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Evogue Dental Unit series are intended for the Dentists, and Dental assistants for traditional and normal patient treatment procedures in the dental operatory.

This product is an active therapeutic device intended to administer or exchange energy of electric, air and water for the exclusive use for diagnoses, treatments and relative procedures of dentistry, and its characteristic is not in a potentially hazardous way between such energy and human body, taking account of the nature, the density and site of application of the energy. The product must be operated or handled by the qualified dentists or by dental staffs under the supervision of the dentist. Such dentists or dental staffs should instruct and/or assist the patients to approach to and leave from the product. Patients should not be allowed to operate or handle the product unless he/she is so instructed. The air unit system uses compressed air to drive air motor and air scaler. The new Evogue Dental Unit is air unit system. The function and components used for Evogue Dental Unit are very similar to X-Calibur unit (Belmont Model 2000 Series, K000799). Though the Evogue Dental Unit is typical air system, it does have upgrade ability to use micro motor with external touch pad (MX2 Optima) and integrated type electric scaler (Cavitron). The foot control regulates drive air to the active handpiece to control the rotation speed of turbine and air motor. Also controls the frequency of air scaler. It provides an air signal that activates air coolant and water coolant flow. The foot control is equipped with a wet/dry toggle to turn the water coolant on or off.

Here's an analysis of the provided text regarding the Evogue Dental Unit, focusing on the acceptance criteria and the study that proves the device meets those criteria:

Based on the provided document, there is no study that proves the device meets specific performance acceptance criteria in the traditional sense of a clinical or analytical performance study.

The document is a 510(k) Premarket Notification, which primarily focuses on demonstrating substantial equivalence to a previously marketed predicate device. This means the manufacturer is asserting their new device is as safe and effective as a legally marketed device and does not require a new Pre-Market Approval (PMA) process.

Instead of a study proving a device meets performance criteria, the document refers to performance standards applied, which are international standards (ISO and IEC) that the device should comply with or was tested against to ensure its safety and basic functionality.

Therefore, many of your requested points will either be "Not Applicable" or inferable from the context of a 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied by Applied Standards):

Summary of Device Performance (from the 510(k) perspective):

The Evogue Dental Unit is represented as having the same intended use and technology characteristics as the predicate device (Belmont Unit, Model 2000 Series). The conclusion drawn by the manufacturer is that the "proposed device is substantially equivalent to the noted predicate," implying that its performance is comparable and acceptable for the given indication based on compliance with the listed performance standards and the comparison of features.

Detailed Answers to Your Specific Questions:

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

   • See the table above. The "acceptance criteria" here are the requirements outlined in the cited international standards (IEC 60601-1-2, ISO 7405, ISO 7494-1, ISO 7494-2, ISO 9168, ISO 14457) and the stated "intended use." The "reported device performance" is a general affirmation that the device meets these standards and functions equivalently to the predicate. Specific quantitative performance metrics are not provided in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not Applicable (N/A) / Not provided. This document does not describe a clinical or performance study with a "test set" in terms of patient data or a specific number of units tested to achieve a statistical outcome. The testing performed would have been against the cited engineering/material standards, typically involving a representative number of units or materials for compliance testing, but the specifics are not detailed in this 510(k) summary. The data provenance would be from internal testing by the manufacturer, likely in Japan (country of origin of Takara Belmont Corporation, LTD).

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):

   • N/A. This is not a study requiring expert-established ground truth on diagnostic or clinical outcomes. The "ground truth" for the device's safety and effectiveness relies on its compliance with established engineering and biocompatibility standards, and its functional similarity to a predicate device. This typically involves engineers and quality control personnel.

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

   • N/A. Adjudication methods like 2+1 or 3+1 are used in clinical trials to resolve discrepancies in expert interpretations of medical data. This type of study was not conducted for this 510(k) submission.

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:

   • N/A. This device (a dental operative unit) is not an AI-powered diagnostic tool, and no MRMC study was performed. The concept of "human readers improving with AI assistance" is entirely irrelevant to this device submission.

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

   • N/A. This device does not involve an algorithm that performs tasks independently. It's a manual dental unit operated by humans (dentists, hygienists, assistants).

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

   • The "ground truth" for this 510(k) submission is primarily based on:
     • Compliance with recognized international standards (engineering, electrical safety, biocompatibility, mechanical function). This is established through laboratory testing.
     • Demonstration of substantial equivalence to a predicate device. This is established through a feature-by-feature comparison and by confirming the new device shares the same fundamental technology and intended use as the predicate.
     • Manufacturer's internal testing and quality control data to ensure the device meets its design specifications and the applied standards.

8. The sample size for the training set:

   • N/A. This device is not an AI/machine learning device that requires a "training set."

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

   • N/A. As there is no training set, this question is not applicable.

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