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The VELA Ventilator is intended to provide continuous or intermittent respiratory support in an institutional health care environment (e.g. hospitals) for individuals who require mechanical ventilation. The ventilator is a restricted medical device intended for use only by qualified trained personnel under the direction of a physician. It may be used on adult and pediatric patients. Specifically, the ventilator is applicable for adult and pediatric patients weighting at least 5 kg (11lb), who require the following types of ventilation support, as prescribed by an attending physician.

• Positive pressure ventilation
• Assist / control, SIMV, or CPAP modes of ventilation
  The ventilator is suitable for use in institutional and transport settings. It is not intended of use in an emergency medical transport ventilator or for home care applications.

A VELA with the CO2 monitoring option is intended to monitor the effectiveness of ventilation. It may be used on adult and pediatric patients. It is suitable for use in a hospital critical care environment, and is a restricted medical device intend for use by qualified trained personnel under the direction of a physician.

The VELA Series Ventilator is a modified Tbird Ventilator and like its predecessor, is an easy to use, self-contained, servo-controlled, software-driven ventilator. It has a dynamic range of breathing gas delivery that provides for pediatric through adult patients. Its revolutionary user interface module provides maximum flexibility with simple operator interaction. It has a flat panel color LCD with real time charting and digital monitoring capabilities, a touch screen for easy interaction, membrane keys and a dial for changing settings and operating parameters. A precision gas delivery turbine with servo controlled active inhalation and exhalation improves performance over previous generations.

The VELA Series Ventilator may be configured as a conventional ventilator or non-invasive positive pressure ventilator (NPPV). It is easy to clean and its design does not allow liquids to pool on the casing, reducing the likelihood of fluid leakage into the body of the ventilator.

The VELA Series Ventilator base model comes with comprehensive features for the critical care environment. Optional features can be added at time of purchase or at a later date.

The provided text describes the VELA Ventilator and its intended use, but it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in terms of accuracy or clinical effectiveness.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific quantitative performance targets against a defined acceptance criterion.

Here's what can and cannot be extracted from the provided text according to your request:

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

• Not Available: The document does not specify any quantitative acceptance criteria or reported device performance metrics in the way you've outlined (e.g., sensitivity, specificity, accuracy against a gold standard). The "Summary of Testing and Validation" states, "In Summary Performance testing verified that the VELA Ventilator meets it's performance requirements and that this device is substantially equivalent to predicate medical devices currently legally marketed in the United States." This is a general statement and does not provide specific criteria or results.

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

• Not Available: The document does not describe a clinical test set, its sample size, or data provenance. The validation seems to be based on performance testing to ensure it meets requirements for substantial equivalence, not a clinical study with a "test set" in the context of AI/diagnostic device performance.

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: Since there is no described test set or study involving "ground truth" establishment by experts (as would be for an AI or diagnostic device), this information is not provided.

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

• Not Applicable/Not Available: As above, no such adjudication method 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/Not Available: The VELA Ventilator is a mechanical ventilator, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is not relevant or included.

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

• Not Applicable/Not Available: The device is a ventilator, a mechanical medical device, not an algorithm.

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

• Not Applicable/Not Available: Ground truth as typically defined for diagnostic or AI devices is not relevant to the information provided about this mechanical ventilator. The "ground truth" in this context would likely be the accurate delivery of ventilation parameters as measured by engineering tests.

8. The sample size for the training set

• Not Applicable/Not Available: As a mechanical device, there is no "training set" in the machine learning sense.

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

• Not Applicable/Not Available: As above, there is no training set mentioned.

In summary: The provided document is a 510(k) summary for a ventilator, focusing on demonstrating substantial equivalence to existing predicate devices. It describes the device, its intended use, and indicates that performance testing was conducted to verify it meets its requirements. However, it does not detail specific acceptance criteria, study methodologies, or performance metrics in the format typically required for diagnostic or AI-based devices.

