(165 days)
The ETView Double Lumen Video Tracheoscope (DLVT™) is intended to isolate the left or right lung of a patient for intensive care or surgery, one lung ventilation or one lung anesthesia. The DLVT™ System is indicated for verifying tube placement and repositioning.
The ETView Double Lumen Video Tracheoscope (DLVT™) System functions as a standard 37 French size endobronchial tube that additionally has an embedded video imaging device in its tracheal lumen. The system provides a video image of the patient's bronchus, which is displayed on the monitor, for as long as the DLVT™ is inside the patient's bronchus. Visualization of the bronchus is used to verify placement and repositioning of the endobronchial tube during the intubation procedure or throughout surgery. The device is indicated for non-MRI environment only.
The provided text describes the ETView Double Lumen Video Tracheoscope (DLVT™) System and its performance testing for 510(k) clearance, but it does not include acceptance criteria in a table format, nor does it detail a study that explicitly 'proves' the device meets acceptance criteria in the way a clinical trial might for AI/ML devices. Instead, the document outlines a series of performance tests to demonstrate substantial equivalence to predicate devices.
However, based on the provided text, I can infer the general approach and key information relevant to your request, adapting the structure to fit the available data.
Here's a breakdown of the requested information based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in a quantitative table with corresponding device performance metrics for features like sensitivity, specificity, or accuracy, which are typical for AI/ML devices. Instead, the acceptance criteria are demonstrated through compliance with established medical device standards and functional testing for properties like flow, diameter, and material integrity. The "reported device performance" is essentially that the device "complies with the following standards" and "demonstrated that the Double Lumen Video Tracheoscope (DLVT™) is as safe and effective as the cleared predicate devices."
| Acceptance Criteria (Inferred from Standards & Testing Goals) | Reported Device Performance (Summary) |
|---|---|
| Material & Design Standards Compliance: | |
| ISO 5361:1999 Anaesthetic and respiratory equipment -- Tracheal tubes and connectors | Complies with the standard. |
| ISO 16628:2008 Tracheobronchial Tubes Sizing and marking | Complies with the standard. |
| Sterilization Standards Compliance: | |
| ANSI/AAMI/ISO 11135-1:2007 Sterilization of health care products - Ethylene oxide | Complies with the standard. |
| AAMI TIR28:2001 Product adoption and process equivalency for ethylene oxide sterilization | Complies with the standard. |
| Risk Management & Biocompatibility Standards Compliance: | |
| ISO 14971-1:2007 Risk management for medical devices | Complies with the standard. |
| ISO 10993-1:2003(E), Biological evaluation of medical devices -- Part 1: Evaluation and testing | Complies with the standard. |
| Functional Performance (bench & limited in-vivo): | |
| Determination of Cuff Resting Diameter | Performance demonstrated to be safe and effective as predicate. |
| Cuff Leak Resistance Integrity | Performance demonstrated to be safe and effective as predicate. |
| Resistance to Cuff Herniation | Performance demonstrated to be safe and effective as predicate. |
| Cuff Symmetry | Performance demonstrated to be safe and effective as predicate. |
| Resistance to tube collapse | Performance demonstrated to be safe and effective as predicate. |
| Air Flow Resistance | Performance demonstrated to be safe and effective as predicate. |
| Thermal Safety | Performance demonstrated to be safe and effective as predicate. |
| Determination of effective inside diameter | Performance demonstrated to be safe and effective as predicate. |
| Tracheal Seal | Performance demonstrated to be safe and effective as predicate. |
| Determination of the bronchial segment | Performance demonstrated to be safe and effective as predicate. |
| Cadaver Test (to verify tube placement and repositioning by visualization) | Performance demonstrated to be safe and effective as predicate. |
| MR Environment Non-Clinical Test (to confirm not for MRI environment) | Performance demonstrated to be safe and effective as predicate (indicates non-MRI environment only). |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions a "Cadaver Test" as part of performance testing. However, it does not specify the sample size (i.e., number of cadavers) used for this test. It also does not explicitly state the country of origin for the cadaver data or whether it was retrospective or prospective. Given it's a cadaver test, it would be considered a prospective test for the device's functional performance in a cadaveric model.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
The document does not specify the number of experts or their qualifications used to evaluate the Cadaver Test results. Given the nature of a 510(k) for a medical device (as opposed to an AI/ML diagnostic tool), such details are often less extensively documented in the summary unless it involves subjective interpretation of images that are integral to a diagnostic claim.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the Cadaver Test or any other performance 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
This document describes a traditional medical device (a video tracheoscope) and not an AI/ML-driven diagnostic or assistive technology. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed/reported.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This device is not an algorithm, so standalone algorithm performance is not applicable. The DLVT™ System is a physical medical device that provides direct video visualization for a clinician.
7. The Type of Ground Truth Used
For the functional performance tests, particularly the "Cadaver Test" regarding verifying tube placement and repositioning, the "ground truth" would be established by direct observation and professional judgment of the clinicians/researchers performing the test. For the other tests (e.g., cuff integrity, airflow), the ground truth is based on objective measurements against engineering and physical standards. There is no mention of pathology, outcome data, or expert consensus in the context of a diagnostic ground truth.
8. The Sample Size for the Training Set
This device is a physical medical instrument, not an AI/ML algorithm that requires a training set. Therefore, a training set sample size is not applicable.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for an AI/ML algorithm, this question is not applicable.
§ 868.5740 Tracheal/bronchial differential ventilation tube.
(a)
Identification. A tracheal/bronchial differential ventilation tube is a device used to isolate the left or the right lung of a patient for anesthesia or pulmonary function testing.(b)
Classification. Class II (performance standards).