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510(k) Data Aggregation

    K Number
    K030718
    Device Name
    SCB COMPUTER MOTION INTERFACE CONTROLLER
    Manufacturer
    COMPUTER MOTION, INC.
    Date Cleared
    2003-06-05

    (90 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 :

    SCB COMPUTER MOTION INTERFACE CONTROLLER

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

    The SCB Computer Motion Interface Controller is indicated for use with the Storz Communication Bus (SCB) manufactured by Karl Storz to connect HERMES-Ready™ devices to the SCB.

    Device Description

    The SCB Computer Motion Interface Controller (SCIC) connects devices that are controlled by Computer Motion's voice-control system to the Storz Communication Bus (SCB) manufactured by Karl Storz.

    AI/ML Overview

    The provided document is a 510(k) summary for a medical device called the "SCB Computer Motion Interface Controller" (SCIC). It focuses on establishing substantial equivalence to a predicate device and demonstrating adherence to various electrical and safety standards.

    There is no information in the provided document about:

    • Acceptance criteria for clinical performance or diagnostic accuracy. The document exclusively discusses electrical safety and functional equivalence.
    • A clinical study involving human patients or data to prove device performance in terms of diagnostic or clinical outcomes.
    • Sample sizes for test sets or training sets.
    • Data provenance (country of origin, retrospective/prospective).
    • Number of experts or their qualifications for establishing ground truth.
    • Adjudication methods.
    • Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
    • Standalone algorithm performance.
    • Types of ground truth (pathology, outcomes data).

    The "Device Testing" section only mentions "Hazard analyses and hardware/software validations procedures were provided in this submission." This indicates that the testing focused on engineering and functional validation, not clinical performance.

    Based on the provided text, the only "acceptance criteria" and "device performance" described are related to compliance with electrical and medical device safety standards.

    Here's a summary of what is available regarding acceptance criteria and performance:

    1. Table of Acceptance Criteria and Reported Device Performance

    Test / StandardTitleDevice Performance (Implied)
    IEC 601-1International Standard for Medical Electrical EquipmentCompliant (Implied by submission for 510(k))
    IEC 601-1-1International Standard for Medical Electrical EquipmentCompliant (Implied by submission for 510(k))
    IEC 601-2-18International Standard for Medical Electrical EquipmentCompliant (Implied by submission for 510(k))
    UL 2601-1Underwriters Laboratory (Standard for Medical Electrical Equipment)Compliant (Implied by submission for 510(k))
    EN55011/A1 CISPR 11Conducted EmissionCompliant (Implied by submission for 510(k))
    EN55011/A1 CISPR11Radiated EmissionCompliant (Implied by submission for 510(k))
    EN61000-4-2Electrostatic DischargeCompliant (Implied by submission for 510(k))
    EN61000-4-3 and EN50140RF ImmunityCompliant (Implied by submission for 510(k))
    EN61000-4-4EFT/Bursts ImmunityCompliant (Implied by submission for 510(k))
    EN61000-4-5Surge ImmunityCompliant (Implied by submission for 510(k))
    EN61000-4-6Conducted ImmunityCompliant (Implied by submission for 510(k))
    EN60601-1International Standard for Medical Electrical EquipmentCompliant (Implied by submission for 510(k))
    EN60601-1-1General Requirements for Safety - Collateral StandardCompliant (Implied by submission for 510(k))
    EN 60601-1-2Emissions and Immunity Test MeasurementsCompliant (Implied by submission for 510(k))
    CAN/CSA-C22.2 No. 601.1Medical Electrical Equipment Part 1, General Requirements for Safety, General Instructions Part 1Compliant (Implied by submission for 510(k))
    VA-19795CMI Environmental TestingCompliant (Implied by submission for 510(k))
    Substantial Equivalence to HERMES® Port ExpanderFunctional equivalence in extending connectivity from a central control system for medical devices.Achieved (FDA determined substantially equivalent)
    Hazard analyses and hardware/software validationsSafety and effectiveness of the device when connecting HERMES-Ready™ devices to the Storz Communication Bus.Demonstrated safety and effectiveness

    Study Demonstrating Acceptance Criteria:

    The "study" or rather, the evidence provided to demonstrate that the device meets its acceptance criteria, consists of the following:

    • Compliance with various international and national electrical and medical device safety standards (IEC, UL, EN, CISPR, CSA). The document explicitly lists these tests that the SCIC was subjected to.
    • Hazard analyses and hardware/software validation procedures. These were submitted as part of the 510(k) application.
    • Establishment of substantial equivalence to the predicate device (HERMES® Port Expander) in terms of intended use and technological characteristics (providing additional device connection ports). The FDA's letter confirms this determination.

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

    • Not Applicable. This device is an interface controller, not a diagnostic or clinical AI device that processes data from a test set of patient cases. The testing described relates to electrical safety and functional validation of the hardware and software components.

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

    • Not Applicable. See point 2.

    4. Adjudication method for the test set

    • Not Applicable. See point 2.

    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 is not an AI device involved in diagnostic interpretation or human reader assistance.

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

    • Not Applicable. This is not an algorithm or AI device. It's a hardware interface controller.

    7. The type of ground truth used

    • Not Applicable. The "ground truth" for this device's validation is adherence to engineering specifications, electrical safety standards, and functional performance as an interface. There is no biological or diagnostic "ground truth" in the context of this submission.

    8. The sample size for the training set

    • Not Applicable. This is not a machine learning or AI device that requires a training set.

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

    • Not Applicable. See point 8.
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