(118 days)
The ETView Tracheoscopic Ventilation Tube (TVT) is intended for intubation procedures. The ETView Tracheoscopic Ventilation Tube (TVT) 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 tube placement and repositioning, for viewing during suctioning and for general inspection of the airway.
The ETView Tracheoscopic Ventilation Tube (TVT) System is a visualized endotracheal tube The ETV10 Pacelleosooped Pulmonx VETT System (K973191), except that the ETView System same as tiny CMOS video camera and light source and the Pulmonx device uses fiberoptic components.
The provided document is a 510(k) summary for the ETView Tracheoscopic Ventilation Tube (TVT) System, a medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study that proves acceptance criteria for a new AI/software device. As such, information regarding acceptance criteria and performance studies in the context of AI/software device evaluation (e.g., sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) is not present in this document.
However, I can extract information about the performance testing conducted for this device, which might be considered the "acceptance criteria" based on the substantial equivalence pathway.
Here's a summary based on the provided text, addressing the points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Bench Testing) | Reported Device Performance |
|---|---|
| Functional Equivalence to Predicate Device: | "Bench testing demonstrated that the Tracheoscopic Ventilation Tube (TVT) System is at least as safe and effective as the Pulmonx VETT System for oral and nasal intubation and in providing visualization of the airway." |
| Cuff Resting Diameter | Results "attached to this submission" (details not provided in the summary) |
| Resistance to Tube Collapse | Results "attached to this submission" (details not provided in the summary) |
| Resistance to Cuff Herniation | Results "attached to this submission" (details not provided in the summary) |
| Cuff Symmetry | Results "attached to this submission" (details not provided in the summary) |
| Air Flow Resistance | Results "attached to this submission" (details not provided in the summary) |
| Thermal Safety | Results "attached to this submission" (details not provided in the summary) |
| Imaging Performance (Higher Resolution compared to predicate) | The TVT System "provides higher video resolution and thus accuracy compared to the existing cleared device." (Specific quantitative performance details not provided in the summary). |
| Cuff Leak Resistance Integrity | Results "attached to this submission" (details not provided in the summary) |
| Mechanical Integrity (Fatigue, Burst, Cuff Compliance) | Results "attached to this submission" (details not provided in the summary) |
| Efficacy of Selective Suctioning | Results "attached to this submission" (details not provided in the summary) |
| Software Validation | Results "attached to this submission" (details not provided in the summary) |
| Adherence to Standards | Conforms to ISO 5361 and ANSI/AAMI/ISO 11135. |
The study described is a series of bench tests and a comparison to a predicate device (Pulmonx Visualized Endotracheal Tube - VETT). The core of the "proof" is the demonstration of substantial equivalence, meaning the TVT is at least as safe and effective as the legally marketed predicate.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text. The testing was bench testing, not clinical studies with patients.
- Data Provenance: Not applicable in the context of clinical data. The tests would have been performed in a laboratory setting by the manufacturer (ETView Ltd. in Israel).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is bench testing comparing physical and functional characteristics, not evaluation of AI/software performance with human expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as this is bench testing.
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:
- No, an MRMC comparative effectiveness study was not done. This device is a physical endotracheal tube with an integrated camera, not an AI/software diagnostic tool for image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The "imaging performance" listed refers to the camera's ability to produce an image, not an algorithm's performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the bench tests, the "ground truth" would be the established engineering and medical device standards (e.g., ISO 5361, ANSI/AAMI/ISO 11135) and the performance characteristics of the predicate device.
8. The sample size for the training set:
- Not applicable as this is not an AI/machine learning device requiring a training set in that sense.
9. How the ground truth for the training set was established:
- Not applicable.
§ 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).