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This product is a surgical device in the form of a temporary screw used as an aid in orthodontic movement procedures.

The Neodent Implant for Orthodontic Anchorage (Neodent Anchor) is a device that is temporarily implanted into the bone to provide a fixed anchorage point for various orthodontic tooth movements. The single-piece design features a self-drilling threaded shaft for bony fixation and a low profile head having a conical transmucosal segment and points for attachment of various appliances to facilitate orthodontic movement of teeth.

The provided text describes a 510(k) premarket notification for a medical device called "Neodent Implant for Orthodontic Anchorage." This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment is not available in the provided text. The document is primarily a regulatory submission for premarket clearance based on equivalence, not a report on a performance validation study.

Here's a breakdown of why the requested information cannot be extracted from the given text:

1. Acceptance Criteria and Reported Device Performance: The document does not specify quantitative acceptance criteria (e.g., success rates, complication rates, force limits) or report specific performance metrics for the Neodent Implant beyond stating its intended use and design characteristics. It focuses on the similarity to predicate devices.

2. Sample Size and Data Provenance: The document does not describe any clinical or pre-clinical study with a test set, sample size, or data provenance. The assessment is based on a comparison to existing, already cleared devices.

3. Number of Experts and Qualifications: There is no mention of experts being used to establish ground truth for a test set, as no such test set is described.

4. Adjudication Method: Not applicable, as there's no described test set requiring adjudication.

5. MRMC Comparative Effectiveness Study: Not applicable. This is a substantially equivalent claim for a physical device, not an AI or imaging device that would typically involve human reader performance studies.

6. Standalone Performance Study: Not applicable. The document does not present a standalone performance study. Its primary aim is to show equivalence.

7. Type of Ground Truth: Not applicable, as no external "ground truth" (like pathology or outcome data) is described for a performance evaluation study. The "ground truth" for the submission is the regulatory clearance of the predicate devices.

8. Sample Size for Training Set: Not applicable. As this is a physical medical device and not an AI/machine learning algorithm, there is no "training set."

9. Ground Truth for Training Set: Not applicable for the same reason as above.

In summary, the provided 510(k) summary is a regulatory submission demonstrating substantial equivalence to predicate devices, and therefore, it does not contain the detailed performance study information typically associated with establishing acceptance criteria and proving device performance in a clinical or pre-clinical trial.

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