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510(k) Data Aggregation

    K Number
    K990441
    Device Name
    INSIGHT SPHINCTER OF ODDI MANOMETRY MODULE, MODEL S981300
    Manufacturer
    SANDHILL SCIENTIFIC, INC.
    Date Cleared
    1999-05-12

    (90 days)

    Product Code
    FFX
    Regulation Number
    876.1725
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K984444,K932306,K900058
    Why did this record match?
    Device Name :

    INSIGHT SPHINCTER OF ODDI MANOMETRY MODULE, MODEL S981300

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

    The Sphincter of Oddi Manometry Module is intended for use by Gastroenterologists or Surgeons to determine intraluminal pressures within the pancreaticobiliary ductal system and motor activity within the sphincter of Oddi zone. The InSIGHT Sphincter of Oddi Manometry Module includes analysis software, but requires skilled interpretation by a physician to make a diagnosis.

    Device Description

    The Sphincter of Oddi Manometry Module is intended for use by Gastroenterologists or Surgeons to determine intraluminal pressures within the pancreaticobiliary ductal system and motor activity within the sphincter of Oddi zone. The InSIGHT Sphincter of Oddi Manometry Module includes analysis software, but requires skilled interpretation by a physician to make a diagnosis. The SOM Module is intended for use only with the InSIGHT Model S980000 Gastrointestinal Motility system (K984444). The InSIGHT system consists of three basic subsystems: Signal conditioning and recording hardware, Analysis software, and Probes and transducers.

    AI/ML Overview

    The provided text describes a medical device called the InSIGHT Sphincter of Oddi Manometry Module and its submission for 510(k) clearance. However, it explicitly states that no formal clinical testing was performed. Therefore, there is no study described that proves the device meets specific acceptance criteria based on performance metrics.

    Here's a breakdown of the requested information based on the provided text, highlighting the absence of performance-based acceptance criteria and a corresponding study:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Not explicitly defined as performance criteria. The submission focuses on substantial equivalence to predicate devices in terms of safety and performance, and compliance with general safety standards.The device is stated to exhibit "features equivalent in safety and performance to those included on prior legally marketed devices." No specific performance metrics (e.g., sensitivity, specificity, accuracy, precision) are provided. The device "performs as well as or better than the legally marketed predicate devices" but no data is presented to support this.
    Compliance with UL 2601-1: Standard for Medical Electrical Equipment, Part 1: General Requirements for Safety.Design certified through internal design testing to written protocols and outside laboratories.
    Mitigation or elimination of all known health hazards.Accomplished by rigorous application of a risk management program, including design modifications, detection and alarming of hazard conditions, and clear labeling in the instruction manual.

    2. Sample Size Used for the Test Set and Data Provenance

    • Sample Size: Not applicable. No test set for performance evaluation was used as no formal clinical testing was performed.
    • Data Provenance: Not applicable.

    3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

    • Not applicable. No test set was used to establish ground truth for performance evaluation.

    4. Adjudication Method for the Test Set

    • Not applicable. No test set was used for performance evaluation.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

    • No and Effect Size: No MRMC comparative effectiveness study was done. The submission explicitly states, "No formal clinical testing has been performed, nor is any believed to be necessary." Therefore, there is no reported effect size regarding human reader improvement with AI assistance. The device includes analysis software, but relies on "skilled interpretation by a physician to make a diagnosis," indicating a human-in-the-loop system, but its comparative effectiveness was not studied.

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

    • No: The device "includes analysis software, but requires skilled interpretation by a physician to make a diagnosis." This indicates a human-in-the-loop system, and no standalone algorithm performance was reported or evaluated.

    7. The Type of Ground Truth Used

    • Not Applicable for Performance: Since no formal clinical testing or performance study was conducted, no ground truth (e.g., expert consensus, pathology, outcomes data) was established for validating device performance against clinical reality. The "ground truth" for the submission's claims revolves around comparison to technical specifications and general safety standards of predicate devices.

    8. The Sample Size for the Training Set

    • Not Applicable / Not Provided: The nature of the device (a manometry recording system with analysis software, not explicitly an AI/ML algorithm requiring extensive training data in the modern sense) and the stated lack of formal clinical testing mean no training set sample size is provided or appears relevant to this submission.

    9. How the Ground Truth for the Training Set Was Established

    • Not Applicable / Not Provided: As no training set is described in the context of performance-based ground truth, this information is not available.
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