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AnapnoGuard 100 Respiratory Guard System is intended for airway management by oral/nasal intubation while providing continuous endotracheal cuff pressure control using non-invasive measurement and monitoring of carbon dioxide concentration in the subglottic space and evacuation of secretions from above the endotracheal tube's cuff.

AnapnoGuard 100 Respiratory Guard System is comprised of the following three main components: The AnapnoGuard endotracheal tube (ETT) with inflatable cuff (FDA cleared under K093126). The AnapnoGuard 100 Respiratory Guard System interconnection harness of tubes, connecting the ETT to the AnapnoGuard 100 control unit The AnapnoGuard 100 Respiratory Guard System control unit which consists of the following main modules: Host computer (PC) Microcontroller (MCU) Suction module (regulator and flow potency meter): including . a set of valves and pipes controlling the secretions suction/evacuation from above the ETT cuff. Rinsing module: Pumps saline to rinse the Suction and Vent/ ● CO2 lumens. CO2 analyzer module: including CO2 analyzer assembly, ● pump, valve and flow filter which sucks air from the subglottic space above the ETT cuff into the CO2 analyzer. . Cuff pressure module: includes two pressure gauges which monitor cuff pressure, a miniature air pump and two valves. Pneumatic module: valves, pipes and filters . Connectors panel for connecting the interconnection harness . (ETT), vacuum, trap bottle, rinsing fluid and filters. Operation buttons panel and navigation wheel . I/O communication panel . Display monitor . AnapnoGuard 100 Respiratory Guard System, including its three components monitors leak between the endotracheal tube's cuff and the trachea by measuring the Carbon Dioxide levels in the subglottic area above the cuff through a dedicated lumen in the endotracheal tube. Detection of a high level of Carbon Dioxide is an objective indicator for a leak (improper sealing of the trachea by the endotracheal tube cuff). The system continuously monitors and adjusts the cuff pressure to prevent a leak at minimum possible pressure (all within pressure limits preset by the user). Preventing a leak reduces the likelihood of aspiration of secretions from the upper airways into the lungs and increases the likelihood for no loss of ventilation and delivery of anesthetic and nebulized drugs into the lungs. Keeping the cuff pressure as low as possible reduces the mechanical pressure of the cuff on the tracheal tissue throughout the intubation period. The system also performs evacuation of secretions from above the endotracheal tube's cuff through a dedicated lumen at the dorsal side of the endotracheal tube.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The document describes several performance criteria derived from a comparison with predicate devices and specific performance bench tests. The clinical study primarily focuses on the effectiveness of the AnapnoGuard 100 Respiratory Guard System in optimizing cuff pressure and reducing CO2 leakage.

Table 1: Acceptance Criteria and Reported Device Performance

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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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The HAMILTON-C3 ventilator is intended to provide positive pressure ventilatory support to adults, pediatrics, infants, and neonates.

Intended areas of use:

• In the intensive care ward or in the recovery room.
• During transfer of ventilated patients within the hospital.

The HAMILTON-C3 ventilator is a medical device intended for use by qualified, trained personnel under the direction of a physician and within the limits of its stated technical specifications.

The HAMILTON-C3 has been designed to ventilate adult and pediatric patients in the critical care environment. With optional support, the HAMILTON-C3 is also able to ventilate infants and neonates. The HAMILTON-C3 ventilator uses the same graphical user interface (GUI) used by the predicate HAMILTON-C2, which features a touchscreen "Ventilation Cockpit". This provides the exact information that the user needs and helps focus on what is important. In addition, the HAMILTON-C3 includes the ASV ventilation-mode, which automatically applies lung-protective strategies, reduces the risk of operator error, and promotes early weaning.
The HAMILTON-C3 has been designed with built-in batteries and a turbine thereby giving the user maximum independence and flexibility to accompany a patient everywhere. The HAMIL-TON-C3 offers the same ventilation modes as the HAMILTON-C2, which provides for both full and partial ventilatory support.

1. The HAMILTON-C3 offers all the conventional modes, as well as advanced invasive and non-invasive ventilation modes: ASV, (S)CMV+, SIMV+, PCV+, SPONT, APRV, DuoPAP, NIV, NIV-ST, nCPAP-PS, PSIMV+, and PSIMV+ with IntelliSync.
2. All 41 monitoring parameters can be trended over 1, 6, 12, 24, and 72 hours.
3. The ability to turn off the Apnea alarm in the nCPAP-PS mode.
4. The HAMILTON-C3 includes a 12.1" wide-screen monitor.

The Hamilton-C3 is a continuous ventilator. The provided text outlines its characteristics, intended use, and a comparison with a predicate device and other FDA-cleared ventilators. However, it does not include detailed acceptance criteria or a study that specifically "proves the device meets the acceptance criteria" in the way one might expect for a diagnostic or AI-driven device with performance metrics like sensitivity, specificity, or F1-score.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel performance. The "acceptance criteria" discussed are primarily related to safety, effectiveness, and adherence to recognized standards, rather than specific performance metrics for a novel diagnostic function.

Here's a breakdown based on the information provided, and where information is not present:

1. Table of acceptance criteria and the reported device performance

Based on the document, "acceptance criteria" are inferred from the demonstration of substantial equivalence and adherence to recognized standards. The "reported device performance" is largely presented as meeting the same functional capabilities as the predicate device (HAMILTON-C2) and adhering to various medical device standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable in the traditional sense for this submission type. This is a 510(k) submission based on substantial equivalence, not a clinical trial with a "test set" of patient data to evaluate a diagnostic algorithm's performance. The "testing" referred to is non-clinical verification and validation of the device's functionality and adherence to standards. There is no mention of patient data.

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. As per point 2, there is no "test set" with ground truth in the context of diagnostic performance presented in this document.

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

• Not Applicable. See point 3.

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. This document describes a continuous ventilator, not an AI-assisted diagnostic device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or mentioned.

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

• No. This is a medical device (ventilator), not a standalone algorithm. While it contains software, the evaluation in this document focuses on the integrated system's safety and effectiveness and its equivalence to a predicate device, not on the performance of a standalone algorithm or AI.

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

• Not Applicable. As per point 2, there is no "test set" requiring ground truth for diagnostic performance evaluation. The "ground truth" for the device's functionality is its design specifications and compliance with recognized standards.

8. The sample size for the training set

• Not Applicable. This document does not describe the development or evaluation of an AI/ML algorithm that would require a "training set" of data.

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

• Not Applicable. See point 8.

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