Search Results

Boeing is indicated for the treatment and prevention of atelectasis. Boeing facilitates opening of airways in patients requiring prevention or treatment of atelectasis. Boeing also has the ability to provide supplemental oxygen when used with compressed oxygen.

The DHD Boeing is a single-patient-use Respiratory Therapy device. The standard system consists of a flow amplification body, compressed oxygen/air tubing, pressure port cap, and mouthpiece. The mouthpiece can be replaced with a mask.

The DHD Boeing device (Positive Airway Pressure (PAP) Device) was determined to be substantially equivalent to the predicate device, TheraPEP, based on non-clinical bench testing.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance for Test Set:

• The submission does not specify the exact sample sizes used for each bench test. However, it states that the non-clinical bench testing compared the DHD Boeing against the predicate device and against its own performance specifications.
• Data Provenance: The tests were non-clinical bench tests performed by the manufacturer, DHD Healthcare Corporation. No information is provided regarding data provenance in terms of country of origin or whether it was retrospective or prospective, as it pertains to bench testing.

3. Number of Experts and Qualifications for Ground Truth:

• This information is not applicable for this submission. The "ground truth" in this context refers to established performance specifications and the performance of the predicate device, which are determined through engineering principles and existing regulatory decisions rather than expert consensus on individual cases.

4. Adjudication Method for Test Set:

• Not applicable as this was non-clinical bench testing comparing against specifications and a predicate device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study is typically used for diagnostic or screening devices involving human interpretation of results, which is not applicable to a Positive Airway Pressure (PAP) device.

6. Standalone Performance Study (Algorithm Only):

• Yes, a form of standalone performance study was done through the "non-clinical bench testing" which compared the DHD Boeing against its "own performance specifications." This indicates the device's technical performance was evaluated independently of human-in-the-loop operation, reflecting its inherent functionality.

7. Type of Ground Truth Used:

• The ground truth used was based on:
  • Performance Specifications: The device met its own predefined performance specifications for airway pressure (expiratory and inspiratory) and supplemental oxygen delivery.
  • Predicate Device Performance: The Boeing's performance was compared to and found substantially equivalent to the legally marketed predicate device, TheraPEP, regarding these performance characteristics.

8. Sample Size for Training Set:

• This information is not applicable. This device is a mechanical medical device, not an AI/ML algorithm that requires a "training set" in the computational sense. The design and development would involve engineering prototypes and iterative testing, but not a "training set" as understood in machine learning.

9. How Ground Truth for Training Set was Established:

• Not applicable, as there is no "training set" for this type of medical device. The "ground truth" for its design and testing would be derived from engineering standards, material properties, physiological requirements for PAP therapy, and the performance characteristics of existing predicate devices.

Ask a specific question about this device