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The CAREvent Handheld CPAP System is intended to provide CPAP to spontaneously breathing patients in the hospital and pre-hospital (EMS) environments.

The proposed CAREvent Handheld CPAP System is a pneumatically powered device designed to provide CPAP (Constant Positive Airway Pressure) to spontaneously breathing patients who require respiratory support. The patient can breathe spontaneously through the device while the device provides constant positive airway pressure via a face mask. It has only one control for the adjustment of CPAP pressure from 0 to 20 cmH2O.

The device may be used in pre-hospital transport applications including accident scene, emergency rescue vehicles, hospital transport applications including emergency, surgery, post anesthesia/ recovery and air transport via helicopter or fixed wing.

The device is a restricted medical device intended for use by qualified medical personnel under the direction of a physician.

The main accessories for the proposed device are Patient Circuit, Face Mask and Airway Pressure Manometer. They are all disposable for single-patient use.

The CAREvent Handheld CPAP System (K093862) underwent non-clinical bench testing to demonstrate its safety and essential performance.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The studies were non-clinical bench tests. The specific sample sizes for each test are not explicitly detailed in the provided summary, but it's implied that sufficient samples were tested to meet the "Comply" criteria for each standard. All testing was performed internally by O-Two Medical Technologies or by BET Service Inc. and Exova, indicating the data provenance is from laboratory testing of the device itself. The data is prospective in nature as it involves testing of the device.

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

Not applicable. This was a non-clinical bench study assessing device performance against engineering standards and specifications, not clinical outcomes based on human expert assessment.

4. Adjudication method for the test set:

Not applicable. The tests were objective measurements against quantitative physical and performance standards.

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:

Not applicable. This device is a medical hardware device (CPAP system), not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. This device is not an algorithm or AI system. Its performance as a standalone medical device was evaluated through the non-clinical bench tests.

7. The type of ground truth used:

The ground truth used for these non-clinical tests were the established industry standards (ISO 10651-5:2006, IEC60068-2-6, IEC60068-2-36, IEC60068-2-29) and the device's own product specifications, along with specific quantitative criteria (e.g., +/- 10% for static pressure, +/- 4% for pressure gauge accuracy, adequately reducing carbon dioxide rebreathing).

8. The sample size for the training set:

Not applicable. There is no concept of a "training set" for this type of non-clinical device performance testing.

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

Not applicable. As there is no training set, this question is not relevant.

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The CAREvent PAR (Public Access Resuscitator) is indicated for Cardio Pulmonary Resuscitation (CPR) and short -term ventilatory support. It incorporates voice instructions, compression beeps and automatic ventilations to assist CPR Trained personnel for both inter - and intra-hospital transport and pre-hospital (EMS) settings for non-breathing adult patients.

The CAREvent PAR® is an electronically controlled, pneumatically powered resuscitator with a . 12V, internal, rechargeable battery is used to power the electronics. It incorporababliator instructions to assist the user during CPR.

The provided text describes a Premarket Notification 510(k) for the CAREvent PAR device, which is an electronically controlled, pneumatically powered resuscitator. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria and detailed performance data often seen with AI/ML devices.

Therefore, many of the requested categories for AI/ML study descriptions are not applicable to this 510(k) submission. However, I can extract and present the information that is available, and explicitly state where information is not present in the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state "acceptance criteria" for specific performance metrics in the way an AI/ML device study would. Instead, it presents a comparative table detailing the features and performance specifications of the proposed device against its predicate devices. The "acceptance criteria" here are implicitly that the proposed device's features and performance meet or are substantially equivalent to those of the legally marketed predicate devices.

2. Sample size used for the test set and the data provenance
The document does not describe a "test set" in the context of data or studies typically associated with AI/ML devices. The submission relies on a comparison of design features and technical specifications to predicate devices. There is no mention of a specific number of test cases or data provenance for any performance evaluation in the provided text.

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 and not provided. The submission relies on design specifications and functional equivalence rather than expert-established ground truth from performance studies.

4. Adjudication method for the test set
This information is not applicable and not provided.

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 and not provided. The CAREvent PAR is a medical device (resuscitator) that provides automated ventilations and voice instructions; it is not an AI-based diagnostic or assistive technology for human "readers" in the sense of image interpretation.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The device's operation inherently involves human interaction for setup and monitoring, and its functionality is not solely algorithmic in the AI sense. Its performance is measured by its physical output (e.g., tidal volume, respiratory rate).

