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510(k) Data Aggregation

    K Number
    K212458
    Date Cleared
    2022-01-20

    (168 days)

    Product Code
    Regulation Number
    876.1500
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    Flexible Video-Uretero-Renoscope SSU System

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

    The SSU Flexible Video-Uretero-Renoscope System is indicated for endoscopic examination in the urinary tract and can be used to examine the interior of the kidney, and using additional accessories, to perform various diagnostic and therapeutic procedures.
    E-Box: the product serves as an adaptor for operating the flexible single-use videoscope on the compatible CCU.

    Device Description

    The videoscopes in the modified Flexible Video-Uretero-Renoscope SSU System are sterile single-use, flexible video-endoscopes. The distal tip houses the CMOS (Complementary Metal Oxide Semiconductor) imaging sensor and the LED light source. The raw data captured at the distal tip CMOS imaging censor is transferred to the E-Box adaptor, where it is converted to a standard NTSC (National Television System Committee) video signal by the PCB (Printed Circuit Board), which is then driven into one of the CCUs (C-MAC, C-HUB II, or X-LINK + IMAGE 1S Connect) for further processing and video formatting for output to a display monitor. The videoscopes and E-Box are powered by the CCUs through the connecting cords.

    AI/ML Overview

    Here's a summary of the acceptance criteria and study information based on the provided text, focusing on the performance of the SSU Flexible Video-Uretero-Renoscope System:

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

    The document does not explicitly state acceptance criteria in numerical terms for the performance characteristics. Instead, it compares the subject device's performance characteristics to those of a predicate device (KARL STORZ Flexible Video-Uretero-Renoscope System K141250) to demonstrate substantial equivalence. The "Acceptance Criteria" column below will reflect the predicate device's corresponding specifications where applicable, or indicate "Met design specifications" if specific targets for the subject device are not detailed but performance testing was done.

    CharacteristicAcceptance Criteria (Predicate Device K141250)Reported Device Performance (SSU Flexible Video-Uretero-Renoscope SSU System)
    Maximal Outer diameter Insertion PortionSame as subject device3.2 mm
    Outer diameter Insertion TubeSame as subject device2.9 mm
    Outer diameter Distal EndSame as subject device3.2 mm
    Insertion portion length675 mm700 mm
    Working channelPresentPresent
    Inner diameter Working ChannelSame as subject device1.2 mm
    Tip deflection up/downSame as subject device270°/270°
    Field of view90°110°
    Direction of ViewSame as subject device
    Depth of Field4 - 60 mm5 - 50 mm
    On-axis Resolution (at 5/4 mm)11.0 Lp/mm at 4 mm12.5 Lp/mm at 5 mm
    On-axis Resolution (at 15/12 mm)4.0 Lp/mm at 12 mm4.5 Lp/mm at 15 mm
    On-axis Resolution (at 50/60 mm)1.0 Lp/mm at 60 mm1.25 Lp/mm at 50 mm
    Chip typeSame as subject deviceCMOS
    Chip locationSame as subject deviceDistal
    Illumination sourceSame as subject deviceLED
    Compatible CCUImage 1SC-MAC, C-HUB II, Image 1S
    How device is providedUnsterile, reusableSterile single-use
    EO Sterilization cycleN/AEO, Overpressure 2.7 bar absolute, 8.5 % ETO in 91.5 % C02
    Sterilizing AgentN/AEthylene Oxide (EO)
    Electrical Safety and EMCIEC 60601-1, IEC 60601-1-2, IEC 60601-2-18Met requirements of these standards
    IEC 62471Met requirements of this standardMet requirements of this standard
    ISO 10993Met requirements of this standardMet requirements of this standard
    ISO 8600Met requirements of this standardMet requirements of this standard
    Performance Testing (General)Not explicitly detailedPerformed (Color Contrast Enhancement, Image intensity uniformity, Depth of field & Spatial Resolution, Distortion, Signal-to-Noise Ratio (SNR) & Sensitivity) - Met design specifications.

    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, "Clinical testing was not required to demonstrate the substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establish the substantial equivalence of the modifications." This indicates that no clinical test set (i.e., human patient data) was used.

    The performance was evaluated through non-clinical bench testing. The sample size for these bench tests is not explicitly stated in the provided text, nor is the provenance of the data from these bench tests (e.g., if specific components were sourced from different countries or if testing was done in a specific lab location). The submitter, KARL STORZ SE & Co. KG, is located in Tuttlingen, Germany.

    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)

    Since no clinical testing was performed, no experts were used to establish ground truth for a clinical test set. The performance was evaluated against design specifications and recognized consensus standards by the technical personnel conducting the bench testing.

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

    As no clinical test set was used, no adjudication method was applicable or performed.

    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 MRMC comparative effectiveness study was done. The device itself is an endoscope system, not an AI-assisted diagnostic tool.

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

    Not applicable. This device is an endoscope system that requires human operation and interpretation. It is not an algorithm performing a standalone task.

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

    For the non-clinical bench testing, the "ground truth" implicitly used would be engineering and physical measurements taken against established specifications and recognized consensus standards. For example, "on-axis resolution" would be measured using standardized targets and optical equipment, with the expected values derived from known optical principles and predicate device data.

    8. The sample size for the training set

    Not applicable. This device is a hardware medical device (an endoscope system), not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its design and performance are based on engineering principles and verified through bench testing.

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

    Not applicable. As there is no training set for an AI algorithm.

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