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The SQ IS System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. I IS System is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. Also, implants with diameters larger than 5mm are indicated for molar regions.

The SQ IS System is a dental implant system made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches. The system is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. IS System is made from pure titanium and the surface treatment is done with R.B.M.

I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that the device meets such criteria. The document is a 510(k) summary for a dental implant system (SQ IS System), detailing its description, indication for use, materials, and substantial equivalence to predicate devices. It also includes the FDA's clearance letter.

Therefore, I cannot fulfill your request to provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone performance results.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This type of information is typically found in design verification and validation reports, which are not part of this 510(k) summary.

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