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The butterflyBVM™ when used in transport and non-clinical emergency settings (e.g., EMS, non-hospital) is a single-use resuscitator that may be manipulated to provide pulmonary resuscitation of patients including adults, adolescents, children, infants, and neonates.

The butterflyBVM™ when used in professional healthcare facilities (e.g., hospitals) is a single-use resuscitator that may be manipulated to provide pulmonary resuscitation of patients including adults, adolescents, children, and infants.

The butterflyBVM™ is a three-in-one bag-valve-mask capable of resuscitating adults, adolescents, children, infants, and neonates. The maximum tidal volumes (Vt) delivered by the butterflyBVM™ can be set via the tidal volume dial, as needed, to ranges that are generally appropriate for the size of patient receiving care. The butterflyBVM™ also has an adjustable peak inspiratory pressure (PIP) dial to help prevent barotrauma. The tidal volume and PIP are selected by aligning the dials to the Vt/PIP indicator. Patient-facing accessories such as masks, laryngeal mask airways, endotracheal tubes, end-tidal CO2 samplers, and the like can be connected to the patient connection port. Exhalation accessories such as bio filters and PEEP valves can be connected to the exhalation port. Supplemental oxygen can be added via the oxygen inlet port. The device is operated by manually squeezing the side arms together with either one or two hands. A cover is provided over the PIP dial to provide instruction to the user via images and words to first set the tidal volume for the procedure based on the assessment of the patient.

The provided FDA 510(k) clearance letter and summary for the butterflyBVM device offers details about its acceptance criteria and the study conducted to demonstrate performance. Here's a breakdown of the requested information:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Details of the Study Proving Acceptance Criteria

The primary study mentioned directly addressing quantitative performance criteria is a "Comparative Testing" study titled "In a study of the butterflyBVM versus the Ambu Spur II [Merrell et al. 2023]".

2. Sample Size for the Test Set and Data Provenance

• Sample Size: The document does not explicitly state a sample size for the comparative testing portion of the PIP Dial study. It mentions failures (e.g., "1 failure", "23 failures", "32 failures"), which implies multiple tests were conducted, but the total number of tests or devices tested is not provided.
• Data Provenance: The study is referenced as [Merrell et al. 2023]. Given this is a 510(k) submission, it is assumed to be an internal, pre-market engineering or bench-top study conducted by Compact Medical, Inc., or a contracted firm. The country of origin and whether it was retrospective or prospective is not explicitly stated, but such a study would typically be prospective bench testing.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable. The study described is a bench testing/engineering study, not a clinical or human perception study requiring expert ground truth setting. The ground truth (target pressures, delivered volumes, oxygen concentrations) is established by measurement devices and consensus standards (ISO 10651-4).

4. Adjudication Method for the Test Set

• Not applicable. This was a bench testing study comparing device measurements to target values and predicate device performance. No human adjudication was involved.

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 study described is a bench testing comparison of device performance parameters. It does not involve human readers (clinicians) interacting with cases or assessing improvements with AI assistance.

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

• This is not an AI/Software as a Medical Device (SaMD). The butterflyBVM is a manual emergency ventilator. Therefore, the concept of standalone algorithm performance (without human-in-the-loop) is not applicable. The device's performance is inherently tied to a human operator, but the presented data focuses on the device's mechanical and functional capabilities.

7. The Type of Ground Truth Used

• The ground truth for the performance parameters (PIP, delivered volume, oxygen concentration) was established through measurement against recognized consensus standards (primarily ISO 10651-4) using calibrated laboratory equipment. For comparative testing, the performance of the predicate device (Ambu Spur II) also served as a comparative benchmark to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

• Not applicable. This is a mechanical medical device, not an AI/machine learning product. Therefore, there is no "training set" in the context of AI model development.

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

• Not applicable, as explained in point 8.

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