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The Equinox® Advantage Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery System is indicated for administering an adjustable mixture of Nitrous Oxide analgesic gas and Oxygen, on demand, to a conscious, spontaneously breathing patient.

Equinox® Advantage Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery System is a portable pneumatically powered device intended to administer an adjustable mixture of Nitrous Oxide analgesic gas and Oxygen mixture to provide pain relief, on demand, to a conscious, spontaneously breathing, patient.

The device provides two input connection with nitrous oxide and oxygen cylinders through pressure regulators. The device has a control knob for turning ON or OFF the device. When it is turned ON, the output of N2O/O2 gas mixture will only be administered by an inspiratory effort by the patient.

A selection knob is used to select desired N20/02 gas mixture. The adjustable range is from 25% O2 (NJO 75%) to 100% O2 (N3O 0%), with the minimum of 25% oxygen output to eliminate the possibility of delivering a hypoxic mixture.

The Oxygen Enrichment Function is designed to provide 30 L/min of 100% oxygen in order to flush any residual gas from the patient circuit following the completion of the patient treatment.

The built-in pneumatically powered alarm system will generate both visual and audible alarms should either nitrous oxide or oxygen input fall below 40 PSI, and the device will be automatically shut off should oxygen input falls below 35 PSI.

The main accessories for the proposed device are a disposable Patient Circuit and a Mouth Piece or a universal Face Mask.

The provided text describes the regulatory clearance of a medical device, the Equinox® Advantage Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery System, and its substantial equivalence to a predicate device, the Equinox® Relieve (K113687). However, the document does not contain the typical comprehensive study report details that would allow for a complete answer to all parts of your request. This document is a 510(k) Summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a de novo clinical trial.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" in the format typically seen for algorithm performance (e.g., specific sensitivity, specificity, or AUC thresholds). Instead, it relies on demonstrating equivalence to a predicate device and adherence to relevant standards. The "performance" reported is primarily comparative.

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

The document describes "comparative performance testing" and "bench testing." These are laboratory-based tests comparing the proposed device against the predicate and against standards. It does not involve human subjects or patient data in the sense of a clinical trial. Therefore, specific "sample sizes" of a test set derived from patient data are not applicable here.

• Sample size for test set: Not applicable (bench testing, not patient data).
• Data provenance: Bench testing results, comparing the proposed device to the predicate device and relevant international standards (e.g., ISO 11195, ISO 80601-2-13). The country of origin for the test data is not specified but is presumably where the manufacturing and R&D for O-Two Medical Technologies Inc. takes place (Canada, as per the address). The testing is prospective for the purpose of demonstrating equivalence for the new device.

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

This information is not provided. For bench testing, ground truth is established by objective measurements against known physical and chemical standards and the specifications of the predicate device. Experts in this context would likely be engineers and testers.

4. Adjudication method for the test set

Not applicable. The testing described is objective, physical measurement and comparison, not expert adjudication of a diagnostic outcome.

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 gas mixing and delivery system, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted or mentioned.

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

This refers to an algorithm's performance without human intervention. This concept is not applicable to a physical gas mixing and delivery system. Its "performance" is inherent in its mechanical and pneumatic operation.

7. The type of ground truth used

For the aspects involving comparison to the predicate device, the "ground truth" for equivalence was the performance and specifications of the legally marketed predicate device (Equinox® Relieve/K113687). For aspects related to safety and functionality specifications, the ground truth was defined by international standards such as ISO 11195:1995 and ISO 80601-2-13:2011.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

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

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o two e700, e600 and e500 are a time-cycled, volume-constant and pressure-controlled (only e700) emergency and transport ventilator designed for use in the pre-hospital, inter-hospital and transport settings. It is intended for use with adult, child, infant patients with a tidal volume from 50 ml (100 ml for e500) upwards who are in respiratory and/or cardiac arrest or respiratory distress and who require ventilatory support.

The proposed o_two e700, o_two e600 and o_two e500 are time-cycled, volume-constant and pressure controlled (o_two e700 only) emergency and transport ventilators. They are electronically controlled, pneumatically powered ventilators which can be run using AC/DC power adapter or an internal rechargeable Lithium Ion battery pack. The devices use a 4.3" TFT screen to display live ventilation parameters (Tidal and minute volumes, proximal airway pressure and breathing rate) as well as ventilation pressure & volume wave forms, ventilation modes, settings, alarm limits and battery status. The wide range of both visual and audible alarms provides the healthcare professional with warnings of any changes in patient or device parameters.

The provided text describes the O-Two Medical Technologies' e700, e600, and e500 Electronic Transport Ventilators and their substantial equivalence to predicate devices, but it does not contain the specific information requested in the prompt regarding acceptance criteria, performance tables, sample sizes, expert qualifications, or ground truth establishment.

