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510(k) Data Aggregation

    K Number
    K200325
    Device Name
    Orbit Subretinal Delivery System
    Manufacturer
    Orbit Biomedical
    Date Cleared
    2020-07-14

    (155 days)

    Product Code
    FMF,HMX
    Regulation Number
    880.5860
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    K182274
    Predicate For
    K203264,K213467
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Orbit Subretinal Delivery System is indicated for microinjection into the subretinal space.

    Device Description

    The Orbit Subretinal Delivery System (SDS) is comprised of 3 primary component sets including the Subretinal Injection Device Set, the Tubing Set, and the Dosing Set. Each Orbit SDS Set contains sterile single-use only components. The Subretinal Injection Device set includes the magnetic pad, ophthalmic marker, and subretinal injection device (SID). The Tubing Set includes the components for priming the BSS line and pneumatic BSS control via a vitreoretinal surgical console. The Dosing Set includes the syringe for delivery of a precise dose of Balanced Salt Solution (BSS) or BSS PLUS® infusate.

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) summary for a medical device called the "Orbit Subretinal Delivery System." This document focuses on demonstrating substantial equivalence to a predicate device and outlines various performance tests conducted.

    However, it does not contain the specific information requested regarding acceptance criteria and a study proving a device meets those criteria in the context of an AI/ML powered device. Specifically, it lacks:

    1. A table of acceptance criteria and reported device performance for an AI/ML component.
    2. Sample size used for the test set and data provenance.
    3. Number of experts used to establish ground truth and their qualifications.
    4. Adjudication method for the test set.
    5. Information on a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or human reader improvement with AI assistance.
    6. Details about a standalone (algorithm only) performance study.
    7. Type of ground truth used (e.g., expert consensus, pathology, outcomes data).
    8. Sample size for the training set for an AI/ML model.
    9. How the ground truth for the training set was established for an AI/ML model.

    The document describes performance data related to biocompatibility, sterilization, packaging, shelf life, and simulated use for a physical medical delivery system, not an AI/ML algorithm.

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