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The intended use of the dental instrument heater – The EndoTwinn - is to provide continuous heat and/or vibration at the tip of a dental instrument. The EndoTwinn is designed for processing gutta percha (cutting softening, spreading, compacting) and cutting plastic handles of obturators during a root canal treatment The device may only be operated by dentists and endodontists.

The device is a battery-operated dental instrument heater which is designed to provide continuous heat and/or vibration at the tip of a dental instrument. The low frequency vibration stimulates the transformation of gutta percha in a solid mass. The temperature is regulated by the type of tip attached to the handpiece and it automatically maintains a preset temperature for consistent results. The cordless handpiece is easily operated by a single button and can be recharged by placing the handpiece in a charger. The tips are autoclavable and the handpiece can be disinfect with 80% alcohol.

This document is a 510(k) summary for the EndoTwinn dental instrument heater. It describes the device, its intended use, and states that it has been tested and complies with relevant standards, thereby establishing substantial equivalence to predicate devices. However, it does not contain the specific acceptance criteria or the study that proves the device meets those criteria.

Here’s a breakdown of the information requested, based on the provided text, and explicit statements about what is NOT present in the document:

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

• Not provided. The document states, "The devise is tested thoroughly and it complies to the standards for this class II a medical device." However, it does not specify what those standards are, what the acceptance criteria defined by those standards were, or what the specific performance results were against those criteria.

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. There is no mention of a specific test set, sample size, or data provenance.

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 / Not provided. The device is a "dental instrument heater," which is a physical tool, not a diagnostic or AI-driven device that would require ground truth established by experts for performance evaluation in the typical sense (e.g., for image interpretation). The "testing" mentioned is likely related to electrical safety, temperature accuracy, and mechanical function, not clinical diagnostic accuracy.

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

• Not applicable / Not provided. Similar to point 3, this is not relevant for the type of device described.

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

• No. This is not an AI-based device, nor is it a diagnostic device that would involve human readers or comparative effectiveness studies of this nature.

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

• No. This is a physical dental instrument, not an algorithm.

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

• Not applicable / Not provided. The concept of "ground truth" as it applies to diagnostic or AI performance is not relevant here. The testing would involve objective measurements against engineering specifications and safety standards for the device's physical functions (heating, vibration, safety).

8. The sample size for the training set

• Not applicable / Not provided. This is not an AI/machine learning device that requires a training set.

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

• Not applicable / Not provided. This is not an AI/machine learning device.

In summary, the provided document is a 510(k) summary focused on establishing substantial equivalence for a physical dental instrument. It confirms the device was tested and complies with standards but does not detail the specific acceptance criteria or the specific results of those tests as would be expected for a diagnostic or AI-powered device.

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