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The Heliox Low Flow Sentry Blender is designed to provide a continuous heliox/oxygen qas mixture to infant, pediatric, and adult patients. It is intended as a device to mix an 79% Helium / 21% Oxygen gas source with a 100% oxygen gas source to provide low flow mixtures containing 20% to 100% oxygen with the balance of the gas being Helium for patients who are spontaneously breathing. It is a medical device intended for use by qualified, trained personnel, under the direction of a physician, in institutional environments where the delivery and monitoring of helium/oxygen mixture is required.

The helium/oxygen and oxygen blender/monitor combines a precision helium/oxygen (79%/21%) and oxygen mixing valve with an integral battery operated oxygen concentration analyzer and user adjustable alarms.

Here's a breakdown of the acceptance criteria and study information for the Heliox Low Flow Sentry Blender, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document lists performance requirements and indicates that the device met these requirements. No specific quantitative acceptance values are given for most criteria, only a "Pass" status. The table below paraphrases the descriptions as presented in the document.

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

• Sample Size: 4 units were used for the majority of verification tests.
• Data Provenance: Not explicitly stated, but given it's a 510(k) submission for a medical device by Cardinal Health 207, Inc., in Yorba Linda, CA, the testing likely occurred internally or by a contracted lab within the United States. The document describes "Non-clinical Testing," implying laboratory or engineering tests rather than clinical human data. The testing is retrospective in relation to the submission date.

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

This information is not provided in the document. The tests appear to be objective engineering/performance verification tests against predefined specifications (ER3348 sections). There's no mention of human experts establishing "ground truth" in the context of diagnostic interpretation, as this is a device for blending gases, not an imaging or diagnostic AI.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. The testing described is performance verification of a device against specifications, not a diagnostic task requiring adjudication of human performance or expert consensus.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

An MRMC comparative effectiveness study was not performed or mentioned. This type of study is relevant for diagnostic AI tools that assist human readers (e.g., radiologists). The Heliox Low Flow Sentry Blender is a physical device for gas blending and monitoring, not an AI diagnostic tool.

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

This concept is not applicable to this device. The device itself is a standalone blender, but the "standalone performance" term usually refers to the performance of an AI algorithm without human involvement in a diagnostic or interpretive task. The "performance testing" described in the document is effectively a standalone test of the device's technical specifications.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests was defined by the device's own performance requirements and specifications as outlined in "ER3348" (Verification Test Protocol Reference Number) and potentially other internal design history files (e.g., "Sentry Blender DHF" for Environmental Withstand). For example, "Oxygen Range, Resolution, & Accuracy" would have specific numerical targets against which the device's output was measured.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. This device is a mechanical/electronic medical device, not an AI model that requires a training set.

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

This information is not applicable as there is no training set for this type of device.

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The Puresom Nasal (CPAP) Mask system is for use with continuous positive airway pressure devices (CPAP), operating at or above 3cmH2O for the treatment of obstructive sleep apnea. The mask is intended for single patient use and can be used in the home or in a hospital/ institutional environment. The mask is to be used on adult patients (>30Kg) for whom continuous positive pressure airway has been prescribed.

The Puresom Nasal (CPAP) Mask is intended to be used with positive airway pressure devices such as CPAP. It provides a seal such that positive pressure from positive pressure source is directed into the patient's nose. It is held in place with an adjustable headgear. It may be cleaned with a mild detergent, such as Ivory® dishwashing liquid or unscented baby shampoo in water. The design consists of latex-free silicone cushion designed to fit over the patients' nose. The cushion is designed in such a way that it minimizes leaks and is comfortable for the patient. The cushion shall be connected to a polycarbonate frame that supports the cushion and provides a connection for a 90º elbow. The elbow shall be capable of rotating freely through 360º. The silicone cushion is designed in such a way that it can be easily removed by the patient, from the polycarbonate frame for cleaning or replacement purposes. The elbow connects to a conventional air delivery hose between the mask and the positive airway pressure source via a 22mm polycarbonate fitting on the elbow. The 22 mm connector is designed in such a way that it can rotate freely through 360º. The built in vent openings are molded into the front side of the elbow and a snap-on shroud is assembled to the elbow to direct the air away from the patient's face and chest. The vent openings may be visually inspected for obstruction prior to use.

