(280 days)
The Rusch Single Use Crystal Tracheostomy Tube Set is indicated for airway management of tracheostomized patients.
The Rusch Single Use Crystal Tracheostomy Tube set consists of a polyvinyl chloride tube with a radiopaque stripe, terminated with a flange and connector. The tube is fitted with a high volume cuff inflated through a luer-activated valve, pilot balloon, inflation tube and a lumen in the wall of the main tube. Inner cannulas made of low density polyethylene and specifically designed for use with this tube are individually sterile packed. These cannulas may be boxed with the tracheostomy tube and will be available separately.
The provided text is a 510(k) summary for the Rüsch Single Use Crystal Tracheostomy Tube Set. It describes the device, its intended use, and a summary of performance data. However, it does not contain the detailed information necessary to answer your specific questions related to acceptance criteria, specific study design, sample sizes, ground truth establishment, or AI-related metrics.
Here's an analysis of what can and cannot be answered from the provided text:
What can be extracted:
- Device Name: Rüsch Single Use Crystal Tracheostomy Tube Set
- Intended Use: "airway management of tracheostomized patients."
- Regulatory Class: Class II
- Comparison Devices: Rüsch (Warne Surgical Products) Crystal Tracheostomy Tube -Preamendment, Smiths Industries D.I.C. & Portex Blue Line Tracheostomy Tubes - K934465, Bovina Medical Technologies Cuffed Pediatric Tracheostomy Tubes - K913270, K914088.
What cannot be answered from this document:
The provided document is a 510(k) summary, which typically provides a high-level overview for substantial equivalence. It does not include the detailed study protocols, results, acceptance criteria, or ground truth methodologies that would be found in a full study report or the complete 510(k) submission.
Specifically, the document states: "Laboratory bench testing has been completed to demonstrate compliance with appropriate sections of ISO 5366." This indicates that bench testing was performed against a specific standard, but it does not provide:
- A table of acceptance criteria or reported device performance metrics in detail.
- Sample sizes used for any test set or data provenance. The testing was "lab bench testing," which implies physical device testing, not typically data-driven like AI studies.
- Number of experts or their qualifications for establishing ground truth. (Ground truth in this context would likely be defined by the ISO standard itself, or engineering specifications, not expert consensus as in medical image analysis).
- Adjudication method for a test set.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study, as this is not an AI device.
- Information about standalone (algorithm only) performance, as this is not an AI device.
- The type of ground truth used beyond "compliance with appropriate sections of ISO 5366."
- Sample size for a training set. (Training sets are relevant for AI/ML, not for this type of physical device).
- How the ground truth for the training set was established.
In summary: The document confirms that bench testing was done to meet ISO 5366. To answer your questions, one would need access to the full 510(k) submission, specifically the detailed test reports outlining the methodology, specific acceptance criteria from ISO 5366, and the actual performance results obtained from those tests. This document only states that compliance was demonstrated.
§ 868.5800 Tracheostomy tube and tube cuff.
(a)
Identification. A tracheostomy tube and tube cuff is a device intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff may be a separate or integral part of the tracheostomy tube and is, when inflated, intended to establish a seal between the tracheal wall and the tracheostomy tube. The cuff is used to prevent the patient's aspiration of substances, such as blood or vomit, or to provide a means for positive-pressure ventilation of the patient. This device is made of either stainless steel or plastic.(b)
Classification. Class II.