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510(k) Data Aggregation
K Number
K230463Device Name
NSite Scoliosis Assessment App
Manufacturer
Date Cleared
2023-11-15
(267 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
NSite, Inc.
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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