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The Breas Vivo 40 is an assist ventilator intended to augment the breathing of spontaneously breathing adult patients (>30 kgs) suffering from respiratory failure, respiratory insufficiency, or obstructive sleep apnea. It is not intended to provide the total ventilatory requirements of the patient. It is intended to be used for both invasive and non- invasive applications. The Breas Vivo 40 is intended to be operated by qualified and trained personnel. The Breas Vivo 40 is intended for use in clinical settings (e.g., hospitals, sleep laboratories, sub-acute care institutions) and home environments. The Breas Vivo 40 must always be prescribed by a licensed physician.

The Vivo 40 is a pressure-supported and pressure-controlled ventilator with a CPAP function intended for spontaneous breathing patients who require long-term support by mechanical ventilation during night and part of the day. In the treatment of chronic respiratory failure, positive airway pressure ventilation is well established and common practice as a mean to assure sufficient gas exchange. There are a number of devices legally marketed in the United States for this application. The Vivo 40 can be used in clinical settings (e.g., hospitals, sleep laboratories, sub-acute care institutions) and home environments. It must always be prescribed by a licensed physician. It is not intended for life support applications or for transport of critical care patients. The therapy delivered by the Breas Vivo 40 System can be either: 1) Pressure Controlled Ventilation (PCV) or 2) Pressure Support Ventilation (PSV) or 3) Constant Positive Airway Pressure (CPAP). The Vivo 40 airflow is delivered via a single lumen outlet tube that may be connected to various invasive and non-invasive patient interfaces, such as nasal masks. To minimize CO2 rebreathing, masks or other interfaces permitting a leak flow of at least 12 liters/minute at the output pressure setting of 4 cmH20 are recommended. The Vivo 40 has an auto-switching power supply that facilitates use in conjunction with international travel (100 - 240 VAC). It can also be used with an external 12.5/ 24 VDC power source when AC mains line voltage is not available. The outer dimensions of the Vivo 40 housing are 7.2 × 9.1 × 8.9 inches, and the device weighs 8.9 pounds.

Here's an analysis of the provided text regarding the Breas Vivo 40 System, focusing on acceptance criteria and the study proving it meets those criteria:

Device: Breas Vivo 40 System (Bilevel system, Ventilator)
Intended Use: For spontaneous breathing adult patients (>30 kg) requiring long-term support by mechanical ventilation (night and part-day), and for CPAP therapy for obstructive sleep apnea. Not for life support or transport of critical care patients.

1. Acceptance Criteria and Reported Device Performance

The provided document describes the device's adherence to various regulatory and performance standards rather than specific quantitative acceptance criteria with numerical targets. The "reported device performance" is essentially a statement of compliance or "passed all tests."

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

The document explicitly states that "Non-clinical testing was conducted" and "Comparative testing... was performed." These refer to bench-testing and device-level verification.

• Sample Size for Test Set: Not specified in the provided text, but it pertains to physical units of the ventilator and possibly components, not patient data.
• Data Provenance: The tests were conducted on the device itself, likely within a laboratory or manufacturing setting. No patient data (e.g., country of origin, retrospective/prospective) is associated with this testing as it was non-clinical.

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

This question is not applicable in the context of the provided information. The testing was non-clinical bench-testing, comparing the device to pre-established standards and a predicate device. "Ground truth" in this context would be the performance characteristics of the standards or the predicate device, not established by human experts for a test set of medical cases.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (e.g., 2+1, 3+1) typically refer to expert review processes for clinical data or imaging, which were not part of this submission's testing. The "adjudication" for the bench-tests would be whether the device passed the specified criteria, which is a binary outcome based on measurement, not expert consensus.

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

No, an MRMC comparative effectiveness study was not done.

The document explicitly states: "Clinical studies were not required to support a substantial equivalence determination."

Therefore, there is no information on:

• Effect size of how human readers improve with AI vs without AI assistance. (This is an AI-specific question, and this device is a ventilator, not an AI diagnostic tool.)

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

This question is not applicable in the context of this device. The Breas Vivo 40 is a mechanical ventilator, not an AI algorithm or a diagnostic software. Its performance is inherent to its hardware and controlling software, which directly delivers therapy. There isn't a separate "algorithm only" performance to be evaluated outside of the device's functional operation. The software testing mentioned was for compliance with FDA guidance, not for standalone diagnostic performance.

7. The Type of Ground Truth Used

For the non-clinical and comparative bench testing, the "ground truth" was established by:

• Engineering Specifications / Pre-defined Measurement Criteria: For meeting its own "stated performance specifications" (e.g., pressure delivery accuracy, flow rates).
• International Standards: Compliance with standards like IEC 601-1, ISO 10651-6, ISO 17510-1 for safety and performance.
• Predicate Device Performance: For the comparative testing (Wave-form performance, Work of Breathing, Pressure Dynamic regulation), the performance of the legally marketed predicate devices (Respironics Vision, Breas Vivo 40 (K053607)) served as the benchmark for substantial equivalence.

No pathology, expert consensus on clinical cases, or outcomes data were used as ground truth for this submission, as no clinical studies were performed.

8. The Sample Size for the Training Set

This question is not applicable. The Breas Vivo 40 System is a mechanical ventilator, not a machine learning or AI-driven device that requires a "training set" of data in the typical sense for algorithm development. The software testing mentioned refers to verification and validation of the embedded control software, not training a predictive model.

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

This question is not applicable, as there was no "training set" for an AI algorithm.

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