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The Obtura is intended for used by professionally qualified dentists, endodontists and dental clinicians to heat Gutta Percha and to place it into the previously prepared root canals of human teeth, in order to provide a quick and complete obturation of the canal.

The device is an electrically powered dental device used for heating gutta percha and placing the softened material in prepared root canals of teeth during rot canal therapy. The Obtura is an established device that has been marketed for over 20 years with an estimated 30,000 in use worldwide. This model incorporates interchangeable handpieces, membrane switches and temperature memory controls. The user gently squeezes the trigger to express the desired amount of gutta percha in to the root canal through a soft silver applicator needle as the predicate Heated Gutta Percha System, #K832654.

This document is a 510(k) summary for the Obtura Heated Gutta Percha System and its FDA clearance letter. It does not contain information about acceptance criteria or a study demonstrating device performance against such criteria.

The 510(k) process is primarily a premarket notification mechanism to demonstrate that a device is substantially equivalent to a legally marketed predicate device. It typically does not require clinical trials or studies proving specific performance metrics against pre-defined acceptance criteria, especially for Class I or II devices like this one.

Therefore, I cannot provide the requested information, which includes:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth establishment.
4. Adjudication method for a test set.
5. MRMC comparative effectiveness study results.
6. Standalone (algorithm-only) performance results.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document states that the device is "an established device that has been marketed for over 20 years with an estimated 30,000 in use worldwide" and that it "has the same technological characteristics" as the predicate device, with electronics updated "to comply with current standards and regulations," and materials/design selected for "better aesthetics and asepsis." This indicates a focus on equivalence and regulatory compliance rather than novel performance claims requiring new clinical evidence.

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