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ProFound AI® V3.0 is a computer-assisted detection and diagnosis (CAD) software device intended to be used concurrently by interpreting physicians while reading digital breast tomosynthesis (DBT) exams from compatible DBT systems. The system detects soft tissue densities (masses, architectural distortions and calcifications in the 3D DBT slices. The detections and Certainty of Finding and Case Scores assist interpreting physicians in identifying soft tissue densities and calcifications that may be confirmed or dismissed by the interpreting Physician

The ProFound Al® V3.0 device detects malignant soft-tissue densities and calcifications in digital breast tomosynthesis (DBT) images. The ProFound AI V3.0 software allows an interpreting physician to quickly identify suspicious soft tissue densities and calcifications by marking the detected areas in the tomosynthesis images. When the ProFound AI V3.0 marks are displayed by a user, the marks will appear as overlays on the tomosynthesis images. Each detected finding will also be assigned a "score" that corresponds to the ProFound AI V3.0 algorithm's confidence that the detected finding is a cancer (Certainty of Finding). Certainty of Finding scores are a percentage in range of 0% to indicate CAD's confidence that the finding is malignant. ProFound AI V3.0 also assigns a score to each case (Case Score) as a percentage in range of 0% to 100% to indicate CAD's confidence that the case has malignant findings. The higher the Certainty of Finding or Case Score, the higher the confidence that the detected finding is a cancer or that the case has malignant findings.

ProFound™ AI V2.1 Software is a computer-assisted detection and diagnosis (CAD) software device intended to be used concurrently by interpreting physicians while reading digital breast tomosynthesis (DBT) exams from compatible DBT systems. The system detects soft tissue densities (masses, architectural distortions and asymmetries) and calcifications in the 3D DBT slices. The detections and Certainty of Finding and Case Scores assist interpreting physicians in identifying soft tissue densities and calcifications that may be confirmed or dismissed by the interpreting physician.

ProFound AI V2.1 detects malignant soft-tissue densities and calcifications in digital breast tomosynthesis (DBT) images. ProFound AI V2.1 has the same performance with the DBT systems cleared for use with ProFound AI V2; furthermore, it provides support for additional DBT systems. The ProFound AI V.2.1 Software allows a radiologist to quickly identify suspicious soft tissue densities (masses, architectural distortions and asymmetries) and calcifications by marking the detected areas in the tomosynthesis images. When the ProFound AI V2.1 marks are displayed, the marks will appear as overlays on the 3D tomosynthesis images. For 3D tomosynthesis cases and depending on the functionality offered by the viewing/reading application, the ProFound AI V2.1 marks may also serve as a navigation tool for users because each mark can be linked to the tomosynthesis slice where the detection was identified. Each detected region is also assigned a "score" that corresponds to the ProFound AI V2.1 algorithm's confidence that the detected region is malignant (certainty of finding). Each case is also assigned a case score that corresponds to the ProFound AI V2.1 algorithm's confidence that a case is malignant. The certainty of finding scores are represented as an integer in range of 0 to 100 to indicate the CAD confidence that the detected region or case is malignant. The higher the certainty of finding or case score, the more likely the detected region or case is to be malignant.

PowerLook® Tomo Detection V2 Software is a computer-assisted detection and diagnosis (CAD) software device intended to be used concurrently by interpreting physicians while reading digital breast tomosynthesis (DBT) exams from compatible DBT systems. The system detects soft tissue densities (masses, architectural distortions and asymmetries) and calcifications in the 3D DBT slices. The detections and Certainty of Finding and Case Scores assist interpreting physicians in identifying soft tissue densities and calcifications that may be confirmed or dismissed by the interpreting physician.

PLTD V2 detects malignant soft-tissue densities and calcifications in digital breast tomosynthesis (DBT) image. The PLTD V2 software allows a interpreting physician to quickly identify suspicious soft tissue densities and calcifications by marking the detected areas in the tomosynthesis images. When the PLTD V2 marks are displayed by a user, the marks will appear as overlays on the tomosynthesis images. The PLTD V2 marks also serve as a navigation tool for users, because each mark is linked to the tomosynthesis plane where the detection was identified. Users can navigate to the plane associated with each mark by clicking on the detection mark. Each detected region will also be assigned a "score" that corresponds to the PLTD V2 algorithm's confidence that the detected region is a cancer (Certainty of Finding Score). Certainty of Finding scores are relative scores assigned to each detected region and a Case Score is assigned to each case regardless of the number of detected regions. Certainty of Finding and Case Scores are computed by the PLTD V2 algorithm and represent the algorithm's confidence that a specific finding or case is malignant. The scores are represented on a 0% to 100% scale. Higher scores represent a higher algorithm confidence that a finding or case is malignant. Lower scores represent a lower algorithm confidence that a finding or case is malignant.

The Axxent® Electronic Brachytherapy System Model 110 XP 1200 is a high dose rate Brachytherapy device for use with Axxent Applicators to treat lesions, tumors and conditions in or on the body where radiation is indicated. Only Xoft Axxent Surface Applicators can be used with the Axxent Electronic Brachytherapy System Model 110 XP 1200.

The Axxent Electronic Brachytherapy System consists of two primary components: the Axxent System Controller (Controller); the Axxent HDR X-ray Source-2.2 (Catheter/Source). The System is designed to deliver doses of X-ray radiation to tissue in proximity to the applicator using a miniature X-ray tube powered by the Controller. The Axxent Electronic Brachytherapy System is a mobile, computer-controlled platform that is responsible for the overall operation of the System. The Controller is designed to work with the Source, which is a miniature X-ray tube located at the end of a flexible catheter. The Catheter/Source is inserted into a lumen of an appropriate Applicator which are cleared separately under their 510(k). The Axxent Electronic Brachytherapy System Model 110 XP 1200 described in this 510(k) will only be used for surface applications using Xoft Axxent Surface Applicators.

The Second Look® Viewer is intended to be used to display low resolution, nondiagnostic medical images with annotations such as pre-computed regions-ofinterest or pre-computed CAD marks.

The Second Look® Viewer is composed of three primary components. The major component is the computer (1), which is supported by a touchscreen monitor (2) and a barcode reader (3). The computer is a conventional Intel based computer that is connected to the Second Look® CAD processing unit via a network. The Second Look Viewer serves no other purpose than viewer support. The physician interfaces to the software using the touch screen or barcode reader. The physician first barcodes a given patient whose mammography case has already been processed by the Second Look CAD processing unit. The viewer displays the Mammagraph™s with the pre-computed CAD marks overlayed. Second Look Viewer allows a radiologist to review Second Look® Analog CAD output, in softcopy format. The physician may touch any of the small images and see a higher resolution, magnified image along with characterization information for that image. After viewing the mammography case, the radiologist may use the Second Look® Viewer to review pre-computed ultrasound results, such as CADStream® output, if such results already exist for the case under review.