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The APEX POINTER+ is indicated for root canal and other related dental procedures, to be used by a trained professional in general dentistry.

The APEX POINTER+ is an electronic apparatus that employs the bio-impedance principal to estimate the position of an endodontic file in the root canal with respect to the apex point.

The provided text does not describe acceptance criteria for the device, nor does it detail a specific study proving the device meets acceptance criteria in the manner typically expected for a medical device efficacy study (e.g., performance metrics compared against a predefined threshold).

Instead, the document primarily focuses on establishing substantial equivalence to a predicate device (Techdent's APX21, K073185). The "performance" section describes subjective observations from an expert and compliance with general safety standards.

Therefore, many of the requested items cannot be extracted from the provided text.

Here's a breakdown of what can be inferred or directly stated:

1. Table of acceptance criteria and reported device performance:

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

• Sample size: Not specified. The "test" mentioned is an evaluation by a single expert, not a formal study with a defined sample size.
• Data provenance: The evaluation was conducted in a clinical setting ("in his clinic") by Prof. Pierre Machetou. The country of origin of the data is not specified, but the manufacturer is French. It appears to be a prospective evaluation by an expert.

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

• Number of experts: One (Prof. Pierre Machetou).
• Qualifications: "renowned worldwide for his expertise in Endodontics."

4. Adjudication method for the test set:

• Not applicable. The evaluation was performed by a single expert, not a process requiring adjudication among multiple reviewers.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

• A MRMC study was not conducted. The device is an electronic apex locator, not an AI-assisted diagnostic tool that would typically involve human readers interpreting output.

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

• The device itself is a standalone electronic apex locator. Its performance evaluation (as far as described) does not involve a human interpreting its output in comparison to a human interpreting things manually. Instead, the human (Prof. Machetou) is assessing the device's overall performance.

7. The type of ground truth used:

• The document does not explicitly define a formal "ground truth" used for a quantitative performance study. The expert's observations ("Good precision") serve as a qualitative assessment of accuracy. For an apex locator, a typical ground truth might involve radiographic measurements or direct visualization post-extraction, but this is not described in the document.

8. The sample size for the training set:

• Not applicable. This is a medical device, not an AI/machine learning model that typically has a "training set."

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

• Not applicable, as there is no "training set" for this type of device.

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