(457 days)
The SonarMed AirWave Airway Monitoring System is used to assist in verifying placement of the endotracheal tube (ETT), to assist in detecting movement of the ETT tip, to assist in detecting obstruction of the ETT, and to assist in listening to breath sounds.
The SonarMed AirWave Airway Monitoring System is intended for use by qualified personnel to assist with artificial airway management for patients in an in-hospital setting (intensive care, operating room, and emergency department settings, as well as intra-hospital transport).
The SonarMed AirWave Airway Monitoring System is to be used as an adjunct to normal clinical practice, and is not to be used as a stand-alone diagnostic system.
It is intended for use with patients who use ET tube sizes 2.5, 3.0, 3.5, and for sizes 6.5, 7.0, 7.5, 8.0, 8.5, and 9.0 mm.
The SonarMed AirWave is comprised of a SonarMed Monitor (Monitor) that is used in conjunction with a single-patient use SonarMed Sensor (Sensor) and software that operates the Monitor and Sensor. The Monitor is powered from an external power supply and has a battery backup. When in use, the SonarMed Sensor is placed in-line between the ventilator circuit and the proximal end of the endotracheal tube (ETT) of a patient who is connected to a ventilator.
Using acoustic reflection technology, signals from the Sensor are displayed on the Monitor showing the clinician:
• The baseline location of the ETT tip as established by the clinician
• Quantification of diameter of the anatomical structure around the tip of the ETT
• ETT movement relative to the baseline location
- ETT occlusion / obstruction information including percent obstructed and location of the obstruction
The clinician can choose whether to view information about the patient's airway in either a waveform or graphic on the Monitor's LCD. Additionally the clinician can use the microphones to listen to breath sounds. This information should only be used in an adjunctive manner to assist with management of the artificial airway of the patient.
The monitor allows the user to manually adjust the sound of speed. This is to compensate for the changes in the sound of speed with high oxygen concentrations and the use of anesthesia gases. The monitor also has an auto-speed of sound mode. This mode automatically changes the speed of sound.
The monitor allows the user to manually enter the distance to the carina from the chest x-ray. This is an optional feature that the user can elect from the setting menu. Once selected the algorithm will calculate the distance to the carina based on the movement of the tip of the tube.
The provided text describes the SonarMed™ AirWave Airway Monitoring System (K143042) and its conformity with a predicate device through non-clinical testing. It focuses on demonstrating substantial equivalence to a previously cleared device (SonarMed Airway Management System K092611).
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" in a quantitative format typical for clinical trials or performance goals. Instead, the performance is demonstrated through comparisons to the predicate device and verification of intended function in various tests. The key performance aspects evaluated are:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| ETT Tip Movement & Passageway Size Accuracy (Infant vs. Adult Size Sensor) | The new, infant sized sensors are at least as accurate as the predicate, adult sized sensors in detecting movement and passageway size. This was concluded from bench testing and a pre-clinical animal study. The pre-clinical study concluded that the tracking algorithm is accurate in determining ETT tip movement and passageway size. |
| ETT Obstruction Accuracy (Infant vs. Adult Size Sensor) | The new, infant sized sensors are at least as accurate as the predicate, adult sized sensors in detecting obstruction. This was concluded from bench testing. |
| Functionality during Prolonged Use (Heated, Humidified, Positive Pressure Ventilation) | The SonarMed AirWave Sensor functions as intended during prolonged use for over 30 days. This was demonstrated in a long-term bench study. |
| Biocompatibility | Testing for cytotoxicity, sensitization, and intracutaneous reactivity all passed. Exhaustive E&L (extractable and leachable) testing determined compounds were present at levels well below health consequences for the neonatal population with large safety margins. |
| Safety and Effectiveness Equivalence to Predicate | The conclusions drawn from the nonclinical testing demonstrate that the device is as safe, as effective, and performs as well as the predicate device. This is the overall conclusion of the substantial equivalence determination for non-clinical aspects. |
2. Sample Size Used for the Test Set and Data Provenance
- Bench Testing: The text mentions "Several bench tests were performed" and "A long-term bench study was conducted." It compares "movement and passageway accuracy of the infant sized sensor to the predicate, adult sized sensor" and "obstruction accuracy of the infant sized sensor to the predicate, adult sized sensor." However, specific sample sizes for the bench tests (e.g., number of ETTs, number of tests run) are not provided.
- Pre-clinical Animal Study: "The study utilized an animal model (rabbit)." The number of rabbits used in the study is not specified.
- Data Provenance: The studies were conducted by SonarMed, Inc. and are described as non-clinical bench and pre-clinical animal studies. The text does not refer to human data or data from a specific country of origin in terms of patient population.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of human experts to establish ground truth for the test sets. The ground truth in the bench and animal studies would have been established through controlled experimental setups (e.g., precisely measured ETT movements, intentionally created obstructions, known ETT tip positions).
4. Adjudication Method for the Test Set
Since human expert assessment for ground truth is not mentioned, an adjudication method for test set ground truth is not applicable or described in this context. The "adjudication" would be inherent in the controlled experimental design of the bench and animal studies.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or described. The device is an airway monitoring system for direct measurement, not an AI-assisted diagnostic imaging interpretation tool that would involve "human readers" interpreting "cases."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The performance described (accuracy in determining ETT tip movement, passageway size, and obstruction) is the standalone performance of the device's sensing and algorithm. The device is intended to provide information to a clinician, but the accuracy studies themselves evaluated the device's ability to measure these parameters directly. It is stated: "The SonarMed AirWave Airway Monitoring System is to be used as an adjunct to normal clinical practice, and is not to be used as a stand-alone diagnostic system." This statement regarding its clinical use as an adjunct does not negate that the performance evaluation of its measurements (as described in the non-clinical tests) is essentially its standalone accuracy.
7. The Type of Ground Truth Used
- Bench Testing: The ground truth for bench testing would be known, controlled, and precisely measured physical parameters (e.g., exact movement distances, known obstruction percentages, measured passageway sizes) created within the experimental setup.
- Pre-clinical Animal Study: For the animal study, the ground truth for ETT movement would be based on known physical manipulations of the ETT within the rabbit trachea, bronchus, and esophagus, likely verified by external measurement or direct observation during the procedure.
8. The Sample Size for the Training Set
The document does not mention a concept of a "training set" as would be relevant for machine learning or AI algorithm development in the traditional sense. The device appears to be based on more traditional acoustic reflection technology and algorithms, which likely don't involve a distinct "training set" in the way a deep learning model would. If an algorithm was "trained," the details are not provided.
9. How the Ground Truth for the Training Set Was Established
As no training set is described, this question is 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).