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The THERMAPREP® PLUS OVEN is specially developed for heating ThermaFil® endodontic obturators. Do not use the oven for any other purpose.

The THERMAPREP® PLUS OVEN is a heating unit for obturators. The system allows for individual heating of ThermaFil® gutta percha obturators. Microwave technology is used to produce uniform predictable heating results.

This document is a 510(k) summary for a medical device called the "THERMAPREP® PLUS OVEN," which is a heating unit for endodontic obturators. It's a pre-market notification that demonstrates the device is substantially equivalent to a legally marketed predicate device.

Based on the provided text, here's an analysis of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: "Various sizes of ThermaFil® endodontic obturators" were tested. No specific number is provided.
• Data Provenance: The data appears to be prospective, as it describes experiments conducted with the new device and a predicate device. The country of origin is not specified, but the applicant (Tulsa Dental Products) is based in Tulsa, OK, USA, suggesting the study was likely conducted in the US.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• This information is not provided in the document. The testing appears to be performance-based (heating times, uniformity) rather than dependent on expert interpretation of results.

4. Adjudication Method for the Test Set

• This information is not applicable/provided. The evaluation seems to be based on objective performance metrics (heating times, uniformity) rather than subjective expert adjudication. As such, there is no mention of 2+1, 3+1, or other adjudication methods.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

• No, an MRMC comparative effectiveness study was not conducted. This device is a heating oven, not an imaging or diagnostic AI tool that would typically involve human readers. The comparison was between the new device and a predicate device's performance characteristics.

6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) was Done

• Yes, in a sense, a "standalone" study of the device's performance was done. The document describes testing the THERMAPREP® PLUS OVEN independently and in comparison to the predicate device to evaluate its heating capabilities and efficiency. "Algorithm only" is not relevant here as it's a physical device, not a software algorithm.

7. The Type of Ground Truth Used

• The ground truth appears to be based on objective performance measurements related to heating – specifically, heating times and the ability to achieve uniform and predictable heating of obturators. There's no mention of expert consensus, pathology, or outcomes data as "ground truth" in the traditional sense for diagnostic tools.

8. The Sample Size for the Training Set

• This information is not provided and is not applicable. This device is a physical heating appliance, not a machine learning model that requires a "training set."

9. How the Ground Truth for the Training Set was Established

• This information is not provided and is not applicable. As mentioned above, there is no training set for this type of device.

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Indicated clinical applications include use as repair of pulpal exposures.

Mineral Trioxide Aggregate (MTA) is a cement-like substance which seals off all pathways of communication between the root canal system and the external surface of the tooth. Indicated clinical applications include use as repair of pulpal exposures. The powder consists of fine hydrophilic particles which set in the presence of moisture. Hydration of the powder results in a colloidal gel which solidifies to a hard structure.

Mineral Trioxide Aggregate is biocompatible, and exhibits significantly better adaptation to dentinal walls than other materials. It possesses a high degree of sealability; the presence or absence of blood does not affect its sealing ability. Setting time after hydration and application is approximately three hours. In tests, its compressive strength at 21 days is about 70 Mpa. Use of MTA requires only the appropriate hydration of the powder to a viscous consistency. The mixture can then be placed over the exposure site and gently patted into place using a moistened cotton ball if necessary.

This document provides a summary for a 510(k) submission for a medical device, Mineral Trioxide Aggregate (MTA), a dental cement. It does NOT contain the details of an acceptance criteria study as typically understood in the context of an AI/ML or diagnostic device.

The information provided describes the device, its intended use, and states that it is substantially equivalent to other devices on the market. It highlights some performance characteristics like setting time and compressive strength, but these are descriptive properties of the material, not acceptance criteria from a formal study proving clinical effectiveness or diagnostic accuracy.

Therefore, most of the requested information cannot be extracted from this text. Here's a breakdown of what can and cannot be answered:

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

Missing Information/Not Applicable:
The document does not define specific, quantifiable acceptance criteria for clinical outcomes (e.g., success rate of pulpal exposure repair) or diagnostic performance (e.g., sensitivity, specificity, AUC), nor does it present data from a formal clinical study designed to meet such criteria. The "performance" values described are material properties from laboratory tests.

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

• Not provided. This document is a summary for a 510(k) submission, not a detailed study report. The "tests" mentioned (e.g., for compressive strength) are likely laboratory material tests, not clinical trials with a test set of patients.

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 "test set" of patient data in the sense of a diagnostic or AI study mentioned. Ground truth as typically defined for such studies is not relevant here.

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

• Not applicable. See point 3.

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/ML-driven diagnostic or assistive device for human readers.

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

• Not applicable. This is not an algorithm.

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

• Not applicable. The "ground truth" for a dental cement would be its measured physical and biological properties in laboratory and potentially animal studies, and then clinical outcomes in human trials. This document reports some physical properties ("compressive strength") from "tests" (implying lab measurements), but doesn't detail clinical ground truth or how it was established.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an AI/ML device.

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

• Not applicable. See point 8.

In summary, this document fulfills the requirements of a 510(k) summary for a traditional medical device by describing its properties and claiming substantial equivalence. It does not provide the kind of detailed study information (especially concerning acceptance criteria for diagnostic performance, sample sizes, expert ground truth, or AI/ML study design) that would be expected for a submission involving software or AI.

Ask a specific question about this device

Ask a specific question about this device