Search Results

For the delivery of high concentrations of oxygen or Heliox gas mixtures in combination with aerosolized medications and diagnostic formulations. This device has not been tested for use with Pentamidine or the combination of Heliox and metered dose inhaler.

The Neb-U-Mask® System is intended to be with oxygen-helium (Heliox) mixtures that include a non-rebreathing mask connected to a wye adaptor featuring a valved port. This valve allows a small volume nebulizer to be connected / disconnected to the wye adapter for drug administration without interrupting primary medical gas flow to patient. Attached to the adaptor is a reservoir bag and a nebulizer, both linked to the gas sources with delivery tubing allowing clinicians to independently control the flow to each side. The Neb-U-Mask® System is comprised of:

• Non-rebreathing oxygen mask (several sizes)
• Wyc is valved,
• o contains an MDI port,
• connectors for nebulizer and reservoir, and 0
• o inlet port for Heliox mixture
• . Delivery tubing
• Heliox / Oxygen to nebulizer
• Heliox / oxygen to ported wye o
• . Small volume nebulizer

Here's an analysis of the provided 510(k) summary regarding the Neb-U-Mask® System, focusing on acceptance criteria and supporting studies, based only on the provided text.

Important Note: The provided document is a 510(k) Summary, which typically focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed clinical study results in the way one might find for a novel device requiring a PMA. Therefore, some of the requested information (like specific performance metrics from a dedicated study, sample sizes for test/training sets, expert qualifications, and MRMC study details) is not present in this type of document. The acceptance criteria here are primarily based on equivalence to predicate devices and general performance characteristics of nebulizers.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Neb-U-Mask® System are primarily established through direct comparison to legally marketed predicate devices, demonstrating substantial equivalence in function, indications for use, and basic operational characteristics. The performance is "reported" implicitly by stating "Yes" for attributes that match the predicate devices or are considered standard for this device type.

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

The document does not describe a separate "test set" in the context of a clinical study with a specific sample size. The primary method of demonstrating performance is through comparison to existing predicate devices. The data provenance is implicitly from the characteristics of these predicate devices and general industry standards for nebulizers. It does not specify country of origin or whether "testing" was retrospective or prospective in the clinical study sense. The document refers to "This device has not been tested for use with Pentamidine or the combination of Heliox and metered dose inhaler," which suggests some elements were tested, but details are not provided.

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

This information is not provided in the 510(k) summary. The "ground truth" for this type of device (a nebulizer) is generally based on engineering and performance specifications (e.g., aerosol output, particle size, flow rates) rather than expert consensus on diagnostic images.

4. Adjudication Method for the Test Set

This information is not provided as there is no described test set in the sense of a clinical study requiring adjudication.

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.

An MRMC study is relevant for AI-powered diagnostic devices. The Neb-U-Mask® System is a medical device (nebulizer), not an AI diagnostic device. Therefore, an MRMC study was not performed or described as it is not applicable.

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

This question is also relevant for AI algorithms. The Neb-U-Mask® System is a physical medical device. Therefore, a standalone algorithm performance study was not done or described.

7. The Type of Ground Truth Used

The "ground truth" for this device seems to be established through:

• Comparison to the established performance and characteristics of legally marketed predicate nebulizer devices.
• Engineering specifications and tests (e.g., "Particle size characterization via Cascade Impactor" is mentioned, implying technical testing was performed to establish this characteristic).
• Intended use and safety profiles of similar devices.

There is no mention of pathology, expert consensus (in a diagnostic sense), or outcomes data for a specific clinical study in this summary.

8. The Sample Size for the Training Set

This information is not provided and is not applicable to this type of device submission, which relies on engineering and comparative performance, not machine learning models with training sets.

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

This information is not provided and is not applicable.

Ask a specific question about this device