Search Results

The Qorda QD is intended as a room recirculating air cleaner. The system is used for filtering out and inactivating airborne particles from the air for medical purposes.

The Qorda QD1 has been demonstrated to remove the following organisms under the following exposure conditions:

Oorda OD1 is a freestanding medical recirculation air cleaner that facilitates movement with wheels. The device includes two pre-filters, two deodorizing filters, two HEPA filters - 3 filters in the front panel and 3 filters in the rear panel), and a manual for users.

The device can adjust the air volume in four stages through manual operation (Level 1, Level3, Turbo) and Sleep mode. When operating in sleep mode, the equipment LED and PlasmaWave are turned off and operated with low noise.

The device contains the following additional functions.

(1)Child lock: Button lock function that prevents children or pets from changing their current motion mode even if they accidentally operate device.

(2)Filter Replacement Guide: The remaining filter life is displayed on the front display of the device and tells you when to replace the filter.

(3)Adjustment of illuminance: You can adjust the illuminance in four stages (100%, 50%, 20%, OFF).

(4)You can turn on or off the PlasmaWave.

(5)The timer allows the equipment to turn off automatically after a certain period of time.

Qorda QD1 inhales air in both directions on the front and rear of the device and purifies it through the four cleaning steps below:

[Pre-Filter]

The air is drawn in through the cover front, passes through the Pre-Filter then moves to two filters stages(CD Carbon Filter, True HEPA Filter). The Pre-Filter protects CD Carbon Filter, True HEPA Filter inside the Pre-Filter.

[CD Carbon Filter]

Reduces any ozone generated as a byproduct of the plasma field. It also prolongs the True HEPA Filter lifespan.

[True HEPA Filter]

True HEPA Filter captures 99.99%* of airborne ultrafine particles as small as 0.003 microns. *Based on independent laboratory test conducted on particles as small as 0.003 microns in size.

[PlasmaWave]

PlasmaWave Technology has been tested by an independent third-party to remove particles from the air for medical purposes.

Here's an analysis of the acceptance criteria and study information for the Qorda QD1 device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for biological reduction and particle filtration: The text mentions the tests were conducted in "a chamber (internal dimensions are 9.1 ft x 9.1 ft x 7 ft, with a displacement volume of 579 ft³, or 16.4 m³)." This suggests a single test environment or chamber was used for multiple tests (ozone, particle filtration, and biological reduction). The exact number of runs or repetitions within this chamber for each test is not specified, but the phrasing implies controlled laboratory conditions rather than a large-scale field study.
• Data Provenance: The studies are non-clinical, controlled laboratory tests. There is no information regarding the country of origin of the data explicitly, but Winix Inc. is based in the Republic of Korea, and the correspondent is in the USA. The tests were likely performed in a controlled laboratory setting by a third-party testing facility. The nature of these tests is prospective as they were designed and executed to evaluate the device's performance against predefined criteria.

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

Not applicable. The ground truth for these performance tests is established by objective measurements and scientific methodologies in a laboratory setting (e.g., measuring ozone concentration, particle counts, and biological log reduction) rather than expert interpretation of images or clinical outcomes.

4. Adjudication Method for the Test Set

Not applicable. As these are objective performance tests measuring physical and biological parameters, there is no need for an adjudication method typically used for subjective assessments.

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

No. This document describes non-clinical performance testing of an air cleaning device, not a diagnostic or clinical imaging device that would involve human readers or MRMC studies.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, in a sense. The tests described are for the standalone performance of the Qorda QD1 device in an automated manner (filtering and inactivating at different fan speeds) without human intervention during its operation or performance assessment.

7. The Type of Ground Truth Used

The ground truth used in these studies is based on:

• Direct Measurement of Physical and Chemical Properties:
  • Ozone concentration (ppb).
  • Particle counts and sizes (µm).
  • Air volume and air change rates (ft³/h or m³/h).
• Direct Measurement of Biological Inactivation/Reduction:
  • Log reduction of specified microorganisms (MS2 bacteriophage and Bacillus subtilis endospores).

These are objective, quantifiable measurements derived from controlled laboratory experiments.

8. The Sample Size for the Training Set

Not applicable. This device is an air cleaner, not an AI/machine learning algorithm that requires a training set.

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

Not applicable. As there is no AI/machine learning component, there is no training set or associated ground truth establishment for a training set.

Ask a specific question about this device