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The Vivo 40 is an assist ventilator intended to augment the breathing of spontaneously breathing adult patients >66 lbs (>30 kg) suffering from respiratory failure, respiratory insufficiency, or obstructive sleep apnea.

The Vivo 40 is not intended to provide the total ventilatory requirements of the patient.

The Vivo 40 is intended to be used for both invasive and non-invasive applications.

The Vivo 40 is intended to be operated by qualified and trained personnel.

The Vivo 40 is intended for use in clinical settings (e.g., hospitals, sleep laboratories, sub-acute care institutions) and home environments.

The 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 spontaneously breathing patients to augment the breathing.

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 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 non-invasive and 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 housine are 7.2 × 9.1 × 8.9 inches, and the device weighs 8.9 pounds.

This document describes the Breas Vivo 40 ventilator with a new "Target Volume" feature, seeking 510(k) clearance from the FDA. The submission largely relies on predicate device comparison and bench testing rather than extensive clinical studies.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

• Pressure stability
• Dynamic pressure regulation
• Waveform performance
• Target volume feature | Bench testing confirmed substantial equivalence for:
• Wave-form performance
• Work of Breathing
• Pressure Dynamic regulation
• Target Volume feature |
  | Safety and Effectiveness | As safe and effective as therapy without the Target Volume feature. | Clinical article attached (Appendix 12) supporting the use of volume-controlled ventilation in combination with pressure-controlled ventilation. |

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

• Test Set Sample Size: Not applicable. The primary evidence presented is bench testing and a single clinical article, not a clinical study with a defined patient test set for the device itself.
• Data Provenance:
  • Bench Testing: Performed by Breas Medical AB (Sweden). This is retrospective as it's testing a modification to an existing device.
  • Clinical Article: Referencing "one clinical article" provided in Appendix 12. The provenance (country of origin, retrospective/prospective) of this article's data is not specified in the provided text.

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

• Not applicable. As no clinical study with a patient test set for the device was performed by Breas Medical, there were no experts used to establish ground truth for such a test set. The bench testing relies on engineering standards and measurements, not expert human assessment. The cited clinical article would have its own ground truth establishment methods, but these are not for the device's specific performance in this submission.

4. Adjudication Method for the Test Set

• Not applicable. No human-involved test set requiring adjudication was conducted by Breas Medical for this submission.

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

• No. An MRMC comparative effectiveness study was not done. The submission explicitly states: "No clinical testing has been performed by Breas Medical."

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

• Yes, in a sense, standalone performance testing was done in the form of "bench testing." The "Target Volume" feature is a software-based algorithm that adjusts pressure. The bench tests evaluated the performance of this algorithm (and the integrated device) in a controlled environment, without human intervention in the device's operation during the tests.

7. The Type of Ground Truth Used

• Bench Testing: The ground truth for bench testing is established by engineering specifications, physical principles, and measurement standards for ventilator performance (e.g., precise pressure and flow measurements, waveform analysis, tidal volume delivery).
• Clinical Article: The ground truth for the cited clinical article (not part of Breas Medical's direct testing) would depend on the study's design, but typically in clinical ventilation studies, it could involve physiological measurements (e.g., blood gas analysis, lung mechanics), patient outcomes, or expert clinical assessment.

8. The Sample Size for the Training Set

• Not applicable. The Vivo 40 with the Target Volume feature is a medical device, not an AI/ML algorithm that is "trained" on a dataset in the conventional sense. Its "training" or development would involve engineering design, simulation, and iterative hardware/software development and testing, not a labeled training dataset.

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

• Not applicable, as there is no "training set" in the context of AI/ML for this device. The development of the device's control algorithms would be based on established physiological models, control theory, and engineering principles, with validation through simulations and bench testing.

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The Breas Vivo 40 is designed for spontaneous breathing patients who require long-term support by mechanical ventilation during night and part of the day. The CPAP function is intended to deliver continuous positive airway pressure therapy for the treatment of obstructive sleep apnea. The Breas Vivo 40 shall only be used by patients with spontaneous breathing. The Breas Vivo 40 is not intended for life-sustaining applications or for transport of critical care patients. The Breas Vivo 40 is intended for non-invasive use.

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 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.

The Breas Vivo 40 System is a ventilator. The 510(k) summary does not include specific acceptance criteria values or detailed performance results in the format requested. Instead, it broadly states that the device passed various tests and met its stated performance specifications.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• The document describes bench testing, meaning the tests were conducted in a laboratory setting, not on human subjects.
• The sample size for the test set (number of devices tested for each category) is not specified in the provided summary.
• The data provenance is not explicitly stated beyond being non-clinical testing performed by the manufacturer, Breas Medical AB, which is based in Sweden.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

• This information is not applicable as the summary describes non-clinical, bench testing of the device's physical and functional performance against technical standards and predicate devices. No human experts were used to establish a "ground truth" for diagnostic or clinical evaluation.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• This is not applicable as the summary describes non-clinical, bench testing. Adjudication methods are typically used in clinical studies for human interpretation or diagnosis.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The device is a ventilator, and the testing described is non-clinical bench testing, not a study involving human readers or AI assistance.
• The document explicitly states: "Clinical studies were not required to support a substantial equivalence determination."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• This is not applicable in the context of this device. The Breas Vivo 40 System is a physical medical device (ventilator) with embedded software, not a standalone diagnostic algorithm. The software itself was documented and tested for compliance with FDA guidance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For the non-clinical bench testing, the "ground truth" was established by technical standards, engineering specifications, and the performance characteristics of legally marketed predicate devices. This is not a clinical ground truth like pathology or outcomes data.

8. The sample size for the training set:

• This is not applicable. The device is a ventilator, not a machine learning model that requires a training set of data.

9. How the ground truth for the training set was established:

• This is not applicable as there is no training set for this device.

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