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510(k) Data Aggregation

    K Number
    K230463
    Device Name
    NSite Scoliosis Assessment App
    Manufacturer
    Date Cleared
    2023-11-15

    (267 days)

    Product Code
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    LDK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The NSite Scoliosis Assessment App is intended as an adjunct tool for qualified healthcare professionals to provide deformity measurements and guide management recommendations based on a calculated Asymmetry Index for patients with or at risk for idiopathic scoliosis, which will yield an output of clinically significant scoliosis, which is defined as a Cobb Angle greater than 20 degrees.
    Device Description
    NSite Medical leverages 3D scanning on a mobile device for scoliosis screening and monitoring. NSite's proprietary algorithm calculates the risk of having clinically significant scoliosis that may require treatment by a specialist. The NSite Scoliosis Assessment App generates a 3D scan of the individual using a mobile device camera. Using the 3D scan, the application analyzes the asymmetry of the individual's back surface and calculates an Asymmetry Index (AI). The Asymmetry Index is a quantitative measure of the back asymmetry. The Asymmetry Index is then used to calculate a high/low risk stratification that a patient will have clinically significant scoliosis (defined as Cobb angle > 20 degrees) using a logistic regression model. This risk stratification, when considered in combination with the stated NSite Scoliosis Assessment App performance, is intended to provide health care providers with information that can be used for management recommendations. The model was developed using a database of patient Asymmetry Indexes with known Cobb angles.
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    K Number
    K232023
    Device Name
    Momentum Spine
    Date Cleared
    2023-10-04

    (89 days)

    Product Code
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    LDK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Momentum Spine app is an optical contour sensing mobile application intended to quantify asymmetries, assess body angles and curve progression related to postural asymmetries, including scoliosis. The device is available directly to lay users (Over-the-Counter) and may also be prescribed for use by physicians. The device is intended for use in patients 8 years and older.
    Device Description
    Momentum Spine is an optical contour sensing mobile application intended to quantify asymmetries, assess body angles and curve progression related to postural asymmetries, including scoliosis. The device is available directly to lay users (Over-the-Counter) and may also be prescribed for use by physicians. From a simple video taken on a mobile device. Momentum Spine ('app') reconstructs a 3D model of the torso to quantify asymmetry using 3D imaging and artificial intelligence. The app is intended to be used by a combination of lay users (parents, guardians etc.) and health care professionals. The patients do not use the device on themselves. The app is intended to be used on patients 8 years and older to scan and monitor postural asymmetries. The app can be used by patient populations suffering from postural deformities mainly scoliosis. Additionally, the device can also be used by an otherwise healthy population to scan for and monitor their overall spinal health.
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    K Number
    K183485
    Device Name
    CryoVizion System
    Date Cleared
    2019-08-28

    (254 days)

    Product Code
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    LDK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CryoVizion is indicated as a tool to quantify angles on digital photograph depictions such as body angles related to postural asymmetries. It is intended for use in professional health specialists such as podiatrists, orthopedist, physiotherapists, chiropractors, osteopaths, and kinesiotherapists
    Device Description
    The CryoVizion System is a non-invasive and radiation-free system. Patients, suitably undressed, are placed in an observation booth. Two digital colour cameras mounted on a column are placed facing the patient booth. Patients are illuminated by two LED lighting units-one on each side of the imaging column. Using the CryoVizion System, the health specialist can then take images of the patient at various heights and in different positions. These images are then saved in the patient's file. The health specialists can then visually review anatomical and morphological features related to the patient's posture. To do this, the CryoVizion System provides an image analysis toolbox including a palette of six graphic filters. Surface markers corresponding to the anatomical body landmarks placed using palpation by healthcare professionals, prior to taking the photographs, may also be used to help identify and reference anatomical landmarks in the photographs. The CryoVizion System is composed of two sections: hardware and software. The data and the images collected with the CryoVizion System are available immediately for clinical use and may be downloaded to a computer for storage or further analysis or comparison. The hardware section comprises the above noted two digital colour cameras and two LED lighting units, mounted on a column and a positioning booth. The two cameras are mounted in the central tube of the imaging column. The LED lighting systems are vertically disposed to each side of the column. The column also houses the control centre which, linked to a computer, controls the two digital cameras and the intensity of the lighting. The software comprises image manipulation functions, including the user selectable filters noted above and controls to operate each of the cameras.
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