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For use as an endosseous dental implant in the upper or lower jaw arches to provide support for prosthetic devices.

The modified Hybrid Endopore Implant also are identical to the predicates, except for the addition of three selftapping threads in the coronal region of the implant. The dimensions of the modified Hybrid Endopore Implant, 9.5 mm and 11 mm in length x 4.0 mm diameter; and 7.5 mm and 9.5 mm in length x 5.0 mm diameter, are very similar to the dimensions of previously cleared Endopore implants.

The provided text describes a 510(k) premarket notification for a dental implant system. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing extensive performance data or clinical study results in the manner requested.

Therefore, much of the information asked for, particularly regarding acceptance criteria, specific study design, sample sizes, ground truth establishment, and expert involvement, is not available in this submission. This document is a regulatory filing, not a detailed scientific report of a clinical trial.

However, based on the information provided, here's what can be inferred:

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

• Acceptance Criteria: Not explicitly stated in terms of performance metrics. The implicit acceptance criterion for a 510(k) is "substantial equivalence" to a predicate device.
• Reported Device Performance: Not provided empirically. The document states that the "minor modification to the surface of the Endopore Implant does not alter its indications for use or its fundamental scientific technology." This is the core "performance" claim in a 510(k) for a modified device – that its performance is equivalent to the predicate.

2. Sample size used for the test set and the data provenance

• Sample size: Not applicable/not provided. This 510(k) submission does not detail a study involving a test set of data. It relies on the substantial equivalence to previously cleared devices.
• Data provenance: Not applicable/not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of experts: Not applicable/not provided. No test set requiring expert ground truth is described.
• Qualifications of experts: Not applicable/not provided.

4. Adjudication method for the test set

• Adjudication method: Not applicable/not provided. No test set requiring adjudication is described.

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

• MRMC study: No. This device is a dental implant, not an AI-powered diagnostic tool. Such a study would not be relevant.
• Effect size: Not applicable.

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

• Standalone performance: No. This device is a physical dental implant, not an algorithm.

7. The type of ground truth used

• Type of ground truth: Not applicable/not provided. No ground truth is established in this filing; it's a comparison to predicate devices and their known clinical performance.

8. The sample size for the training set

• Sample size: Not applicable/not provided. This submission is about a physical medical device, not a machine learning algorithm that requires a training set.

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

• How ground truth was established: Not applicable/not provided for the reasons stated above.

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