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510(k) Data Aggregation

    K Number
    K221589
    Device Name
    Starly pad
    Manufacturer
    Shenzhen Xingyuanli Technology Co., Ltd.
    Date Cleared
    2023-03-24

    (296 days)

    Product Code
    GXY
    Regulation Number
    882.1320
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K190700
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Starly pad is intended to transmit electrical current to patient skin for use with legally marketed electrical stimulation devices, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). The Starly pad is for OTC (Over-The-Counter) or Prescription use. The Starly pad is for adults only.

    Device Description

    The Starly pad consists of Insulation backing layer, Adhesive layer, Conducting film, Gel layer, Protective film and Snap fastener.

    AI/ML Overview

    This document details the FDA 510(k) clearance for the Starly pad, a cutaneous electrode. The information provided is primarily focused on demonstrating substantial equivalence to a predicate device, rather than a detailed "study that proves the device meets the acceptance criteria" in the context of an AI/ML-based medical device.

    Therefore, many of the requested elements for an AI/ML study (like sample size for test set, number of experts, MRMC studies, ground truth establishment for AI training) are not applicable or not present in this document, which pertains to a Class II physical medical device.

    However, I can extract the relevant acceptance criteria and performance data for this physical device as described in the provided text.

    Device Name: Starly pad
    Device Type: Cutaneous Electrode
    Regulation Number: 21 CFR 882.1320 (Cutaneous Electrode)
    Product Code: GXY

    Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance (Starly pad)Predicate Device Performance (Electrodes pad - K190700)
    DimensionThickness: 2.0mm ± 0.5mm
    Width: 20 mm ~ 300 mm (integers specification only, ±0.5mm)
    Length: 20 mm ~ 300 mm (integers specification only, ±0.5mm)Length: 20~300 mm
    Width: 20~300 mm
    Height (thickness): 1~20 mm
    Impedance100-300Ω
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