Search Results

These devices are intended for oral or nasal intubation and are indicated for use in airway management, including those procedures requiring flexing of the neck or movement of the patient (e.g., to a lateral or prone position).

The subject devices are sterile, single-use tracheal tubes that incorporate a pre-formed Magill curve and have a continuous stainless-steel spiral wire incorporated into the wall to reduce the risk of collapse or kinking during patient positioning. All tracheal tubes feature standard depth marks, glottic depth marks and 15mm connector. The cuffed devices are provided with two different low-pressure cuff types, featuring a thin compliant wall that, when inflated, adapts and conforms to the irregular borders of the tracheal wall. The cuffed devices have an inflation system consisting of an inflation line, pilot balloon and self-sealing inflation valve, allowing for inflation and deflation of the cuff.

Five families of the subject devices share the same indications for use and intended use but differ in specific design features such as size, cuff presence, cuff shape, presence of murphy eye and stylet.

N/A

Ask a specific question about this device

Provide tracheal access for airway management and subglottic secretion management in adult patients. It is also intended for use with percutaneous dilatational tracheotomy (PDT) procedures.

The subject device is a single patient use tracheostomy tube that features an outer cannula with a radiopaque line alonq its length and a standard 15mm connector for direct connection to standard ventilation and anesthesia equipment. It has an integrated evac suction line in the outer cannula for suctioning of subqlottic secretions that may pool above the cuff. It is available in three configurations: single cannula (no inner cannula), disposable inner cannula (DIC) and single patient use reusable inner cannula (RIC).

It appears there may be a misunderstanding. The document provided is an FDA 510(k) clearance letter and associated summary for a medical device (tracheostomy tube), not a study proving an AI/software device meets acceptance criteria.

The document details the equivalence of a new tracheostomy tube (Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff) to previously cleared predicate devices, based on similar technological characteristics, intended use, and performance data from bench testing, biocompatibility, sterilization, and human factors. It does not involve AI or software, and therefore, it does not contain the information you requested about acceptance criteria and a study proving an AI device's performance.

To answer your request, I would need a document describing an AI/software medical device's performance study, including its acceptance criteria and the results of that study.

The document you provided is about a conventional medical device.

Ask a specific question about this device