7. The type of ground truth used
The "ground truth" for this type of device submission is based on engineering specifications, adherence to recognized standards (though not explicitly detailed here, often part of such submissions), and a comparison to the established performance and safety profiles of predicate devices. There is no "expert consensus," "pathology," or "outcomes data" in the AI/ML context mentioned for performance validation.

8. The sample size for the training set
This information is not applicable and not provided, as the device is not an AI/ML system that undergoes a "training set" process.

9. How the ground truth for the training set was established
This information is not applicable and not provided, as the device is not an AI/ML system.

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The CareVent is intended for use with a Foley Urinary Catheter for the management of urinary drainage.

The CareVent device is used with a Foley catheter for the management of urinary drainage. The CareVent offers the physician/user a means to temporarily control the flow of urine from the bladder. Temporary control of urine may be desired for bladder conditioning, diagnostic procedures or patient comfort. The CareVent valve is easily inserted into the distal end of a Foley catheter and may be left open for continuous drainage or manually operated for temporarily closure. The device is provided sterile and for single patient use.

The provided 510(k) summary for the CareVent device does not contain the detailed information requested for acceptance criteria and the study proving it meets those criteria. The document is a regulatory submission for premarket notification, not a full study report.

Here's a breakdown of what is and is not in the document:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated as quantifiable metrics. The document mentions "conformance to product specification" but doesn't define those specifications.
• Reported Device Performance:
  • Qualitative: "All testing was successful."
  • Specific tests mentioned: "general operation, valve operation, and fluid leak." No quantitative results (e.g., specific leak rates, operational pressures, durability cycles) are provided.

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

• Sample Size: Not mentioned.
• Data Provenance: Not mentioned (e.g., country of origin, retrospective/prospective). It's implied the testing was conducted in-house by the manufacturer.

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

• This is not applicable as the testing described ("general operation, valve operation, and fluid leak") does not involve expert interpretation or ground truth establishment in the clinical sense. These are engineering/performance verification tests.

4. Adjudication method for the test set

• Not applicable as no expert adjudication was involved.

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

• Not applicable. This device is a mechanical component (a valve for a Foley catheter), not an AI-powered diagnostic or decision-support system.

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

• Not applicable as this is a mechanical device, not an algorithm.

7. The type of ground truth used

• Not applicable in the clinical sense. The "ground truth" for the tests performed would be adherence to internal engineering specifications for general operation, valve function, and absence of fluid leaks.

8. The sample size for the training set

• Not applicable as this is a mechanical device, not a machine learning model.

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

• Not applicable.

Summary of Information from the Document:

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The CAREvent ATV+ and CAREvent MRI are pneumatically powered, time cycled, intermittent, positive pressure automatic transport ventilator used to provide resuscitation and/or ventilatory support to a wide range of patients (from above 5 kg (11 lbs.) and higher) during transport.

They are designed to be used by suitably trained medical personnel in the prehospital, Intra-hospital, inter-hospital and air ambulance settings.

In addition CAREvent MRI is suitable for use in 1.5 - 3.0 Tesla MRI medical imaging suite environments, where ventilatory support may also be required during an MRI imaging procedure.

The ventilator is suitable for use in:

• · Pulmonary resuscitation during respiratory and/or cardiac arrest.
• · Short term ventilatory support in the pre-hospital, Intra-hospital, inter-hospital and air ambulance transport of non-breathing patients.
• · In addition CAREvent MRI only is suitable for use in 1.5 3.0 Tesla MRI medical imaging suite environments, where ventilatory support may also be required during an MRI imaging procedure.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA regarding the CAREvent ATV+ and CAREvent MRI ventilators. It confirms substantial equivalence to predicate devices and outlines general regulatory requirements. However, it does not contain any information regarding acceptance criteria, device performance metrics, sample sizes, expert qualifications, adjudication methods, details of comparative effectiveness studies (MRMC), or standalone algorithm performance, or how ground truth was established for training or test sets.

Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance or other study details based solely on the provided text. The document is primarily an approval letter, not a detailed study report.

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The CAREvent CA and CAREvent DRA are pneumatically powered, time/volume cycled ventilators used to provide ventilatory support in confined space rescue in IDLH (Immediately Dangerous to Life and Health) environment. The ventilator is suitable for use in: Pulmonary resuscitation during respiratory and/or cardiac arrest. Short term ventilatory support in the confined space rescue in IDLH (Immediately Dangerous to Life and Health) environment, pre-hospital, Intra-hospital and inter-hospital transport of non-breathing patients.

