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The Inspiration® 7i / 5i Ventilator System is intended for use with patients having body weights in the range of 0.3kg to 200kg and Tidal Volumes of 5ml to 2000ml. The Inspiration® Ventilator System is to be used by healthcare professionals in hospitals or healthcare facilities and intrahospital transport.

This product is intended for a wide range of patients from infant to adult and for a wide variety of clinical conditions.

The intended patient population includes infant through adult patients who require pressurebased or volume-based continuous respiratory support with tidal volumes as low as 5 ml and inspiratory pressures as low as 1 cm H2O.

The device is intended for use in hospital-type facilities, which provide respiratory care for patients requiring respiratory support.

The device is intended for sale by or on the order of a physician only. The device is intended for operation by trained and qualified personnel.

The Inspiration™ 71 / 51 Ventilator System provides continuous ventilation to patients requiring respiratory support by means of pressure-based and volume-based mandatory and spontaneous breaths. The device is identical to the cleared device, the Inspiration™ Ventilator System (K072950), with the following additions:

• . a GUI change to deliver a GUI similar to that of the eVolution ventilator.
• Additional monitored and trended parameters. .
• . Additional waveforms and loops.
• Additional medium and high priority alarms. .
• . Additional patient setup and default setting criteria.
• . : Integration of SNMP fields for settings, monitored and trended data.
• . Integration of Volumetric and Sidestream Capnography capability (7i model only) The capnography addition will require specific adaptors and sensors to allow use of this feature.
• Integration of various maneuvers

The eVent Medical Ltd. Inspiration 5i/7i Ventilator System is a continuous ventilator. The provided text outlines the device's characteristics and its substantial equivalence to previously cleared predicate devices, but it does not contain typical acceptance criteria and study data as one might expect for an AI/ML powered medical device. Instead, the document focuses on demonstrating substantial equivalence through a comparison of technical characteristics and compliance with established performance standards for ventilators.

Here's a breakdown based on the provided text, aligning with the requested information to the best extent possible given the nature of the submission:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (a ventilator), "acceptance criteria" are generally tied to meeting established performance standards for medical electrical equipment and critical care ventilators, rather than statistical performance metrics like sensitivity/specificity for an AI model.
The device demonstrates performance by adhering to the following standards:

The document also provides a detailed comparison to predicate devices, showing that the Inspiration 5i/7i shares similar specifications for:

• Description: Functionally identical, with added features (GUI, monitored parameters, waveforms, alarms, setup criteria, SNMP, Capnography, maneuvers).
• Indications for Use: Expanded patient weight and tidal volume ranges (0.3kg-200kg, 5ml-2000ml) compared to the predicate's general "infant through adult" but remains within the same scope.
• Patient Types: Adult, Pediatric, Infant.
• Ventilation Modes (Volume, Pressure, VTV, Apnea backup): All listed modes are identical to the predicate.
• Settings/Controls: Similar primary and advanced settings.
• Monitoring: Includes expanded monitoring parameters compared to the predicate. Integration of Volumetric and Sidestream Capnography capability (7i model only) is a new feature, for which the predicate Hamilton G-5 Ventilator also monitors Capnography parameters.
• Electrical, Battery, Physical, and Environmental Specifications: All are identical or substantially similar to the predicate.

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

This document does not describe a test set in the context of validating an AI/ML model with a specific sample size. The "performance" assessment is based on compliance with established engineering and medical device standards for ventilators, which typically involve testing the physical device against specified operational parameters, safety limits, and durability. Such testing would involve:

• Test Setup: Specialized test lungs, flow meters, pressure sensors, gas analyzers, and other equipment designed to simulate various patient conditions and measure ventilator performance.
• Data Provenance: The testing would be conducted in a controlled laboratory environment by the manufacturer (eVent Medical, Ltd.). The data generated would be from these laboratory tests rather than patient-derived data from specific countries or being retrospective/prospective in nature.

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

This information is not applicable to this submission. Ground truth, in the context of AI/ML, refers to expert-labeled data used to train or evaluate models. For a ventilator, the "ground truth" for performance is defined by the technical specifications outlined in the referenced standards (e.g., how accurately a set tidal volume is delivered, or how precisely a pressure control algorithm maintains a target pressure). Performance is measured by calibrated instruments, not by expert human assessment of outputs that require subjective interpretation.

4. Adjudication Method for the Test Set

This information is not applicable. Since there is no expert labeling or subjective interpretation of results, no adjudication among experts is required. The device's performance is objectively measured against quantitative 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

An MRMC comparative effectiveness study is not applicable here. This type of study is relevant for diagnostic or interpretive AI systems where human readers (e.g., radiologists) rely on the AI's output. The Inspiration 5i/7i Ventilator System is a life-support device that directly delivers therapy, not an AI-powered diagnostic or interpretive tool that assists human decision-making in the same way.

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

This concept is not applicable in the AI/ML sense. The ventilator itself operates as a "standalone" system in delivering ventilation based on its internal algorithms and controls, but this is not analogous to the standalone performance of a diagnostic AI algorithm. The device's performance stands alone in its ability to ventilate according to user settings and clinical needs, guided by its software and hardware. The evaluation of its "standalone" performance is covered by the compliance testing to the referenced standards.

