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510(k) Data Aggregation

    K Number
    K041120
    Device Name
    EV APAN DIGITAL, MODEL K1VSM2000
    Manufacturer
    AFP IMAGING CORP.
    Date Cleared
    2004-08-30

    (123 days)

    Product Code
    MUH
    Regulation Number
    872.1800
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K002432
    Why did this record match?
    Reference Devices :

    K002432

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The EVApan Digital / K1VSM2000 System is intended to be used with standard dental panoramic systems such as the Villa Strato X (K002432) X-ray system and Dental Image Management Software computer stations for system operation, archive data storage, image capture and enhancement, and patient data and support by qualified dental professionals.

    The EVApan Digital / K1VSM2000 Dental Panoramic Sensor is intended to be used with the STRATO Panoramic X-ray System (K002432), manufactured by VILLA SISTEMI MEDICALI S.P.A (registration number 8021091) and a computer work station for Dental Panoramic Radiographic Imaging.

    Device Description

    The EVApan Digital K1VSM2000 System is a digital imaging system in which traditional dental X-ray film has been replaced by a solid-state sensor. The sensor, when exposed to radiation, captures the image in the form of a charge pattern on its surface. The resulting electronic signals are digitized and sent to a computer screen for image presentation.

    AI/ML Overview

    The provided text is a 510(k) Premarket Notification Summary for the Owandy SA EVApan Digital (K1VSM2000) Dental Panoramic Sensor. This document primarily focuses on establishing substantial equivalence to previously marketed predicate devices, rather than presenting a detailed study with acceptance criteria and performance data in the format requested.

    Therefore, much of the requested information regarding specific acceptance criteria, study methodologies, sample sizes, expert qualifications, and ground truth establishment is not available in the provided text. The document is a regulatory submission for market clearance based on equivalence, not a research paper detailing performance against a defined metric.

    Here's a breakdown of what can be extracted and what is not available:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Not Stated (No explicit numerical performance criteria are mentioned in the summary)The device is stated to capture images in the form of a charge pattern on its surface, which are then digitized and sent to a computer screen for image presentation.
    "capture, evaluation, and storage of high quality digital dental X-rays" (This is a qualitative statement of capability, not a measurable performance metric against an acceptance criterion).

    2. Sample Size Used for the Test Set and Data Provenance

    • Test Set Sample Size: Not provided. The document does not describe a performance study with a specific test set.
    • Data Provenance: Not provided.

    3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

    • Number of Experts: Not provided.
    • Qualifications of Experts: Not provided.

    4. Adjudication Method for the Test Set

    • Adjudication Method: Not provided.

    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

    • MRMC Study: Not indicated. The device is a digital imaging sensor, not an AI-powered diagnostic tool. The document focuses on the sensor's ability to produce digital images, not on an AI's impact on human reader performance.

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

    • Standalone Performance Study: Not indicated. As above, this document describes an imaging sensor, not an algorithm.

    7. The Type of Ground Truth Used

    • Type of Ground Truth: Not applicable for this type of submission. The device is a digital replacement for traditional X-ray film; its "ground truth" would be the fidelity of the captured radiographic image, which is implicitly assessed against predicate devices rather than a ground truth for a diagnostic task.

    8. The Sample Size for the Training Set

    • Training Set Sample Size: Not applicable. The device is an imaging sensor, not a machine learning algorithm that requires a training set.

    9. How the Ground Truth for the Training Set was Established

    • Ground Truth Establishment for Training Set: Not applicable.

    Summary of what the document does provide regarding equivalence, which is the core of a 510(k) submission:

    • Intended Use: To be used with standard dental panoramic systems and Dental Image Management Software for system operation, archive data storage, image capture and enhancement, and patient data and support by qualified dental professionals.
    • Device Description: Replaces traditional dental X-ray film with a solid-state sensor that captures images as a charge pattern, digitizes electronic signals, and sends them to a computer for presentation.
    • Predicate Devices: Signet Radiology DXIS (K983283) and Trophy DigiPan (K961826, K991912, K012514).
    • Substantial Equivalence Argument: The EVApan Digital / K1VSM2000 System is substantially equivalent to the predicate devices because they share the same intended use (capture, evaluation, and storage of high-quality digital dental X-rays with existing X-ray equipment), and similar technological characteristics (X-ray sensitive solid-state imaging array, connected via cable to digitizing and control electronics, interfacing with a computer).
    • Regulatory Clearance: The FDA found the device substantially equivalent to legally marketed predicate devices, allowing it to be marketed.
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