(245 days)
The SonarMed™ AMS is used to assist in verifying placement of the endotracheal tube (ETT), to assist in detecting movement of the ETT tip, and to assist in detecting obstruction of the ETT.
The SonarMed AMS 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 AMS 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 from 6.5 mm to 9.0 mm, with a body weight of >35 kg.
The SonarMed AMS is comprised of a SonarMed Monitor (Monitor) that is used in conjunction with a sterile, single-use SonarMed Adapter (Adapter) and software that operates the Monitor and Adapter. The Monitor is powered from an external power supply and has a battery backup. When in use, the SonarMed Adapter 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 sonic reflection technology, signals from the Adapter allow the color LCD on the Monitor to display to a clinician:
The baseline location of the ETT tip as established by the clinician
Quantification of passageway diameter relative to the ETT diameter (for example a reading of less than 1 may indicate the tube is in a passageway that is smaller than itself, such as the esophagus)
ETT movement relative to the baseline location
ETT occlusion / obstruction information including percent obstructed
The clinician can choose whether to view information about the patient's airway in either a waveform or graphic on the Monitor's color LCD. This information should only be used in an adjunctive manner to assist with management of the artificial airway of the patient.
SonarMed™ Airway Monitoring System: Acceptance Criteria and Study Details
The provided 510(k) summary for the SonarMed™ Airway Monitoring System indicates that "The results of non-clinical (lab) performance testing demonstrate that the device is safe and effective." It explicitly states "Clinical data and conclusions were not needed for this device."
Based on this information, the device relies on non-clinical (lab) performance testing to demonstrate its safety and effectiveness, and no clinical study was conducted or deemed necessary for this submission. Therefore, some of the requested information regarding clinical studies (like sample sizes for test/training sets, expert involvement, adjudication, MRMC studies, or specific ground truth based on patient outcomes/pathology) is not applicable or provided in this document.
1. Table of Acceptance Criteria and Reported Device Performance
Since the provided document only mentions "non-clinical (lab) performance testing" without detailing specific acceptance criteria or quantitative performance metrics, this table cannot be fully completed. The document broadly states the device's capabilities.
| Acceptance Criteria Category | Specific Acceptance Criteria (from Study) | Reported Device Performance (from Study) |
|---|---|---|
| ETT Tip Placement Verification | Not specified in the document. | Ability to display the baseline location of the ETT tip as established by the clinician. |
| Passageway Diameter Quantification | Not specified in the document. | Quantification of passageway diameter relative to the ETT diameter (e.g., a reading of less than 1 may indicate the tube is in a passageway that is smaller than itself, such as the esophagus). |
| ETT Movement Detection | Not specified in the document. | Ability to display ETT movement relative to the baseline location. |
| ETT Occlusion/Obstruction Detection | Not specified in the document. | Ability to display ETT occlusion/obstruction information, including percent obstructed. |
| General Safety & Effectiveness | Not specified in the document. | "The results of non-clinical (lab) performance testing demonstrate that the device is safe and effective." |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable as no clinical test set was used/described. The document refers to "non-clinical (lab) performance testing."
- Data Provenance: Not applicable as no clinical data or country of origin is mentioned for the non-clinical lab testing. The testing was reported as "non-clinical (lab) performance testing," implying an engineered or simulated environment rather than patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical test set requiring expert ground truth establishment was used/described. The performance was assessed through non-clinical lab testing.
4. Adjudication method for the test set
Not applicable, as no clinical test set involving human interpretation and needing adjudication was used/described.
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 MRMC comparative effectiveness study was indicated or performed. The device is an "adjunct to normal clinical practice" and is "not to be used as a stand-alone diagnostic system," implying it does not replace human interpretation but provides additional information.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document describes "non-clinical (lab) performance testing" which would represent a standalone evaluation of the device's ability to measure and display the stated parameters. However, the device's intended use is adjunctive, meaning it is designed to be used with human clinicians, not as a standalone diagnostic. The lab tests would have validated the technical performance of the algorithm in a controlled environment.
7. The type of ground truth used
For the "non-clinical (lab) performance testing," the ground truth would have been established through calibrated physical models or simulations where the true values of ETT tip location, movement, diameter, and obstruction were precisely known and controlled. This is characteristic of laboratory-based engineering validation.
8. The sample size for the training set
Not applicable, as no clinical training set was used/described. For non-clinical lab testing, the "training" equivalent would involve iterative testing and calibration during the device's development using controlled physical setups.
9. How the ground truth for the training set was established
Not applicable, as no clinical training set was used/described. For non-clinical lab testing, ground truth for development and calibration would have been established by precisely creating known conditions (e.g., ETT at a specific depth, tubes of known diameter, controlled obstructions) within a laboratory setup and using highly accurate measurement tools to verify these conditions.
§ 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).