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SNUCONE Bone Level Implant System is indicated 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 intermediate Abutment support for fixed bridge work. SNUCONE Bone Level 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 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.

This document describes the SNUCONE Bone Level Implant System, a dental implant system. The information provided outlines the device, its components, and a comparison to predicate devices for substantial equivalence. It does not contain information about a study proving the device meets specific acceptance criteria in the way a clinical performance study would. Instead, it focuses on bench testing and adherence to recognized standards.

Here's an analysis of the provided text in relation to your request:

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

The document details various non-clinical tests and the standards they adhere to. However, it does not provide a table with specific quantitative acceptance criteria for each test and the numerical reported performance of the device against those criteria. It generally states that "The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the predicate device."

Here's a summary of the tests and the general statement of performance:

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

• Sample Size for Test Set: The document does not specify the exact sample sizes used for each of the non-clinical bench tests (e.g., number of implants tested for fatigue). It refers to standards like ISO 14801 which would dictate sample sizes, but the numerical value is not explicitly stated.
• Data Provenance (Country of Origin, Retrospective/Prospective): The document does not provide details on the country of origin of the data or whether the data was retrospective or prospective. Given that these are non-clinical bench tests, the concept of "retrospective" or "prospective" as applied to clinical studies is not directly applicable.

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)

This information is not applicable to the provided document. The document describes non-clinical bench testing of a dental implant system, not a diagnostic device requiring expert interpretation for ground truth establishment. The "ground truth" here refers to the physical and chemical properties and performance characteristics determined by the test methods outlined in the specified standards.

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

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human readers or expert consensus, which is not the nature of the tests described in this document. The results of the mechanical, sterilization, MRI, endotoxin, and biocompatibility tests are determined by adherence to established, objective engineering and scientific standards.

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

This information is not applicable. This document describes a dental implant system, not an AI-powered diagnostic device, so an MRMC comparative effectiveness study involving human readers and AI assistance would not be relevant.

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

This information is not applicable. The device is a physical dental implant system, not a software algorithm.

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

The "ground truth" for the non-clinical tests described is defined by the objective, measurable criteria within the referenced international and national standards (e.g., ISO 14801, ISO 17665, ASTM F1980, ANSI/AAMI ST72, ISO 10993). For example:

• Fatigue testing: The "ground truth" is whether the implant withstands a specified number of cycles at a certain load without failure, as defined by ISO 14801.
• Sterilization validation: The "ground truth" is achieving the required sterility assurance level (SAL), as defined by ISO 11737.
• Biocompatibility: The "ground truth" is that the material does not elicit adverse biological responses, as assessed by the tests specified in ISO 10993.

8. The sample size for the training set

This information is not applicable. There is no "training set" in the context of non-clinical bench testing for a physical medical device. Training sets are relevant for machine learning algorithms.

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

This information is not applicable as there is no training set for the reasons stated above.

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