Search Results

Temp F is indicated for the following applications: Temp F is a paste for consumer application to temporarily repair teeth with cavities and lost fillings and inlays.

Temp F is a paste

This is an FDA 510(k) clearance letter for a dental cement called "Temp F". The document states that the device is "substantially equivalent" to legally marketed predicate devices. However, this type of document does not contain the detailed study information or acceptance criteria typically found in a clinical study report or a premarket approval (PMA) application.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, ground truth establishment, or study designs (MRMC, standalone) based solely on the provided text. The 510(k) pathway for medical device clearance primarily focuses on demonstrating substantial equivalence to a predicate device, rather than requiring extensive clinical trials with pre-defined acceptance criteria and detailed performance reporting as would be expected for novel or higher-risk devices.

Here's what I can extract and what I cannot, based on the provided text:

Information I CAN provide:

• Trade/Device Name: Temp F
• Regulation Number: 872.3275
• Regulation Name: Dental Cement
• Regulatory Class: II
• Product Code: EMA
• Indications for Use: Temp F is a paste for consumer application to temporarily repair teeth with cavities and lost fillings and inlays.
• 510(k) Number: K040343
• Use Type: Over-The-Counter Use (X marked)

Information I CANNOT provide from the given document:

1. A table of acceptance criteria and the reported device performance: This document confirms substantial equivalence but does not detail specific performance metrics, acceptance criteria, or a table comparing them to reported results.
2. Sample sizes used for the test set and the data provenance: Not mentioned in this clearance letter.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or mentioned as this is not a study report.
4. Adjudication method for the test set: Not applicable or mentioned.
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 cement, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable or mentioned in this type of document.
8. The sample size for the training set: Not applicable or mentioned.
9. How the ground truth for the training set was established: Not applicable or mentioned.

To obtain the detailed study information, acceptance criteria, and performance data, one would typically need to review the full 510(k) submission summary (if available publicly) or the actual studies referenced within the submission, which are not part of this clearance letter.

Ask a specific question about this device