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510(k) Data Aggregation

    K Number
    K974732
    Device Name
    NIDEK MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-7000
    Manufacturer
    NIDEK, INC.
    Date Cleared
    1998-03-18

    (90 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K932468,K930543
    Why did this record match?
    Device Name :

    NIDEK MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-7000

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

    Laser beam generated by MC-7000 is to be used for photocoagulation in ophthalmic indications in transpupillary and inter operative areas as in:

    Transpupillary Retinal Photocoagulation, either limited or Pan-Retinal
    Macular Photocaogulation
    Trabeculoplasty for Open Angle Glaucoma
    Iridotomy for Acute Angle Closure Glaucoma
    Inter Operative Retinal Photocoagulation, either limited or Pan-Retinal
    Macular Photocoagulation

    Device Description

    The Nidek MC-7000 now combines the benefits of Red, Yellow, Yellow-Green, and Green wavelengths into one single laser photocoagulation system. It's designed to work with the variety of slit lamp delivery systems in ophthalmology, and performs extended applications in endo and laser indirect photocoagulation.

    The MC-7000's design provides reliablility and ease of use. Its self-contained cooling eliminates the need for external cooling fixtures. The display panel attaches to the front of the console, or detaches to function as a remote, either way providing clear, concise information on settings and energies during every procedure.

    Laser Source: Multi-wavelength Single Tube Krypton Laser
    Wavelength: Red: 647.1nm, Yellow: 568.2nm, Green: 520.8 - 530.9nm
    Power To Cornea: Red: 50 - 1000mw, Yellow: 50 - 600mw, Yellow/Green: 50 - 1500mw, Green: 50 - 900mw
    Exposure Times: .02 sec to continuous (21 steps)
    Auto - Repeat: .2 - 1.0 sec between exposures (9 steps)
    Aiming Beam: 670nm Diode red, .8mw or less to the cornea.
    Deliver Systems: Nidek SL1600, Zeiss SL130 Full System, 30SL Adaptor, Haag 900BQ Full System, BIO, MIO, Combo, Endoprobe, OM adaptor
    Spot Sizes: Nidek SL1600 (50 - 1000mic.m Parfocal, 1000 - 2000mic.m Defocused), Zeiss SL130 (50 - 1000mic.m Parfocal, 1000 - 2000mic.m Defocused) Haag 900BQ (50 - 990mic.m Parfocal) Slit Lamp Adaptor (50 - 500mic.mParfocal) 50mic.m Fiber, 2.5m Light Cable
    Cooling: Internal Water Cooling
    Power Requirements: 190 -245V AC, 3 Phase, 50 Amp
    Size: Console - 16 x 39 x 48
    Weight: 389lbs

    AI/ML Overview

    The provided text is a 510(k) summary for the Nidek MC-7000 Photo coagulator and does not contain the specific information requested about acceptance criteria and a study proving the device meets those criteria. The document focuses on establishing substantial equivalence to predicate devices, describing the device, its intended use, and software validation processes. It lacks the quantitative performance data, sample sizes, expert qualifications, and study design details typically found in a clinical or performance study report.

    Therefore, I cannot extract the following information from the provided text:

    1. A table of acceptance criteria and the reported device performance
    2. Sample sizes used for the test set and data provenance
    3. Number of experts used to establish ground truth and their qualifications
    4. Adjudication method for the test set
    5. Multi-reader multi-case (MRMC) comparative effectiveness study details or effect size
    6. Standalone performance study details
    7. Type of ground truth used
    8. Sample size for the training set
    9. How the ground truth for the training set was established
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