Here's a breakdown of the acceptance criteria and study information for the Puresom Nasal Mask based on the provided text:

Acceptance Criteria and Device Performance

Study Information

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

   • The document does not explicitly state the sample sizes for the test sets used in each non-clinical test (e.g., how many masks were dropped for the drop test, or how many units were subjected to the shipping test). It generally refers to "All material," "The cavities of each model," "All sample plots," and "All units."
   • The provenance of the data (country of origin, retrospective or prospective) is not specified. However, given it's a 510(k) submission to the FDA, the testing would be conducted in controlled environments by the manufacturer or authorized testing facilities. It's not a clinical study involving patient data.

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

   • This question is not applicable to the non-clinical engineering and performance tests described. Ground truth established by human experts (e.g., radiologists) is typically relevant for AI/imaging device studies. The tests here relate to physical and functional properties of the mask.

3. Adjudication method for the test set:

   • Not applicable. The tests involve objective measurements against predefined requirements (e.g., volume, CO2 percentage, flow rates, dBA levels, physical damage).

4. 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 non-clinical 510(k) submission for a physical medical device (nasal mask) and does not involve AI or imaging analysis with human readers.

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

   • No. This is a physical medical device; there is no algorithm or AI component involved.

6. The type of ground truth used:

   • The "ground truth" for these tests are the established industry standards, regulatory requirements, and engineering specifications (e.g., ISO standards, specific volume limits, CO2 percentages, sound levels, physical damage criteria). The device's performance is compared directly against these objective criteria.

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device. There is no concept of a "training set" in this context.

8. 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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The ADVANTAGE SERIES® Non-vented (NV) Full Face Mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators which have adequate alarms and safety systems for ventilator failure, and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure, respiratory insufficiency, or obstructive sleep apnea. The mask is disposable and for single patient use. It is for use on adult patients (> 30 kg), who are appropriate candidates for noninvasive ventilation and use in a hospital/institutional environment.

THE ADVANTAGE SERIES® Non-vented (NV) Full Face Mask provides a seal around the nose and mouth such that pressure from a positive pressure source is directed into the patient's nose and mouth. It is held in place with an adjustable headgear. The design consists of latex-free silicone cushion connected to a molded polycarbonate frame with an elbow that can swivel 360°. The elbow shall have an interconnection mating with the tubing from the positive pressure device. The interconnection shall conform to ISO 5356-1 (EN1281-1) with a 22mm female connector that can also swivel through 360°. This mask can be used to deliver positive pressure therapy to patients requiring pressures up from 3 to 40 cmH2O. This mask can be used with a range of devices that provide a low level of pressure and that have a mechanism to adequately remove exhaled gases as well as a safety valve that opens to atmosphere to provide room air in the event of loss of supply pressure. THE ADVANTAGE SERIES® Non-vented (NV) Full Face Mask is functionally similar to Cardinal Health Advantage Series Full Face mask (K043382) except that it does not have the anti-asphyxia or an exhalation port. Due to the fact that this is a non-vented mask, there is a need for a separate mechanism to remove exhaled gases.

The provided text describes a 510(k) submission for a medical device, the ADVANTAGE SERIES® Non-vented (NV) Full Face Mask. The submission focuses on its substantial equivalence to predicate devices and results from non-clinical performance testing.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the sample size for each test conducted during the "non-clinical performance testing." It only states that the device "was tested under various conditions using the Cardinal Health design control process." The data provenance is internal to Cardinal Health, and it is a retrospective evaluation of the device's design parameters through bench testing, not involving human subjects or real-world data collection.

