Search Results

Pharmaéthyl® Local pulp and vitality testing agent is indicated as topical pulp and tooth vitality testing agent.

Not Found

The provided text is a 510(k) clearance letter from the FDA for the device "Pharmaethyl Local Pulp and Vitality Testing Agent" and its Indications for Use statement. However, it does not contain any information about acceptance criteria, device performance, study details (sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance), or training set information.

This document is a regulatory approval, stating that the device is substantially equivalent to a predicate device, and does not include the technical study report that would contain the requested information.

Therefore, I cannot provide the requested table and study details based on the input text.

Ask a specific question about this device

Ask a specific question about this device

Quickset™ is a quick-setting temporary restorative material.

Quickset™ Liquid and Powder

I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study proving that the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a device called "Quickset™ Liquid and Powder," which is a quick-setting temporary restorative material.

The letter states that the FDA has reviewed the 510(k) notification and determined the device to be substantially equivalent to devices marketed prior to May 28, 1976. However, it does not provide details about:

• A table of acceptance criteria and reported device performance.
• Sample sizes or data provenance for any test sets.
• The number or qualifications of experts used to establish ground truth.
• Adjudication methods.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done.
• Whether a standalone (algorithm only) performance study was done.
• The type of ground truth used.
• The sample size for the training set.
• How the ground truth for the training set was established.

This document is a regulatory clearance and not a scientific study report.

Ask a specific question about this device

SECURALLOY ™ is a dental amalgam for use in the obturation of the cavities of posterior teeth and building of false stumps.

Not Found

The provided document is a 510(k) clearance letter from the FDA for a dental amalgam device called SECURALLOY™. This document primarily concerns the regulatory approval of the device based on its substantial equivalence to a legally marketed predicate device.

This document DOES NOT contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or multi-reader multi-case studies.

Therefore, I cannot provide the requested information based solely on this document. The letter only confirms that the FDA has reviewed the 510(k) notification and determined the device is substantially equivalent for its stated Indications For Use. The details about the studies conducted to demonstrate this equivalence would typically be found in the original 510(k) submission, not in the clearance letter itself.

Ask a specific question about this device

Softening and removal of root canal fillings

Not Found

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a device called "ENDOSOLV E." This document primarily addresses the regulatory approval of the device and confirms its substantial equivalence to a predicate device.

It does not contain any information regarding specific acceptance criteria, study details, performance metrics, sample sizes, expert qualifications, or ground truth establishment. The document is a regulatory communication, not a performance study report.

Therefore, I cannot fulfill your request for the information outlined in the prompt based on the provided text.

Ask a specific question about this device