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The HMEF Mini is a disposable single-use device indicated for patients who require humidification during the delivery of ventilator gases and provide filtration for reducing possible cross contamination between patient and equipment. The HMEF Mini is for use in hospital, ICU, anesthesia, respiratory therapy, during transport and with resuscitators. The device can be used on adult and pediatric patients. The device is indicated for use by qualified medical personnel only.

The HMEF Mini incorporates a hygroscopically treated HME media and electrostatic filter media into a housing made of translucent plastic.
Dimensions and Materials

• Diameter: 45 mm .
• . Length: 64 mm
• . Housing: PP Polypropylene
• . HME-element: PU Polyurethane impregnated with calcium chloride CaCl2
• Filter: PP and acrylic fibers .
  Filtration efficiency:
• Filtration efficiency viral 99.98 % ●
• . Filtration efficiency bacterial 99.999 %
  The HMEF Mini is for use in small adult and pediatric patients 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 provided document describes a 510(k) premarket notification for the Datex-Ohmeda HMEF Mini, a disposable heat and moisture exchanger and bacteria/viral filter. The document focuses on demonstrating substantial equivalence to a predicate device, the Datex-Ohmeda HMEF500 (K021265), rather than providing detailed acceptance criteria and a study proving the device meets those criteria in the context of an AI/algorithm-based medical device.

Therefore, the information required to answer the questions in the prompt, such as sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, training set details, and ground truth establishment for an AI/algorithm device, is not present in this document. The provided text details the physical characteristics, intended use, and non-clinical testing of a physical medical device.

However, I can extract the acceptance criteria (performance specifications) and reported device performance from the document where applicable for this physical device:

1. Table of Acceptance Criteria and Reported Device Performance

Note on Differences: The document explicitly states differences in length, weight, dead space, moisture output, moisture loss, breathing resistance, and minimum tidal volume between the HMEF Mini and the HMEF500, primarily due to the HMEF Mini's smaller size. However, specific numerical acceptance criteria (e.g., "dead space must be < X ml") are not provided for these parameters, only that they differ. The most significant difference highlighted and explained is the BFE, with the current BFE for both devices being 99.999% due to different laboratory measurement sensitivities.

The remaining questions (2-9) are typically relevant for AI/algorithm-based medical devices which involve analyzing data sets and establishing ground truth based on expert consensus or pathology. This document describes a physical medical device (a heat and moisture exchanger/filter), and therefore, these questions are not applicable to the information provided. The "study" mentioned in the document refers to nonclinical testing and verification against safety standards rather than a clinical trial or algorithm performance study.

Given the nature of the device (physical filter) and the type of document (510(k) summary for substantial equivalence), information about:

• Sample size for test set and data provenance
• Number/qualifications of experts for ground truth
• Adjudication method
• Multi-reader multi-case (MRMC) comparative effectiveness study
• Standalone performance (algorithm only)
• Type of ground truth (for an algorithm)
• Sample size for the training set (for an algorithm)
• How ground truth for the training set was established (for an algorithm)

...is not contained within this 510(k) submission. The "ground truth" for a physical device like this is typically established by physical measurements and standardized testing procedures (e.g., filtration efficiency tests in accredited labs), rather than expert consensus on medical images or pathology.

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