Search Results

The Lung Vision System is intended to enable users to segment previously acquired 3D CT datasets and overlay and register these 3D segmented data sets with fluoroscopic live X-ray images of the same anatomy in order to support catheter/device navigation during pulmonary procedures.

The LungVision System is designed enabling users to segment previously acquired 3D CT datasets and overlay and register these 3D segmented data sets with fluoroscopic live X-ray images of the same anatomy in order to support catheter/device navigation during pulmonary procedures.

The Lung Vision System is designed to assist the physician in guiding endobronchial tools towards the target area of interest inside the patient lungs. Prior to the endoscopic procedure the system allows planning the target location and the path to the target area on the CT scan. During the endoscopic procedure the system overlays planned data over fluoroscopic images to support endobronchial tool navigation towards the area of interest. The system does not include the Fluoroscope, Bronchoscope or the external monitor.

Lung Vision image processing algorithms are executed on a PC based hardware platform, which can perform the following functions:

• segment previously acquired DICOM 3D CT image data, .
• register DICOM 3D CT image data with live fluoroscopic X-ray image
• overlay the segmented 3D CT dataset over a live fluoroscopic X-ray image of the same anatomy, ● obtained on a Fluoroscopic system.

The provided document describes the LungVision System, a device intended to enable users to segment previously acquired 3D CT datasets and overlay and register these 3D segmented data sets with fluoroscopic live X-ray images of the same anatomy to support catheter/device navigation during pulmonary procedures.

The 510(k) summary (pages 3-6) focuses on demonstrating substantial equivalence to a predicate device (Philips EP-Navigator K062650) rather than providing detailed acceptance criteria and a study proving the device meets those specific criteria. The document states "No clinical testing was performed." and "No animal testing was performed."

Therefore, based solely on the provided text, a comprehensive answer to your request is not possible. However, I can extract the available information regarding performance and testing:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics. Instead, it describes general claims of equivalence to a predicate device. The "Performance and Specifications" section states: "The performance and specifications demonstrate that the Lung Vision and predicate devices perform the same functions using the same technologies thus can be found substantially equivalent."

The "Nonclinical / Bench" section states: "We have performed bench tests and found that the Body Vision met all requirements specifications and was found to be equivalent in comparison to the predicate. Testing includes verification testing of the requirements, testing of hazards mitigations, and performance testing of the system."

Without the specific "requirements specifications" or direct comparative performance data, it's impossible to generate a table of acceptance criteria and reported device performance.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "bench tests" and "testing has also been performed with pig lungs to test accuracy in deformable tissue." However, it does not specify the sample size for these tests, the data provenance (e.g., country of origin), or whether the tests were retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document does not describe the establishment of a ground truth for a test set using experts. Since no clinical or animal testing was performed to evaluate the diagnostic or navigational accuracy against defined ground truth, this information is not available.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no clinical or animal studies with a test set requiring expert adjudication for ground truth were described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was done. The document explicitly states "No clinical testing was performed."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The document mentions "bench tests" and "verification testing of the requirements, testing of hazards mitigations, and performance testing of the system," as well as "testing has also been performed with pig lungs to test accuracy in deformable tissue." These appear to be standalone tests of the device's technical performance attributes. However, specific metrics of "algorithm only" performance (e.g., accuracy of segmentation or registration) are not provided, nor is the "performance" explicitly defined in terms of measurable outcomes. The application is for a navigation aid where a human is in the loop.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For the "testing has also been performed with pig lungs to test accuracy in deformable tissue," the type of ground truth is not specified. Given it was in vitro testing on pig lungs, it would likely involve physical measurements or anatomical references, but this is not detailed. For other bench tests, "ground truth" would refer to the expected functional behavior or output as per the requirements specifications, rather than a clinical ground truth like pathology.

8. The sample size for the training set

The document describes the device as a "PC based software application" that utilizes algorithms to process existing 3D CT datasets and live fluoroscopic images. This suggests the system employs algorithms that might have been developed or trained. However, the document does not provide any information regarding a training set, its sample size, or how it was used in the development of the device's algorithms.

9. How the ground truth for the training set was established

Not applicable, as no information about a training set is provided.

Ask a specific question about this device

Innova Vision Applications software is intended to enable users to load 3D datasets and overlay and register in real time these 3D datasets with radioscopic or radiographic irnages of the same anatomy in order to support catheter/device guidance during interventional procedures.

Innova Vision Applications image processing alaorithms are executed on a commercially available hardware platform called AW (Advantage Workstation), which can perform the followina functions:

• Superimpose the seamented DICOM 3D XA, CT, MR dataset on radioscopic or radioaraphic image of the same anatomy, obtained on an Innova Fluoroscopic Xrav svstem
• Register the segmented DICOM 3D XA, CT, MR data with radioscopic or radiographic images obtained on an Innova Fluoroscopic X-ray system for interventional procedures.
  The Innova Vision Applications software will be available as three different options (Innova Vision, TrackVision and EP Vision) that tarqet different clinical indications: catheter-based interventions for interventional procedures such as neuroradiology or interventional radiology; needle-based interventions for interventional radiology; and interventional cardiology procedures such as electro-physiology procedures, respectively.
  Each option contains specific functions and settings and supports 3D datasets from specific modalities.
  Innova EP Vision provides image stabilization features such as ECG gated display or motion tracking in the image.
  To enhance quidance capabilities, the Innova Vision Applications software can load planning data, deposited on the 3D model in Volume Viewer, such as 3D landmarks, ablations lines or traiectories for needle path, and display them on the 3D-2D fused image to support the physician during procedures. The application also allows marking points of interest such as ablation points during the procedures.
  To provide efficient workflow during the interventional procedures, the most frequently used functions can be controlled from tableside.

The provided 510(k) summary for the Innova Vision Applications states that no clinical studies were required to support substantial equivalence. Therefore, there are no acceptance criteria, device performance data, sample sizes, expert qualifications, or details about the ground truth from a clinical study to extract from this document.

The document primarily focuses on demonstrating substantial equivalence to predicate devices based on:

• Not introducing new indications for use.
• Not raising new issues of safety and effectiveness.
• Not introducing new technology.

It also mentions compliance with voluntary standards (IEC60601-1-4 and IEC62304) and details quality assurance measures applied during development, such as risk management, requirements reviews, design reviews, and various levels of testing (unit, integration, system, and final acceptance testing/validation). However, these are internal development and compliance processes, not external clinical study results proving performance against specific acceptance criteria.

Therefore, I cannot provide the requested table and study details as they are explicitly stated as not being part of this submission.

Here's a summary of what is stated regarding testing and evaluation, though it does not address the questions about acceptance criteria or specific study results:

• Summary of Non-Clinical Tests: The Innova Vision Applications Software complies with voluntary standards IEC60601-1-4 (2000) and IEC62304 (2006). Quality assurance measures included Risk Management, Requirements Reviews, Design Reviews, Software Unit Testing, Software Integration Testing, System Testing, and Final Acceptance Testing (Validation).
• Summary of Clinical Tests: "The subject of this premarket submission, Innova Vision Applications, did not require clinical studies to support substantial equivalence."

Ask a specific question about this device