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Model 3500/01 is a replacement part for the ventilator. The Inlet Filter removes particles of 0.3 micron size (or larger) from entering the ventilator. It is a HEPA grade particulate filter for use with the NPB Achieva or LP 10 ventilators. The filter is in the gas flow pathway. As a HEPA particulate filter for the inlet air to be supplied to the patient from the ventilator.

Model 3500/01 is a replacement part for the ventilator. The Inlet Filter removes particles of 0.3 micron size (or larger) from entering the ventilator. It is a HEPA grade particulate filter for the NPB Achieva or LP 10 ventilators, which is in the gas flow pathway. Screw-in cartridge to fit the inlet air filter port of the ventilator housing.

The Air Safety HEPA Model 3500 Filter is an inlet filter designed to remove particles of 0.3 micron size or larger from entering ventilators, specifically the NPB Achieva and LP 10 models. It is a HEPA grade particulate filter.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

The document describes performance testing based on "standard DOP aerosol testing methods" and references specific standards (DOE 3025-99, DOE 3020-97, and ASTM D2986 - DOP). However, it does not specify the sample size for the test set used to generate the reported performance data. The data provenance is implied to be from internal testing conducted by Air Safety Ltd. in England. It's a prospective testing for the device's performance characteristics.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This device is a physical filter, and its performance (filtration efficiency and resistance to flow) is assessed through objective laboratory testing using recognized standards. Therefore, the concept of "experts establishing ground truth" in the way it applies to image analysis or clinical diagnoses is not relevant in this context. The ground truth is the result of the objective measurements obtained through the specified test methods.

4. Adjudication method for the test set:

Not applicable. As described above, the performance is determined by objective, standardized measurements, not through expert judgment or consensus.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or imaging devices where human interpretation is involved. This device's performance is quantifiable through laboratory testing.

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

Yes, the performance testing of the HEPA filter can be considered a standalone assessment. The filtration efficiency and resistance to flow are measured attributes of the device itself, independent of human interaction in its primary function (filtering air).

7. The type of ground truth used:

The ground truth used for this device's performance assessment is based on objective measurements obtained through standardized laboratory protocols. Specifically, it involves:

• DOP aerosol testing for particulate filtration efficiency (retention).
• Measurement of resistance to flow at specified flow rates.

These are established engineering and scientific methods to quantify the physical properties of filters.

8. The sample size for the training set:

Not applicable. This device is a physical product, not an algorithmic model that requires a training set.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set for this type of device.

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