Search Results

• Temporary restoration of inlay and onlay preparations
• Temporary fillings and sealings

used for the temporary restoration of inlay and onlay preparations and all kind of temporary fillings. Spacer™ is easy to handle because it is not sticky. Spacer™ has high elasticity and without any debris in the cavity.

The provided text is a 510(k) summary for a dental temporary filling material called "Spacer™" by Vericom Co., Ltd. It focuses on regulatory approval based on substantial equivalence to a predicate device, rather than performance studies with acceptance criteria as typically found in AI/ML medical device submissions. Therefore, many of the requested categories cannot be directly extracted from this document.

Here's an analysis of the available information and what cannot be provided:

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

This document does not provide a table of acceptance criteria or specific performance metrics like sensitivity, specificity, accuracy, etc. It mentions properties like "easy to handle because it is not sticky" and "high elasticity and without any debris in the cavity," but these are descriptive statements, not quantified performance criteria with acceptance thresholds. The 510(k) summary is primarily focused on demonstrating substantial equivalence to a predicate device, not on presenting detailed performance study results against predefined acceptance criteria in the way an AI/ML device would.

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

No information about a test set, sample size, or data provenance is provided. This type of information is typically found in performance studies, which are not detailed in this 510(k) summary.

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):

Not applicable. There is no mention of a test set, ground truth establishment, or experts for this device in the provided document.

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

Not applicable. There is no mention of a test set or adjudication method.

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. This device is a dental material, not an AI-powered diagnostic tool, so an MRMC study comparing human readers with and without AI assistance is irrelevant.

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

Not applicable. This device is a dental material, not an algorithm.

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

Not applicable. No ground truth is established or discussed for this dental material.

8. The sample size for the training set:

Not applicable. There is no training set discussed for this dental material; it's a physical product.

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

Not applicable. There is no training set or ground truth established for it.

Ask a specific question about this device