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510(k) Data Aggregation

    K Number
    K190300
    Device Name
    BIOK7600W Wireless Flat Panel Detector
    Manufacturer
    Biokinemetrics Inc.
    Date Cleared
    2019-03-13

    (29 days)

    Product Code
    MQB,90M
    Regulation Number
    892.1680
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K092307,K181565,K182551
    Why did this record match?
    Reference Devices :

    K092307, K181565

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

    The BIOK 7600W is intended for use by a qualified doctor or technologist on both adult and pediativ for taking diagnostic radiographic exposures of all body parts of the patients. The BIOK 7600W provides digital image capture and is intended to replace radiographic film/screen. The x-ray generator, x-ray tube and associated equipment are not provided with the proposed sensor. Prescription use only.

    The BIOK7600W is not intended for mammography.

    Device Description

    The BIOK7600W sensor is a wireless digital radiography sensor which automatically collects x-ray images from an x-ray source. The BIOK7600W sensor (flat panel type) collects x-rays and digitizes the images for their transfer and display to a computer. The sensor does not have an x-ray source, which is provided by independent manufacturers. The sensor includes a flat panel for x-ray acquisition and a computer (including proprietary processing software) for processing, annotating and storing x-ray images.

    An X-ray generator with a minimum voltage output range between 55 to 120 kVp and a minimum power of 30 KW can be used with the BIOK7600. The BIOK7600 does not connect to the generator. It automatically detects x-rays and enables the image acquisition (AEC). No changes to the generator hardware or software are required to operate the BIOK7600.

    The ChiroSight software runs on a PC workstation and provides the user interface to control the BIOK7600 flat panel. ChiroSight initiates the taking of X-ray images from the BIOK7600. through the Sensor Driver application. Once an X-ray is taken. Sensor Driver reads it from the flat panel and transfers it to ChiroSight. After it receives an image from the BIOK7600, ChiroSight:

    Automatically optimizes the image quality
    Permanently stores the image to its database
    Displays the image to the user
    Allows the user to perform image manipulations and to add annotations
    Allows the user store and transfer the images in DICOM format.

    AI/ML Overview

    The provided text describes the Biokinemetrics BIOK7600W Wireless Flat Panel Detector and its 510(k) submission. Here's a breakdown of the acceptance criteria and the study conducted:

    Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategorySpecific Criteria/TestsReported Device Performance
    Non-Clinical PerformanceEquivalent performance to predicate deviceThe non-clinical considerations document demonstrates that the BIOK7600W sensor offers equivalent performance (including biocompatibility, effectiveness, thermal, electrical, and mechanical safety) to the predicate device. The design, development, and production of the sensor conforms to 892.1680 and ISO 13485 quality systems.
    Software FunctionalityEquivalent functionality to predicate reference device (BIOK4600)The BIOK7600W software functionality is equivalent to the original BIOK4600 reference device, with the exception of the Imaray interface application, which now reads images from the new BIOK7600W sensor instead of the BIOK4600 sensor.
    Image QualityProduction of images of similar quality and characteristics to predicate deviceThe BIOK7600W produces images of similar quality and characteristics that are equivalent to those of the predicate device, as demonstrated in the clinical considerations - concurrence study. A set of test images have been submitted along with the equivalent images from the predicate device.

    Study Details

    1. Sample size used for the test set and the data provenance:

      • Test Set Size: "A set of test images" was used. The exact number of images is not specified in the provided text.
      • Data Provenance: Not explicitly stated, but the "clinical considerations - concurrence study" involved comparing images from the BIOK7600W with images from the predicate device. This implies retrospective comparison of clinical image data or a controlled collection for this specific study. The country of origin of the data is not mentioned.

    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

      • The document does not specify the number or qualifications of experts used. It refers to a "clinical considerations concurrence study" where images were compared, but details on ground truth establishment or expert involvement for image evaluation are missing.

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

      • The document does not specify any adjudication method for the test set's ground truth.

    4. 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:

      • No MRMC comparative effectiveness study is mentioned. This device is a flat panel detector, not an AI-assisted diagnostic tool. The study focuses on demonstrating equivalence in image output rather than user performance with or without AI.

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

      • Yes, implicitly. The performance of the BIOK7600W (including its software for image optimization and processing) was evaluated directly by comparing its output images and functionalities to a predicate device. This is a standalone performance evaluation of the device as a system.

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

      • The "ground truth" for the clinical study appears to be the image quality and characteristics of the predicate device. The study aims to show that the BIOK7600W produces images "equivalent to those of the predicate device." This is a comparative equivalence ground truth, rather than an absolute diagnostic ground truth (like pathology).

    7. The sample size for the training set:

      • The document does not provide information about a "training set" in the context of machine learning or AI. The BIOK7600W is a digital radiography sensor, and its "software" primarily handles image processing, annotation, and storage. If any internal parameters of the image optimization algorithms were "trained," this is not disclosed.

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

      • As no training set is mentioned in the context of an AI/ML algorithm requiring ground truth, this information is not applicable from the provided text.
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