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The Endomax™ is a cordless handpiece used primarily for root canal enlargement. This application area extends to endodontic procedures using a root canal instrument which is intended by the manufacturer for use in the mechanical and rotary preparation of root canals.

The Endomax" Cordless Endodontic Handpiece has a number of substantially equivalent (SE) predicate devices. These predicate devices use the same technological methods to perform mechanical and rotary preparation of root canals with a cordless handpiece. A modular electrical system consisting of a drive handpiece, a rechargeable battery, contraangle head and a charging station are the main components of the predicate devices. The materials used in this device are composed of brass, silicon and Type II plastic as in the substantially equivalent devices.

The provided text is a 510(k) summary for the Endomax™ Cordless Endodontic Handpiece. It focuses on establishing substantial equivalence to predicate devices and provides regulatory information. Crucially, the document does not contain details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study details based on the provided input. The document is primarily a regulatory filing rather than a scientific study report.

The request asks for information that is not present in the provided text.

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The Digirex™ Digital Dental Radiography System replaces the traditional film approach to x-ray imaging. A digital sensor rather than film is used to capture x-rays from an external source and produce digital images of a patient's mouth. The digital sensor and the USB controller allow the images to be transferred to a computer for analysis, archiving and electronic transmission.

The Digirex™ Digital Dental Radiography System replaces the traditional film approach to x-ray imaging. A digital sensor rather than film is used to capture x-rays from an external source and produce digital images of a patient's mouth. The digital sensor and the USB controller allow the images to be transferred to a computer for analysis, archiving and electronic transmission.

Here's an analysis of the provided text regarding the DENTAMERICA KOGOGAO 510(k) Summary, focusing on acceptance criteria and study data:

Based on the provided document, the DENTAMERICA Digirex™ Digital Dental Radiography System does not include information on specific acceptance criteria or a study that proves the device meets those criteria.

This 510(k) summary is for a device that was found substantially equivalent to predicate devices. The focus of this type of submission is typically on demonstrating that the new device has the same technological characteristics and intended use as existing, legally marketed devices. It does not primarily involve studies to prove performance against specified acceptance criteria in the same way a novel, higher-risk device submission might.

Therefore, many of the requested details about acceptance criteria, study design, and ground truth establishment are not provided in this document.

Here's a breakdown of the requested information based only on the provided text:

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

   • Acceptance Criteria: Not specified in the provided text.
   • Reported Device Performance: Not specified in terms of quantitative metrics or performance against pre-defined criteria. The document states its function ("A digital sensor rather than film is used to capture x-rays... and produce digital images...") and its benefits ("images appear instantaneously," "much smaller dose of x-ray radiation").

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

   • Not specified. The document does not describe a performance study with a test set.

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)

   • Not applicable, as no ground truth establishment for a test set is described.

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

   • Not applicable, as no test set adjudication is described.

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. The device is a digital radiography system, not an AI-assisted diagnostic tool. No MRMC or human reader improvement studies are mentioned.

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

   • Not applicable. This device is a digital imaging capture system, not an algorithm that performs diagnostic analysis independently.

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

   • Not applicable, as no ground truth for performance evaluation is described.

8. The sample size for the training set

   • Not applicable. This type of device (digital X-ray sensor) does not typically involve a "training set" in the context of machine learning or AI.

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

   • Not applicable.

Summary of the K060640 Filing:

The DENTAMERICA Digirex™ Digital Dental Radiography System's 510(k) summary focuses on demonstrating "Substantial Equivalence" to legally marketed predicate devices (RSV Radiology System Visiodent - K031448, EVA Digital Dental X-Ray System - K030647, Visualix Radiographic Image Detecting and Process - K925094).

The core argument for substantial equivalence is based on:

• Intended Use: Replacing traditional film-based dental x-ray imaging to capture and produce digital images of a patient's mouth for analysis, archiving, and electronic transmission.
• Technological Characteristics: Utilizing a digital sensor to capture x-rays from an external source and a USB controller to transfer images to a computer, which is the same method used by the predicate devices.
• Benefits: Instantaneous image display and reduced x-ray radiation dose for the patient, which are inherent benefits of digital radiography over film.

The FDA's review concluded that the device is substantially equivalent, allowing it to be marketed under the general controls provisions of the Act. This type of clearance typically relies on comparing the new device's specifications and functionality to those of already cleared devices, rather than requiring extensive de novo performance studies with defined acceptance criteria and statistical proof.

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