(18 days)
The PER-FIT™ Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and Disposable Inner Cannula is indicated for use in providing percutaneous temporary tracheal access for airway management.
The PER-FIT™ Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and Disposable Inner Cannula is designed to permit percutaneous insertion of a specifically designed tracheostomy tube. This single cannula Percutaneous Tracheostomy Tube has a radiopaque blue line and is constructed of biocompatible polyvinylchloride material and incorporates a tapered and beveled distal tube tip to facilitate insertion through the percutaneously dilated stoma site. The tracheostomy tube has a neck flange, an integral 15 mm connector, and a cuff which deflates to a low profile on the tube for a smooth transition during insertion. The cuff inflation line has a self sealing luer valve. The tracheostomy tube is supplied with a disposable inner cannula of the appropriate size. The Percutaneous Tracheostomy Kit comes with the necessary components for percutaneous tracheostomy tube insertion into a stoma created by serial dilation.
The provided text describes a 510(k) summary for the PER-FIT™ Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and Disposable Inner Cannula. This document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific acceptance criteria and proving performance through a detailed clinical study with performance metrics.
Based on the provided information, I can answer some of your questions and explain why others cannot be answered from this text:
1. A table of acceptance criteria and the reported device performance
This information is not available in the provided text. The document is a 510(k) summary, which aims to demonstrate "substantial equivalence" to a predicate device rather than setting or meeting specific performance acceptance criteria with detailed metrics like sensitivity, specificity, or inter-reader agreement. The "Conclusion" section states: "The testing performed and comparison to the predicate devices demonstrate that the proposed device is safe and effective and is substantially equivalent to the predicate devices." This implies that the device meets the safety and effectiveness standards derived from the predicate, but it doesn't quantify specific performance metrics or acceptance criteria as you would find in a clinical trial report.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not available in the provided text. The document refers to "testing performed and comparison to the predicate devices" but does not detail any specific human subject test sets, their sample sizes, or data provenance. It's highly probable that the testing referred to was primarily bench testing and material compatibility assessments, rather than a clinical study requiring human subject data provenance.
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)
This information is not available in the provided text. Since there's no mention of a clinical test set with human data requiring ground truth establishment by experts, this detail is not relevant to the content provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available in the provided text. Again, without a clinical test set for human readers, adjudication methods are not discussed.
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
This information is not available in the provided text. The device described is a medical instrument (tracheostomy kit) and not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving AI assistance would not be applicable or expected for this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not available and not applicable to the device described. This question typically relates to the performance of artificial intelligence algorithms. The PER-FIT™ Percutaneous Dilational Tracheostomy Kit is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not available in the provided text. As explained above, the submission claims substantial equivalence through testing and comparison to predicates, which likely involved engineering and material testing rather than clinical ground truth establishment in the traditional sense for diagnostic tools.
8. The sample size for the training set
This information is not available in the provided text. This question is typically relevant for machine learning algorithms, which is not what this device is.
9. How the ground truth for the training set was established
This information is not available in the provided text and is not applicable to this device.
§ 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.