(204 days)
The EasyOne Filter is intended to be used in combination with NDD breathing mouthpieces to reduce bacteria, viruses and other particulates from the patient's exhaled air while performing flow measurements, such as spirometry tests. The EasyOne Filter is a single-use device and intended for single-patient use only.
The EasyOne Filter is a viral, bacterial filter designed to be used with NDD breathing mouthpieces during flow measurements, e.g. for spirometry testing with NDD spirometers. The EasyOne Filter exists in two variants which differ in the connection interface to enable mounting on the EasyOne FlowTube. The EasyOne Filter is composed of two injection molded polymeric parts which enclose a filter medium. The EasyOne Filter is an optional accessory and reduces viruses, bacteria, and other particles that may be released by the patient and thus contaminate the test environment. The EasyOne Filter is non-sterile and for single use.
The provided text is a 510(k) summary for the EasyOne Filter, a breathing circuit bacterial filter. It details the device's characteristics, comparison to predicate devices, and the results of non-clinical, and usability tests. However, it does not describe a study involving an AI/algorithm or human readers for diagnostic purposes (e.g., radiologists interpreting images). The device itself is a physical filter for spirometry, not a diagnostic AI tool.
Therefore, many of the requested points, such as MRMC studies, standalone algorithm performance, number of experts for ground truth, and training set details, are not applicable to this type of medical device submission.
Here's an attempt to answer the applicable points based on the provided text, and explicitly state when information is not present or not relevant to this specific device:
1. A table of acceptance criteria and the reported device performance
| Test | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| Biocompatibility | Evaluate device's biological safety for the intended use, in accordance with ISO 10993-5, ISO 10993-10 and FDA's corresponding guidance document. | Biological Evaluation per ISO 10993-5 and ISO 10993-10 | Justification for cytotoxicity, sensitization, and irritation tests based on results of ViroMax filter (K063526), same filter body and filter cap materials used for EasyOne Filter as well as VBMax filter (K000654). |
| Gas Path Emissions (Particulate Matter) | Assess if airborne particulate is emitted into the gas stream in accordance with ISO 18562 | Measured concentrations of particulate matter ≤ 2.5 µm and ≤ 10 µm were compared to air quality guidelines in ISO 18562-2. | The minimum, maximum, and average particulate concentrations are all below acceptable limits. |
| Gas Path Emissions (Volatile Organic Compounds) | Assess if airborne VOCs are emitted from the filter into the gas stream per ISO 18562 | Gas path emissions of volatile organic compounds per ISO 18562-3; Risk assessment per ISO 10993-17 and ISO 18562-1 | Exposure of the individual VOCs released are unlikely to result in toxicological effects. (Implicitly passed) |
| Filtration Efficiency | Evaluate aerosol bacterial and viral removal | Bacterial filtration 99.999% (BFE); Viral filtration 99.999% (VFE) | All results were acceptable. |
| Dead Space | Determination of dead space According to ATS/ERS standard 2005 | Dead space is within the ATS/ERS recommendation of 90% | Calibration check of NDD spirometers can be performed with EasyOne Filter. |
| Configuration | Configuration of NDD spirometers for use with optional EasyOne Filter | EasyOne Air firmware V1.18 or higher and EasyOne Connect V3.9.3 or higher allows setup of spirometery testing with or without EasyOne Filter. | Passed |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Filtration Efficiency: Not explicitly stated, but implies lab testing.
- Human Test (System test): The document mentions "Human subjects performed a FVL test session". The number of subjects is not specified.
- Data Provenance: Not specified, but given the manufacturer is based in Switzerland, it's likely to be European or internationally sourced lab/human data. The tests are general performance tests for a physical device, not tied to specific patient populations or retrospective/prospective clinical data in the way an AI diagnostic would be.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This device is a physical filter, not a diagnostic tool requiring expert interpretation or ground truth establishment in the context of diagnostic accuracy. The tests are based on established engineering and medical device standards (e.g., ISO, ATS/ERS).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
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 is not an AI-assisted diagnostic device. Its function is to filter exhaled air. The "human test" was to confirm the device doesn't negatively impact spirometry measurements, not to assess human diagnostic performance with/without AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical filter, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for this device exists in the form of established engineering and medical standards (e.g., ISO 10993 for biocompatibility, ISO 18562 for gas path emissions, ATS/ERS standards for spirometry). The performance of the filter is measured against specified physical and biological parameters. Not ground truth from medical diagnoses.
8. The sample size for the training set
- Not applicable. This is a physical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
- Not applicable.
§ 868.5260 Breathing circuit bacterial filter.
(a)
Identification. A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit.(b)
Classification. Class II (performance standards).