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The Astral 100/150 provides continuous or intermittent ventilatory support for patients weighing more than 11lb (5kg) who require mechanical ventilation.

The iVAPS mode with optional AutoEPAP is intended for patients weighing more than 66lb (30kg).

The Astral device is intended to be used in home, institution/hospital and portable applications for both invasive and noninvasive 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 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 alarms (e.g. tidal volume) and technical alarms (e.g. system fault), 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

The provided text describes a 510(k) premarket notification for the ResMed Astral 100/150 ventilator, focusing on the addition of an AutoEPAP feature within its iVAPS therapy mode. This submission argues for substantial equivalence to a previously cleared predicate device.

Here's an analysis of the acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present a formal table of "acceptance criteria" for the AutoEPAP feature in the same way one might find for diagnostic accuracy (e.g., sensitivity, specificity thresholds). Instead, it discusses the performance in terms of demonstrating non-inferiority to the predicate device's manual EPAP feature.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: The exact number of patients in the multi-center clinical trial is not explicitly stated in the provided text.
• Data Provenance: The data came from a multi-center, single-blind, randomized, cross-over clinical trial. This indicates a prospective study design. The country of origin is not specified, but the applicant (ResMed Ltd) is based in Australia, and the correspondent is in the USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The text describes a clinical trial comparing AutoEPAP to manual EPAP. For this type of study involving respiratory support, the "ground truth" isn't typically established by a panel of independent experts reviewing data for diagnostic accuracy. Instead, the ground truth is based on physiological measurements (like ODI4%) and clinical outcomes in patients under observation by medical professionals. The study design (clinical trial) itself serves as the method for assessing efficacy. Therefore, there's no mention of a specific number of experts establishing "ground truth" in the diagnostic sense, nor are their qualifications detailed in this context. Rather, the expertise lies within the medical professionals conducting and overseeing the clinical trial.

4. Adjudication Method for the Test Set

The study was a single-blind, randomized, cross-over clinical trial. In this setup, patients are switched between AutoEPAP and manual EPAP, and their outcomes (e.g., ODI4%) are compared within the same patient. The "adjudication" in this context refers to the assessment of clinical endpoints by the study investigators/medical team, rather than an independent expert review of specific cases for a diagnostic outcome. The text does not elaborate on a specific adjudication committee or process beyond the trial design itself.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. MRMC studies are typically used to evaluate the performance of diagnostic devices or algorithms where multiple readers interpret cases with and without AI assistance. This submission describes a clinical trial evaluating a therapeutic device (a ventilator with a new feature) where the performance is measured by physiological outcomes in patients.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the clinical trial described effectively evaluates the "standalone" performance of the AutoEPAP algorithm in conjunction with the iVAPS mode by comparing it directly to manual EPAP. While "human-in-the-loop" is always present in a therapeutic device setting (clinicians set parameters, monitor patients), the comparison focuses on the automatic adjustment provided by the AutoEPAP algorithm versus a constant manual setting, demonstrating the algorithm's performance in a real-world clinical application. Bench testing also verified the algorithm's response to simulated conditions, which is another form of standalone assessment.

7. The Type of Ground Truth Used

The primary "ground truth" or endpoint used in the clinical study was:

• Oxygen Desaturation Index (ODI4%) as a measure of upper airway obstruction.
• Safety outcomes (absence of serious adverse events or complications).

These are objective physiological measures and clinical safety data from patients.

8. The Sample Size for the Training Set

The text does not provide information on the sample size for the training set for the AutoEPAP algorithm. Algorithms typically undergo a development and training phase using data, but this submission focuses on the validation of the finalized algorithm through bench and clinical testing.

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

The document does not specify how the ground truth for the training set was established. Given that this is a therapeutic algorithm for a ventilator feature, the training would likely involve:

• Physiological models of respiratory mechanics.
• Data from patients with respiratory conditions and various levels of upper airway obstruction.
• Expert clinical knowledge and engineering principles to develop the algorithm to respond appropriately to changes in flow and apnea events, aiming to maintain optimal EPAP levels.

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The Astral 100/150 provides continuous or intermittent ventilatory support for patients weighing more than 5kg (11 lb) who require mechanical ventilation.

The iVAPS mode is intended for patients weighing more than 66lb (30kg).

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 is directed to the patient via one of three ventilator breathing circuit, single circuit with expiratory valve, or single circuit with intentional leak. Supplemental oxygen can be entrained at the main turbine. The device provides both therapeutic alarms (e.g. tidal volume) and technical alarms (e.g. system fault), 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

The provided document is a 510(k) premarket notification for a medical device (ventilator). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific acceptance criteria for AI or a new diagnostic tool.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, device performance derived from a test set, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth types, training set information, or how ground truth was established for a new AI/diagnostic device.

The document discusses:

• Device Name: Astral 100/150
• Regulation Name: Continuous Ventilator
• Predicate Device: ResMed Astral 100/150 (K133868)
• Reference Device: Respironics Trilogy 200 (K093416)
• Reason for Submission: New device (specifically, the addition of the iVAPS therapy mode).
• Non-Clinical Performance Data: Stated that design and verification activities were performed, including accuracy of ventilation, volume & pressure controls and monitoring, waveform performance, accuracy and repeatability of triggering and cycling, endurance and environmental testing, and alarm verification. It explicitly states, "All tests confirmed the product met the predetermined acceptance criteria." However, it does not list these specific acceptance criteria in a table or provide quantitative performance results against them. It also mentions side-by-side performance testing for the new therapy mode (iVAPS) and electrical changes testing.
• Conclusion: The device is substantially equivalent to the predicate and reference devices based on intended use, technological characteristics, and principles of operation. Clinical testing was not required for this submission.

In summary, this document is a 510(k) submission for a ventilator, focusing on substantial equivalence to a predicate device and not a study validating a new AI/diagnostic device with the specific criteria you've outlined.

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