The CAREvent CA and CAREvent DRA are pneumatically powered, time/volume cycled ventilators.

I am sorry, but based on the provided document, the information required to answer your request is not present. The document is an FDA 510(k) clearance letter for the CAREvent CA and CAREvent DRA devices, indicating that the devices are substantially equivalent to legally marketed predicates. It covers regulatory aspects, such as product codes, regulation numbers, and instructions for marketing, but it does not contain details about specific acceptance criteria, study designs, sample sizes, expert qualifications, or ground truth establishment for performance testing.

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for the test set or data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. Information on a multi-reader multi-case comparative effectiveness study or its effect size.
6. Confirmation of whether a standalone performance study was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

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• Pulmonary resuscitation during respiratory and/or cardiac arrest.
• Short term ventilatory support for both inter and intra-hospital transport of non-breathing patients.

The CAREvent BLS automatic/manually triggered resuscitators are designed to provide respiratory support to patients in either respiratory arrest or respiratory distress. The device incorporates the features of Automatic Ventilation and Manual Ventilation into a single handpiece design that is a derivative of the Genesis® II BLS device. The device is totally pneumatic in its function therefore requiring no batteries or other power sources apart from a compressed gas supply of either air or oxygen (as specified by the customer) and a regulated output from the gas source between 50 and 90 psi.

The CAREvent ALS automatic/manually triggered resuscitators are designed to provide respiratory support to patients in either respiratory arrest or respiratory distress. The device incorporates the features of Automatic Ventilation and Manual Ventilation into a single handpiece design that is a derivative of the Genesis® " Adult/Child device. The device is totally pneumatic in its function therefore requiring no batteries or other power sources apart from a compressed gas supply of either air or oxygen (as specified by the customer) and a regulated output from the gas source between 50 and 90 psi.

The CAREvent BLS* is an automatic time cvcled resuscitator designed to provide respiratory support to patients in either respiratory arrest or respiratory distress. The device incorporates the features of Automatic and Manual Ventilation into a control module with separate hose and patient valve. This device is identical in terms of features to the Autovent 1000 - 510K #: K983785 with the addition of the ability to select the manual flowrate equivalent to that selected on the tidal volume/frequency control. The device is a pneumatically powered, requiring no batteries or other power sources apart from a compressed gas supply of either air or oxygen (as specified by the customer) and a regulated output from the gas source between 50 and 90 psi. The device is a time-cycled ventilator with a range of 12, pre-set, automatic settings in which both the tidal volume and frequency of ventilation are adjusted simultaneously by the rotation of a vertically mounted rotary control. A manual button is provided to enable the operator to control the patient's breathing parameters with a flowrate equivalent to that selected on the tidal volume/frequency control. The patient's airway is protected by an over pressure alarm, pre-set to 60 cmHzO. which gives an audible signal of over pressure and vents the remaining tidal volume delivery for that breath to atmosphere.

The CAREvent ATV is an automatic time cycled ventilator designed to provide respiratory support to patients in either respiratory arrest or respiratory distress. The device incorporates the features of Automatic Ventilation, Manual Ventilation, and Demand Breathing into a control module with separate hose and patient valve. This device is identical in terms of features to the Autovent 1500 product - 510K # K983857 with the addition of independent minute volume and frequency controls. adjustable pressure relief, 60/100% air/oxygen mix and the ability to select the manual flowrate with a flowrate equivalent to that selected on the minute volume control. An additional alarm feature has also been added to warn of low input pressure. The device is a pneumatically powered, requiring no batteries or other power sources apart from a compressed gas supply of either air or oxygen (as specified by the customer) and a regulated output from the gas source between 50 and 90 psi. The device is a time-cycled ventilator with a range of 12, automatic frequency settings and 12 minute volume settings which are both adjusted by the rotation of a vertically mounted rotary control. A manual button is provided to enable the operator to control the patient's breathing parameters with a flowrate equivalent to that selected on the minute volume control. Should the patient commence spontaneous breathing while being ventilated, their inspiratory effort will cause the device to provide breathing on demand while simultaneously causing the automatic cycling to cease. Should the patient cease to breathe spontaneously the automatic cycling will recommence without intervention by the operator being necessary. The patient's airway is protected by an over pressure alarm (adjustable from 20 to 60 cmH20), which gives an audible signal of over pressure and vents the remaining tidal volume delivery for that breath to atmosphere.

