LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K960944
    Device Name
    PPV VAPORIZER (MODIFICATION)
    Manufacturer
    PENLON LTD.
    Date Cleared
    1996-04-02

    (49 days)

    Product Code
    CAD
    Regulation Number
    868.5880
    Type
    Traditional
    Panel
    Anesthesiology (AN)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PPV VAPORIZER (MODIFICATION)

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

    Not Found

    Device Description

    Penlon PPV Vaporizers

    AI/ML Overview

    This document is a summary of safety and effectiveness for Penlon PPV Vaporizers, submitted in accordance with SMDA 1990. It describes compliance with "ASTM F1161:1988 Clause 12" and "Clause 4" of the same standard. It also mentions a hazard analysis and user manual improvements.

    However, the provided text does not contain the specific information required to complete your request, which focuses on:

    • Acceptance Criteria Table and Device Performance: The document states compliance with a standard but doesn't list specific acceptance criteria (e.g., performance metrics, thresholds) or reported device performance against those criteria. It only mentions general compliance.
    • Sample size and data provenance for test set: No information.
    • Number of experts and qualifications for ground truth: No information.
    • Adjudication method for test set: No information.
    • Multi-reader multi-case (MRMC) comparative effectiveness study: No information on human reader improvement with/without AI.
    • Standalone algorithm performance: This document describes a medical device (vaporizer), not an AI algorithm, so standalone performance is not applicable in the requested context.
    • Type of ground truth used: Not applicable as it's not a diagnostic AI study.
    • Sample size for training set: Not applicable.
    • How ground truth for training set was established: Not applicable.

    The document is purely a regulatory submission summary for a physical medical device, not a study report for an AI/software-as-medical-device (SaMD) that would typically involve the requested performance evaluation details.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1