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The BiPAP A40 ventilator is intended to provide invasive and non-invasive ventilatory support to treat adulate and pediatric weighing over 10 kg (22 lbs) with Obstructive Sleep Apnea (OSA), Respiratory Insufficiency, or Respiratory Failure. It is intended to be used in the home, institutional/hospital, and portable applications such as wheelchairs and gurneys.

The Respironics BiPAP A40 Ventilatory Support System is a microprocessor controlled blower and valve based positive pressure ventilatory system. The device can provide non-invasive or invasive ventilation. The device augments patient breathing by supplying pressurized air through a patient circuit. It senses the patients breathing effort by monitoring airflow in the patient circuit and adjusts its output to assist in inhalation and exhalation. This therapy is known as Bi-level ventilation. Bi-level ventilation provides a higher pressure, known as IPAP (Inspiratory Positive Airway Pressure), when you inhale, and a lower pressure, known as EPAP (Expiratory Positive Airway Pressure), when you exhale. The higher pressure makes it easier for you to inhale, and the lower pressure makes it easier for you to exhale. This device can also provide a single pressure level, known as CPAP (Continuous Positive Airway Pressure).

The BiPAP A40 Ventilator is compatible with the System One Heated Humidifier. The System One heated humidifier, previously cleared for use in K113053, is an accessory for the Philips Respironics A Series therapy devices to provide moisture to the circuit.

The BiPAP A40 ventilator introduces a new therapy mode called AVAPS-AE. This therapy mode combines an improved AVAPS algorithm with an auto-back up to treat hypoventilation. An auto-EPAP algorithm runs simultaneously with the bi-level therapy to deliver the pressure support at the optimal PEEP. Additionally the ventilator can be operated using AC power, a detachable battery, or an external battery.

A Graphical user interface displays device data and device settings.

The BIPAP A40 Ventilatory Support System is fitted with alarms to alert the user to changes that will affect the treatment. Some of the alarms are pre-set (fixed), others are user adjustable,

Like its predicates, the BiPAP A40 Ventilatory Support System is intended for use with a patient circuit that is used to connect the device to the patient interface device (mask or trach). A typical patient circuit consists of a six-foot disposable or reusable smooth lumen tubing, an exhalation device, and a patient interface device.

This document describes the BiPAP A40 Ventilatory Support System, a continuous ventilator intended for invasive and non-invasive ventilatory support in both adult and pediatric patients weighing over 10 kg. It's meant for use in various settings, including home, hospital, and portable applications.

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1. Table of Acceptance Criteria and Reported Device Performance

The document describes performance testing that confirmed the product met "predetermined acceptance criteria" (Page 5). However, specific numerical acceptance criteria (e.g., "Pressure Accuracy: +/- X cmH2O") are not explicitly listed in a table format alongside specific numerical performance results. Instead, the document generally states that "All tests confirmed the product met the predetermined acceptance criteria."

The closest information to acceptance criteria is found in the "Technological Characteristic" table on page 3, which lists specifications for pressure accuracy and alarm indicators. The document then states that "Performance testing comprises pressure performance, trigger and cycling, as well as volume assured pressure support ventilation" and "All tests confirmed the product met the predetermined acceptance criteria." This implies that the device's performance aligned with these listed characteristics.

The "Pressure Accuracy" is stated as "+/- 2.5 cmH2O of the setting". The document does not provide a separate table of specific acceptance criteria values versus reported performance values with numerical results for each test. It simply states that the device "passing all test protocols" and "All tests confirmed the product met the predetermined acceptance criteria."

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

The document describes "bench testing" and "non-clinical tests" (Page 4, 5, 6, 7). No specific sample size (e.g., number of patients or patient data sets) for a test set is provided. The testing appears to be primarily focused on the device's functional performance in a laboratory setting, rather than with a human patient test set.

The data provenance is from non-clinical bench testing rather than human subject data. There is no mention of country of origin of data or whether it was retrospective or prospective, as it pertains to bench testing.

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

This information is not applicable as the testing described is non-clinical bench testing, not involving human experts for ground truth establishment of a medical condition. The "ground truth" for the device's performance was established by its design input specifications and engineering verification.

4. Adjudication Method for the Test Set

This information is not applicable as the testing was non-clinical bench testing and did not involve expert adjudication of results.

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 done. The document describes "comparative testing" (Page 5) and "side-by-side bench testing methodologies" (Page 6) with predicate devices to demonstrate substantial equivalence, but this refers to comparing the device's technical performance against other devices, not a study involving human readers with and without AI assistance.

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

The testing described is primarily standalone in nature for the device itself (algorithm only without human-in-the-loop performance in a clinical context). The device is a ventilatory support system, not an AI diagnostic tool requiring human interpretation. The "algorithms" mentioned (AVAPS, AVAPS-AE, Trigger Type Options) are intrinsic to the device's operation. The bench testing verified their functional performance.

7. The Type of Ground Truth Used

The ground truth used for the non-clinical testing was based on design input specifications, engineering principles, and validated test protocols for ventilator performance (e.g., pressure accuracy, breath rates, tidal volume delivery). For the algorithms, the ground truth was their ability to perform to these specifications, to "safely change pressure support to maintain a target tidal volume" and "safely adjust the EPAP setting" under varying conditions (Page 6).

8. The Sample Size for the Training Set

The document does not describe a training set in the context of machine learning. The device's algorithms (like AVAPS-AE) appear to be rule-based or control-loop systems, rather than trained machine learning models requiring a distinct "training set." Therefore, this information is not applicable in the conventional sense of machine learning.

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

As there is no mention of a training set for machine learning, this information is not applicable. The "ground truth" for the device's operational parameters would have been established through engineering design, physiological models, and clinical requirements and specifications for ventilator performance.

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