Search Results

This product is indicated for use whenever the physician or healthcare professional administering or prescribing medical aerosol products to a patient with a Salter Labs nebulizer wishes to minimize the amount of medical aerosol exhaled into the air.

The Salter Labs Aerosol Filter is designed to connect to the exhalation valve of the Salter Labs nebulizer mouthpiece. Since the exhalation valve of the Salter Labs Nebulizer product is designed with a non-standard diameter, the Salter Labs Nebulizer Exhalation Aerosol Filter is configured in such a way that it only fits the Salter Labs nebulizer product line: this device is not intended to be used with any other product. Product labeling clearly defines this product as an accessory to the Salter Labs nebulizer assembly.

The aerosol filter is a rectangular component that has been preformed to fit into an injection molded plastic housing. There are two design configurations: disposable and reusable. The reusable configuration allows the filter to be easily inserted and removed after each use. The filter is specified as a bacterial filter, although the intended use of the device is to remove aerosol particles, only. The surface area of the filter is ≥ 6.0 square inches, resulting in a specified resistance (exhalation force) of ≤ 2,0 cm Ho0 from the patient. Product design performance has been validated using product design specifications according to Salter Labs procedures and validation requirements.

There are two defined product configurations for this device: disposable and reusable.

Here's an analysis of the provided text regarding the Salter Labs Nebulizer Aerosol Expiration Filter, focusing on the acceptance criteria and the study proving it.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a distinct "test set" in the context of a clinical study or a separate dataset used for final validation. The performance validation to design specification and aerosol removal testing were likely conducted as part of the product development and verification process.

• Sample Size: Not explicitly stated. The statement "aerosol removal testing and validation" and "met all design requirements and passed all validation test requirements" suggests internal testing was performed, but no specific number of units tested is provided.
• Data Provenance: The data appears to be from internal testing conducted by Salter Labs. There is no mention of country of origin of the data or whether it was retrospective or prospective in the sense of a multi-center study. It's best described as prospective internal laboratory or engineering testing.

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

This information is not provided. The study described is a performance validation and aerosol removal testing, not a study involving expert assessment of performance in a real-world scenario or against a "ground truth" established by human experts.

4. Adjudication Method for the Test Set

This is not applicable to the type of study described. "Adjudication" typically refers to the process of resolving discrepancies between human readers or experts, which is not relevant to instrumental aerosol filtration testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The described study evaluates the physical performance of the filter, not its impact on human reader performance or diagnostic accuracy.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance evaluation was done. The study specifically assessed the aerosol removal efficiency and exhalation resistance of the filter itself, independent of human interaction or a human-in-the-loop system. The device is a passive filter, so its performance is inherently "standalone."

7. The Type of Ground Truth Used

The ground truth for the performance claim of aerosol removal was established through direct measurement of aerosol concentration before and after filtration using scientific instrumentation. Similarly, the ground truth for exhalation resistance was established through direct measurement of pressure difference across the filter. This can be considered physical measurement/instrumentation data against a defined standard or expected performance.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical filter, not an AI or machine learning algorithm that requires a "training set" in the computational sense. The "training" in this context would refer to material and engineering specifications and manufacturing processes.

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

This information is not applicable for the reasons mentioned in point 8. The "ground truth" for manufacturing and design would be based on engineering specifications, material quality controls, and established manufacturing standards, but not a dataset as commonly understood in AI/ML.

Ask a specific question about this device