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Biodenta bone level dental implants are intended for surgical placement in mandibles or maxillae to support single or multiple tooth restorations or intermediate abutment support for fixed or removable bridgework and to retain overdentures.

The Biodenta Dental Implant System - Bone Level is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, abutments and prosthetic parts and related surgical instruments.

The provided text describes a 510(k) premarket notification for the Biodenta Dental Implant System - Bone Level. This document primarily focuses on demonstrating substantial equivalence to predicate devices and includes non-clinical testing data (fatigue testing). It does NOT describe an AI/ML powered medical device, nor does it contain information regarding acceptance criteria or a study that typically involves these concepts for AI/ML devices.

Therefore, the requested information cannot be extracted from the provided text as it pertains to a traditional medical device (dental implant) that does not utilize AI/ML.

Here's why each point cannot be addressed:

1. A table of acceptance criteria and the reported device performance: Not applicable. The document discusses "sufficient mechanical strength" based on fatigue testing, but there are no specific numerical acceptance criteria or performance metrics in a table format that would typically be associated with AI/ML device evaluations (e.g., sensitivity, specificity thresholds).
2. Sample sized used for the test set and the data provenance: Not applicable. The "test set" here refers to physical dental implants used in fatigue testing, not a dataset for an AI model. The document mentions "worst case scenario" for the implants but no sample size for a test set in the context of AI.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of AI/ML, refers to labels or diagnoses provided by experts on a dataset. This is irrelevant for a physical dental implant.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are used to resolve disagreements among experts on ground truth for AI datasets. This is not mentioned as the device is not AI-powered.
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: Not applicable. MRMC studies are specific to evaluating AI's impact on human performance in diagnostic tasks. This device is an implant, not a diagnostic tool assisted by AI.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This refers to the performance of an AI algorithm on its own. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. Ground truth for AI is not relevant here. The "proof" for this device lies in its physical properties and mechanical strength demonstrated through non-clinical testing.
8. The sample size for the training set: Not applicable. This device does not involve a training set for an AI model.
9. How the ground truth for the training set was established: Not applicable. This device does not involve a training set for an AI model.

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