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510(k) Data Aggregation

    K Number
    K182407
    Device Name
    Exceed Microneedling device
    Manufacturer
    Mt. Derm GmbH
    Date Cleared
    2019-07-19

    (318 days)

    Product Code
    QAI
    Regulation Number
    878.4430
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    DEN160029
    Predicate For
    K233709,K241790,K250188
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Exceed is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in Fitzpatrick skin types I, II, III and IV in adults aged 22 years or older.

    Device Description

    The Exceed micro needling device is intended to create many, very tiny, microscopic punctures in the epidermal and dermal layers of the skin using sterile stainless-steel needles. The Exceed micro needling device consists of 7 component parts; Control Unit, Sterile single use Safety needle cartridge, Handpiece, Handpiece holder, Handpiece cover, Footswitch, Power supply.

    The control unit switches the device on and off and contains the power source (5.5-12 V, DC (150mA)). The control unit adjusts the frequency of the needle stroke from 100-150Hz using a digital display and a keypad. The control unit receives power via a coaxial connector from a standard 100-240V, 50-60Hz, 1.2A wall socket transformer with an output of 15V. The handpiece contains a motor that moves the needles and a needle protrusion gauge that allows the user to control the depth of the needle protrusion from 0 - 1.9mm. The handpiece contains a scale that allows for the needle protrusion depth to be adjusted by the operator. The scale has a tolerance of ±0.15 mm. The standard safety needle cartridge is a 6-stainless steel micro needle plate of 1.5 mm length. The safety needle cartridge is screwed into the handpiece. The safety needle cartridge is sterile and for single use only. This standard safety needle cartridge is used for Microneedling only. The length of needles is 1.5 mm. In combination with the handpiece needle protrusion can be adjusted between 0.0 mm (min) and a maximum of 1.5 mm.

    AI/ML Overview

    This document describes the safety and effectiveness study for the Exceed Microneedling device.

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria are implied through the study's focus on demonstrating improvement in facial acne scars and safety outcomes. While no explicit percentage or threshold for "improvement" is stated as an acceptance criterion in an absolute sense, the study aims to show statistically significant or clinically meaningful improvement, and acceptable safety profiles compatible with similar aesthetic devices.

    Acceptance Criterion (Implied)Reported Device Performance (Effectiveness)Reported Device Performance (Safety)
    Improvement in appearance of facial acne scars (Physician-assessed)Mean ASAS score reduction from 2.89 at baseline to 2.27 at final follow-up.- 59% of subjects improved by 1 grade (as agreed by 2 of 3 blinded physicians).- 83% of subjects showed some improvement (improvement > 0 but < 1).N/A
    Improvement in appearance of facial acne scars (Subject-assessed - SASIS)88% of subjects reported some improvement (1-99% improvement).- 41.9% reported 1-25% improvement.- 34.9% reported 25-50% improvement.- 9.3% reported 50-75% improvement.- 2.3% reported 75-99% improvement.N/A
    Improvement in appearance of facial acne scars (Subject-assessed - SGAIS)77% of subjects reported some improvement.- 9.3% reported 'Much Improved'.- 67.4% reported 'Improved'.N/A
    Subject satisfaction with treatment86% of subjects noticed improvement in how their acne scars looked.81.5% were satisfied or extremely satisfied (16.3% extremely, 41.9% satisfied, 23.3% slightly satisfied).88% would recommend the treatment to friends and family.N/A
    Acceptable safety profile (Adverse Events)N/ANo serious adverse events reported.No adverse events persisted at final follow-up.26 adverse events in 18 subjects (32%).- 88.5% mild, 11.5% moderate.- Most common: Bruising (6 events), Swollen lymph-nodes (6 events).
    Acceptable safety profile (Pain and Discomfort)N/AMean pain score: 2.8 on treatment evening, <1 by day 3, 0.05 by day 7.Mean discomfort score: 3.20 on day 1, <1 by day 4, 0.12 by day 7.
    Acceptable safety profile (Redness)N/A49% moderately red, remainder mild or less on treatment evening.94% minimal or absent redness by day 5.

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

    • Sample Size: 56 subjects were recruited for the clinical study. 47 subjects (83.9%) completed all treatment and follow-up visits.
    • Data Provenance: The document does not explicitly state the country of origin. It indicates "a single center" for the study. Since the applicant is "MT.DERM GmbH" from Germany, it is plausible the study was conducted there, but not definitively stated. The study was prospective, clinical, and interventional.

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

    • Number of Experts: 3 physicians.
    • Qualifications of Experts: The document states they were "3 blinded physicians" but does not provide specific qualifications (e.g., years of experience, specialty beyond 'physician'). They used a validated 5-point photo numeric descriptive grading scale (Acne Scar Assessment Scale - ASAS) to grade acne scarring.

    4. Adjudication Method for the Test Set

    • The digital images were "randomized and analyzed independently by 3 physicians."
    • For the "Physician measurement of effectiveness," one of the reported metrics is "Subjects improved 1 grade as agreed upon by 2 of 3 blinded physicians." This indicates a 2+1 majority consensus method for this specific outcome.

    5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

    • No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This study is for a microneedling device used for aesthetic purposes, not an AI-assisted diagnostic tool.

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

    • No, a standalone (algorithm only) performance study was not done. This device is a physical microneedling device for aesthetic treatment, not a software algorithm.

    7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)

    • The ground truth for effectiveness was established through:
      • Expert Consensus: Independent assessment by 3 blinded physicians using the validated Acne Scar Assessment Scale (ASAS) based on digital photographs. A 2-out-of-3 consensus was used for some metrics.
      • Subject-Reported Outcomes: Self-assessed Scar Improvement Scale (SASIS), Subject Global Aesthetic Improvement Scale (SGAIS), and direct satisfaction questions.
    • The ground truth for safety was established through:
      • Physician-recorded adverse events.
      • Subject-reported pain, discomfort, and redness via daily diaries and visual analogue/descriptive scales.

    8. The Sample Size for the Training Set

    • There is no mention of a separate "training set" in the context of this microneedling device study, as it is a physical treatment device, not an AI model requiring a training dataset. The 56 subjects represent the clinical study (test) population.

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

    • Not applicable, as there was no explicit "training set" for an AI model. The mentioned clinical study focused on evaluating the device's performance in a prospective manner on its target population.
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