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510(k) Data Aggregation

    K Number
    K173022
    Device Name
    SeaSpine Ventura NanoMetalene System
    Manufacturer
    SeaSpine Orthopedics Corporation
    Date Cleared
    2017-10-26

    (28 days)

    Product Code
    MAX
    Regulation Number
    888.3080
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K162715,K142488,K082310,K102026
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    When used as an intervertebral body fusion device, the system is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had six months of non-operative treatment. The device is intended to be used with autogenous bone graft (autograft) and supplemental fixation.

    Device Description

    The SeaSpine Ventura NanoMetalene (NM) System is an intervertebral fusion device manufactured from polyetheretherketone (PEEK) per ASTM F2026 with tantalum markers per ASTM F560 for radiographic visualization. The implants have a one-micron thick surface coat of commercially pure (CP) titanium. The devices have a central canal for receiving autogenous bone graft and are offered in a variety of sizes and geometries to accommodate variations in pathology and patient anatomy.

    AI/ML Overview

    This document is a 510(k) premarket notification for the SeaSpine Ventura NanoMetalene System, an intervertebral body fusion device.

    Based on the provided text, there is NO information about acceptance criteria or a study proving the device meets acceptance criteria related to a software algorithm or AI performance.

    The document explicitly states under "Clinical Testing":
    "Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data."

    The "Non-Clinical Testing" section describes tests related to:

    • Packaging
    • Shipping
    • Sterilization
    • Bacterial Endotoxin testing (BET)

    These tests are for the physical device's sterility and packaging integrity, not for the performance of a diagnostic algorithm or AI system.

    Therefore, I cannot provide the requested information for acceptance criteria and a study proving a device meets them, specifically regarding an AI-driven or diagnostic device performance, because the provided filing pertains to a physical medical implant device (intervertebral body fusion device) and states that clinical performance data was not used for the substantial equivalence determination.

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