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MINICONE are dental implants that are intended for the stabilization of removable dentures.

MINICONE Implants ø2.6 mm are suitable for oral endosteal implantation in the upper and lower jaw of fully or partially edentulous patients. The implants can be placed with immediate function when good primary stability is achieved. Furthermore, they are to be used in combination with the corresponding prosthetic Optiloc® matrix system and individual new or existing Optiloc® compatible overdentures or partial dentures.

For mandibular restorations, at least 4 MINICONE Implants should be placed.

For maxillary restorations, at least 6 MINICONE Implants should be placed.

MINICONE consists of 2 MINICONE tapered implants with an external diameter of 2.6 mm and lengths of 10 and 12 mm, as well as related accessories.

The implants are manufactured utilizing Titanium Grade 5 ELI material (Ti-4Al-6V) and are finished with a roughened surface (sandblasted/acid etched). The implant neck is machined, and the attachment element of the implants is acting as a retention feature for dentures. This retention feature is coated using a Titanium Nitride (TiN) to obtain a more wear resistant surface and has the Optiloc® geometry which is connected to the denture.

MINICONE Implants Ø2.6mm are suitable for oral endosteal implantation in the upper and lower jaw of fully or partially edentulous patients.

The implants can be placed with immediate function when good primary stability is achieved. The MINICONE implants are intended for the stabilization of removable dentures. The removable dentures are connected to the MINICONE implants through the incorporated Optiloc® attachment element.

The provided document is a 510(k) summary for the MINICONE Implant, a dental device. It does not contain information about a study proving the device meets acceptance criteria related to AI/algorithm performance. The information provided is for a traditional medical device, specifically an endosseous dental implant, and focuses on performance testing for mechanical properties and sterilization.

Therefore, many of the requested categories for AI/algorithm-related studies cannot be answered from the provided text.

Here's a breakdown of the information that can be extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is not provided in the document. The document describes the types of engineering and mechanical tests performed (insertion torque, wear, fatigue), but does not specify sample sizes for these tests, nor the "data provenance" in the context of clinical/imaging data as typically asked for AI studies.

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 as the document describes performance testing for a physical medical device (dental implant), not an AI algorithm that requires expert ground truth for interpretation of images or other data.

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

This information is not applicable as the document describes performance testing for a physical medical device, not an AI algorithm requiring adjudication of interpretations.

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 as the document describes performance testing for a physical medical device, not an AI algorithm that would be used in conjunction with human readers.

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

This information is not applicable as the document describes performance testing for a physical medical device, not an AI algorithm.

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

This information is not applicable in the context of AI studies. For the engineering tests performed:

• Insertion Torque, Wear, Fatigue: Ground truth is established by measured physical properties against established industry standards (e.g., ISO 14801) and comparison to predicate devices, rather than expert consensus on interpretations of data.
• Biocompatibility: Ground truth is based on the known, previously cleared status of the materials (Titanium Grade 5 ELI and TiN coating).
• Sterilization: Ground truth is established by validated processes against microbiological standards (SAL of 10-6 according to ISO 11137-1 and -2).
• Shelf Life: Ground truth is established by accelerated aging tests projecting real-time performance.

8. The sample size for the training set

This information is not applicable as the document describes performance testing for a physical medical device, not an AI algorithm that requires a training set.

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

This information is not applicable as the document describes performance testing for a physical medical device, not an AI algorithm that requires a training set with ground truth.

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