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

This information is not provided in the document. The non-clinical performance testing appears to be objective bench testing against established specifications and international standards (e.g., ISO 5356-1 for interconnection). Therefore, "ground truth" in the traditional sense (e.g., expert consensus on medical images) is not applicable here. The "ground truth" would be the successful adherence to engineering specifications and performance benchmarks.

4. Adjudication Method for the Test Set

This information is not applicable as the testing described is non-clinical performance testing against objective criteria, not a subjective evaluation requiring adjudication among experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

No, an MRMC comparative effectiveness study was not done. This device is a physical medical mask, not an AI-powered diagnostic or assistive technology. The study described is bench testing of the mask's physical performance characteristics.

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

This question is not applicable. The device is a physical mask for non-invasive ventilation, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical performance testing was based on established design specifications, international standards (e.g., ISO 5356-1), and pre-defined test criteria for physical device performance.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical product, not an AI/ML model that requires a training set. The "design control process" refers to the engineering and development process, not machine learning training.

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

This information is not applicable for the same reasons as #8.

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The AVEA Ventilator is intended to provide continuous respiratory support in an institutional health care environment (e.g. hospitals). It may be used on adult, pediatric, and neonatal patients. It should be operated by properly trained clinical personnel, under the direction of a physician.

The AVEA Ventilator is a fourth generation servo-controlled, software-driven ventilator. It has a dynamic range of breathing gas delivery that provides for neonatal through adult patients. Its revolutionary user interface module (UIM) provides maximum flexibility wit6h simple operator interaction. It has a flat panel color LCD with real time graphic displays and digital monitoring capabilities, a touch screen for easy interaction, membrane keys and a dial for changing settings and operating parameters. A precision gas delivery engine with servo controlled active inhalation and exhalation improves performance over previous generations. The only design change is an optional Disposable Expiratory Filter / Water Trap to be used exclusively with the AVEA Ventilator.

The provided text is a 510(k) summary for the AVEA Ventilator's optional Disposable Expiratory Filter / Water Trap. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device performance claim through a clinical study with specific acceptance criteria.

The key points from the document regarding "acceptance criteria" and "study" are:

• Acceptance Criteria: The device is considered to meet acceptance criteria if it is "substantially equivalent in terms of BFE / VFE and resistance performance" to the predicate device (Clear-Guard II, K990949) and "has the same indicated use as the reusable existing filter / water trap" (integral to the AVEA Ventilator, K013642).
• Study: "Verification and Validation Testing demonstrated that the AVEA Disposable Expiratory Filter / Water Trap meets its performance requirements at both: Component Level and System Level, and, that this device is substantially equivalent to medical devices currently legally marketed in the United States."

This 510(k) summary does not provide the kind of detailed clinical study information (e.g., sample sizes, ground truth establishment, expert qualifications, MRMC studies) that would typically be associated with a device making a new performance claim or AI algorithm. It is a "substantial equivalence" review for a modification (an optional disposable filter) to an already cleared ventilator.

Therefore, the requested table and detailed information mostly cannot be extracted because the provided document does not contain that level of detail for this type of submission.

Here's a breakdown of what can be inferred or stated from the text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified. The document refers to "Verification and Validation Testing" but does not break down the specific sample sizes used for BFE/VFE or resistance testing.
• Data Provenance: Not specified. It's likely laboratory testing rather than patient data, given the nature of the filter.

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

• Not applicable as this is not a diagnostic device involving expert interpretation or ground truthing of clinical data in the traditional sense. Performance is based on physical and biological filtration efficiency measurements.

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

• Not applicable for the type of testing described (performance testing of a filter).

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, an MRMC study was not done. This device is a ventilator filter, not an AI-assisted diagnostic tool for human readers.

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

• No, this is a hardware device (filter), not an algorithm.

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

• The "ground truth" here is the measured performance metrics (BFE, VFE, resistance) against established engineering standards and the performance of the predicate device. It's not clinical "ground truth" derived from patient outcomes or expert consensus.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device requiring a training set.

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

• Not applicable.

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