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510(k) Data Aggregation

    K Number
    K171877
    Device Name
    SLM-1ER, SLM-2ER, SLM-3ER
    Manufacturer
    Chongqing Kanghua Ruiming S&T Co., Ltd.
    Date Cleared
    2017-12-21

    (181 days)

    Product Code
    HJO
    Regulation Number
    886.1850
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    K131589
    Why did this record match?
    Device Name :

    SLM-1ER, SLM-2ER, SLM-3ER

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

    The KH Ophthalmic Slit-lamp Microscope is an AC-powered slitlamp biomicroscope intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affects the structural properties of the anterior eye segment.

    Device Description

    The KH Ophthalmic Slit-lamp Microscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light. The KH Ophthalmic Slitlamp Microscope is composed of the following components: microscope unit, illumination unit, base unit, chinrest, and table and power unit. The slitlamp biomicroscope is used for the observation of the eye. It has an illumination unit to illuminate the eye, and a binocular stereoscopic microscope to zoom and observe patient's eyes, and also can observe the three-dimensional image.

    AI/ML Overview

    The provided text is a 510(k) summary for an ophthalmic slit-lamp microscope (SLM-1ER, SLM-2ER). It describes the device, its intended use, a comparison to a predicate device, and non-clinical testing performed to support substantial equivalence.

    Based on the content, this document does not describe an AI/ML-driven medical device, nor does it detail a study that proves a device meets acceptance criteria related to AI/ML performance metrics (like sensitivity, specificity, or AUC). The acceptance criteria described are for a traditional medical device (slit-lamp biomicroscope) and focus on safety, EMC, biocompatibility, and general performance standards.

    Therefore, it is not possible to provide the requested information about acceptance criteria for an AI/ML model and a study proving device performance against those criteria, including details on sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set details, or effect sizes for human readers.

    The document focuses on demonstrating substantial equivalence to a predicate device (Keeler Slit Lamp H-Series, K131589) by showing compliance with established medical device standards for safety and performance of an ophthalmic slit-lamp.

    Here's an overview of what is in the provided text, related to its acceptance:

    Acceptance Criteria and Reported Device Performance (as per the document):

    The acceptance criteria are implied by the compliance to various international standards. The "reported device performance" is essentially that the device met these standards.

    Acceptance Criteria (Implied by Standards Compliance)Reported Device Performance (as stated in document)
    Safety: Compliance with IEC 60601-1:2005 + CORR.1(2006) + CORR.2(2007) + AM1(2012) or IEC 60601-1:2012Met the requirements.
    EMC (Electromagnetic Compatibility): Compliance with IEC 60601-1-2:2007Met the requirements.
    Biocompatibility: Compliance with ISO 10993-1:2009 for contact materials (Cytotoxicity, Skin irritation, Vaginal irritation, Sensitization)Passed each biocompatibility test.
    General Ophthalmic Instruments Requirements: Compliance with ISO 15004-1:2006Met the requirements.
    Light Hazard Protection: Compliance with ISO 15004-2:2007 (Device classification)Device found to be a Group 2 instrument. (This is a classification based on the standard, implying compliance).
    Slit-lamp Microscope Specific Requirements: Compliance with ISO 10939:2007Complies with the requirements of the standard.
    Photobiological Safety: Compliance with IEC 62471:2006No explicit pass/fail statement, but listed as testing performed, implying compliance within the scope of the others. The text does mention "As a result of photo-toxicity testing to ISO 15004-2 maximum exposure increased from 13 to 17 minutes for bulb option," which is a performance characteristic derived from this testing.

    Regarding the other requested information (which is not applicable to this document as it's not an AI/ML device study):

    • Sample size for the test set and data provenance: Not applicable. The testing is for compliance with physical and electrical standards, not diagnosis or detection using a dataset.
    • Number of experts used to establish ground truth & qualifications: Not applicable. Ground truth for AI/ML performance is not relevant here.
    • Adjudication method: Not applicable.
    • MRMC comparative effectiveness study: Not applicable. This is not an AI/ML diagnostic aid.
    • Standalone (algorithm only) performance: Not applicable. This is a physical device, not an algorithm.
    • Type of ground truth used: Not applicable.
    • Sample size for the training set: Not applicable. There is no AI/ML model trained here.
    • How the ground truth for the training set was established: Not applicable.

    In summary, the provided document details the submission for a traditional ophthalmic slit-lamp biomicroscope, not an AI/ML diagnostic or assistive device. Therefore, the requested information pertaining to AI/ML acceptance criteria and performance studies cannot be extracted from this text.

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