(56 days)
DirectPath is a virtual bronchoscopic navigation software program designed to assist the physician during bronchoscopic examination. The main purpose of the software is to generate a tracheobronchial tree using chest CT scan data in order to help the physician find an optimal bronchial route to the target region. The DirectPath software allows the physician to view a three-dimensional representation of the bronchial tree that displays virtual images of the inside surface of the bronchi. DirectPath is intended for use only as a guidance tool and does not make any medical diagnosis.
The DirectPath is a virtual bronchoscopic navigation software program designed to assist the physician during a bronchoscopic examination. The main purpose of the software is to generate a tracheobronchial tree using chest CT scan data in order to help the physician find an optimal bronchial route to the target region. The DirectPath software allows the physician to view a three-dimensional representation of the bronchial tree that displays virtual images of the inside surface of the bronchi, DirectPath is intended for use only as a guidance tool and does not make any medical diagnosis.
DirectPath is a Windows-based image software package. It is designed to capture pulmonary CT slice data and display results to assist the user in guiding endoscopic tools or catheters in the pulmonary tract. The software utilizes data from a CT scan to generate a three-dimensional image of the bronchus. DirectPath provides computed tomography viewing via Multi-Planar Reconstruction (MPR) to generate the three-dimensional image. DirectPath does not interface directly with any CT or data collection equipment; CT datasets are delivered via external storage devices (basically CD, DVD and USB Flash memory).
The Cybernet Systems Co., Ltd. DirectPath device is a virtual bronchoscopic navigation software program. There is no information in the provided text about specific acceptance criteria or a study that proves the device meets them. The document states that "There was no clinical testing required to support the medical device as the indications for use are equivalent to the predicate device. The substantial equivalence of the device is supported by the non-clinical testing. The verification and validation testing of the device was found to be acceptable and supports the claims of substantial equivalence."
Therefore, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method for the test set
- If a multi reader multi case (MRMC) comparative effectiveness study was done, or the effect size of how much human readers improve with AI vs without AI assistance
- If a standalone performance study was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing and software verification and validation, rather than clinical performance studies with specific acceptance criteria.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).