(339 days)
The Sotair™ device is intended for use with a manual resuscitator with air-tight connections, in non-breathing patients that require flow controlled ventilation using ambient air or a supplemental oxygen source. The Sotair device is a single use, disposable device added to a manual resuscitator and can be used for in-hospital, emergency, and transport care. The adult Sotair device comprises a flow-limiting valve that limits the inspiratory flow enabling providers to ventilate approximately 55 liters-per-minute (LPM). The flow-limiting valve is intended to minimize gastric inflation during manual ventilation. The Sotair device can be disabled by removing the manual resuscitator to its conventional operation. The Sotair device is intended for adult use only.
The Sotair™ device is a universal safety accessory device that is compatible with all manual resuscitators and airway interfaces that have standard ISO 5356-1:2015 15/22 mm connections. The Sotair device's flow-limiting function has been tested with the following bag resuscitators: [List of compatible resuscitators provided in the document]. The Sotair device is not compatible with manual resuscitators that have a built-in flow limiting device. The Sotair device uses a flapper valve with a blade design to limit the flow rate.
The provided text describes the Sotair™ Device, a flow-limiting valve for manual resuscitators, and its equivalence to a predicate device. However, the text does not include a table of acceptance criteria and reported device performance in the specific format requested. It also does not contain information on sample sizes, data provenance, ground truth establishment methods, or the involvement of experts in establishing ground truth for a test set. There's no mention of a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm performance study, as this is a medical device, not an AI/software product in the traditional sense described by those elements of the prompt.
Based on the available information, here's a breakdown of what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes various performance tests conducted. While it states that the testing "met the requirements" or "demonstrated that the Sotair device met the product specifications and also performed equivalent to the predicate device," it does not provide specific acceptance values or the quantitative results from these tests in a table format.
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Met requirements of ISO 10993 and ISO 18562 | "Overall, the testing met the requirements of ISO 10993 and ISO 18562." |
| Mechanical Testing | Met product specifications and performed equivalent to predicate | "The performance data demonstrated that the Sotair device met the product specifications and also performed equivalent to the predicate device in the Valve Functionality Testing..." |
| Human Factors / Usability | Met criteria for use with intended users, uses, and environments | "The study concluded that the Sotair device met the criteria for use with the intended users, uses, and use environments. The overall result... confirm that the Sotair device is designed, functions and meets the expectations and need for use." |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated for any of the tests.
- Data Provenance: The studies were conducted by SafeBVM Corporation (submitter) and its contracted consultants/labs. The country of origin for the data is not specified beyond the submitter's address in Chesterfield, MO, USA. The studies are described as "performance testing" and "simulated-use Human Factors Engineering / Usability Engineering (HFE/UE) Summative / Validation Study," implying prospective testing rather than retrospective data analysis.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided. The "ground truth" for the device's performance appears to be established through adherence to engineering standards (ISO) and functional testing against design specifications and a predicate device, rather than expert consensus on a diagnostic output.
4. Adjudication method for the test set:
Not applicable or not described in the document, as it pertains to a physical medical device's performance against predefined criteria and standards.
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:
Not applicable. The Sotair™ Device is a mechanical medical device (flow-limiting valve), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The device is a mechanical component of a manual resuscitator, not an algorithm. Its performance is inherent to its physical design and function.
7. The type of ground truth used:
The ground truth used for evaluating the Sotair™ device's performance is based on:
- Biocompatibility Standards: Adherence to ISO 10993 and ISO 18562.
- Mechanical and Functional Specifications: Meeting predetermined product specifications for various mechanical properties and functionality (e.g., flow rate, leakage, resistance, valve function).
- Equivalence to Predicate Device: Direct comparison testing to demonstrate equivalent performance to the legally marketed predicate device (Smart Bag MO) in Valve Functionality Testing.
- Human Factors/Usability Criteria: Meeting usability criteria for intended users, uses, and use environments as per FDA guidance.
8. The sample size for the training set:
Not applicable. The device is a mechanical product, not an AI model requiring a training set. The descriptions relate to performance testing and usability studies.
9. How the ground truth for the training set was established:
Not applicable. There is no training set for this type of medical device.
§ 868.5915 Manual emergency ventilator.
(a)
Identification. A manual emergency ventilator is a device, usually incorporating a bag and valve, 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).