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510(k) Data Aggregation

    K Number
    K120932
    Device Name
    OPELASER PRO II AND THE OPELASER LITE II
    Manufacturer
    THE YOSHIDA DENTAL MFG. CO., LTD.
    Date Cleared
    2012-12-07

    (254 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K031440,K030147
    Why did this record match?
    Device Name :

    OPELASER PRO II AND THE OPELASER LITE II

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

    The Opelaser Family is CO2 Medical Laser Systems (and the delivery system that are used to deliver laser energy) are indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynecology (including laparoscopy), neurosurgery, orthopedics (soft tissue), arthroscopy (knee), general and thoracic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery.

    Device Description

    These are CO2 Laser devices designed for surgical applications. The maximum power output for the PRO model is 7 watts, and for the LITE model, 5 watts. Type of laser is a CO2 gas laser (class 4); Oscillation system: RF discharge excitation oscillation; Light guiding system: SiO2 hollow fiber or 6 point articulated arm depending on model; Oscillation wavelength: 10.6um.

    AI/ML Overview

    The provided text is a 510(k) summary for the OPELASER PRO II and OPELASER Lite II surgical laser devices. It outlines the device's identification, description, indications for use, and a comparison to predicate devices. Crucially, it primarily discusses the regulatory process of demonstrating "substantial equivalence" to already legally marketed devices, rather than a clinical study establishing specific performance metrics against pre-defined acceptance criteria for a novel AI/software component.

    Therefore, many of the requested details about acceptance criteria, clinical study specifics, ground truth, and expert involvement are not present in the provided document, as this type of information is typically associated with studies demonstrating the performance of a diagnostic or algorithmic device, especially in the context of AI. This document focuses on the safety and effectiveness of a physical surgical laser, not an AI or software-based diagnostic tool.

    Here's an attempt to answer the questions based only on the provided text, indicating where information is not available:

    1. A table of acceptance criteria and the reported device performance

    Acceptance CriteriaReported Device Performance
    Not explicitly stated as quantifiable metrics. The overarching criterion is "Substantial Equivalence" to predicate devices for safety and effectiveness."This device has the same indications for use as the predicate device and employs nearly identical technology to accomplish the same task. Delivered energy levels and wavelengths are essentially the same."
    "The OPELASER systems have undergone extensive safety and bench testing as well as software validation and risk analysis."
    "The ability to sterilize the laser tips has been validated."
    "Tested and certified by the NRTL (Nationally Recognized Test Lab) Intertek. Certification to IEC/UL 60601-1 and IEC 60601-1-22 has been accomplished."

    Note: The document focuses on regulatory compliance and substantial equivalence rather than specific performance metrics (e.g., sensitivity, specificity, accuracy) typically associated with AI or diagnostic device studies.

    2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

    • Sample Size for Test Set: Not applicable/Not provided. The submission describes non-clinical safety, bench, and software validation tests directly on the device, not a test set of data.
    • Data Provenance: Not applicable/Not provided.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

    Not applicable/Not provided. This type of expert involvement would be relevant for a diagnostic AI study, but the provided text concerns a physical surgical laser.

    4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

    Not applicable/Not provided.

    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. This document does not mention an MRMC study or any AI component designed to assist human readers.

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

    Not applicable. The device is a surgical laser, not a standalone algorithm.

    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

    Not applicable/Not provided. The "truth" in this context is the device's ability to meet safety standards and perform its intended surgical functions as demonstrated through engineering tests and comparison to predicates.

    8. The sample size for the training set

    Not applicable/Not provided. There is no mention of a training set as this is not an AI/machine learning submission.

    9. How the ground truth for the training set was established

    Not applicable/Not provided.

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