efficacy studies, which are not detailed or relevant in this hardware device 510(k) submission.
§ 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.)