The document is a 510(k) premarket notification for device clearance, which focuses on demonstrating substantial equivalence to existing legally marketed devices (predicates) rather than providing detailed acceptance criteria and performance study outcomes in the format you've requested.

Here's what can be extracted based on the document, and what is explicitly not available:

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

• Not explicitly provided in the requested format with specific numerical acceptance criteria and performance metrics for an AI/algorithm-based device.

• The document primarily presents a comparative table showing the characteristics and specifications of the proposed devices against the predicate devices (Oxylog 3000 and CAREvent PAR) to demonstrate "Substantial Equivalence." Instead of acceptance criteria, it lists features and parameters and asserts "Yes" for substantial equivalence or notes specific differences.

  • Example from the document (partial):

• The "Summary of Performance Testing" section lists qualitative findings from a comparative bench test:
  • "Both ventilators delivered equivalent volume-time, pressure-time and flow-time wave forms under the same ventilation mode;"
  • "Both ventilators were responsive to spontaneous breathing trigger;"
  • "Ventilation Vt, frequency and I:E ratio or Ti of both units were close to target or preset parameters;"
  • "Both units delivered similar pressure supports."

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

• Not available. The document mentions "comparative side-by-side bench testing" but does not specify sample sizes (e.g., number of test cases, simulated patient scenarios, or real patient data) or data provenance. It's bench testing, implying simulated rather than 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 / Not available. This is a ventilator device, and the testing described is bench testing against established performance metrics and comparison to predicate devices, not an AI/imaging diagnostic device requiring human expert ground truth for interpretation.

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

• Not applicable / Not available. Adjudication methods are typically used for establishing ground truth in diagnostic studies, which is not the nature of this submission.

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 was not done. This is not relevant for an electronic transport ventilator. The study focused on proving substantial equivalence through bench testing and comparison of specifications to predicate devices, not on human reader performance with or without AI assistance.

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

• Not applicable. The device is a ventilator, a physical system with embedded software, not a standalone algorithm for diagnostic or interpretative tasks. The "Summary of Performance Testing" refers to bench testing of the device's operational performance.

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

• For the bench testing, the "ground truth" would be the expected physical performance parameters and waveforms based on established engineering and medical device standards (e.g., IEC 60601 series, EN 794-3, ISO 10651-3, ISO 80601-2-12) and the known performance of the predicate devices. The device's output (volume-time, pressure-time, flow-time waveforms, Vt, frequency, I:E ratio, etc.) was compared against these established targets.

8. The sample size for the training set

• Not applicable / Not available. This is not an AI/machine learning device that uses a "training set" in the conventional sense. The device's software logic is developed based on engineering principles and validated through testing.

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

• Not applicable / Not available. As this is not an AI/machine learning device requiring a training set, the concept of establishing ground truth for a training set does not apply.

In summary: The provided FDA document is a 510(k) clearance letter and summary for a medical device (electronic transport ventilator). It demonstrates "substantial equivalence" to predicate devices through comparative bench testing and specifications. It does not contain the specific information about AI/algorithm performance, detailed acceptance criteria tables, sample sizes for AI model development/testing, or expert-based ground truth evaluations as typically found in submissions for AI-enabled diagnostic or interpretive devices.

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The Equinox Relieve® Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery System is indicated for delivering a 50%/ 50% mixture of nitrous oxide and oxygen, on demand, to a conscious, spontaneously breathing patient.

The proposed Equinox Relieve® Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery System is a portable pneumatically powered device designed to provide a 50/50% nitrous oxide and oxygen mixture. The device provides two input connection with nitrous oxide and oxygen cylinders through pressure regulators. The device has only one control for turning ON or OFF the device. When it is turned ON, the output of N20/02 gas mixture will only be activated by an inspiratory effort by the patient. The out put of N20/O2 gas mixture is pre-set at 50/50%. Neither the patient nor medical personnel are able to adjust, eliminating the risk of delivering a hypoxic mixture. The gas specific built-in alarm system will generate both visual and audible alarms should either nitrous oxide or oxygen input fall below 40 PSI, and the device will automatically shut off should either nitrous oxide or oxygen input fall below 35 PSL. The device is also equipped with a secondary "fail safe" circuit that will activate an alarm and shut off the device should internal malfunction occur in the mixer or any internal hoses rupture or kink. The main accessories for the proposed device are a disposable Patient Circuit and a universal Face Mask.

The provided text is a 510(k) Premarket Notification summary for the Equinox Relieve® Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery System. It is a regulatory document and does not contain details about a study to prove acceptance criteria or device performance in the way typically associated with AI/ML devices.

