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The SIC pro System Dental Implant is a root form endosseous dental implant system that is indicated to be implanted in the upper and/or lower jaw arches. The implants may be used in combination with various SIC pro System Abutments for single or multiple unit prosthetic attachment to restore a patient's chewing function.

Patient's must be applicable for dental treatment with endosseous implants. In cases where the ridge is too narrow to recieve a 4.2mm or 5.3mm diameter implant, the 3.3mm implant can be used. Under such conditions, we highly recommend the placement of additional fixtures to share the occlusal load of the prosthetic restoration. The SIC pro System Abutment is intended to be placed into the SIC pro System Implant to provide a safe and effective fit of screw retained and/or cementable crowns and bridges.

SIC pro System solid screw dental implants are root-form endosseous dental implant devices ono of of grade 4 titanium according ASTM F 67. The implants are available in three different diameters (ø3.3 mm, ø4.2 mm, ø5.3 mm) and various length from 7.5 mm up to 16 mm. All ø3.3 mm diameter implants are cylindrical as well as the implants in diameter ø4.2 mm and ø5.3 mm in length of 7.5mm. All other implants in diameter ø4.2 mm and ø5.3 mm are partly tapered. The rength of 7.3mm. All other implants in acid etched for faster osseointegration and secondary stability.

The face side of the implant has a hexagon drill hole and a standard screw thread to ensure a The face side of the implant not a noxagon and the implant. Throughout the implant. Throughout the different diameters the hexagon drill hole has identical measurements.

SIC pro System Implants are delivered single packed in combination with a implant cover screw and supplied in sterile condition (sterilized by gamma-radiation).

SIC pro System Abutments & Accessories are various in shape, length and diameters and made out of three different materials (titanium grade 5, implant steel 316L, zirconium oxide). Through a hexagon socket and a vertical drill hole, the abutments can be connected with the implant secure and anti-rotational.

SIC pro System Abutments & Accessories are supplied single packed in non-sterile condition. These parts of the system are intended to be sterilized by the user by and have been validated by These parts of the system are intoneed steam (autoclave) sterilization process (15 min., 136°C, 3 bar).

This K040757 submission describes a dental implant system. The document is a 510(k) summary and subsequent FDA clearance letter, which means rather than a study with acceptance criteria and device performance as one might find for a novel device, it asserts substantial equivalence to predicate devices already on the market. Therefore, the information you're looking for will not be presented in the typical format of a new device study.

Here's an interpretation based on the provided document:

1. A table of acceptance criteria and the reported device performance

Since this is a substantial equivalence submission, direct "acceptance criteria" for performance are not explicitly stated in the document in the way they would be for a de novo device. Instead, the "acceptance criteria" are implicitly met by demonstrating that the SIC pro System Dental Implants, Abutments, and Accessories are equivalent to the existing legally marketed predicate devices. The reported "performance" is that the device is substantially equivalent.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document is a 510(k) summary for substantial equivalence. It does not describe a clinical study or a test set with a specific sample size. The "data" used for comparison would be technical specifications, material properties, and intended use as compared to the predicate devices. There is no mention of country of origin of "data" in the context of a study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. As this is a substantial equivalence claim based on comparison to predicate devices, there isn't a "test set" requiring expert ground truth establishment in the traditional sense of a clinical or performance study. The "experts" involved are presumably the engineers and regulatory specialists who compiled the technical comparison and the FDA reviewers who assessed the submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There was no test set requiring adjudication in this 510(k) submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a physical dental implant system, not an AI-powered diagnostic tool, and therefore an MRMC study comparing human readers with and without AI assistance is irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The "ground truth" for a substantial equivalence submission is the features, materials, and intended use of the legally marketed predicate devices. The applicant needs to demonstrate that their new device shares these fundamental characteristics with the predicates, and that any differences do not raise new questions of safety or effectiveness.

8. The sample size for the training set

Not applicable. No training set is mentioned or relevant for this type of submission.

9. How the ground truth for the training set was established

Not applicable. As there is no training set, there is no ground truth to establish for it in this document.

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