Search Results

Straumann® Variobase™ prosthetic components directly connected to the endosseous dental implants are indicated for use as an aid in prosthetic rehabilitations. The prosthetic restoration (bridge or over-denture) can be cemented on the Straumann® Variobase™ prosthetic components. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and form the soft tissue during the healing phase. They may not be placed into occlusion. Final abutments and restorations may be placed into occlusion when the implant is fully osseointegrated.

Straumann® Variobase® abutments are intended to be placed into Straumann dental implants to provide support for prosthetic reconstructions such as bridges and over-dentures.

The Straumann Variobase Abutments for Bars & Bridges are non-engaging abutments made from Ti-6Al-7Nb (TAN) that support a bridge or bar reconstruction (framework or full contour) on two or more dental implants. The corresponding basal screw is delivered with the abutment for connecting the abutment to the implant. A dental laboratory technician designs and manufactures the bridge/bar reconstruction via their preferred workflow using traditional or CAD/CAM methods.

The provided text is a 510(k) Summary for the Straumann® Variobase® Abutment for Bridges/Bars. It outlines the characteristics of the device and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a specific study proving the device meets those criteria in the typical sense of a diagnostic or clinical performance study.

Instead, the "study" referred to is a bench study focused on mechanical performance and material characteristics to demonstrate substantial equivalence to legally marketed predicate devices, rather than a clinical study evaluating diagnostic accuracy or effectiveness.

Here's a breakdown of the requested information based on the provided text, highlighting what is available and what is not:

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

The document doesn't present explicit "acceptance criteria" in a quantitative, pass/fail table for clinical performance. Instead, it discusses "equivalence" based on various features and a dynamic fatigue test.

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

The document primarily relies on bench testing for dynamic fatigue. It doesn't specify a sample size for this testing other than "data have been referenced." No information is provided about data provenance ( країни of origin or retrospective/prospective nature) as it's not a clinical data 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)

This information is not applicable here because the "test set" refers to physical samples for mechanical testing (dynamic fatigue), not a dataset for a diagnostic algorithm where expert ground truth would be established.

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

This information is not applicable. Adjudication methods are typically used for establishing ground truth in clinical or image-based studies, not for mechanical bench testing.

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 is not applicable. The device is an endosseous dental implant abutment, a physical component, not an AI or diagnostic tool. Therefore, MRMC studies and AI assistance comparisons are irrelevant.

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

This is not applicable as the device is a physical medical device, not a software algorithm.

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

The "ground truth" in this context is the mechanical performance standards (e.g., ISO 14801 for dynamic fatigue) and the material properties of the device, which are evaluated through bench testing. There is no biological or diagnostic "ground truth" from human subjects involved in this 510(k) submission for mechanical equivalence.

8. The sample size for the training set

This is not applicable. There is no "training set" as this is not a machine learning or AI-based device.

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

This is not applicable for the same reason as point 8.

Ask a specific question about this device

Medentika abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.

Medentika Abutment System is an abutment system including ten abutment designs compatible with eleven currently marketed implant systems. The abutment designs include abutments for single-tooth and multiple-tooth restoration for supporting cement-retained, screw-retained or overdenture prostheses. Platform diameters range from 3.3 mm to 7.0 mm. Corresponding implant diameters range from 3.25 mm to 7.0 mm. Angled abutment designs for connections with anti-rotational features are available in two orientations, Type 1 and Type 2. Type 1 is for abutments with the cone angle oriented toward the flat of the anti-rotational feature and Type 2 is for abutments with the cone angle oriented toward the corner or lobe of the anti-rotational feature. The maximum angle for any abutment within the eleven systems is 21 °

The provided text is a 510(k) summary for the Medentika Abutment System, a medical device. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

The context of this type of document is a regulatory submission, not a study evaluating AI performance or a diagnostic device. Therefore, the questions related to AI, ground truth establishment, expert consensus, sample sizes for AI training/testing, adjudication methods, and MRMC studies are not applicable to the information contained in this document. The document describes a "substantial equivalence" claim for a physical medical device (dental abutments), meaning it demonstrates the device is as safe and effective as a legally marketed device.

Here's the information that can be extracted or inferred based on the provided text, with responses to your questions where applicable and an explanation when not applicable:

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

The document does not explicitly state "acceptance criteria" in the traditional sense of a performance study with defined thresholds. Instead, it refers to regulatory compliance and equivalence to predicate devices. The "reported device performance" is demonstrated through various non-clinical tests designed to show the physical and mechanical properties are comparable to existing, legally marketed devices.

2. Sample sized 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 refers to "non-clinical testing data" for sterilization, biocompatibility, engineering, dimensional, and static/dynamic compression-bending tests. These types of tests typically involve a sample of units for each test, but the specific number of units is not detailed in this summary. The data provenance is also not specified, though the manufacturer (Medentika GmbH) is based in Germany. The tests are prospective in nature, as they involve testing the actual device components.

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 question is not applicable. This document describes a medical device approval based on physical properties and comparison to predicate devices, not an AI or diagnostic study requiring expert ground truth for a test set.

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

This question is not applicable. There is no "test set" in the context of expert review or diagnostic assessment for this type of device approval.

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 question is not applicable. This is a physical medical device (dental abutment), not an AI-assisted diagnostic or imaging system.

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

This question is not applicable. This is a physical medical device, not an algorithm.

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

This question is not applicable in the context of expert-determined ground truth for a diagnostic task. For this device, the "ground truth" equivalent would be established by:

• Established ISO standards: For sterilization (ISO 17665-1, ISO 17665-2), biocompatibility (ISO 10993-5), and mechanical fatigue (ISO 14801). Compliance with these standards is considered the "truth" for safety and performance in their respective domains.
• Performance of predicate devices: The "truth" is that the predicate devices are legally marketed and considered safe and effective. The subject device demonstrates comparable performance to these established devices.

8. The sample size for the training set

This question is not applicable. This document describes the approval of a physical medical device, not an AI algorithm requiring a training set.

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

This question is not applicable. There is no "training set" in the context of AI for this device approval.

Ask a specific question about this device