Search Results

The Astral 100/150 provides continuous or intermittent ventilatory support for patients weighing more than 5kg (11 lb) who require mechanical ventilation. The Astral device is intended to be used in home, institution/hospital and portable applications for both invasive and non-invasive ventilation.

The Astral ventilator system uses a micro-processor controlled blower, which, along with valves and pressure and flow sensors, achieves pressure, flow and time regulation of air delivery. Air is directed to the patient via one of three ventilator breathing circuits; double circuit, single circuit with expiratory valve, or single circuit with intentional leak. Supplemental oxygen can be entrained at the inlet to the main turbine. The device provides both therapeutic and technical alarms, and a user interface allowing adjustment of clinical parameters and display of monitored clinical data. The Astral can use external AC or DC power supply and contains an integrated battery.

The Astral is capable of providing the following types of ventilatory support:

• Assist/Control and SIMV with either volume or pressure control
• Continuous Spontaneous Ventilation in either Pressure Support or CPAP
• Volume Assurance and Apnea Ventilation

Acceptance Criteria and Study for Astral 100/150 Ventilator

The provided documentation details the non-clinical performance evaluation of the Astral 100/150 ventilator to establish its substantial equivalence to predicate devices (Respironics Trilogy 200 and Pulmonetic LTV 1200).

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that "All tests confirmed the product met the predetermined acceptance criteria." The specific numerical or qualitative values for these criteria are not provided in this summary but are implied to have been met for substantial equivalence.

2. Sample Size and Data Provenance

• Sample Size for Test Set: Not explicitly stated. The document refers to "Design and Verification activities" and "non-clinical side-by-side performance testing" for each therapy mode and supplementary feature. This suggests a comprehensive, but unquantified, series of tests.
• Data Provenance: The study was conducted as part of the device's design and verification by ResMed Corp., in San Diego, CA, USA. This indicates the testing was performed internally by the manufacturer, likely in a controlled laboratory environment. The data would be prospective as it was generated specifically for the 510(k) submission to demonstrate compliance.

3. Number of Experts and Qualifications for Ground Truth

• This information is not applicable as the study was a non-clinical performance evaluation of a medical device (ventilator). Ground truth in this context would refer to the established engineering specifications, performance standards, and the capabilities of the predicate devices, rather than expert interpretation of clinical data. The performance was assessed against these known standards and functional requirements.

4. Adjudication Method for the Test Set

• This information is not applicable. As a non-clinical performance study, there would be no human "adjudication" in the sense of resolving disagreements among experts on clinical findings. Performance was assessed against predefined technical specifications and standards using objective measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The document explicitly states: "Clinical testing was not required." The evaluation was entirely non-clinical and focused on device performance against technical standards and comparison to predicate devices, not on human-in-the-loop performance or clinical outcomes.

6. Standalone (Algorithm Only) Performance Study

• Yes, a standalone performance study was done in the sense that the device's performance was evaluated independently without human intervention during the technical tests. The "Design and Verification activities" and "non-clinical side-by-side performance testing" assessed the device's inherent mechanical and software-driven functionalities (e.g., accuracy of volume/pressure controls, waveform generation, triggering, alarms). This is implicitly a standalone performance evaluation of the device as an engineered system.

7. Type of Ground Truth Used

• The ground truth used was based on established engineering specifications, performance standards, and the known operational characteristics of the predicate devices. The testing confirmed that the Astral device met "predetermined acceptance criteria" and demonstrated "substantially equivalent" performance to the predicates. This encompasses:
  • Applicable FDA guidance documents (e.g., Draft Reviewer Guidance for Ventilators, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices).
  • International standards (e.g., ASTM F 1246-91, ASTM F 1100-90, ISO 10651-2:2004, IEC 60601-1:2005, IEC 60601-1-2:2007).
  • The performance characteristics and range/accuracy of the predicate devices (Respironics Trilogy 200 and Pulmonetic LTV 1200).

8. Sample Size for the Training Set

• This information is not applicable. The Astral 100/150 is a medical device (ventilator) that relies on micro-processor controlled mechanics and software for its operation. It is not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The "software based pressure, flow and time regulation" is developed through engineering and control system design, not through machine learning from data.

9. How the Ground Truth for the Training Set Was Established

• This information is not applicable as there was no AI/machine learning training set. The "ground truth" for the device's design and functional parameters would have been established through established engineering principles, physics, medical requirements for ventilation, and regulatory standards.

Ask a specific question about this device