(126 days)
The Bi-Flow D/R is designed to provide manual mechanical ventilation triggered by the operator to a nonbreathing patient. This is accomplished by providing the patient a source of oxygen from the Bi-Flow D/R through a device such as a facemask or endotracheal tube. Between the oxygen source and the patient interface is the Bi-Flow valve, which allows for the release of oxygen from its source when triggered by the operator thus providing emergency respiratory support. For the spontaneous breathing patient, the Bi-Flow D/R may be used as an Inhalator. This is accomplished by the patient triggering the valve with his her negative inspiratory force and the source gas being delivered to the patient through a face mask.
Additionally, there is a non-rebreathing valve (reusable version or single patient use version) attached to the Bi-Flow D/R which directs the patient's exhalation back to atmosphere. The combination of the Bi-Flow D/R and the non-rebreathing valve as a single device is commonly referred to as a Demand Valve.
The power for the device is provided by the compressed oxygen source. There is no additional source of power for this device.
The Bi-Flow D/R will be sold by Spiracle Technology only by or on the order of a physician and is intended to be used exclusively by trained health care professionals. The Bi-Flow D/R will be sold as a component of a respiratory support system to be configured by the health care provider. As such, it will be compatible with all commonly available oxygen source and face mask connections.
The Bi-Flow D/R is designed to provide manual mechanical ventilation triggered by the operator to a nonbreathing patient. The small portable device is primarily constructed of aluminum components and utilizes a plastic and silicone rubber inhalation valve. The device is gas powered and has no electronic components or software. The device is pilot actuated.
The provided text is a 510(k) summary for the Spiracle Technology Bi-Flow D/R, a medical device (Demand Valve) intended to provide manual mechanical ventilation. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than a detailed performance study with acceptance criteria and statistical analysis typical of AI/software devices.
Therefore, many of the requested categories for AI/software device evaluation cannot be fully addressed from this document.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria in a table format with specific performance metrics and target values (e.g., accuracy > 95%, sensitivity > 90%). Instead, it refers to general functional and environmental testing.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Meets performance objectives | "demonstrated that the device meets its performance objectives" |
| Complies with applicable standards and FDA guidelines | "complies with applicable standards and FDA guidelines" |
| Withstands various environmental conditions (impact/drop, vomitus, immersion, storage temperature, operating temperature) | "testing of the device has been performed under various environmental conditions, including impact/drop testing, vomitus testing, immersion testing, storage temperature testing and operating temperature testing." |
| Provides manual mechanical ventilation and acts as an Inhalator (functional) | "The Bi-Flow D/R is designed to provide manual mechanical ventilation..." and "For the spontaneous breathing patient, the Bi-Flow D/R may be used as an Inhalator." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of data used for an algorithm. It discusses "functional and environmental testing" on the physical device. Therefore, no information is provided regarding data provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is a mechanical ventilator, not an AI/software diagnostic tool that requires expert-established ground truth for performance evaluation.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of adjudication, as this is a hardware device assessment.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This device is not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a mechanical hardware device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance would be engineering specifications and functional requirements (e.g., proper oxygen flow, valve actuation, pressure limits, environmental resilience). The document indicates performance was assessed against "performance objectives" and "applicable standards and FDA guidelines."
8. The Sample Size for the Training Set
Not applicable. This device does not use a training set as it is a mechanical device, not an AI algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set is used.
§ 868.5925 Powered emergency ventilator.
(a)
Identification. A powered emergency ventilator is a demand valve or inhalator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.(b)
Classification. Class II (performance standards).