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510(k) Data Aggregation
K Number
K223621Device Name
DeepXray
Manufacturer
Date Cleared
2023-09-08
(277 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Alpha Intelligence Manifolds, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Deep Xray is a radiological fully automated image processing software device of either computed (CR) or directly digital (DX) images intended to aid medical professionals in the measurement of minimum joint space width; the assessment of the presence or absence of sclerosis, joint space narrowing, and osteophytes based on OARSI criteria for these parameters; and, the presence or absence of radiographic knee OA based on Kellgren & Lawrence Grading of standing, fixed-flexion radiographs of the knee.
It should not be used in-lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis.
The system is to be used by trained professionals including, but not limited to, radiologists, physicians and medical technicians.
Device Description
Deep Xray is a standalone software device that utilizes artificial intelligence (AI) and computer vision algorithms to assist clinical professionals in analyzing and measuring radiographic abnormalities of knee osteoarthritis (OA) during review of posterior or anterior-posterior knee radiographs. DeepXray provides automated metric measurements of the joint space width and angular measurements of the femoral-tibial angle. DeepXray also performs assessments of knee osteoarthritis based on the Kellgren-Lawrence Grade (KL Grade), as well as individual radiographic features of osteoarthritis, including joint space narrowing, osteophyte and sclerosis based on the OARSI (Osteoarthritis Research Society International) grading criteria.
The output of DeepXray is rendered as a summary report and can be viewed on a web browser. Using this web interface, the user can verify the AI report side-by-side with the original radiograph using standard DICOM image tools and review each AI analysis result with the help of markup images overlaid with highlighted disease location or reference lines used for automated measurements. The web report also notifies the user for potential data quality issues. The clinical professionals can make modifications to the AI analysis results based on their professional judgement before saving and outputting the report.
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