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The Provox® Micron HME™ is a specialized stoma cover that acts as a heat and moisture exchanger (HME) and air filtration device for laryngectomized patients. Provox® Micron HMETM partially restores lost breathing resistance due to laryngectomy.

For patients with a voice prosthesis or surgical speech fistula it may also facilitate voicing.

It is intended to be used with the Provox® HME System.

Environments of use include - hospitals, sub-acute care institutions and home.

The Provox® Micron HME™ is a device which covers the stoma of a laryngectomy pationt. It is dcsigned to heat and humidify inhaled air to reduce the drying out of the airway as well as it incorporates filter media to filter the inhaled air of bacteria, virus and particulate matter.

It also incorporates a feature whereby the user may close the device, diverting exhaled air through the esophagus to facilitate voicing. This feature is identical to the predicate, Provox® HME cassette (K014102) and Provox® FreeHands HME (K022125), the only difference between the proposed device and the predicates in the addition of filter media.

Here's an analysis of the acceptance criteria and the study information for the Provox® Micron HME™ device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The provided text does not contain details about specific test set sample sizes or data provenance (e.g., country of origin, retrospective/prospective) for the performance evaluations. The performance metrics listed are presented as single values, likely representing the results of a conducted test or series of tests, but the methodology and sample size for these tests are not described in this summary. The document focuses on demonstrating substantial equivalence to predicates through comparison of specifications.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable to the data provided. The performance metrics (moisture loss, filtration efficiency, pressure drop) are objective measurements typically determined through laboratory testing according to established standards (e.g., ISO 9360, ASTM F2101), not through expert consensus or interpretation of subjective data requiring ground truth establishment by human experts.

4. Adjudication method for the test set

This information is not applicable as the performance metrics are objective measurements, not subjective evaluations requiring 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

This information is not applicable. The device is a medical device (HME and filter for laryngectomized patients), not an AI-powered diagnostic or interpretive tool that would involve human readers or AI assistance in the way described.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not applicable. The device is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the reported performance metrics would be laboratory measurements conforming to established international standards.

• HME function (Moisture loss): Measured according to ISO 9360.
• Filtration BFE/VFE: Measured according to ASTM F2101.
• Pressure drop: Measured under controlled airflow conditions.
  These standards define the precise methodology and equipment for obtaining these objective measurements.

8. The sample size for the training set

This information is not applicable. The Provox® Micron HME™ is a physical medical device, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable for the same reason as #8.

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