Search Results

The DHD Healthcare Lichen Filter Kit is intended to filter airborne particulate matter and certain bacteria (i.e., Staphylococcus) with a mean diameter of 3.2 microns or greater. The Lichen may reduce cross-contamination between patient and equipment attachments such as use with Respiratory Therapy low flow pressure indicators and gauges (i.e., an example would be for use with the DHD TheraPEP® Pressure Indicator and aneroid gauges). The use of the Lichen Filter Kit may allow the reuse of aneroid gauges and pressure indicators from patient to patient per your institution's protocol. The device also incorporates tubing for use in connection to low flow pressure indicators and gauges.

The DHD Lichen Product is a kit consisting of a hydrophobic bi-directional filter with tubing that is connected to each side of the hydrophobic bi-directional filter. This assembled filter kit is a single-patient-use device intended for infection control for use with low flow pressure indicators and both inspiratory and expiratory maneuvers with low flow pressure indicators and gauges where the patient exhales at a pressure of less than 120cm H20.

The provided document, K980662, is a 510(k) summary for the DHD Healthcare Lichen Filter Kit. It explicitly states that "There were no specific studies completed in association with this submission." As a result, the following information regarding acceptance criteria and a study proving the device meets those criteria cannot be extracted because such a study was not performed and therefore not submitted.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance
Not applicable, as no studies were performed or submitted.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no studies were performed or submitted.

4. Adjudication method for the test set
Not applicable, as no studies were performed or submitted.

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
Not applicable. This device is a physical filter, not an AI-assisted diagnostic tool, and no studies were performed or submitted.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical filter, not an algorithm, and no studies were performed or submitted.

7. The type of ground truth used
Not applicable, as no studies were performed or submitted.

8. The sample size for the training set
Not applicable, as no studies were performed or submitted.

9. How the ground truth for the training set was established
Not applicable, as no studies were performed or submitted.

Ask a specific question about this device