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    K Number
    K230837
    Device Name
    PlazMagik
    Manufacturer
    Agnes Medical Co., Ltd
    Date Cleared
    2024-02-29

    (339 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K201735
    Why did this record match?
    Reference Devices :

    K201735

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

    PlazMagik is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

    Device Description

    The AGNES MEDICAL CO.,LTD PlazMagik is an electro-surgical device for use in dermatological applications. The effect of the device is achieved by heating the outer layer of the skin to that part or all or the epidermis becomes non-viable and there is controlled damage to the underlying dermis.

    The PlazMagik system consists of a system console, footswitch, Two type of handpiece and tip guide.

    AI/ML Overview

    This document describes the regulatory clearance for the PlazMagik electrosurgical device. It outlines the safety and performance testing conducted to demonstrate substantial equivalence to a predicate device, but it does not include acceptance criteria or a study proving that specific performance metrics are met against those criteria.

    Here's a breakdown of the information provided, and what is missing based on your request:

    1. Table of Acceptance Criteria and Reported Device Performance:

    • Missing from the document. The document lists various tests performed (Biocompatibility, Electrical Safety, Software Verification, Bench Testing, Ex Vivo Study), but it does not provide specific acceptance criteria for these tests nor does it report the precise performance metrics of the PlazMagik device against such criteria. For example, for "Output Energy" in bench testing, it states "Tested parameters included: Output Energy" but doesn't provide what the acceptable range for output energy was or what the device's actual output energy was.

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

    • Biocompatibility: Not specified.
    • Electrical Safety & EMC: Not specified.
    • Software Verification and Validation: Not specified.
    • Bench Testing: Not specified.
    • Ex Vivo Study:
      • Sample Size: "Ex Vivo testing conducted on three types of tissue - Liver, skin and Muscle." The number of samples within each tissue type is not specified.
      • Data Provenance: Not explicitly stated, but Ex Vivo studies are generally conducted in a laboratory setting. It's not retrospective or prospective in the clinical trial sense.

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

    • Not applicable. The document describes non-clinical testing. There is no mention of human-established ground truth or experts for these tests.

    4. Adjudication Method for the Test Set:

    • Not applicable. The document describes non-clinical testing. There is no mention of an adjudication method as would be used in a clinical study with human readers/assessors.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

    • No, an MRMC study was not done. The document explicitly states: "Clinical testing is not a requirement and has not been performed."

    6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

    • Not applicable. This device is an electrosurgical cutting and coagulation device, not an AI/algorithm-based diagnostic or therapeutic software. The "Software Verification and Validation Testing" refers to the control software within the device, not a standalone AI algorithm for medical image analysis or similar.

    7. The Type of Ground Truth Used:

    • Biocompatibility: Based on compliance with ISO standards (e.g., cell viability, presence/absence of irritation).
    • Electrical Safety & EMC: Based on compliance with IEC standards (e.g., meeting specified limits for electrical leakage, electromagnetic emissions/immunity).
    • Software Verification and Validation: Based on meeting design specifications and requirements.
    • Bench Testing: Based on predefined design specifications (e.g., output energy within a certain range, tip integrity after use).
    • Ex Vivo Study: Based on GLP Thermal testing in accordance with FDA guidance, likely assessing tissue effects (e.g., coagulation depth, thermal spread) against expected outcomes or safety limits.

    8. The Sample Size for the Training Set:

    • Not applicable. This device is hardware with embedded control software; it does not involve machine learning or a "training set" in the context of AI.

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

    • Not applicable. (See point 8).

    Summary of what is present vs. missing:

    The document provides evidence of various non-clinical tests conducted to support the safety and substantial equivalence of the PlazMagik device. It lists the types of tests and the standards followed, and generally reports "Pass" for biocompatibility and indicates that electrical safety/EMC and software testing were "conducted" and "shows that the device is safe and meets requirement." However, it does not provide the specific quantitative acceptance criteria or the measured performance values that would allow for a direct comparison in a table as requested. It also explicitly states that no clinical (human) testing was performed, which means no human reader studies, ground truth experts, or training sets in the AI context were involved.

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