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

The Autovent 1500 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 Flynn Genesis product - 510K # K913039/B except in the range of automatic settings of the device which have been extended and chosen to provide the output requirements of the latest AHA recommendations.

The document describes the Autovent 1500, an automatic time-cycled resuscitator, and its clearance based on substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the international standard for these devices, ISO 8382-1988, which the predicate device's performance data addressed. The Autovent 1500's performance was then compared against the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state a "test set" in the context of human data. The assessment of performance data relies on non-clinical test data.

• Sample Size: Not applicable. The testing was non-clinical.
• Data Provenance: The standard is "international standard for these devices - ISO 8382-1988." The testing was undertaken by the manufacturer, O-Two Systems International Inc. The document does not specify a country of origin for the test data itself, beyond the device manufacturer's location in Canada. The data is retrospective in the sense that it evaluates a completed device design against established standards.

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

Not applicable. The performance assessment was based on non-clinical testing against an international standard, not on expert-established ground truth from a human dataset.

4. Adjudication Method for the Test Set

Not applicable, as the evaluation was based on non-clinical testing against a standard and comparison to a predicate device, not on expert adjudication of a test set.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission focuses on device performance against a standard and equivalence to a predicate, not on human reader performance with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

Yes, a standalone study was done in the sense that the device's technical specifications and performance were evaluated independently as a piece of equipment ("algorithm only" in the context of device function, not AI). The "Assessment of Performance Data" section states that the predicate device submission incorporated significant non-clinical test data to support its claim of substantial equivalence, and this new device was verified against that performance. This testing would be considered standalone evaluation of the device's functional performance characteristics.

7. The Type of Ground Truth Used

The ground truth used was technical specifications and performance characteristics defined by the international standard ISO 8382-1988, as demonstrated by the legally marketed predicate device (Flynn® Genesis® II Adult/Child - 510K # K913039/B).

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML device that requires a training set in the typical sense. Its performance is based on its mechanical and pneumatic design.

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

Not applicable, as there is no "training set" for this device.

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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 Genesis® 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® " 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 provided text is a 510(k) submission for the Genesis® BLS Resuscitator, which is a device for respiratory support. This document is a regulatory submission for premarket notification and does not contain the detailed information necessary to fully answer the request as it pertains to a study proving the device meets acceptance criteria derived from a performance study involving a test set, experts, and specific statistical analyses.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Genesis® II A/C - 510K #: K932170) based on technological characteristics and non-clinical test data comparing it to existing standards.

Here's what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing Information:

• Specific quantitative acceptance criteria (e.g., specific flow rates, tidal volumes, pressure safety limits, etc.) are not detailed.
• The exact numerical performance metrics of the device against these specific criteria are not provided. The document only states that it "performed within specification" and met referenced standards.

The following questions cannot be answered from the provided text, as the document describes a regulatory submission based on non-clinical testing and substantial equivalence, not a clinical or performance study with a test set, ground truth, or human-in-the-loop assessments.

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/Information Not Provided: The document refers to "non-clinical test data" and compliance with standards, not a test set of data (e.g., patient cases) typically used in AI/diagnostic device performance studies.

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/Information Not Provided: No test set of cases requiring expert ground truth is mentioned. The device is a resuscitator, not an imaging or diagnostic device that typically relies on expert interpretation of test data.

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

• Not Applicable/Information Not Provided: No test set requiring expert adjudication is mentioned.

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/Information Not Provided: This device is an automatic/manually triggered resuscitator, not an AI-assisted diagnostic tool. Therefore, an MRMC study with human readers assessing AI improvement is not relevant to this device's type.

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

• Partially Applicable/Information Not Explicit: The "non-clinical test data" would inherently be a standalone evaluation of the device's physical performance (e.g., flow, pressure, timing) without human intervention in its operation for assessment. However, this is not in the context of an "algorithm only" as understood for AI devices. The document implies the device's mechanical and pneumatic functions were tested in a standalone manner against specifications.

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

• Not Applicable/Information Not Provided: "Ground truth" in the context of clinical/diagnostic AI studies is not relevant here. The "ground truth" for this device's performance would be the physical and functional specifications derived from engineering design and safety standards (like ISO 8382-1988). The document states testing verified performance against these specifications.

8. The sample size for the training set

• Not Applicable/Information Not Provided: There is no mention of a "training set" as this device is not an AI or machine learning product.

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

• Not Applicable/Information Not Provided: There is no training set.

