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TechCare Trauma is intended to analyze 2D X ray radiographs using techniques to aid in the detection, localization, and characterization of fractures and/or elbow joint effusion during the review of commonly acquired radiographs of: Ankle, Foot, Knee, Leg (includes Tibia/Fibula), Femur, Wrist, Hand/Finger, Elbow, Forearm, Arm (includes Humerus), Shoulder, Clavicle, Pelvis, Hip, Thorax (includes ribs).

TechCare Trauma can provide results for fracture in neonates and infants (from birth to less than 2 years), children and adolescents (aged 2 to less than 22 years) and adults (aged 22 years and over).

TechCare Trauma can provide results for elbow joint effusions in children and adolescents (aged 2 to less than 22 years) and adults (aged 22 years and over).

The intended users of TechCare Trauma are clinicians with the authority to diagnose fractures and/or elbow joint effusions in various settings including primary care (e. g., family practice, internal medicine), emergency medicine, urgent care, and specialty care (e. g. orthopedics), as well as radiologists who review radiographs across settings.

TechCare Trauma results are not intended to be used on a stand-alone basis for clinical decision-making. Primary diagnostic and patient management decisions are made by the clinical user.

The TechCare Trauma device is a software as Medical Device (SaMD). More specifically it is defined as a "radiological computer assisted detection and diagnostic software for suspected fractures".

As a CADe/x software, TechCare Trauma is an image processing device intended to aid in the detection and localization of fractures and elbow joint effusions on acquired medical images (2D X-ray radiographs).

TechCare Trauma uses an artificial intelligence algorithm to analyze acquired medical images (2D X-ray radiographs) for features suggestive of fractures and elbow joint effusions.

TechCare Trauma can provide results for fractures in neonates and infants (from birth to less than 2 years), children and adolescents (aged 2 to less than 22 years) and adults (aged 22 years and over) regardless of their condition.

TechCare Trauma can provide results for elbow joint effusions in children and adolescents (aged 2 to less than 22 years) and adults (aged 22 years and over).The device detects and identifies fractures and elbow joint effusions based on a visual model's analysis of images and provides information about the presence and location of these prespecified findings to the user.

It relies solely on images provided by DICOM sources. Once integrated into existing networks, TechCare Trauma automatically receives and processes these images without any manual intervention. The processed results, which consist of one or more images derived from the original inputs, are then sent to specified DICOM destinations. This ensures that the results can be seamlessly viewed on any compatible DICOM viewer, allowing smooth into medical imaging workflows.

TechCare Trauma can be deployed on-premises or on cloud and be connected to multiple DICOM sources / destinations (including but not limited to DICOM storage platform, PACS, VNA and radiological equipment, such as X-ray systems), ensuring easy integration into existing clinical workflows.

Here's a detailed breakdown of the acceptance criteria and study findings for the TechCare Trauma device, based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria for the TechCare Trauma device appear to be based on achieving high diagnostic accuracy, specifically measured by the Area Under the Curve (AUC) of the Receiver Operating Characteristic (ROC) curve for both standalone performance and multi-reader multi-case (MRMC) comparative studies. The study demonstrated successful performance against these implied criteria.

Table of Acceptance Criteria and Reported Device Performance

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