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The BEGO Semados® RS/RSX implant is indicated for single or multiple unit restorations on splinted or non-splinted applications both in the upper and lower jaw. This can be achieved by a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading on sufficient primary stability and appropriate occlusal loading.

The BEGO Semados® RS/RSX implant 3.0 is only indicated for single unit restorations of the lower lateral, central incisors or upper lateral incisors.

The healing posts are indicated for patients treated with BEGO Semados® RS/RSX implants for the time during healing of the surrounding soft tissue.

The abutments are indicated for patients treated with BEGO Semados® RS/RSX implants as an aid in prosthetic rehabilitation.

PS ITA, PS TTiA and PS TTiA NH are intended to be used for a maximum period of 6 months.

The BEGO Semados® RS/RSX Implant System consists of implants, healing posts and abutments.

BEGO Semados® RS/RSX implants are self-tapping, conical endosseous dental implants made of commercially pure titanium Grade 4. In contrast to the RSX implant family, the RS implant family has a 0.5 mm machined neck region. BEGO Semados® RS/RSX implants are marketed together with cover screws and insertion posts.

The healing posts are sterile packaged Titanium Grade 5 dental healing abutments that are available in two different sizes. Healing posts can be used either to shape the soft tissue after sub-merged healing of an implant (two-stage) or to keep the shape of the soft tissue after having placed the implant (one-stage).

The abutments are prefabricated prosthetic components made of Titanium Grade 5 directly connected to BEGO Semados® implants with Platform Switch design such as BEGO Semados® RS/RSX implants. They are delivered non-sterile but have to be sterilized by the end-user. They serve as an aid in temporary (provisional) and permanent prosthetic rehabilitation. The abutments are used for single or multiple tooth restorations. There are two types of abutments regarding the duration of use: provisional abutments intended for a limited period of ≤ six months and permanent abutments. The abutments are marketed with the compatible prosthesis and a technician screw.

The MultiPlus system consists of the PS MultiPlus abutments, the MultiPlus Titanium abutment, the MultiPlus Healing posts, the MULTI PLUS UNIVERSAL component and various supporting tools. The MultiPlus system is intended for occlusal screw-retained bridge, full dentures and bar constructions in the mandible and maxilla.

The Easy-Con system consists of the PS Easy-Con abutment and the Easy-Con laboratory set. The Easy-Con system is used to retain full supported dentures in the mandible or maxilla on two to four implants.

The provided document is a 510(k) Premarket Notification for the BEGO Semados® RS/RSX Implant System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the safety and effectiveness of a novel device through extensive clinical trials with pre-defined acceptance criteria.

Therefore, the document does not contain the kind of information requested in your prompt (e.g., acceptance criteria for an AI/ML model's performance, sample sizes for test sets, expert ground truth establishment, MRMC studies, or training set details). The "performance data" section (Section 11) refers to non-clinical testing of the physical implant system, such as biocompatibility, mechanical properties (fatigue, corrosion), and sterilization, typical for traditional medical devices. Section 12 explicitly states that "no human clinical testing was required."

This submission is about demonstrating that a new dental implant system is as safe and effective as existing, legally marketed implant systems, based on similar technology, materials, and non-clinical performance characteristics. It is not an AI/ML device submission.

Thus, I cannot extract the requested information as it is not present in the provided text.

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