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510(k) Data Aggregation
K Number
K231683Device Name
inHEART Models
Manufacturer
Date Cleared
2024-02-29
(265 days)
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
inHEART, SAS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
inHEART MODELS comprises a suite of medical imaging software modules that are intended to provide qualified medical professionals with tools to aid them in reading, interpreting, and treatment planning, inHEART MODELS accepts DICOM compliant medical images acquired from a variety of imaging devices, including CT and MR*. The software is designed to be used by qualified medical professionals (including physicians, cardiologists, radiologists, and technicians) and the users are solely responsible for making all final patient management decisions.
* inHEART Models AI software module is indicated for adults only and is designed for CT images only.
Device Description
inHEART MODELS is a suite of medical image processing software tools that enables 3D visualization and analysis of anatomical structures.
This software suite is composed of three software as a medical device components:
- . inHEART MODELS AI: a medical image processing software for automatic 3D modelling, used to pre-process medical images (acquired only by CT devices).
This software module uses a machine-learning based approach with the following characteristics:
- Training dataset: 796 cases (3D CT original images and the segmentation । masks) from previously manually performed segmentations (time period 2018-2022); origins of the data are public and private clinical and hospital institutions located in US (40%) and Europe (60%).
- -Training process: Machine learning algorithm (UNet) is trained applying data augmentation (including patch mirroring) and regularization (including Instance Normalization, Dropout, Data Augmentation, Weight Initialization, Leaky ReLU Activation) methods. Loss functions (soft dice loss and binary cross entropy) and optimization methods (stochastic gradient descent) are used during learning over a fixed number of 1000 epochs, each consisting of 250 iterations with a batch size of 2.
- Data anonymized prior to its processing by inHEART team, therefore no । personal data (gender, age, ethnicity) is exploitable. CT scanner manufacturers include Siemens (40%). GE Medical Systems (30%). Toshiba (10%) and other manufacturers (20%) among which Philips and Canon.
- inHEART MODELS Shaper: a standalone image processing software used to . generate digital 3D models of the patient heart from medical images acquired by CT and/or MR devices and;
- inHEART MODELS Explorer: a web-based 3D visualization software that permits . display, review, analysis, annotation and export of the cardiac 3D models generated from inHEART MODELS Shaper.
Specifically, these software modules read DICOM compatible pre-operative CT and MR images acquired by commercially available imaging devices. These images are then processed to generate 3D models of the anatomy to allow qualified medical professionals to display, review, analyze, annotate, interpret, export, and plan therapeutic interventions.
inHEART MODELS software suite also includes two non-device Medical Device Data Systems (MDDS) modules that are only intended to transfer, store and convert formats.
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K Number
K220727Device Name
inHEART MODELS
Manufacturer
Date Cleared
2022-05-10
(57 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
inHEART, SAS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
inHEART MODELS comprises a suite of medical imaging software modules that are intended to provide qualified medical professionals with tools to aid them in reading, interpreting, and treatment planning, inHEART MODELS accepts DICOM compliant medical images acquired from a variety of imaging devices, including CT and MR. The software is designed to be used by qualified medical professionals (including physicians, cardiologists, radiologists, and technicians) and the users are solely responsible for making all final patient management decisions.
Device Description
inHEART MODELS is a suite of medical image processing software tools that enables 3D visualization and analysis of anatomical structures. Specifically, the software modules read DICOM compatible anonymized pre-operative CT and MR images acquired by commercially available imaging devices. These images are then processed to generate 3D models of the anatomy to allow qualified medical professionals to display, review, analyze, annotate, interpret, export, and plan therapeutic interventions. inHEART MODELS includes two non-device Medical Device Data Systems (MDDS) modules that are only intended to transfer, store and convert formats.
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