The document primarily focuses on establishing "substantial equivalence" to predicate devices, which is a common regulatory pathway for medical devices. This involves demonstrating that the new device is as safe and effective as a legally marketed device.

Therefore, many of the requested sections (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) are not applicable to this type of regulatory submission and are not present in the provided text.

However, I can extract the acceptance criteria as implied by the substantial equivalence comparison and the device's reported characteristics.

Here's the information that can be extracted from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

For a device like the Equinox Relieve®, "acceptance criteria" are generally derived from the specifications and performance of legally marketed predicate devices, along with relevant safety standards. The "reported device performance" is the device's design specifications and claimed capabilities that are compared to these in the context of substantial equivalence.

Study Proving Acceptance Criteria:

The document describes a "comparative table" which is the primary evidence used to demonstrate substantial equivalence, rather than a stand-alone clinical study with explicit acceptance criteria and statistical analysis. The "study" here is essentially the comparison of the proposed device's specifications and features against those of the predicate devices. The conclusion presented is: "There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices."

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

• Sample Size: Not applicable. This is not a study involving patient data or a test set in the conventional sense. The "test set" is the proposed device's design specifications.
• Data Provenance: Not applicable.

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

• Not applicable. The ground truth, in the context of substantial equivalence, is established by the performance and safety characteristics of the legally marketed predicate devices, which have already undergone regulatory review. There is no mention of external experts establishing a ground truth for a test set for this 510(k) submission.

4. Adjudication Method for the Test Set:

• Not applicable. No adjudication process is described for a test set. The FDA's review process serves as the adjudication for the substantial equivalence claim.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is common for diagnostic imaging AI, but not for a physical device like a gas mixing and delivery system.

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

• Not applicable. This device is a physical medical device, not an algorithm. Its operation is standalone in the sense that it functions automatically based on patient inspiratory effort, but this isn't analogous to "standalone algorithm performance" as typically discussed in AI/ML medical devices.

7. The Type of Ground Truth Used:

• The "ground truth" for this submission is implicitly the established safety and effectiveness of the legally marketed predicate devices (Nitronox® K883833 and CAREvent ALS+ K991195). The substantial equivalence pathway relies on demonstrating that the new device is "as safe and effective" as these known devices, based on their design, indications, and performance characteristics.

8. The Sample Size for the Training Set:

• Not applicable. This is not an AI/ML device that uses a training set.

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

• Not applicable. This is not an AI/ML device.

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o two CPAP System is intended to provide a constant positive airway pressure to spontaneously breathing patients in the hospital environment and emergency medical service applications to treat patients in respiratory distress.

The o two CPAP device provides a constant positive airway pressure to the lungs of patients in respiratory distress from Pulmonary Emphysema, Congestive Heart Failure and a number of other obstructive airway conditions. This open system has no moving parts and uses a "vectored flow valve" to create a wall of resistance to expiration and an additive flow to inspiration. By varying the oxygen flow through the valve the baseline pressure can be raised or lowered to maintain a positive airway pressure. The rise in baseline pressure keeps alveoli from collapsing, forces fluid in the lungs back intro the interstitium and improves medication delivery.

The provided text describes a 510(k) premarket notification for the "o_two CPAP System". This document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than presenting a standalone study with detailed acceptance criteria and performance metrics in the way one might find for a novel AI/software medical device.

Therefore, the requested information elements related to AI/software performance studies, such as sample size for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, and training set details, are not applicable to this 510(k) submission.

The "study" in this context is the comparison against predicate devices to establish substantial equivalence based on design, materials, indications for use, performance, and function.

Here's the information that can be extracted and a clear indication of what is not present given the nature of the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a quantitative, measurable sense for novel performance. Instead, it demonstrates that the o_two CPAP System is comparable to its predicate devices in various characteristics. The "performance" is implied by its similarity to the predicate devices and its stated functional principles.

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

• Not applicable. This submission is a substantial equivalence claim, not a clinical trial or performance study on a test set in the context of an AI/software device. The comparison is based on the technical specifications and intended use of the device against legally marketed predicates.

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

• Not applicable. See point 2.

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

• Not applicable. See point 2.

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 is a hardware medical device (CPAP system), not an AI/software device intended to assist human readers.

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

• Not applicable. This is a hardware medical device, not an algorithm.

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

• Not applicable. The "ground truth" in this context is the established safety and effectiveness of the predicate devices as determined by their prior clearance by the FDA. The o_two CPAP System is deemed substantially equivalent based on its design and performance characteristics matching or exceeding those of the predicates.

8. The sample size for the training set:

• Not applicable. This is a hardware medical device, not an AI/software device trained on data.

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

• Not applicable. See point 8.

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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 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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