(262 days)
This device is intended for use in thoracic surgery, bronchospirometry, administration of Endobronchial anesthesia and other uses commonly requiring Endobronchial intubation. The Endobronchial tube is indicated for main stem bronchus intubation and allows for selective inflation or deflation of either lung.
ANKOR Endobronchial tube is consisted with double lumen tube with the body including 3 cuff (Bronchus Cuff, Trachea Cuff and ANKOR Cuff) / 2 cuff (Bronchus Cuff and Trachea Cuff), the stylet and elbow connector in order to separate connector for isolating and ventilating one lung during surgical procedures. The different point, between ABC Model and HBC Model, is whether ANKOR Cuff is consisted. ANKOR Cuff, which is a part of the ABC Model only, takes to check correct insertion of the catheter. When user is lack of the experience or is not confidence with operation, ABC Model is intended to use. When the suction is necessary, this device can be possible to be assemble with suction catheter which is 10Fr or 12Fr with PVC (Listing Number: D422226) and this device is packaged with these suction catheter (Listing Number: D422226). The device is made of silicone as a main material and is available in 33Fr to 39Fr depending on the patients who is requiring one-lung isolation under OR and ICU including Non-MR Environment only.
The provided text describes the 510(k) summary for the ANKOR Endobronchial Tube, which is a medical device for tracheal/bronchial differential ventilation. It aims to demonstrate substantial equivalence to a predicate device, not necessarily to prove the device meets specific acceptance criteria for AI performance. As such, the document does not contain information related to AI or a study that proves a device meets acceptance criteria for an AI-powered system.
Therefore, I cannot provide the requested information about acceptance criteria and study data for an AI-powered device based on the provided text. The document focuses on performance testing of the physical medical device and its biocompatibility, sterilization, and material properties, rather than AI performance.
Specifically, the document explicitly states in Section 8:
"Clinical and animal testing were not performed for ANKOR Endobronchial Tube as part of the premarket notification requirements for this 510(k) submission and the subject of this premarket submission, ANKOR Endobronchial Tube, did not require clinical and animal studies to support substantial equivalence."
This reinforces that the approval is for a traditional medical device, not an AI-enabled one, and thus the specific metrics and study designs requested for AI performance are not relevant to this submission.
§ 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).