The CAREvent ALS is an automatic time cycled resuscitator designed to provide respiratory support to patients in either respiratory arrest or respiratory distress. The device incorporates the features of Automatic Ventilation, Manual Ventilation, and Demand Breathing into a control module with separate hose and patient valve. This device is identical in terms of features to the Autovent 1500 product - 510K # K983857 with the addition of the ability to select the manual flowrate with a flowrate equivalent to that selected on the tidal volume/frequency control. The device is a pneumatically powered, requiring no batteries or other power sources apart from a compressed gas supply of either air or oxygen (as specified by the customer) and a regulated output from the gas source between 50 and 90 psi. The device is a time-cycled ventilator with a range of 12, pre-set automatic settings in which both the tidal volume and frequency of ventilation are adjusted simultaneously by the rotation of a vertically mounted rotary control. A manual button is provided to enable the operator to control the patient's breathing parameters with a flowrate equivalent to that selected on the tidal volume/frequency control. Should the patient commence spontaneous breathing while being ventilated, their inspiratory effort will cause the device to provide breathing on demand while simultaneously causing the automatic cycling to cease. Should the patient cease to breathe spontaneously the automatic cycling will recommence without intervention by the operator being necessary. The patient's airway is protected by an over pressure alarm, pre-set to 60 cmHzO. which gives an audible signal of over pressure and vents the remaining tidal volume delivery for that breath to atmosphere.

The provided text describes several medical devices, all named "CAREvent" followed by different designations (BLS, ALS, ATV). The common theme across all descriptions is that performance data was assessed based on non-clinical testing against the international standard ISO 8382-1988. The conclusion for each device states that "The testing undertaken verified that the CAREvent [Device Name], when compared with the performance of the device to which substantial equivalence is claimed, performed within specification."

Given the nature of the provided text (a 510(k) submission summary), detailed acceptance criteria in the format of specific numerical thresholds and performance metrics are not explicitly presented. Instead, it relies on demonstrating equivalence to predicate devices and compliance with an international standard.

Here's an attempt to structure the information based on the provided text, acknowledging the limitations inherent in these types of documents:

Acceptance Criteria and Study Details for CAREvent Resuscitators/Ventilators

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document focuses on demonstrating substantial equivalence to predicate devices and compliance with a standard, rather than presenting specific numerical acceptance limits for performance parameters (e.g., tidal volume accuracy, frequency accuracy, pressure relief settings).

2. Sample Size for Test Set and Data Provenance

• Sample Size: The document does not specify a numerical sample size for the test set. It broadly refers to "significant amount of non-clinical test data."
• Data Provenance: The testing was "non-clinical" and likely performed by or for the manufacturer (O-Two Systems International Inc. in Mississauga, Ontario, Canada). The data is retrospective in the sense that it's submitted after the testing was completed. The country of origin for the data is Canada (manufacturer's location) for the testing, referencing an international standard (ISO 8382-1988) which is not country-specific.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Not Applicable: The studies described are non-clinical, likely bench testing or engineering verification. There is no mention of expert-established ground truth in the context of human physiological data or interpretations. The "ground truth" here would be the specified performance parameters of the device and the requirements of the ISO standard.

4. Adjudication Method for the Test Set

• Not Applicable: Given the non-clinical nature of the testing, an adjudication method for a test set (e.g., clinical outcomes, image interpretation) is not relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No: The document does not mention any clinical studies involving human readers or comparative effectiveness studies with or without AI assistance. The testing is non-clinical.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

• Yes (Implied): The "assessment of performance data" is implicitly a standalone evaluation of the device's technical specifications and functionality against a standard and a predicate, without human-in-the-loop performance being a primary measure. The devices are pneumatic and mechanical, not algorithmic in the modern AI sense.

7. The Type of Ground Truth Used

• Engineering Specifications and International Standards: The ground truth for this device's performance is based on its engineering design specifications, the functional requirements outlined for resuscitators/ventilators, and the specific requirements of the international standard ISO 8382-1988. The performance of the legally marketed predicate devices also served as a reference point for equivalence.

8. The Sample Size for the Training Set

• Not Applicable: These are mechanical/pneumatic devices, not AI/machine learning algorithms. Therefore, there is no "training set" in the computational sense. The design and development process for such devices would involve iterative testing and refinement, but not a distinct "training set."

9. How the Ground Truth for the Training Set Was Established

• Not Applicable: As there is no training set, this question is not relevant. The device design and manufacturing processes are validated against engineering principles and regulatory standards.

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