(220 days)
The AG100s is intended to monitor and control the cuff pressures of endotracheal tube (ETT) or tracheostomy tube (TT) and to evacuate secretions from the subglottic space above the cuff during mechanical ventilation.
- When used with a standard ETT or TT, the device automatically maintains the cuff pressure as pre-set by the user.
- When used with ETT or TT with suction line, the device automatically maintains the cuff pressure as pre-set by the user and performs intermittent evacuation of subglottic secretions from above the tube's cuff.
- When used with ETT with suction and venting lines (e.g., AG ETT), the device automatically maintains the cuff pressure as pre-set by the user, or automatically adjusts the cuff pressure based on monitoring of the Carbon Dioxide (CO2) concentration above the cuff. In addition, it performs evacuation, or rinsing and evacuation of subglottic secretions from above the tube's cuff.
The AG100s system is comprised of the following main components:
- The AG100s control unit
- The AnapnoGuard connection kit/harness (AG Connection Kit) connecting a cuffed airway to the AG100s control unit.
Additional device components include cart, secretions canister (Trap Bottle), rinsing fluid (saline) bag and antibacterial air filter.
When the AG100s, is connected to AG ETT, it monitors leaks between endotracheal cuff and the trachea by measuring the Carbon Dioxide levels in the subglottic area above the cuff through a dedicated lumen in the endotracheal tube. Detection of a high level of Carbon Dioxide is an objective indicator for a leak (improper sealing of the trachea by the AG ETT). The system continuously monitors and adjusts the cuff pressure to prevent a leak at minimum possible pressure (all within pressure limits preset by the user). Preventing a leak reduces the likelihood of aspiration of secretions from the upper airways into the lungs and increases the likelihood for no loss of ventilation and delivery of anesthetic and nebulized drugs into the lungs. Keeping the cuff pressure as low as possible reduces the mechanical pressure of the cuff on the tracheal tissue throughout the intubation period. The system also performs evacuation of secretions from above the endotracheal tube's cuff through a dedicated lumen at the dorsal side of the endotracheal tube.
The AG100s also performs cuff pressure monitoring and control in standard FDA cleared TTs and ETTs; depending on the tube type, the system may also perform secretions removal.
The provided text is a 510(k) summary from the FDA, which focuses on demonstrating substantial equivalence of a modified medical device (AG100s) to a previously cleared predicate device. This type of document typically does not contain detailed acceptance criteria and performance data in the format of a clinical study report with specific statistical outcomes, sample sizes, and expert qualifications.
However, I can extract the types of performance evaluations mentioned and general statements about the device's functionality.
Based on the provided document, here is an attempt to address your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance metrics. Instead, it relies on demonstrating that the modified device (AG100s) functions equivalently to its predicate. The "performance data" section lists the types of tests conducted to support this claim.
| Acceptance Criteria (Implied by equivalence claim) | Reported Device Performance (Summary) |
|---|---|
| Cuff Pressure Control: Maintain cuff pressure as pre-set by user (10-50 mmHg) when used with ETT or TT. | Comparative AG100s Cuff pressure control + suction performance when connected to ETTs & TTs: Validated the device functions as intended with both ETT and TT. The system continuously monitors and adjusts cuff pressure to prevent leaks at minimum possible pressure (within user-defined limits). |
| Subglottic Secretion Evacuation: Perform intermittent evacuation of subglottic secretions from above the tube's cuff (Suction Pressure Range: -20 up to -120 mmHg). | Comparative AG100s Cuff pressure control + suction performance when connected to ETTs & TTs: Validated the device functions as intended with both ETT and TT, including subglottic secretion removal. |
| CO2 Monitoring (with AG ETT): Automatically adjust cuff pressure based on monitoring CO2 concentration above the cuff, to prevent leaks. | Cuff Pressure Control (with AG ETT): Demonstrated the system monitors and adjusts cuff pressure based on CO2 levels to prevent leaks, reducing aspiration likelihood and maintaining low cuff pressure. |
| Software Functionality: Software operates as intended and is validated. | Software System V&V Test: Conducted to ensure the software's functionality and reliability. |
| Usability: Device is usable and user-friendly. | AG100s Usability Validation: Performed to confirm the device's usability. |
| Safety and Effectiveness: No new questions of safety and effectiveness are raised by the modifications. | Overall Conclusion: Verification and Validation testing demonstrated that the revised device is substantially equivalent to the previously cleared AG100s, and is as safe and effective without raising new safety or effectiveness concerns. |
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not specify quantitative sample sizes (e.g., number of patients, number of devices) for any of the tests mentioned (Comparative AG100s Cuff pressure control + suction performance, Software System V&V Test, Usability Validation).
Regarding data provenance: The studies were conducted by Hospitech Respiration Ltd., which is based in Israel. The nature of the studies ("Comparative," "V&V Test," "Usability Validation") suggests they are prospective validation and verification tests conducted specifically for this submission, likely involving laboratory or simulated environments, and potentially human factors evaluations. There is no mention of retrospective clinical data from patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide this information. Given the nature of the tests (performance, software V&V, usability), "ground truth" would likely be established by engineering specifications, validated test methods, and human factors validation protocols rather than expert consensus on medical images or diagnoses. For usability, experts in human factors might be involved, but their number and qualifications are not specified.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method. Adjudication is typically used in clinical studies when there's uncertainty in ground truth or to resolve discrepancies among multiple readers. For the verification and validation tests described, results would likely be directly compared against predefined engineering specifications or performance metrics rather than requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not reported. MRMC studies are typically clinical studies evaluating the performance of AI-assisted human readers compared to unassisted readers, especially in diagnostic imaging. This document describes technical verification and validation studies to demonstrate substantial equivalence of a physical medical device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The device itself is an automated system for monitoring and controlling cuff pressures and evacuating secretions. Its core function is inherently "standalone" in that it performs these tasks without immediate human intervention for each action, although it is designed for use by trained medical professionals who would set initial parameters and manage the patient. The performance tests described (cuff pressure control, suction performance, CO2 monitoring functionality, software V&V) inherently evaluate the device's standalone technical performance. There isn't a separate "algorithm only" evaluation as described for, for example, an AI diagnostic algorithm.
7. The Type of Ground Truth Used
The ground truth for the performance tests would be based on:
- Engineering Specifications: For parameters like cuff pressure control range (10-50 mmHg), suction pressure range (-20 to -120 mmHg), and flow rate (0-12 L/min).
- Validated Test Methods: Using calibrated equipment to measure and verify the device's outputs against its intended specifications.
- Functional Requirements: Demonstrating that features like CO2 monitoring leading to cuff pressure adjustment, and secretion evacuation, work as designed.
- User Needs/Human Factors Data: For the usability validation.
There is no mention of pathology, expert consensus on clinical cases, or outcomes data in humans presented in this summary to establish ground truth.
8. The Sample Size for the Training Set
This document is for a modified physical medical device, not an AI/ML algorithm that requires a "training set" in the computational sense. Therefore, the concept of a training set sample size is not applicable here. The device's operation is governed by pre-programmed logic, not by a machine learning model trained on data.
9. How the Ground Truth for the Training Set Was Established
As stated above, the concept of a "training set" is not applicable to this device.
§ 868.5750 Inflatable tracheal tube cuff.
(a)
Identification. An inflatable tracheal tube cuff is a device used to provide an airtight seal between a tracheal tube and a patient's trachea.(b)
Classification. Class II (performance standards).