(205 days)
The Rusch Ultra Tracheoflex Tracheostomy Set-Cuffed is a tracheostomy tube with accessories, intended for intubation through a surgical incision into the trachea, for the purpose of providing a patent airway.
The Ultra Tracheoflex Tracheostomy Set-Cuffed is a sterile, disposable, single use cuffed tracheostomy tube with a fixed flange. The set includes a radiopaque tube, a tube obturator, a cough cap, a 15 mm airway connector, exchangeable inner cannulas, and a neck band. The inner cannula will be also available as a separate item.
The provided text describes a medical device submission (510(k) summary) for the Rüsch Ultra Tracheoflex® Tracheostomy Set - Cuffed. It does not contain information about acceptance criteria or a study proving that a device meets those criteria in the context of a performance study involving AI or human readers, as implied by the detailed questions.
Instead, this document focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and adherence to voluntary standards.
Therefore, I cannot provide answers to most of your questions, as the information is not present in the input text.
Here's what I can extract based on the provided document:
1. A table of acceptance criteria and the reported device performance
- The document doesn't provide specific quantitative acceptance criteria or detailed performance results from a study. It states that the device meets "applicable portions of the following voluntary standards." These standards likely contain implicit acceptance criteria, but they are not explicitly presented as such in the context of a performance study within this document.
- Voluntary Standards Met:
- ASTM F1242-89, Standard Specification for Cuffed and Uncuffed Tracheal Tubes.
- ISO 5366-1, Tracheostomy Tubes, Part 1, Connectors for Tubes for Adults
- ISO 5366.2, Basic requirements for Tracheostomy Tubes for Adults.
- ISO 5356: Anesthesia and Respiration Equipment, Conical Connectors, Cones and Sockets.
- ISO 5361, Tracheal Tubes, Part 5: Requirements and Tests for Cuffs and Tubes.
- Voluntary Standards Met:
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. The document explicitly states: "No clinical testing was completed."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. No clinical testing was performed, so no ground truth establishment by experts is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical testing was performed.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. No clinical testing was performed, and this device is not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. No clinical testing was performed.
8. The sample size for the training set
- Not applicable. This document is not describing an AI/machine learning model, so there is no training set mentioned.
9. How the ground truth for the training set was established
- Not applicable. This document is not describing an AI/machine learning model.
§ 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.