(131 days)
Intubation with Ambu VivaSight 2 DLT is indicated for pathological lung conditions or other medical conditions that require endobronchial intubation, mechanical ventilation of one lung from the other, e.g. for thoracic surgery.
Ambu VivaSight 2 DLT is a sterile, single-use, double-lumen endobronchial tube intended to be used for isolation of the left or right lung of a patient for one lung ventilation.
The VivaSight 2 DLT system is intended to be used for verifying tube placement and repositioning.
Intubation with VivaSight 2 DLT is indicated for patients with pathological lung conditions or other medical conditions that require endobronchial intubation, mechanical ventilation and isolation of one lung from the other, e.g. for thoracic surgery.
Ambu VivaSight 2 DLT is a sterile, single-use, left-sided, double-lumen endobronchial tube with an embedded video camera and light source at the distal end of the tracheal lumen and integrated video cable with video connector.
The embedded video camera is used for visualization during the intubation procedure and to verify the tube placement. The picture is shown on an Ambu displaying unit, which Ambu VivaSight 2 DLT is connected to via Ambu VivaSight 2 Adapter Cable. Ambu VivaSight 2 Adapter Cable is a non-sterile, single patient use accessory to Ambu VivaSight 2 DLT. Ambu VivaSight 2 DLT is connected to and powered by an Ambu displaying unit via Ambu VivaSight 2 Adapter Cable; the whole system is referred to as the VivaSight 2 DLT system.
Ambu VivaSight 2 DLT is indicated for left or right lung isolation and use as a temporary artificial airway in adults requiring mechanical one-lung ventilation and is fitted with a stylet to enable shaping of the tube for navigation during intubation.
A colorless tracheal cuff provides sealing against tracheal wall and the corresponding pilot balloon indicates state of cuff inflation/deflation. Similarly, a blue bronchial cuff provides sealing against bronchial wall and the corresponding pilot balloon indicates state of cuff inflation/deflation.
A flush line with flush exits next to the camera lens ensures possibility for cleaning of the camera lens.
Ambu VivaSight 2 DLT can be connected to ventilation equipment via a Y-connector, which is included with the product. The Y-connector is sterile, single-use. The Y-connector caps enable lung deflation and use of accessories such as bronchoscopes and suction catheters in Ambu VivaSight 2 DLT. Furthermore, valves on the Y-connector enables opening and closing of the ventilation flow to each of the tracheal and bronchial lumens. The Y-connector airway tubes are colour coded to indicate tracheal and bronchial connection.
Ambu VivaSight 2 DLT will be available in four sizes: 35 Fr, 37 Fr, 39 Fr, and 41 Fr.
The provided text is a 510(k) summary for the Ambu VivaSight 2 DLT. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance criteria through a clinical study with human-in-the-loop or standalone AI performance.
Therefore, the requested information regarding acceptance criteria, device performance tables, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment cannot be found in this document because the submission relies primarily on bench testing and compliance with recognized consensus standards to show substantial equivalence.
The document explicitly states: "The following data have been submitted in the premarket notification to support safety and effectiveness of the device: Testing - Bench Declaration of conformity to the following applicable recognized consensus standards..."
It then lists various bench tests and standards with "Result: All tests passed." and concludes: "Performance testing has demonstrated that the device is as safe and effective as the predicate device."
The acceptance criteria and study detailed in your request (focused on AI performance, human reader improvement, and specified ground truth methodologies) are not applicable to the information provided in this 510(k) summary for the Ambu VivaSight 2 DLT.
This device is a medical instrument (double-lumen endobronchial tube with an embedded camera), not an AI-driven diagnostic or assistive technology in the context of the detailed questions. The "visualization during the intubation procedure" refers to a live video feed for direct human observation, not an image analysis AI that would require the kind of performance studies you've outlined.
§ 868.5740 Tracheal/bronchial differential ventilation tube.
(a)
Identification. A tracheal/bronchial differential ventilation tube is a device used to isolate the left or the right lung of a patient for anesthesia or pulmonary function testing.(b)
Classification. Class II (performance standards).