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510(k) Data Aggregation

    K Number
    K163688
    Manufacturer
    Date Cleared
    2017-02-23

    (57 days)

    Product Code
    Regulation Number
    892.1550
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The MEDISONO Ultraonic Diagnostic Imaging System models P1, P3 and P10, are intended for diagnostic ultrasound imaging analysis of adults, pregnant women, pediatic patients in gynecology rooms, obstetrics rooms, examination rooms, intensive care units, and emergency rooms. The system is intended for use by or on the order of a physician or similarly qualified health care professional for ultrasound evaluation of Fetus, Abdomen, Pediatrics, Small Organ, Neonatal Cephalic, Cardiology, Peripheral Vessel, Musculo-skeleton (both conventional and superficial), Urology (including prostate), Transrecta and Transvagina.

    Device Description

    The P1 model is a portable digital ultrasonic diagnostic system applied in ultrasound diagnostic examination of abdominal, obstetrical, small parts, gynecological, orthopedic, cardiac, and urological applications. It is designed to produce ultrasound waves into body tissue and to present the returned echo information on the monitor, the resulting information is displayed in five display modes: B-Mode, 2B3-Mode, M-Mode, B+M Mode, B+M Mode. This system controlled by software is a Track 1 device that employs an array of probes that include linear array, convex linear array, microconvex linear array, transrectal and transvaginal with a frequency range of approximately 2.0MHz- 10.0MHz. The system consists of a main unit, transducers and other accessories.

    The P3 model is a portable digital ultrasonic diagnostic system applied in ultrasound diagnostic examination of abdominal, obstetrical, small parts, gynecological, orthopedic, cardiac, and urological applications. It is designed to produce ultrasound waves into body tissue and to present the returned echo information on the monitor; the resulting information is displayed in the following display modes: B-Mode, B+M Mode and PW Mode. This system controlled by software is a Track 3 device that employs an array of probes that include linear array, convex linear array, microconvex linear array, transrectal and transvaginal with a frequency range of approximately 2.0MHz-10.0MHz. The system consists of a main unit, a display and transducers.

    The P10 model is a portable Diagnostic Ultrasound System, which applies device advanced technologies such as Phased Inversion Harmonic Compound Imaging (eHCl), Multi-Beam-Forming (mBeam), Speckle Resistance Imaging (eSRI), and Spatial Compounding Imaging, etc. Various image parameter adjustments, 12.1 inch LCD and diverse probes are configured to provide clear and stable images. Its function is to acquire and display Ultrasound images in Bmode, M-mode, PW-mode, Color-mode, PDI/DPDI mode. This system provides a series of probes that include linear array, convex array, micro-convex array with a frequency range of approximately 2.5 MHz to 11 MHz.

    AI/ML Overview

    The provided text is a 510(k) premarket notification for a medical device (MEDISONO Ultrasonic Diagnostic Imaging System). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through clinical studies in the way a novel AI/ML device might.

    Therefore, the document explicitly states that clinical testing is not required (Page 32). This means there is no study described that involves patients, human readers, or an AI algorithm's diagnostic performance for the purposes of this submission. The "acceptance criteria" discussed are related to technical performance and safety standards, not clinical efficacy or diagnostic accuracy.

    Based on the provided document, I cannot fulfill most of your request as it pertains to clinical performance and AI/ML evaluation metrics. The document is for an ultrasound imaging system, which is a hardware device for image acquisition, not an AI/ML diagnostic aid.

    However, I can extract information related to the acceptance criteria for non-clinical performance and the testing done to meet them.

    Here's what can be extracted from the document:

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

    Based on the "Non-clinical Test" section (Page 32), the acceptance criteria appear to be compliance with specific international and FDA guidance standards for safety and performance of ultrasonic medical devices. The document states that these tests were conducted, implying the device met the requirements of these standards.

    Acceptance Criteria (Non-clinical)Reported Device Performance
    IEC 60601-1 Medical Electrical Equipment Part 1: General Requirements for Safety and Essential Performance. 2012 A(2)The device complies with this standard.
    IEC 60601-2-37 Medical Electrical Equipment- Part 2-37. Particular requirements for basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment: Nov, 2005The device complies with this standard.
    IEC 60601-1-2 Medical Electrical Equipment Part 1-2 General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Compatibility Requirements and Tests: March 2007The device complies with this standard.
    Acoustic output testing as per the guideline "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" dated September 9, 2008.The device complies with this guideline for acoustic output.
    ISO 10993-1 Biological Evaluation of Medical Devices Tests for In Vitro Cytotoxicity: May, 1999The device complies with this standard regarding cytotoxicity.
    ISO 10993-10 Biological Evaluation of Medical Devices Part 10 -Tests for Irritation and Skin Sensitization: Aug, 2010The device complies with this standard regarding irritation and skin sensitization.
    ISO 14971 Medical Devices Application of Risk Management to Medical Devices: March 1, 2007The device complies with this standard for risk management.

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

    • Sample Size: Not applicable. Non-clinical testing of compliance with standards typically does not involve "samples" in the sense of patient data sets. It refers to testing the physical device and its compliance with engineering and safety specifications.
    • Data Provenance: Not applicable. No clinical data is referenced in this section.

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

    • Not applicable. No "ground truth" in a clinical diagnostic sense is established or mentioned for this type of device submission. The tests are engineering and safety compliance tests, not diagnostic performance evaluations.

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

    • Not applicable. Adjudication methods are relevant for human interpretation or AI performance studies, which were not required for this 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:

    • No. The document explicitly states "Clinical Test: Clinical testing is not required." Therefore, no MRMC study, AI assistance, or effect size comparison was performed or reported for this submission.

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

    • No. This is an ultrasound imaging system, not an AI algorithm for diagnosis.

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

    • Not applicable. The ground truth for this submission relates to the device meeting technical and safety specifications rather than diagnostic accuracy against a clinical reference standard.

    8. The sample size for the training set:

    • Not applicable. There is no mention of a training set as this is not an AI/ML device that learns from data.

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

    • Not applicable. No training set is mentioned.

    In summary, the provided document is a 510(k) premarket notification for a traditional ultrasonic diagnostic imaging system. It demonstrates substantial equivalence to predicate devices primarily through compliance with recognized performance and safety standards, rather than complex clinical performance studies involving AI/ML components.

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