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510(k) Data Aggregation

    K Number
    K141346
    Date Cleared
    2014-06-26

    (35 days)

    Product Code
    Regulation Number
    892.2040
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    SONY HYBIRD GRAPHIC UP-971AD, SONY HYBIRD GRAPHIC PRINTER UP-991AD

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

    Sony Hybrid Graphic Printers UT-971AD and UP-991AD are compact, medical grode hlack and white printers that can accept both anslog and digital signal inpus. They are designed to be integrated into radiology imaging systems such as mobile c-arm, ultrasound, cardine intintion laboratory and other compaible medical imaging systems and produce hard copy prints of still images captured by these systems for the patient rocord or for referrals.

    Device Description

    The UP-991AD and UP-971AD Hybrid Graphic Printers are compact black and white printers designed for use with both analog and digital radiology imaging systems such as mobile C-arm, ultrasound, cardiac catheterization laboratory and other compatible medical imaging systems. They provide 325 dpi high resolution hard copies of still images captured by the imaging system that can then be used as reference prints for patient record purposes or referrals.

    Both the UP-991AD and UP-971AD Hybrid Graphic Printers provide a multi-picture print mode and panoramic print capability. Additionally, the UP-991AD can store images on a connected USB flash drive and print on transparent blue film media, in addition to paper media. Other conveniences offered by the UP-991AD include automatic detection of media type and an integrated media cutter.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for the Sony UP-991AD / UP-971AD Hybrid Graphic Printers. This submission aims to demonstrate substantial equivalence to legally marketed predicate devices, rather than proving the device meets specific performance criteria through clinical studies in the typical sense of AI/CADe devices.

    The acceptance criteria are implicitly defined by compliance with applicable standards and a comparison of technological characteristics to predicate devices. The study proving acceptance is a non-clinical performance testing suite.

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

    1. Table of Acceptance Criteria and Reported Device Performance

    Since this is a substantial equivalence claim for a printer, the "acceptance criteria" are the characteristics of the predicate devices. The device performance is shown by demonstrating that the proposed device is either equivalent or an upgrade in these characteristics.

    CharacteristicAcceptance Criteria (Predicate Devices - e.g., UP-701, UP-811, UP-1000/1100, UP-5000)Reported Device Performance (Sony UP-991AD / UP-971AD)
    Regulatory StatusK882958 (Sony UP Series Video Printers)Proposed device claims substantial equivalence to K882958
    Product CodeLMC (for predicate) / KQM (for some predicates)LMC
    Printing MethodDirect thermal printing, Sublimation heat transfer printingDirect thermal printing
    High Resolution61 dpi to 102 dpi/132 dpi (h/w)325 dpi (an upgrade)
    Gradations16/32 to 256 levels each8 bits (256 levels) processing
    Picture ElementsVarious dot/PELS specificationsDigital: 7680 x 2560 dots; Video NTSC: 720 x 504 dots; Video PAL: 720 x 604 dots (generally improved)
    Picture AreaVarious mm measurementsDIGITAL: 600 x 200 mm (Max); VIDEO: Standard NTSC: 182 x 144 mm, etc. (generally improved)
    Paper SizeVarious paper widths and sheet sizesPaper width of 8.25 in. [210 mm]
    Picture Memory128K x 4 bits to 1024K x 8bitsDigital: 2816 x 7680 x 8 bits; Video: 6 frames (720 x 608 x 8 bits for one frame) (an upgrade)
    InterfaceVarious video inputs, remote portsUSB (type A), Hi-Speed USB (USB 2.0), VIDEO INPUT (BNC), VIDEO OUTPUT (BNC), REMOTE (Stereo mini jack) (digital connectivity is new functionality)
    Power RequirementsAC 100 V to 240 V, 50/60 HzAC 100 V to 240 V, 50/60 Hz
    Weight7lb 15oz [3.6 kg] to 102lb 12oz [46.6 kg]15lb 7oz [7.0 kg]
    Digital Video InputN/A (for predicates)Yes (implies ability to accept digital signals)
    Analog Video InputYesYes
    Multi-picture ModeYes - 4, 9 for some predicatesYes - 2, 4, and 6 (Analog) / 2 and 4 (Digital) (expanded functionality)
    Panoramic PrintingN/A (for predicates)Yes up to a maximum of 600mm in length (new functionality)
    Printing Speed8.5 seconds/screen to 3 minutesApprox. 8 seconds/image (in standard mode)
    Storage MediaN/A (for predicates)USB Flash drive (UP-991AD only) (new functionality)
    DimensionsVarious width, height, depth12.5 (W) x 5.25 (H) x 10.5 (D) inches (compact size)
    LCD Display PanelN/A (for predicates)Yes (new functionality)
    LED BacklightN/A (for predicates)Yes (new functionality)
    Function KeysFront Panel, Operation Panel, KeypadFront Panel
    Settings Auto LockN/A (for predicates)Yes (new functionality)
    Contrast KnobN/A, Yes for some predicatesYes
    Brightness KnobN/A, Yes for some predicatesYes
    Automatic Media CutterN/A (for predicates)Yes (UP-991AD only) (new functionality)
    Automatic Detection of Media TypeN/A (for predicates)Yes (UP-991AD only) (new functionality)
    Print MediaVarious thermal paper and filmUPT-210BL Blue Thermal Transparent Film (UP-991AD only); UPP-2010HD, UPP-210SE Thermal Print Media (new media options)

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

    The document states "SUMMARY OF NON-CLINICAL PERFORMANCE TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE" and "hardware and software testing." It also explicitly says "SUMMARY OF CLINICAL TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE: Not applicable."

    This indicates that no clinical test set was used in the traditional sense for evaluating diagnostic performance with patient data. The testing was likely internal engineering and quality assurance testing of the printer's functionality, safety, and compliance with standards. Therefore, information about sample size for a test set and data provenance in a medical imaging context is not provided and not relevant to this type of device submission.

    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 clinical test set with medical imaging ground truth (e.g., diagnoses) was used. The evaluation centered on engineering specifications and adherence to safety standards.

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

    Not applicable, as no clinical test set requiring expert adjudication was used.

    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. This device is a printer, not an AI/CADe system. No MRMC study was conducted.

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

    Not applicable. This device is a printer, not an algorithm.

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

    Not applicable. The "ground truth" for this device would be its technical specifications and performance against industry standards for safety, electrical compatibility, and output quality (e.g., resolution, printing speed, interface functionality). These are verified through engineering tests, not clinical "ground truth" methodologies.

    8. The sample size for the training set

    Not applicable. This is a hardware device (printer), not a machine learning algorithm that requires 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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