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 Single Patient Use Aerosol Filter is designed to connect to the exhalation valve of the Salter Labs nebulizer mouthpiece for the expressed purpose of removing nonrespired aerosols. 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. The single patient use configuration allows the filter to be easily inserted and removed after each use. The filter element 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 element is ≥ 6.0 square inches, resulting in a specified resistance (exhalation force) of ≤ 2.0 cm H20 from the patient. Product design performance has been validated using product design specifications according to Salter Labs procedures and validation requirements.

Here's a breakdown of the acceptance criteria and the study details for the Salter Labs Single Patient Use Nebulizer Exhalation Aerosol Filter, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

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

• Test Set Sample Size: Not explicitly stated. The document mentions "aerosol removal testing and validation" and "simulated use and cleaning verification," implying that a test set was used, but the specific number of units or test runs is not provided.
• Data Provenance: Not explicitly stated. Given that it's a submission by Salter Labs (based in Arvin, CA, USA) to the FDA, it is highly likely that the testing was conducted prospectively by the manufacturer or a contracted lab in the USA.

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

• Not Applicable. This device is a filter, and its performance is measured objectively through physical testing (aerosol removal efficiency, exhalation resistance) rather than through subjective interpretation by human experts. Therefore, no human experts were involved in establishing ground truth for the test set in the traditional sense of clinical diagnosis or image interpretation.

4. Adjudication Method for the Test Set

• Not Applicable. As mentioned above, the assessment criteria are objective physical measurements, not requiring human adjudication.

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

• No. This type of study (MRMC) is relevant for diagnostic imaging AI or other interpretative tasks where human readers' performance is being evaluated with and without AI assistance. This device is a passive filter, and its effectiveness is measured directly through physical tests, not through human reader performance.

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

• Yes, in essence. The testing of the filter's aerosol removal efficiency and exhalation resistance is a standalone evaluation of the device's physical performance, independent of human interaction beyond the initial setup of the test. The "algorithm" in this context would be the physical design and material properties of the filter, and its performance was measured directly.

7. The Type of Ground Truth Used

• Objective Physical Measurements. The ground truth for the device's performance was established through:
  • Aerosol Removal Testing: Quantifying the reduction of aerosol particles in the air after passing through the filter. The document states "aerosols in the .1 to 10 micron range" and that "aerosol sizes monitored varied from .1 microns to 9.9 microns."
  • Resistance Measurement: Measuring the pressure drop (exhalation force) across the filter element.

8. The Sample Size for the Training Set

• Not Applicable. This device is a physical product (a filter), not an AI algorithm that requires a "training set" of data. Its performance is inherent in its design and materials, and validated through physical testing, not machine learning.

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

• Not Applicable. As there is no training set for a physical device, this question is not relevant. The "ground truth" for the design of such a device stems from engineering principles, material science, and prior knowledge of aerosol filtration, which are then validated through the performance tests described.

Ask a specific question about this device