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SNUCONE Tissue Level Implant System is inticated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations and terminal or internediate Abutment support for fixed bridge work. Snucone implant 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.

SNUCONE Implant System Fixture, also known as an endosseous implant, is surgical component that interfaces with the bone of the jaw or skull to support a dental prosthesis such as a crown, bridge, denture. Snucone's abutment and prosthetic components and tools are compatible with the Snucone's fixture only. The system includes Fixtures and Cover Screw, and Abutment and Component (Solid Abutment, InOcta Closing Screw, InOcta Healing Abutment, InOcta Abutment, InOcta Angled Abutment, InOcta Temporary Abutment, Platform Switching Abutment, and Abutment Screw).

The provided text is a 510(k) premarket notification for a medical device (SNUCONE Tissue Level Implant System). It contains details about the device, its intended use, comparison to predicate devices, and a list of non-clinical tests performed. However, it does not contain information about acceptance criteria or a study that proves the device meets those criteria, especially in the context of an FDA clearance for an AI/ML-driven device.

The document explicitly states: "Bench tests were conducted to verify that the subject device met all design specifications as was Substantially Equivalent (SE) to the predicate device." It details mechanical performance, sterilization, shelf-life, packaging, MR environment conditions, bacterial endotoxin, and biocompatibility.

THERE IS NO MENTION OF AN AI/ML COMPONENT IN THIS DEVICE.

Therefore, I cannot fulfill your request for information regarding:

1. A table of acceptance criteria and the reported device performance for an AI/ML component. The document describes acceptance criteria for mechanical, material, and sterilization properties, but not AI/ML performance metrics (e.g., sensitivity, specificity, AUC).
2. Sample size for test set and data provenance specific to an AI/ML model. The tests mentioned are laboratory bench tests, not data-driven performance studies on patient cohorts for an AI model.
3. Number of experts and their qualifications for ground truth establishment. This is not relevant to the non-clinical tests described.
4. Adjudication method for the test set. Not relevant.
5. MRMC comparative effectiveness study or human reader improvement. Not relevant.
6. Standalone (algorithm only) performance. Not relevant.
7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.). Not relevant to the tests performed.
8. Sample size for the training set. Not relevant, as no AI model is described.
9. How ground truth for the training set was established. Not relevant, as no AI model is described.

In summary, the provided document is a 510(k) submission for a physical dental implant system and does not involve any AI/ML components or related performance studies.

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