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510(k) Data Aggregation
(189 days)
KGT INC.
Bf-NAVI is a virtual bronchoscopic navigation (VBN) software program designed to assist a 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. Bf-NAVI allows the physician to view a 3D representation of the bronchial tree that displays virtual images of the inside surface of the bronchi. Bf-NAVI is intended for use only as a guidance tool and does not make any medical diagnosis.
Bf-NAVI is a virtual bronchoscopic navigation (VBN) software program designed to assist a 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. Bf-NAVI allows the physician to view a 3D representation of the bronchial tree that displays virtual images of the inside surface of the bronchi. Bf-NAVI is intended for use only as a guidance tool and does not make any medical diagnosis.
The Bf-NAVI software is a self-contained Windows-based image software package. Using pulmonary CT slice data, the Bf-NAVI device helps the user in guiding endoscopic tools or catheters in the pulmonary tract. The Bf-NAVI allows the user to view computed tomography via Multi-Planar Reconstruction (MPR). The software uses the CT data to generate a 3D image of the tracheobronchial tree. The Bf-NAVI device does not interface directly with any CT or data collection equipment; the CT data is imported from files previously created on another device.
The software does not perform any function which can not be accomplished manually by a trained operator utilizing manual tracing methods; the software is designed to assist in the compilation of the data to save time and prevent errors. The Bf-NAVI software has functions for loading, analyzing, saving data profiles and will generate screen displays from the results.
Here's a summary of the acceptance criteria and the study details for the Bf-NAVI device, based on the provided 510(k) summary:
The provided 510(k) summary for Bf-NAVI does not include a table of acceptance criteria or details of a specific study proving the device meets those criteria in a quantitative sense (e.g., performance metrics like sensitivity, specificity, accuracy). Instead, it relies on demonstrating substantial equivalence to predicate devices through non-clinical testing of its software development and functionality.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Software Functionality | "All the software specifications have met the acceptance criteria of each module and interaction of processes." |
| Intended Use Equivalence | "The Bf-NAVI device has the same intended use and technological characteristics as the predicate devices." |
| Safety & Efficacy | "The safety and efficacy of the device is supported by the non-clinical testing." "The verification and validation testing of the device software of the device was found to acceptable and supports the claims of substantial equivalence." |
| Hazard Mitigation | "The Device Hazard analysis was completed and risk control implemented to mitigate identified hazards." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of clinical or performance data for the device's diagnostic or guidance accuracy. The software was tested against its own design specifications rather than against a dataset of medical images with known ground truth for establishing diagnostic or guidance performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. The submission does not describe a test set where experts established ground truth for medical conditions or guidance accuracy.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of a test set requiring expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document explicitly states: "There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate devices." Therefore, an MRMC study comparing human readers with and without AI assistance was not performed.
6. Standalone (Algorithm Only) Performance Study
No. The document describes "non-clinical testing" as software verification and validation against its design specifications. It does not mention a standalone performance study in the sense of evaluating the algorithm's accuracy in identifying target regions or optimal routes independently against a gold standard. The device's purpose is "only as a guidance tool and does not make any medical diagnosis."
7. Type of Ground Truth Used
The "ground truth" used for Bf-NAVI's testing was its Software Design Specifications. The device's performance was evaluated against whether it performed as intended according to these internal specifications. This is distinct from medical ground truth (e.g., pathology, expert consensus on disease, or actual surgical outcomes).
8. Sample Size for the Training Set
Not applicable. This device is described as a software program that processes existing CT scan data to generate a 3D representation and assist the physician. It is not an AI/ML device that requires a "training set" in the traditional sense to learn patterns or make predictions. Its functionality is based on pre-programmed algorithms for image reconstruction and visualization.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As Bf-NAVI is not an AI/ML device requiring a training set, the concept of establishing ground truth for a training set does not apply.
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