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510(k) Data Aggregation

    K Number
    K190327
    Device Name
    ENConnect 40 mm Screw Cap to ENPlus Adapter
    Manufacturer
    Cedic S.r.l.
    Date Cleared
    2019-04-09

    (55 days)

    Product Code
    PIF
    Regulation Number
    876.5980
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K170555
    Why did this record match?
    Device Name :

    ENConnect 40 mm Screw Cap to ENPlus Adapter

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

    The ENConnect 40 mm Screw Cap to ENPlus Adapter is intended to connect enteral giving sets, equipped with an ENPlus connector, to enteral nutrition crown cap bottles or wide neck reservoirs in order to deliver nutritional fluids.

    Device Description

    The ENConnect 40 mm Screw Cap to ENPlus Adapter (the proposed device) is a non-sterile, single use device consisting of screw cap with a 40 mm thread, an ENPlus port, vent, and gasket. The proposed device is intended to connect enteral giving sets, equipped with an ENPlus connector, via the ENPlus port to wide neck reservoirs and/or crown cap bottles containing enteral nutrition.

    AI/ML Overview

    This document, K190327, is a 510(k) Premarket Notification for a medical device called the "ENConnect 40 mm Screw Cap to ENPlus Adapter." It describes the device and its testing to demonstrate substantial equivalence to a predicate device.

    However, the request asks for information about acceptance criteria and studies proving an AI/Software as a Medical Device (SaMD) meets those criteria. Specifically, it asks about:

    • A table of acceptance criteria and reported device performance (typical for AI/SaMD metrics like sensitivity, specificity, F1-score, AUC).
    • Sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth, training set sample size, and how training ground truth was established.

    The provided document (K190327) is for a physical medical device (an adapter for enteral feeding), not an AI/SaMD. Therefore, it does not contain any of the information requested regarding AI/SaMD performance, ground truth establishment, or clinical study design specific to AI models.

    The document focuses on demonstrating substantial equivalence for a physical device through:

    • Non-clinical performance testing: This includes biocompatibility, flow rate, fluid leakage, ISO 18250-3 evaluations (dimensions, pressure leakage, stress cracking, resistance to separation), tensile testing, distribution simulation, and packaging tests. These are standard engineering and material science tests for physical devices to ensure safety and function, not AI performance metrics.
    • Comparison to a predicate device: The document explicitly states that the designs are different but do not impact safety and effectiveness, and then lists various physical characteristics and operational aspects for comparison.

    Therefore, it is impossible to extract the requested information from this document because it is not relevant to an AI/SaMD.

    To illustrate, if this were an AI/SaMD document, the acceptance criteria table might look like this (hypothetical, as the document doesn't provide it):

    1. Table of Acceptance Criteria and Reported Device Performance (Hypothetical for an AI/SaMD)

    MetricAcceptance CriteriaReported Device Performance
    Standalone Performance:
    Sensitivity≥ 90%92.5%
    Specificity≥ 80%85.1%
    AUC≥ 0.900.93
    Human-in-the-Loop Performance (with AI assistance):
    Reader AUC ImprovementStatistically significant improvement over unassisted readingp
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