(81 days)
Super Seal is a potassium oxalate based film forming acid resistant liner and desensitizer that is indicated for application prior to restoration of exposed dentin.
Super Seal is a potassium oxalate based film forming acid resistant liner and desensitizer.
This document is a 510(k) clearance letter from the FDA for a dental device called "Super Seal." It does not contain information about acceptance criteria or a study proving device performance in the way you've requested.
The letter states that the FDA has reviewed the 510(k) notification and determined the device to be "substantially equivalent" to legally marketed predicate devices. This means that the device is considered as safe and effective as a device already on the market, and therefore does not require extensive new clinical studies to prove its performance against specific acceptance criteria.
The "Indications For Use" section on page 3 describes what the Super Seal is intended for: "Super Seal is a potassium oxalate based film forming acid resistant liner and desensitizer that is indicated for application prior to restoration of exposed dentin."
To answer your specific questions, based only on the provided document:
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A table of acceptance criteria and the reported device performance
- Not Applicable: This document is a 510(k) clearance letter, not a study report. It does not contain specific acceptance criteria or performance data from a clinical trial or performance study. The clearance is based on substantial equivalence to a predicate device.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable: This document does not describe a test set or study data.
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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: This document does not describe a test set or ground truth establishment.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: This document does not describe a test set or adjudication.
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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 document is for a dental liner/desensitizer, not an AI-powered diagnostic device. No MRMC study is mentioned or relevant.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable: This device is a physical dental product, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable: This document does not describe a study that would require ground truth determination.
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The sample size for the training set
- Not Applicable: This document describes a 510(k) clearance based on substantial equivalence, not a machine learning model or a study with a training set.
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How the ground truth for the training set was established
- Not Applicable: As above, no training set or ground truth establishment is described.
In summary, the provided document is an FDA clearance letter for a medical device based on substantial equivalence. It is not a study report and therefore does not contain the detailed performance data, study design, or expert ground truth information you've requested. Such information would typically be found in a separate submission or study report if a novel device required extensive clinical data for approval.
§ 872.3250 Calcium hydroxide cavity liner.
(a)
Identification. A calcium hydroxide cavity liner is a device material intended to be applied to the interior of a prepared cavity before insertion of restorative material, such as amalgam, to protect the pulp of a tooth.(b)
Classification. Class II.