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EDS Ultrasonic Tips are intended for use by dental professionals for the removal of soft and hard tissue during endodontic root canal preparation procedures. They can also aid in the removal of endodontic posts and other intra-canal blockages.

EDS Ultrasonic Tips are an accessory to a piezoelectric ultrasonic handpiece and scaler unit. These powered components are not included as part of the device submitted for application with the 510(k) submission. EDS Ultrasonic Tips are stainless steel and will be available in M3x0.5 and #5-40 thread with 6 different tip designs. 1 tip design is devised for post removal; the remaining 5 tips are designed for negotiating the various angles and directions of root canals.

The provided text describes the acceptance criteria and the study conducted for the EDS Ultrasonic Tips.

Here's the breakdown of the information requested:

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

2. Sample size used for the test set and the data provenance:

• Sample size: Not explicitly stated in the provided text. The document mentions "Mechanical testing was conducted in the form of breakage resistance testing," but does not specify the number of tips tested.
• Data provenance: Not explicitly stated. Given that the testing was conducted to support a 510(k) submission, it would typically be prospective testing conducted by the manufacturer, Essential Dental Systems.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. The study involved mechanical testing, not expert-based ground truth establishment for a diagnostic or similar device.

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

• Not applicable. The study involved mechanical testing, not a method requiring adjudication of expert opinions.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is an ultrasonic tip used in endodontic procedures, not an AI-powered diagnostic tool requiring human reader studies.
• The document explicitly states: "Discussion of Clinical Tests Performed: Not Applicable."

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

• Not applicable. The device is a physical instrument, not an algorithm.

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

• For the breakage resistance testing, the "ground truth" would be established by engineering standards or specifications for material integrity and performance, likely measured through mechanical stress tests to determine the point of failure or acceptable loads. This is not categorized as expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

• Not applicable. The device is a physical instrument, not an algorithm that requires a training set.

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

• Not applicable. As above, there is no training set for this type of device.

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