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The IntelliCuff device is intended to continuously measure and automatically maintain the userset cuff pressure of an endotracheal tube (ETT) or tracheostomy tube (TT) during mechanical ventilation.

The device can be used with any mechanical ventilator, as follows:

• . When used with a non-Hamilton Medical ventilator, IntelliCuff adjusts the cuff pressure to values set on the device.
• When used with a Hamilton Medical ventilator, IntelliCuff adjusts the cuff pressure to values set either on the device or on the ventilator, depending on configuration.

The device is to be used during ventilation of adults, pediatrics, and neonates, who are intubated with ETT or TT, in the following areas:

• In the intensive care ward or in the recovery room ●
• In the operation room during intubation narcosis
• For emergency medical care or primary care ●
• During transport within and outside of the hospital
• . During transfer by rescue vehicles, ship, jet, or helicopter

The IntelliCuff device continuously measures and automatically maintains cuff pressure during mechanical ventilation of adults, pediatrics, and neonates using a cuffed endotracheal tube or tracheostomy tube. It is an integrated and continuous cuff pressure control solution that secures airway management in intensive care units, operating rooms, and during interhospital transport.

When the IntelliCuff device is connected to a Hamilton Medical ventilator, cuff pressure settings can be manually adjusted by either selecting the appropriate values on the ventilator or the cuff pressure controller.

It is designed for immediate use; no calibration or maintenance is required. It operates in the recommended range of desired cuff pressures for various cuffed endotracheal tubes to provide suitable solutions for various clinical patient situations. For inflation, room air is used and no contact to the respiratory gas system of a patient occurs. A large-scale display and convenient and intuitive interaction buttons maximize safe use and visibility of all important data.

The associated accessories include:

• Cuff Pressure Tube with Filter
• Device Mount Solution ●
• USB Power Supply and Car Adapter

The provided text is a 510(k) Summary for the IntelliCuff device, which is an automatic cuff pressure controller for endotracheal and tracheostomy tubes. Unfortunately, the document does not contain a specific study demonstrating acceptance criteria for device performance as it does not report quantitative performance metrics against specific acceptance thresholds.

The document primarily focuses on demonstrating substantial equivalence to a predicate device through:

• Technological characteristics comparison: Showing that the IntelliCuff shares the same fundamental technological elements with predicate devices (e.g., inflation/deflation, user-controlled set pressure, software control, alarm system).
• Compliance with regulatory standards: Reporting that the device has undergone various electrical safety, electromagnetic compatibility (EMC), mechanical, and software verification and validation testing in accordance with relevant IEC and RTCA standards. These tests confirm the device's safety and functionality within its intended environment.
• Human Factors/Usability Study: Indicating conformance with FDA guidance for optimizing medical device design.

While these are crucial aspects of device clearance, they do not provide quantitative acceptance criteria for the device's primary function (continuously measuring and automatically maintaining cuff pressure) and the results of a study against those criteria. Such data would typically involve metrics like accuracy of pressure measurement, stability of pressure maintenance, response time to pressure deviations, etc., along with predefined acceptable ranges.

Therefore, I cannot fulfill all parts of your request with the information provided. The document states that "The test results show that the device has adequate performance for its intended use" and "the IntelliCuff device was found to have an adequate performance profile that is similar to the predicate devices" but does not quantify this performance or explicitly state acceptance criteria.

Here's a breakdown of what can be extracted from the provided text, and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

• Cannot be created. The document mentions compliance with general safety and performance standards (e.g., IEC 60601-1, IEC 60601-1-2, RTCA/DO 160G) but does not provide specific, quantitative acceptance criteria for cuff pressure measurement or maintenance, nor does it report specific performance values against such criteria. It states that "The test results show that the device has adequate performance for its intended use" but without specific metrics.

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

• Not specified for performance testing. The document mentions "Electrical safety and EMC testing," "Mechanical testing," "Software Verification and Validation Testing," and a "Human Factors / Usability Study." While these involve testing, the sample size (e.g., number of devices tested, number of simulated or actual cases) for these tests is not given. The "data provenance" (country of origin, retrospective/prospective) is also not detailed for any specific performance study, as no such study with quantitative performance metrics is described.

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

• Not specified. This information would typically be relevant for studies involving human assessment or interpretation (e.g., image-based diagnostics, clinical outcomes). Since the IntelliCuff is a mechanical/electronic device for pressure control, the concept of "ground truth established by experts" in this context is not directly applicable to its core performance testing as described. For a human factors study, experts (usability engineers, clinicians) might be involved, but their number and qualifications are not listed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable/Not specified. Adjudication methods are typically used in studies involving subjective interpretation of data (e.g., by human readers). This type of method is not described for the performance testing of the IntelliCuff device.

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:

• No such study was performed/described. MRMC studies are used for evaluating diagnostic aids, often involving AI, where human readers interpret cases with and without the aid. The IntelliCuff device is an automated pressure controller, not a diagnostic aid for human interpretation, so an MRMC study is not relevant to its function and was not reported.

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

• Implied, but not explicitly detailed. The various compliance tests (electrical safety, EMC, mechanical, software V&V) are essentially standalone tests of the device's functionality and safety. The entire document describes the device (the algorithm and hardware) as a standalone system for continuous pressure maintenance. However, specific standalone performance metrics for things like pressure accuracy or response time are not given in the summary.

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

• Not explicitly stated for core performance, but implied by standards. For compliance with standards like IEC 60601-1 (safety) or RTCA/DO 160G (mechanical), the "ground truth" would be the specified limits and test methodologies defined by those standards. For software verification and validation, the "ground truth" would be the documented software requirements. For a human factors study, the "ground truth" relates to usability objectives and error rates, often compared against benchmarks or user feedback. However, for direct performance metrics like pressure accuracy, the "ground truth" would typically come from highly accurate reference measurement equipment. This is not detailed in the summary.

8. The sample size for the training set:

• Not applicable. The IntelliCuff device is described as a cuff pressure controller. The provided text does not indicate that it uses machine learning or AI models that require a "training set" in the conventional sense (e.g., for image recognition or predictive analytics). Its functionality appears to be based on control system algorithms rather than learned models.

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

• Not applicable. As no training set is mentioned or implied for a machine learning model, this question is not relevant based on the provided text.

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