(30 days)
The Magicore II System is intended to replace missing teeth to restore chewing function. The Magicore II System can be placed in support of single or multiple-unit restorations including; cement retained, or overdenture restorations, and terminal or immediate abutment support for fixed bridgework. This system is for one or two stage surgical procedures. This system is intended for delayed loading.
This submission is to add new abutments to the previously cleared device. Magicore II System (K192197). The newly added abutments are Magic Multiunit Abutments (Screw type – Hex. Non-Hex. Cemented type - Hex, Non-Hex) with the new angulations of 5, 10, 20°. For Magic Multiunit Cylinder, Magic Multiunit Abutment ST, and Mazic Multi Abutment Cap, no other changes are being made to the previous clearances except for model names. The Abutments are fabricated from Ti-6AL-4V Eli (Conforming to ASTM Standard F-136). The Abutments are provided non-sterile and packaged separately. The abutment should be sterilized before use.
This document is a 510(k) summary for the Magicore II System, an endosseous dental implant abutment. It does not contain information about acceptance criteria and a study proving device performance in the context of an AI/ML device.
The provided text pertains to a physical dental implant abutment and its substantial equivalence to a previously cleared device. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this document refer to a demonstration that the new abutments are sufficiently similar to an existing predicate device, primarily through dimensional comparison analysis and shared materials/manufacturing processes.
Therefore, I cannot provide the requested table or answer the specific questions related to AI/ML device performance, such as:
- Acceptance criteria and reported device performance (in an AI/ML context).
- Sample size for the test set and data provenance.
- Number of experts and their qualifications for ground truth.
- Adjudication method for the test set.
- MRMC comparative effectiveness study, and effect size with AI assistance.
- Standalone algorithm performance.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Sample size for the training set.
- How ground truth for the training set was established.
The document explicitly states: "No need to perform any non-clinical testing for the subject device since and predicate device are substantially equivalent in indications, fundamental technology, material and design. Although the dimensions and angulations are different, by performing product's dimensional comparison analysis, it concluded that the predicate device is the mechanical worst case and demonstrated the substantial equivalence."
This indicates that the "study" was a non-clinical dimensional comparison analysis focusing on mechanical worst-case scenarios, rather than a performance study involving patient data or expert interpretation.
§ 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.)