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SICmax onepiece implants are intended for use during dental implantation and oromaxillofacial surgery in the bone of the upper and/or lower jaw arches. They provide support for prosthetics, such as artificial teeth, bars or bridges which restore the patient's chewing function. SICmax onepiece Implants are indicated for replacing maxillary lateral incisors and mandibular central and lateral incisors. Splinting with several implants or the residual dentition is possible. SICmax onepiece implants are also indicated for immediate loading when adequate primary stability is achieved and with appropriate occlusal loading.

SICace Implants are intended for use during dental implantation and oromaxillofacial surgery in the bone of the upper and/or lower jaw arches. They provide support for prosthetics, such as artificial teeth, bars or bridges which restore the patient's chewing function. SICace Implants are indicated for immediate loading when adequate primary stability is achieved and with appropriate occlusal loading.

• Only applicable for SICace implants with Ø 3.4 mm: Use without splinting is permissible in the anterior and premolar region. In the molar region, they must be used in rigid combination with other implants. In all cases, they may only be where loads are not extreme.

SICmax Implants are intended for use during dental implantation and oromaxillofacial surgery in the bone of the upper and/or lower jaw arches. They provide support for prosthetics, such as artificial teeth, bars or the patient's chewing function. SICmax Implants are indicated for immediate loading when adequate primary stability is achieved and with appropriate occlusal loading.

• Only applicable for SICmax implants with Ø 3.7 mm: Use without splinting is permissible in the anterior and premolar region. In the molar region, they must be used in rigid combination with other implants. In all cases, they may only be where loads are not extreme.

SIC vantage max Implants are intended for use during dental implantation and oromaxillofacial surgery in the bone of the upper and/or lower jaw arches. They provide support for prosthetics, such as artificial teeth, bars or bridges which restore the patient's chewing function. SICyantage max Implants are indicated for immediate loading when adequate primary stability is achieved and with appropriate occlusal loading.

• Only applicable for SIC vantage max implants with Ø 3.0 mm: Use without splinting is permissible in the anterior region for replacement of maxillary lateral incisors and mandibular incisors. In the premolar and molar region, they must be used in rigid combination with other implants. In all cases, they may only be where loads are not extreme.

SIC Prosthetic Components are intended for use with SIC Dental Implants for prosthetic restorations from single tooth replacements to full arch restorations with fixed or removable superstructures. SIC Prosthetic Components with a post height less than 4 mm are intended for multi-unit loaded restorations only.

SICmax onepiece implants are intended for use during dental implantation and oromaxillofacial surgery in the bone of the upper and/or lower jaw arches. They provide support for prosthetics, such as artificial teeth, bars or bridges which restore the patient's chewing function. SICmax onepiece Implants are indicated for replacing maxillary lateral incisors and mandibular central and lateral incisors. Splinting with several implants or the residual dentition is possible. SICmax onepiece implants are also indicated for immediate loading when adequate primary stability is achieved and with appropriate occlusal loading.

SICace Implants are intended for use during dental implantation and oromaxillofacial surgery in the bone of the upper and/or lower jaw arches. They provide support for prosthetics, such as artificial teeth, bars or bridges which restore the patient's chewing function. SICace Implants are indicated for immediate loading when adequate primary stability is achieved and with appropriate occlusal loading.

• Only applicable for SICace implants with Ø 3.4 mm: Use without splinting is permissible in the anterior and premolar region. In the molar region, they must be used in rigid combination with other implants. In all cases, they may only be where loads are not extreme.

SICmax Implants are intended for use during dental implantation and oromaxillofacial surgery in the bone of the upper and/or lower jaw arches. They provide support for prosthetics, such as artificial teeth, bars or the patient's chewing function. SICmax Implants are indicated for immediate loading when adequate primary stability is achieved and with appropriate occlusal loading.

• Only applicable for SICmax implants with Ø 3.7 mm: Use without splinting is permissible in the anterior and premolar region. In the molar region, they must be used in rigid combination with other implants. In all cases, they may only be where loads are not extreme.

SIC vantage max Implants are intended for use during dental implantation and oromaxillofacial surgery in the bone of the upper and/or lower jaw arches. They provide support for prosthetics, such as artificial teeth, bars or bridges which restore the patient's chewing function. SICyantage max Implants are indicated for immediate loading when adequate primary stability is achieved and with appropriate occlusal loading.

• Only applicable for SIC vantage max implants with Ø 3.0 mm: Use without splinting is permissible in the anterior region for replacement of maxillary lateral incisors and mandibular incisors. In the premolar and molar region, they must be used in rigid combination with other implants. In all cases, they may only be where loads are not extreme.

SIC Prosthetic Components are intended for use with SIC Dental Implants for prosthetic restorations from single tooth replacements to full arch restorations with fixed or removable superstructures. SIC Prosthetic Components with a post height less than 4 mm are intended for multi-unit loaded restorations only.

Based on the provided text, the document is a 510(k) premarket notification decision letter from the FDA to SIC invent AG regarding their Dental Implant Systems. It is a regulatory clearance document, not a study report or a technical performance evaluation for a device, especially an AI/ML powered one.

Therefore, none of the requested information regarding acceptance criteria, study details, sample size, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details can be found in this document.

The document primarily focuses on:

• Device Classification: Class II
• Product Codes: DZE (Endosseous Dental Implant), NHA (Endosseous Unthreaded Titanium Dental Implant)
• Regulation Number: 21 CFR 872.3640 (Endosseous Dental Implant)
• Substantial Equivalence: Concludes the device is substantially equivalent to legally marketed predicate devices.
• Indications for Use: Detailed descriptions for SICmax onepiece implants, SICace Implants, SICmax Implants, SIC vantage max Implants, and SIC Prosthetic Components. These indications specify the types of implants, their intended use in the jaw, support for prosthetics, and conditions for immediate loading or splinting.

To answer your request, a different type of document, such as a clinical study report, a bench test report, or a detailed device design specification, would be needed. This 510(k) clearance letter does not contain the technical performance study details you are asking about, as it is a summary of the FDA's regulatory decision based on submitted data, rather than the data itself.

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