(122 days)
The ETView VivaSight-DLTM System 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 VivaSight-DLTM System is indicated for verifying tube placement and repositioning.
The ETView VivaSight-DLTM System functions as a standard 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 VivaSight-DL™ 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 provided text is a 510(k) summary for the VivaSight-DL™ System, a medical device. It describes the device, its intended use, and claims substantial equivalence to predicate devices. The "Performance Testing" section outlines various tests conducted to demonstrate safety and effectiveness.
Here’s an breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or specific performance values against those criteria for each test. Instead, it states that "Performance tests were performed in order to demonstrate that the new tube dimension of the VivaSight-DLTM is as safe and effective as the market-cleared ETView DLVT™ system."
It concludes that "The results of the performance tests clearly demonstrate that the ETView VivaSight-DLTM device is as safe and effective as its predicate without raising any new safety and/or effectiveness concerns." This implies that the device met all unstated acceptance criteria for each test by demonstrating equivalence to the predicate.
The tests conducted are listed as:
- Determination of Cuff Resting Diameter
- Cuff Leak Resistance Integrity
- Cuff Symmetry
- Resistance to tube collapse
- Determination of effective inside diameter
- Determination of the bronchial segment
- Resistance to cuff herniation
- Air flow resistance
- Thermal safety
- Tracheal seal
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the performance tests. It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective) for these tests. All tests appear to be laboratory or bench tests, not involving direct patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since the performance tests are physical/mechanical tests of the device's characteristics (e.g., cuff diameter, leak resistance), there is no mention of "experts" in the context of establishing ground truth in the way one would for clinical diagnostic studies. The ground truth for these tests would inherently be the measured physical properties of the device components.
4. Adjudication Method for the Test Set
Not applicable. The performance tests are objective measurements of physical properties, not subjective assessments requiring adjudication by experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The testing focused on the physical characteristics and performance of the device itself, not on human reader interpretation or the impact of the device on human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This device is not an algorithm or AI system. It is a physical medical device (an endobronchial tube with an embedded camera). Therefore, the concept of "standalone algorithm performance" is not applicable. The device's "standalone" performance is assessed through the physical performance tests mentioned.
7. The Type of Ground Truth Used
The ground truth for the performance tests was based on objective physical measurements of the device's properties (e.g., diameters, resistance, symmetry) against established standards and equivalence to a predicate device.
8. The Sample Size for the Training Set
This device is a physical medical device, not an AI or machine learning system that requires a "training set." Therefore, this question is not applicable.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 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).