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510(k) Data Aggregation

    K Number
    K990731
    Device Name
    EASTGATE PERSONAL MONITOR
    Manufacturer
    EASTGATE TRADING CORP.
    Date Cleared
    1999-05-19

    (75 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    EASTGATE PERSONAL MONITOR

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

    THE EASTGATE TRADING PERSONAL MONITOR CAN BE USED FOR ANY PROCEDURE THAT REQUIRES A VIDEO DISPLAY. IT IS DESIGNED TO SIT ON THE BRIDGE OF THE NOSE. IN THIS POSITION A MEDICAL PERSON IS ABLE TO SEE THE MONITOR PICTURE AND THE SURROUNDING AREA AT THE SAME TIME.

    THE PERSONAL MONITOR IS PROVIDED WITH ACCESSORIES TO PLUG INTO ANY VIDEO OUTPUT. IT CAN BE USED BY ITSELF OR IN CONJUNCTION WITH OTHER VIDEO MONITORS.

    AS AN EXAMPLE IN ENDOSCOPIC SURGERY THE DOCTOR WOULD ATTACH THE VIDEO FEED TO THE REGULAR MONITOR DEVICE. BY DOING THIS THE DOCTOR COULD VIEW THE PATIENT AND THE CAMERA IMAGE AT THE SAME TIME.

    AS THIS MONITOR HAS A UNIVERSAL VIDEO PLUG IT COULD BE ATTACHED TO ANY MEDICAL DEVICE WITH A VIDEO OUTPUT.

    Device Description

    THE PERSONAL MONITOR IS A BIOCULAR VIDEO MONITOR. DISPLAY-BIOCULAR, SINGLE LCD RESOLUTION-180,000 PIXEL OPITCAL SYSTEM-ACHROMATIC FIELD OF VIEW-18.750 DIAGONAL BRIGHTNESS 20FL CONTRAST 200:1 EYE RELIEF 28MM INTER-PUPILARY DISTANCE 58MM-77 MM ADJUSTABLE HORIZONTAL ANGULAR RESOLUTION 3,37 INTERFACE NTSC/PAL COMPOSITE POWER 7-9V DC FOCUS ADJUSTMENT- NO MONITOR BLOCK WT- 36 GRAMS MONITOR BLOCK SIZE-9.5X4X3.5CM MOUNTING EYEGLASSES. SEE THROUGH-NO SEE-AROUND-YES CONTROLLER NIT WT-80 GRMS ONTROLLER UNIT SIZE-2.0X11X5 CM &BLE DISTANCE OPTIONAL

    AI/ML Overview

    The provided text is a 510(k) summary for the EASTGATE TRADING CORP. Personal Monitor. It describes the device, its intended use, and states that it is substantially equivalent to two previously marketed monitors (ALBATECH PERSONAL MONITOR K-981-999 and MEDIVISION PERSONAL MONITOR K-961-343).

    However, the document does not contain any information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies for the device.

    The 510(k) summary focuses on demonstrating substantial equivalence based on technological characteristics and intended use, rather than presenting a detailed performance study with acceptance criteria.

    Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details based on the provided text.

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