(65 days)
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
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Effectiveness for intended use | Performance data demonstrates safety and effectiveness |
| Ability to heat ThermaFil® obturators | Successfully heats various sizes of ThermaFil® obturators |
| Uniform and predictable heating | Microwave technology used to produce uniform predictable heating results |
| Efficient heating compared to predicate device | Heating times for all sizes of obturators were greatly reduced compared to the predicate ThermaPrep® Oven (K910224) |
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.
§ 872.3850 Gutta percha.
(a)
Identification. Gutta percha is a device made from coagulated sap of certain tropical trees intended to fill the root canal of a tooth. The gutta percha is softened by heat and inserted into the root canal, where it hardens as it cools.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.