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The TrachCuff Cuff Controller is intended to continuously measure and automatically maintain the user-set cuff pressure of an endotracheal tube (ETT) or tracheostomy tube (TT) during mechanical ventilation.

The TrachCuff Cuff Controller can be used with any mechanical ventilator.

The TrachCuff Cuff Controller is to be used during ventilation of adults at least 18 years who are intubated with ETT or TT, in the following areas:

• In the intensive care ward by Respiratory Therapist
  Prescription use only.

The TrachCuff Cuff Controller is an automatic cuff pressure controller specified for use in professional healthcare environments. The device provides the operator with the means to set and control the pressure for cuffed endotracheal tubes and cuffed tracheostomy tubes during mechanical ventilation, and continuous monitoring of the set cuff pressure with alarms.

The TrachCuff Cuff Controller is mains powered via a Mains to DC power adapter, and the enclosure may be mounted on a bed rail by means of an optional mounting bracket.

The TrachCuff Cuff Controller is provided in an enclosure with touch screen operator panel.

It is designed for immediate use; no calibration or maintenance is required. A largescale display and convenient and intuitive interaction buttons maximize safe use and visibility of all important data.

The associated accessories include:

• Disposable Tubing Set with Filter .
• Device Mount Solution Bedside Mounting Bracket. .

The provided document describes the TrachCuff Cuff Controller, a medical device intended to continuously measure and automatically maintain the user-set cuff pressure of an endotracheal tube (ETT) or tracheostomy tube (TT) during mechanical ventilation.

Here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" alongside "reported device performance" in a structured comparison for each criterion. Instead, it lists the standards and types of testing performed and then states that the device "met acceptance criteria."

However, based on the Comparison of Technological Features to Predicate Devices table (page 5-6), we can infer some key performance aspects and their comparison to the predicate device. The primary performance criteria revolve around pressure control and accuracy, and usability.

Inferred Acceptance Criteria and Reported Performance:

Study Details

The document describes non-clinical testing for the TrachCuff Cuff Controller.

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: The document does not specify a distinct "test set" in terms of patient data or a specific number of units for performance testing. Instead, it refers to laboratory testing and usability studies. For durability testing, "the device" was evaluated. For usability, it mentions a "representative population of USA clinical users," but no specific number.
   • Data Provenance: The testing was conducted in a laboratory setting ("The TrachCuff Cuff Controller was laboratory tested"). Usability testing involved "USA clinical users," suggesting prospective data collection for that specific aspect. These are non-clinical studies.

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

   • This information is not provided as the studies are primarily non-clinical engineering and usability tests against predefined standards and specifications, rather than clinical studies requiring expert ground truth for diagnostic or therapeutic accuracy. For usability, "USA clinical users" participated, implying healthcare professionals, but no specific number or detailed qualifications are given.

3. Adjudication method for the test set:

   • This information is not applicable as the studies are non-clinical engineering and usability tests against predefined standards. There is no mention of adjudication for discrepancies in expert assessments.

4. 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:

   • No, an MRMC comparative effectiveness study was not done. This device is a medical device for controlling cuff pressure, not an AI diagnostic or assistive tool, so such a study would not be relevant.

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

   • The document implies standalone non-clinical performance testing of the device's technical specifications (pressure accuracy, electrical safety, etc.) against established standards. The device itself operates automatically to maintain cuff pressure once set by a user, so its core function is "algorithm only" in terms of maintaining the set pressure. The usability evaluation, however, involves human interaction.

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

   • For technical performance, the "ground truth" is defined by established engineering and medical device standards (e.g., IEC 60601-1, IEC 60601-1-2, ISO 14971, IEC 62304, ISTA 3A, IEC 62366), device specifications (e.g., pressure range, accuracy), and manufacturer's technical files (for biocompatibility). There is no "pathology" or "outcomes data" ground truth as this is not a diagnostic device.

7. The sample size for the training set:

   • This information is not applicable/not provided. This device is a hardware-based cuff controller with embedded software, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The software development followed IEC 62304 (software lifecycle process) rather than an AI/ML model training paradigm.

8. How the ground truth for the training set was established:

   • This information is not applicable for the reasons stated above (not an AI/ML device requiring a training set).

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