(77 days)
The ETView Tracheoscopic Ventilation Tube (TVTM) is intended for intubation procedures. The ETView Tracheoscopic Ventilation Tube (TVTM) is indicated for use as a temporary artificial airway in adults requiring mechanical ventilation. It is intended for oral and nasal intubations.
The TVT" System is indicated for viewing during non-difficult and difficult intubation procedures, for verifying endotracheal tube and endobronchial blocker placement and repositioning, for viewing during suctioning and for general inspection of the airway.
The ETView Tracheoscopic Ventilation Tube (TVT™) is a single use, cuffed device that functions as a standard endotracheal tube (ETT) and additionally has an embedded video imaging device embedded in a dedicated lumen. The system provides a video image of the patient's trachea, which is displayed on the monitor, for as long as the TVTTM is inside the patient's trachea.
The provided text does not contain information about acceptance criteria or specific studies detailing device performance against those criteria. It focuses on regulatory approval (510(k) submission) for the ETView Tracheoscopic Ventilation Tube System (TVT™).
Here's an analysis of what is available:
1. A table of acceptance criteria and the reported device performance:
This information is not present in the provided text. The document states that the device was "tested and complies with" several ISO and ANSI/AAMI standards, and that "Performance testing demonstrated that the ETView Tracheoscopic Ventilation Tube (TVT™) is as safe and effective as the cleared predicate device." However, it does not specify the acceptance criteria for these tests or the quantitative results of the performance.
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 present in the provided text. The document refers to "Performance Testing" in general terms but does not detail the methodology, sample sizes, or 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 present in the provided text. The document does not describe any specific studies relying on expert ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not present in the provided text.
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 present in the provided text. The device described is an endotracheal tube with an embedded video imaging device, not an AI-powered diagnostic tool for which an MRMC study would typically be conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not present in the provided text. The device provides a video image to a human user, implying human-in-the-loop performance, rather than standalone algorithmic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
This information is not present in the provided text.
8. The sample size for the training set:
This information is not present in the provided text. If any training was done for an embedded system, it is not described.
9. How the ground truth for the training set was established:
This information is not present in the provided text.
Summary of what is discussed in the provided text regarding device performance and compliance:
The ETView Tracheoscopic Ventilation Tube (TVT™) was found to be "substantially equivalent" to its predicate device (ETView Tracheoscopic Ventilation Tube K082420 and Coopdech Endobronchial Blocker tube K093888).
The device "was tested and complies with the following standards":
- ISO 5361:1999 Anesthetic and respiratory equipment -- Tracheal tubes and connectors
- ANSI/AAMI/ISO 11135-1:2007 Sterilization of health care products - Ethylene oxide
- ISO 14971-1:2007 Risk management for medical devices
- ISO 10993-1:2003(E), Biological evaluation of medical devices -- Part 1: Evaluation and testing
The document states that "Performance testing demonstrated that the ETView Tracheoscopic Ventilation Tube (TVT™) is as safe and effective as the cleared predicate device" and that "the minor addition to the indication for use is safe and effective." Additionally, materials in contact with the human body were "tested and found to be biocompatible in accordance with ISO 10993-1." However, the specific details of these performance tests, including acceptance criteria, sample sizes, and quantitative results, are not provided in this summary.
§ 868.5730 Tracheal tube.
(a)
Identification. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.(b)
Classification. Class II (performance standards).