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Datex-Ohmeda Filters can be used to provide filtration for reducing possible cross contamination between patient and equipment. Filters are for use in the hospital, ICU, anesthesia, respiratory therapy, during transport and with resuscitators for filtering particles including bacteria, viruses and dust from CO2-absorbers.

The Mini-Filter/S can also be used for gas sampling.

The device is indicated for use by qualified medical personnel only.

The Mini-Filter/S incorporates electrostatic filter media into a housing made of translucent plastic.
Dimensions and Materials

• Diameter: 45 mm .
• Length: 64 mm .
• . Housing: PP Polypropylene
• Filter: PP and acrylic fibers .
  Filtration efficiency:
• Filtration efficiency viral 99.98 % .
• Filtration efficiency bacterial 99.999 % .
  The HMEF Mini is for use in the hospital. ICU, anesthesia, respiratory therapy, during transport and with resuscitators.
  It incorporates standard fittings for-
• 15 mm ID x 22 mm OD fitting to connect to the endotracheal tube or face mask .
• 15 mm OD x 22 mm ID fitting to connect to the breathing circuit Y-piece .
• A gas sampling port female luer port with cap to allow sampling of expired CO2 . gases
  The modifications to the device are:
  The Datex-Ohmeda Mini-Filter/S has the following differences when compared to the Datex-Ohmeda HMEF Mini predicate device:
• The devices differ in Moisture output and Breathing resistance -
  The main differences between the Datex-Ohmeda Mini-Filter/S and the predicate Datex-Ohmeda HMEF Mini (K023641) are due to fact that Mini-Filter/s is intended use only as breathing system bacterial and viral filter and HMEF Mini is intended use as breathing system bacterial and viral filter and also as heat and moisture exchanger. Mini-Filter/S is the same as the HMEF Mini without an HME-element.

The Uni-Filter Junior incorporates electrostatic filter media into a housing made of translucent plastic.
Dimensions and Materials

• Diameter: 59 mm .
• Length: 64 mm ●
• Housing: PP Polypropylene .
• . Filter: PP and acrylic fibers
  Filtration efficiency:
• Filtration efficiency viral 99.999 % ●
• Filtration efficiency bacterial >99.99999 % .

{
  "1. A table of acceptance criteria and the reported device performance": {
    "Device": "Datex-Ohmeda Mini-Filter/S",
    "Acceptance Criteria": [
      {
        "Criterion": "Filtration efficiency viral",
        "Target": "99.98 %"
      },
      {
        "Criterion": "Filtration efficiency bacterial",
        "Target": "99.999 %"
      }
    ],
    "Reported Device Performance": {
      "Filtration efficiency viral": "99.98 % (stated as device description)",
      "Filtration efficiency bacterial": "99.999 % (stated as device description)"
    }
  },
  "2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": "The document primarily references compliance with standards (e.g., ISO, EN, ASTM) and claims substantial equivalence to predicate devices based on technological characteristics and performance specifications. It does not provide detailed information on specific sample sizes, data provenance (e.g., country of origin), or whether the data was retrospective or prospective for the validation tests.",
  "3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)": "Not applicable. This is a medical device submission based on engineering and performance specifications, not on expert adjudication of medical images or diagnoses.",
  "4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": "Not applicable. This is a medical device submission based on engineering and performance specifications, not on expert adjudication.",
  "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 a medical device (filter) and does not involve AI or human readers for diagnostic interpretation.",
  "6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done": "Not applicable. This is a physical medical device (filter), not an algorithm.",
  "7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": "The 'ground truth' for device performance is based on established scientific and engineering test methods outlined in the referenced international standards (e.g., ISO 9360, ASTM F 1054-8721) for measuring filtration efficiency, breathing resistance, and adherence to material and dimensional specifications. It is not based on expert consensus, pathology, or outcomes data in a clinical sense for this type of device.",
  "8. The sample size for the training set": "Not applicable. This is a physical medical device (filter) and does not involve a 'training set' in the context of machine learning or AI.",
  "9. How the ground truth for the training set was established": "Not applicable. This is a physical medical device (filter) and does not involve a 'training set' in the context of machine learning or AI."
}

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