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The Ultrasonic Endo Activation Device (Model:Actor I pro ) is an ultrasonic-handpiece which is intended use for rootcanal cleaning and preparation.

The Ultrasonic Endo Activation Device (Model:Actor I pro ) is intended for use by trained dental professionals in professional health care facilities on patients that need root-canal-treatment.

The subject device Ultrasonic Endo Activation Device (Model: Actor I pro) is an auxiliary device for dentists to perform root canal treatment. It is mainly used to clean the root canal with the help of ultrasonic cavitation, so as to assist dentists to complete root canal treatment.

The subject device Ultrasonic Endo Activation Device (Model: Actor I pro) configuration consist of the following components:

(1) ultrasonic handpiece (2) ultrasonic working tip (3) Wrench (4) silicone case (5) charging base

(6) Power Adapter(7) wireless foot switch (Optional)

The provided document, K213947, is a 510(k) Pre-market Notification for the "Ultrasonic Endo Activation Device (Model:Actor I pro)". This document describes the device, its indications for use, and a comparison to a predicate device to establish substantial equivalence.

Based on the content of the document, specifically Sections 8 "Performance Data" and 9 "Conclusion", there was no clinical study conducted to prove the device meets acceptance criteria. The document explicitly states:

• Clinical test: "Clinical testing is not required."

Instead, the submission relies on non-clinical data to demonstrate substantial equivalence to a legally marketed predicate device. This means the acceptance criteria are based on compliance with relevant international standards for safety, performance, usability, electromagnetic compatibility, and biocompatibility, as well as software verification and validation.

Therefore, the requested information regarding acceptance criteria and the study that proves the device meets them, specifically pertaining to a clinical study with human data, cannot be extracted from this document, as such a study was not performed or submitted.

However, I can describe the acceptance criteria based on the non-clinical tests that were conducted, and the way the device "met" these criteria:

1. Table of Acceptance Criteria and Reported Device Performance (Non-clinical)

Since no clinical study was conducted, the "performance" here refers to compliance with established non-clinical standards and benchmarks.

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

• Not applicable. No clinical test set of human subjects was used for this 510(k) submission as clinical testing was not required. The "tests" were non-clinical, involving device testing against engineering and biological standards. Data provenance, in this context, would relate to the laboratory conditions and specific samples used for the engineering and biocompatibility tests (e.g., specific materials tested for cytotoxicity), which are not explicitly detailed in summaries like these but are part of the underlying test reports.

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

• Not applicable. No clinical test set with human data requiring expert ground truth establishment was conducted. The ground truth for non-clinical compliance is based on the adherence of the device's measured parameters to internationally recognized standards and safety limits.

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

• Not applicable. As no clinical ground truth requiring expert consensus or adjudication was established, no adjudication method was used.

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 an ultrasonic handpiece, not an AI-powered diagnostic imaging tool that would typically undergo an MRMC study.

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

• Not applicable. This device is a physical medical instrument, not a standalone algorithm. Its performance is evaluated through its physical and electrical characteristics and biocompatibility, not as an algorithm.

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

• For this submission, the "ground truth" for proving substantial equivalence was adherence to established engineering standards, safety standards, and biocompatibility standards. It was not based on clinical "outcomes data" or "expert consensus" on patient cases, as no clinical study was performed.

8. The sample size for the training set:

• Not applicable. This device is hardware; it does not involve a "training set" in the machine learning sense.

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

• Not applicable. This device is hardware; it does not involve establishing ground truth for a training set.

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