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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 EMT 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 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 provided text describes a 510(k) submission for the EMT Resuscitator, claiming substantial equivalence to the Genesis® II A/C device (K932170). The documentation focuses on non-clinical performance data and does not contain details about a clinical study with human patients, nor does it include information about AI integration or expert review for ground truth.

Here's an analysis of the provided information relative to your request:

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

Explanation: The documentation indicates that the device's performance was compared against thepredicate device and relevant standards (ISO 8382-1988). The conclusion states that the EMT Resuscitator performs "within specification" when compared to the predicate device. However, specific numerical performance metrics, thresholds, or "acceptance criteria" are not detailed in this section of the 510(k) summary.

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

• Sample Size: Not applicable. The submission incorporated "significant amount of non-clinical test data." This suggests bench testing or simulated environments, not a test set derived from a patient population.
• Data Provenance: Not applicable. As it's non-clinical test data, there's no country of origin or retrospective/prospective classification in the sense of patient data. The manufacturer is O-Two Systems International Inc. from Canada.

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. The study is non-clinical performance testing against specifications and standards, not a study requiring expert-established ground truth on medical conditions.

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

• Not applicable. There is no mention of a human-adjudicated test set.

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 is a 510(k) submission for a medical device (resuscitator), not an AI-powered diagnostic tool. Therefore, an MRMC study or AI assistance is not relevant or reported.

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

• No. This is a mechanical resuscitator, not an algorithm.

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

• Not applicable. The "ground truth" for this device's performance is its adherence to engineering specifications and international standards (like ISO 8382-1988) as demonstrated through non-clinical testing.

8. The sample size for the training set

• Not applicable. No training set is mentioned as this is not an AI/machine learning device.

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

• Not applicable. No training set is mentioned.

Summary of Device Performance Study:

The provided information describes a substantial equivalence claim for the EMT Resuscitator. The study to support this claim consisted of non-clinical test data that reviewed the device's performance against both domestic and international standards (specifically referencing ISO 8382-1988) and compared it to the legally marketed predicate device, Genesis® II A/C. The conclusion states that the EMT Resuscitator performed "within specification" when compared to the predicate device. This type of submission relies on demonstrating that the new device has "similar technological characteristics" and performs comparably to a device already on the market, primarily through bench testing and adherence to recognized standards, rather than clinical trials with human subjects or AI-specific validation.

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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 Autovent 1000 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 and Manual Ventilation into a control module with separate hose and patient valve. This device is identical in terms of features to the Genesis® II Adult/Child resuscitator -510K #: K932170. The range of automatic settings of the device have been extended and chosen to provide the output requirements of the latest AHA recommendations and in the removal of the demand breathing function. An automatic/manual on/off control has been added which is separate from the frequency/volume control as in the predicate device. 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. 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.

Below is a breakdown of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

The provided text focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific numerical acceptance criteria. However, it does state the standard against which the performance was evaluated.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state a "sample size" in terms of number of patients or cases. Instead, it refers to "a significant amount of non-clinical test data." The data provenance is not specified beyond being "non-clinical test data," implying laboratory or bench testing. There is no mention of country of origin for this data or whether it was retrospective or prospective.

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

This information is not provided. The "ground truth" for the test set appears to be the performance specifications outlined in the international standard ISO 8382-1988 and the performance of the predicate device (Genesis® II Adult/Child). There's no indication of clinical experts establishing ground truth for individual cases.

4. Adjudication Method for the Test Set

Not applicable. The performance was assessed against an international standard and a predicate device's specifications, not through adjudication by multiple experts on a test set of patient cases.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document describes non-clinical testing and comparison to a predicate device's specifications and an international standard, not a study involving human readers or AI assistance.

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

Yes, the study described is a standalone performance assessment of the device itself. "Algorithm only" is not a direct fit as this is a mechanical device, but the testing performed evaluates the device's intrinsic mechanical performance without human intervention as part of the performance measurement, beyond operating it for the test.

7. The Type of Ground Truth Used

The ground truth used was:

• International Standard: ISO 8382-1988 for automatic resuscitators.
• Predicate Device Specifications: The performance characteristics of the GENESIS® II Adult/Child resuscitator (510K #: K932170).

8. The Sample Size for the Training Set

Not applicable. This device is a mechanical resuscitator, not an AI or algorithm-based system that requires a "training set" in the conventional machine learning sense. The development likely involved engineering design and iterative testing, not data-driven training.

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

Not applicable, as there is no "training set" in the context of this device. The design and development would have been guided by engineering principles, industry standards (like ISO 8382-1988), and the functional requirements for a resuscitator, rather than by establishing ground truth from a data set for training an algorithm.

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