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510(k) Data Aggregation

    K Number
    K964353
    Device Name
    CYBERLASE CO2 LASER SYSTEM
    Manufacturer
    NIDEK, INC.
    Date Cleared
    1997-02-28

    (119 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The CyberLase CO2 Laser Systems are intended for the surgical removal (i.e., excision, incision, cutting, ablation, coaqulation, homeostasis or vaporization) of soft tissue in all surgical applications with the use of wavelength of 10.6um. Areas to be covered are: Head and Neck(ENT) including Uvulopalatoplasty, Neurosurgery, General / Plastic Surgery, Dermatology, Oncology, Obstetrics/Gynecology, Orthopedics, Polymethylmethacrylate(PMMA) Removal during Revision Arthroplasty Procedures, and Thoracoscopic applications.

    Device Description

    Not Found

    AI/ML Overview

    This 510(k) submission (K96433) for the NIDEK CyberLase CO2 LASER SYSTEMS describes a medical device rather than an AI/ML-driven diagnostic or prognostic tool. Therefore, many of the requested criteria related to AI/ML device evaluation, such as sample sizes for test/training sets, ground truth establishment, expert adjudication, and MRMC studies, are not applicable to this submission.

    The submission focuses on demonstrating substantial equivalence to a predicate device for a conventional surgical laser system.

    Here's an attempt to answer the applicable sections based on the provided text, recognizing that many requested fields are not relevant:

    Acceptance Criteria and Device Performance for NIDEK CyberLase CO2 Laser Systems

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategorySpecific CriteriaReported Device Performance
    Regulatory ComplianceCompliance with 21 CFR 1040.10 and 1040.11 (FDA regulations for medical laser products)."The laser systems manufactured by Nidek Inc. comply with 21 CFR 1040.10 and 1040.11, FDA regulations for medical laser products, as applicable."
    Substantial EquivalenceEquivalence in indications for use, materials, method of operation, and physical construction to a predicate device."The Nidek CO2 Laser system is substantially equivalent to the Heraeus LaserSonics Paragon Laser System. The risks and benefits of the Nidek CyberLase CO2 Laser System is comparable to the predicate device when used for similar clinical applications. Since the Nidek CyberLase CO2 Laser System is substantially equivalent with respect to indications for use, materials, method of operation and physical construction to the predicate device, we believe it clearly meets the requirement for substantial equivalence according to Section 510(k) guidelines."
    Safety and EffectivenessReasonable assurance of safety and effectiveness."Safety and effectiveness are reasonably assured, therefore justifying 510(k) clearance for commercial sale." (This is a conclusion based on substantial equivalence.)
    Indications for UseIntended for surgical removal of soft tissue in specified surgical applications (Head and Neck, Neurosurgery, General/Plastic Surgery, Dermatology, Oncology, Obstetrics/Gynecology, Orthopedics, PMMA Removal, Thoracoscopic applications) using 10.6um wavelength.The device's stated indications for use match the intended applications. The comparison to the predicate device affirms that it can perform these functions safely and effectively.

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

    This information is not applicable to this type of 510(k) submission. There is no "test set" in the context of evaluating a conventional surgical laser device for performance metrics like sensitivity, specificity, or accuracy. The evaluation relies on demonstrating compliance with regulations and substantial equivalence to a predicate device through engineering specifications and a review of intended use.

    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)

    This information is not applicable. "Ground truth" in the context of expert review for diagnostic AI/ML devices is not relevant for evaluating a surgical laser system. The "ground truth" for a laser system relates to its ability to perform its intended surgical functions, which is assessed through engineering design, safety testing, and comparison to existing, approved technologies.

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

    This information is not applicable. Adjudication methods are used in AI/ML performance studies to resolve discrepancies among expert readers when establishing ground truth. This is not a component of evaluating a surgical laser system for 510(k) clearance.

    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

    This information is not applicable. MRMC studies are used to evaluate the impact of AI assistance on human reader performance in diagnostic tasks. This type of study is completely irrelevant for a surgical laser system.

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

    This information is not applicable. A surgical laser system is a physical tool operated by a human surgeon. It does not have a "standalone algorithm" in the sense of an AI/ML device that provides a diagnosis or output autonomously.

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

    This information is not applicable in the context of AI/ML performance evaluation. For a surgical laser system, the "ground truth" of its functionality is established through:

    • Engineering specifications and tests: Confirming the laser's power output, wavelength, spot size, safety features, etc., meet design requirements.
    • Clinical experience with predicate devices: The predicate device (Heraeus LaserSonics Paragon Laser System) has an established history of safe and effective use, which serves as a benchmark for the Nidek CyberLase.
    • Compliance with recognized standards: Meeting 21 CFR 1040.10 and 1040.11 provides assurance of performance.

    8. The sample size for the training set

    This information is not applicable. "Training sets" are used to develop AI/ML models. This is not an AI/ML device.

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

    This information is not applicable. As this is not an AI/ML device, there is no "training set."

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