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This instrument has been designed to display virtual bronchoscopy images to be referenced by physicians as an aid to guiding endoscopic tools in the pulmonary tract. It does not make a diagnosis and is not an endoscopic tool.

VB Image Viewer (Virtual Bronchoscopy Image Viewer) is the Windows software to extract the bronchus from the CT data, create 3D virtual bronchoscopy image along the route to the target position, and display the image on the PC monitor as a reference image.

This document, K080581, for Olympus Medical Systems Corp.'s VB Image Viewer (Virtual Bronchoscopy Image Viewer), does not contain specific acceptance criteria or a detailed clinical study demonstrating the device's performance against such criteria. Instead, the submission relies on demonstrating substantial equivalence to a predicate device.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The document does not specify quantitative acceptance criteria (e.g., accuracy, sensitivity, specificity, or specific error rates) for the VB Image Viewer's performance. It primarily focuses on showing that the device is "basically identical to the predicate device in intended use" and "similar in specifications" (Section 6).

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. There is no mention of a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective) for an independent performance evaluation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable. As no independent test set with expert-established ground truth is described, this information is not present.

4. Adjudication Method for the Test Set

Not applicable. No adjudication method is mentioned as there's no described test set requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document does not describe an MRMC study comparing human reader performance with and without AI assistance. The submission focuses on the standalone device's equivalence to a predicate.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in a way. The "Virtual Bronchoscopy Image Viewer" is a software device intended to "extract the bronchus from the CT data, create 3D virtual bronchoscopy image along the route to the target position, and display the image on the PC monitor as a reference image." The evaluation appears to be based on the device's ability to perform these functions as intended, and its similarity to the predicate device, rather than a quantifiable standalone performance metric against human readers or a gold standard. The statement "The clinical literatures provided in this submission supports the safety and efficacy of Virtual Bronchoscopy Imaging Viewer" (Section 6) suggests reliance on existing literature for the underlying technology, but it doesn't detail a specific standalone study performed for this particular device.

7. The Type of Ground Truth Used

Not explicitly stated for this device's evaluation. For the general concept of virtual bronchoscopy, ground truth would typically refer to actual anatomical structures as seen during optical bronchoscopy or surgical dissection, or potentially high-resolution anatomical models. However, the document doesn't detail how ground truth was applied to validate this specific device. Given the reliance on predicate equivalence, the "ground truth" implicitly refers to the predicate device's accepted performance and the established understanding of CT data interpretation for virtual bronchoscopy.

8. The Sample Size for the Training Set

Not applicable. The document does not describe the use of machine learning or AI that would require a dedicated training set in the modern sense. The device is described as "Windows software to extract the bronchus from the CT data, create 3D virtual bronchoscopy image," implying rule-based or algorithmic image processing rather than a learned model.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set is described.

Summary of the Study:

The submission for the VB Image Viewer is a Section 510(k) premarket notification that relies on demonstrating substantial equivalence to a legally marketed predicate device, the "superDimension/Bronchus" (K042438).

Instead of presenting an independent study with acceptance criteria, the manufacturer argues that:

• The VB Image Viewer has an identical intended use to the predicate device: "to display virtual bronchoscopy images to be referenced by physicians to aid guiding endoscopic tools in the pulmonary tract."
• It is similar in specifications to the predicate, with the main difference being the deletion of hardware components (Extended Working Channel, Locatable Guide, Location Board, System Controller, Monitor, Patient Contact Materials) present in the predicate, as the VB Image Viewer is a software-only product running on a recommended PC and monitor.
• The manufacturer states, "The clinical literatures provided in this submission supports the safety and efficacy of Virtual Bronchoscopy Imaging Viewer." This indicates reliance on existing scientific evidence for the general concept and technology of virtual bronchoscopy, rather than a new, specific clinical trial for this particular software.

Therefore, the "study" is less about proving specific quantitative performance against acceptance criteria and more about demonstrating that the new software device functions similarly to an already cleared device for the same intended purpose, and that the differences do not raise new questions of safety or effectiveness. The FDA's letter confirms their review of the 510(k) and their determination of substantial equivalence, allowing the device to be marketed.

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