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The MM-SEAL is a root canal sealer packaged in a dual syringe used for filling of root canals with gutta percha points for endodontic treatments.

MM-SEAL is intended for use by qualified healthcare personnel trained in its use.

The MM-SEAL is a biocompatible root canal sealer packaged in a dual syringe used for filling of root canals with gutta percha points for endodontic treatments.

The device consists of two component (dual syringe) which are mixed before the use in the dental canal, onto a mixing plate with a spatula for 15-20 seconds or until the mixture become creamy and homogeneous.

Application: Thoroughly dry canals walls and apply MM-SEAL, avoiding the formation of air bubbles. Do not exceed the apical limit. Dip the tips of dry, disinfected Gutta-percha points in MM-SEAL. Insert one or more points in the root canal and condense the Gutta-percha. MM-SEAL can be used with thermoplasticized gutta-percha or gutta-percha coated obturator techniques.

MM-SEAL should not be used expiry date.

MM-SEAL is intended for use by qualified healthcare personnel trained in it use.

This submission is for a root canal sealer, MM-SEAL, a medical device, and therefore does not have acceptance criteria or study data of the type requested in the prompt (e.g., sample size, expert qualifications, adjudication methods, MRMC study, standalone algorithm performance, or ground truth types related to AI/ML device performance). The document provided is a 510(k) summary for a medical device seeking substantial equivalence to a predicate device, not a study report for an AI/ML system.

The performance section of the document states:

• "The performance of MM-SEAL has been evaluated following the standard ISO 6876, Dental root canal sealing materials..."
• "...the risk analysis has been conducted following ISO 14971..."
• "...the biological evaluation has been done following ISO 10993-1 Biological evaluation of medical devices."

The submission concludes that MM-SEAL is substantially equivalent to its predicate device (ADSEAL K042769) based on identical manufacturer, intended use, chemical composition, physical properties, manufacturing process, method of application, and similar user manual and packaging.

Since this device is not an AI/ML product, the questions regarding acceptance criteria, study details, and data provenance for such technologies are not applicable here.

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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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Endodontics

canal preparation -

canal cleaning

Not Found

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets such criteria. The document is an FDA 510(k) clearance letter for the "Sonic Air MM 1500+ (MID)" device, indicating that it has been found substantially equivalent to a predicate device for endodontic canal preparation and cleaning.

The letter discusses regulatory compliance requirements but does not detail any performance studies, acceptance criteria, sample sizes, ground truth establishment, or expert involvement as requested in your prompt. These details would typically be found in the 510(k) submission summary or associated testing reports, which are not included in this document.

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Ax's Endo® handpieces are intended to hold burs or other tools and to transmit power to these via a motor.

Ax's Endo® handpieces are intended to hold burs or other tools and to transmit power to these via a motor.

This is an FDA 510(k) clearance letter for the Ax's Endo® dental handpiece. This document is a regulatory approval, not a scientific study report. Therefore, it does not contain information regarding acceptance criteria for a device's performance based on a study, nor does it describe a study proving the device meets particular criteria.

The letter states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for 510(k) clearance. This means the FDA found that the new device is as safe and effective as a legally marketed device that is not subject to PMA.

Therefore, I cannot fulfill your request for the specific points about acceptance criteria and a study from the provided document.

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These contra-angles are intended.for use. on dental motors equipped with a coupling according to ISO Standard 3964.

The speed of the motors may not exceed 40 000 RPM.

These contra-angles may receive all dental instruments for contra-angles (burs, prophylaxis instruments, endodontic instruments) whose shank is of type 1, such as : determined in ISO Standard 1797.

They allow to carry out all low speed dental works

Their usage is of course reserved to dentists or hygienists who are duly graduated and entitled to exercise.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA to MICRO-MEGA SA regarding their Series XE, SE, and TE contra-angles. It acknowledges that the device is substantially equivalent to legally marketed predicate devices.

However, the document does not contain any information about:

• Acceptance criteria or reported device performance for these contra-angles.
• Any study, clinical or otherwise, that proves the device meets specific acceptance criteria.
• Sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

This letter is a regulatory approval document based on substantial equivalence, not a detailed study report. Therefore, I cannot extract the requested information from the provided text.

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Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device