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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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PHOT-X IIs Model 505 is a extraoral source dental radiographic x-ray unit. This unit works as a diagnostic purpose x-ray source for human teeth with the resultant image recorded on intraoral dental x-ray film or image receptor.

PHOT-X IIs Model 505 dental x-ray contains; x-ray generating tubehead, control box and supporting device. Package includes Operator's Manual, Installation Manual and Warranty.

This document is a 510(k) premarket notification for Takara Belmont Corporation's PHOT-X IIs Model 505 dental x-ray unit. It does not describe an AI medical device. Therefore, it does not include information about acceptance criteria for an AI algorithm's performance, nor does it detail a study proving such performance.

Instead, this document focuses on demonstrating substantial equivalence to legally marketed predicate devices, which is the regulatory pathway for many conventional medical devices. The "performance criteria" in this context refer to the technical specifications of the x-ray unit itself, such as tube potential, tube current, filtration, and exposure time, compared against those of predicate devices.

Here's why the requested information cannot be provided from this document:

1. No AI Algorithm: The PHOT-X IIs Model 505 is described as an "extraoral source dental radiographic x-ray unit" that works as "a diagnostic purpose x-ray source for human teeth with the resultant image recorded on intraoral dental x-ray film or image receptor." This is a hardware device that generates X-rays, not an AI software algorithm that processes or interprets images.

2. Substantial Equivalence, Not Performance Study for AI: The document's primary purpose is to show that the new device is "substantially equivalent" to existing, legally marketed devices. This is done by comparing its technical specifications and intended use. It does not involve a clinical study to prove the performance of an AI algorithm in terms of diagnostic accuracy, sensitivity, or specificity against a ground truth.

3. Performance Standards Applied (Section 7): The "Performance Standards Applied" refer to electrical and safety standards for the X-ray equipment itself (e.g., AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-1-3, IEC60601-1-6, IEC60601-2-65, ISO14971). These are standards for the hardware's safety and effectiveness, not for an AI algorithm's diagnostic performance.

Therefore, I cannot provide the requested table and information because the document describes a conventional X-ray device, not an AI device.

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The Bel-Cypher N dental panoramic X-ray system is indicated for use as generator of radiographic images of the dento-maxilofacial region and is intended for dental examination and diagnosis of diseases of the tooth, jaw, and oral structures.

The Bel-Cypher N dental panoramic X-ray system is indicated for use as a generator of radiographic images of the dento-maxilofacial region and is intended for dental examination and diagnosis of diseases of the teeth, jaw, and oral structures.

The provided text is a 510(k) summary and FDA clearance letter for the Bel-Cypher N dental panoramic X-ray system. This document focuses on the device itself (an X-ray system) and its substantial equivalence to a predicate device, rather than on a specific algorithm or AI component that would have acceptance criteria and a study proving device performance against those criteria in the way you've outlined.

The document discusses performance compliance in terms of general electrical and safety standards (IEC 60601 series), which are typical for medical devices like X-ray machines. It does not contain information about:

1. A table of acceptance criteria and reported device performance for an AI algorithm.
2. Sample size for a test set or data provenance related to AI performance.
3. Number of experts for ground truth or their qualifications.
4. Adjudication method.
5. Multi-reader multi-case (MRMC) comparative effectiveness study with AI assistance. The device is the image generator.
6. Standalone (algorithm-only) performance.
7. Type of ground truth used for an AI algorithm.
8. Sample size for a training set.
9. How ground truth for the training set was established.

Essentially, this S510(k) summary is for the hardware (the X-ray machine), not a software algorithm that would require the kind of performance validation you're asking about.

Therefore, I cannot extract the requested information from the provided text as it does not pertain to the evaluation of an AI or algorithmic medical device component against specific performance criteria.

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