7. The Type of Ground Truth Used

The "ground truth" for this device is the technical specifications and performance requirements defined by recognized medical device standards (e.g., IEC 60601-1, IEC 60601-2-12, ASTM F1100-90). The device is tested to ensure it operates within the defined tolerances and safety limits specified by these standards. This is a form of engineering or objective performance ground truth, derived from established industry requirements, rather than expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

This information is not applicable. The Inspiration 5i/7i Ventilator System, as described in the submission, is a traditional medical device with software control, not an AI/ML device that undergoes a "training" phase with a large dataset. Its development involves traditional software engineering, control system design, and rigorous testing against specifications.

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

This information is not applicable. As it is not an AI/ML device, there is no "training set" in the context of machine learning, and therefore no ground truth established for such a set. The design and validation relied on established engineering principles, safety standards, and performance test protocols for ventilators.

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The Inspiration ® Ventilator is indicated for use with a wide range of patients from infant through adult, requiring respiratory support for a wide range of clinical conditions in hospital, hospital-type facilities and intra-hospital transport.

The Inspiration Ventilator System provides continuous ventilation to infant, pediatric and adult patients requiring respiratory support by means of pressure-based and volume-based mandatory and spontaneous breaths. The device is identical to the cleared device, the Inspiration Ventilator System, with the addition of the capability to deliver a Heliox gas mixture.

This modification is implemented on the Inspiration Ventilator through additional functionality in hardware and software. The existing modalities, pneumatic design, electrical circuitry and user interface mechanism have remained unchanged from the cleared Inspiration Ventilator device.

The provided text does not contain detailed information regarding specific acceptance criteria applied to the Inspiration® Ventilator System regarding its performance with Heliox, nor does it describe a study that explicitly proves the device meets such criteria with detailed performance metrics.

However, based on the available information, we can infer the primary "acceptance criterion" being evaluated is substantial equivalence to existing devices, particularly concerning the addition of Heliox gas mixture delivery. The text focuses on demonstrating that the device operates safely and effectively with Heliox, similar to its operation with air and 100% O2, and does not introduce new safety or effectiveness concerns.

Here's an attempt to structure the information based on your request, acknowledging the limitations of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since explicit numerical acceptance criteria for Heliox performance are not given, we will infer them from the safety and effectiveness claims.

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

The document mentions "eVent Medical's bench studies of the Inspiration with high percentages of Helium." However, no specific sample size for a test set (e.g., number of test scenarios, ventilator units tested, or duration of tests) is provided.

The data provenance for the bench studies is internal to eVent Medical ("eVent Medical's bench studies"). It is implied to be prospective testing conducted by the manufacturer for this submission. The document also refers to a "review of the clinical literature on the operation of the Inspiration with Heliox," but this appears to be a separate supporting review rather than a primary study for this specific device modification.

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 text refers to "eVent Medical's bench studies," implying internal testing, but does not detail the personnel or expert involvement in establishing ground truth for these tests.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the context of "bench studies," it's likely internal verification processes were used, but no specific adjudication method (like 2+1/3+1 expert review) is mentioned, as this is typically more relevant for clinical image interpretation or diagnostic device studies.

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

No, an MRMC comparative effectiveness study was not done or at least not described in this document. This type of study is more common for diagnostic imaging AI systems where human readers interpret cases with and without AI assistance. This document describes a continuous ventilator system and its ability to deliver Heliox.

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

The testing mentioned, "eVent Medical's bench studies," appears to be standalone testing of the device's performance characteristics (e.g., FIO2 accuracy, ability to deliver Heliox without anoxic mixtures). There is no mention of "human-in-the-loop" performance testing for this specific modification, although the overall device is used with human operation.

7. The Type of Ground Truth Used

For the "bench studies," the ground truth would be based on instrumentation and reference measurements of FIO2, gas mixture composition, and potentially other ventilator parameters, established through validated laboratory methods. For the claim that "Heliox poses no increased health risk," the ground truth is derived from a review of clinical literature.

8. The Sample Size for the Training Set

The document describes software modifications and bench studies for a ventilator, not a machine learning or AI-based diagnostic device that typically requires a "training set" in the context of model development. Therefore, the concept of a "training set sample size" as commonly understood in AI/ML is not applicable here and is not provided.

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

As explained above, there is no training set in the AI/ML sense described here. The "ground truth" for the device's overall design and software development would be established through engineering specifications, regulatory guidelines, and internal validation processes.

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The Inspiration™ Ventilator System with Smart Positive Airway Pressure (SPAP) and Volume Targeted Ventilation (VTV) options is indicated for use with a wide range of patients from infant through adult, requiring respiratory support for a wide range of clinical conditions in hospital, hospital-type facilities and intra-hospital transport.

The Inspiration™ Ventilator System provides continuous ventilation to patients requiring respiratory support by means of pressure-based and volume-based mandatory and spontaneous breaths. The device is identical to the cleared device, the Inspiration™ Ventilator System, with the addition of the capability to set tidal volumes in volume targeted modes down to 5 ml, while 10 ml is the lower limit on the cleared device. This modification is implemented on the Inspiration™ Ventilator through additional functionality in software only. The existing modalities, pneumatic design, breath delivery control algorithms, electrical circuitry and user interface mechanism have remained unchanged from the cleared Inspiration™ ventilator device.

The provided text describes a 510(k) premarket notification for a medical device, the Inspiration™ Ventilator System. This document focuses on demonstrating substantial equivalence to predicate devices and does not contain detailed information about specific acceptance criteria or a study proving those criteria were met for this particular submission.

Instead, the document states generally that: "The combined testing and analysis of results provides assurance that the device meets its specifications and is safe and effective for its intended use." It also mentions "Software design and development, (including verification and validation testing, test and software quality procedures) was conducted using FDA's Guidance for the Content of Premarket Submissions for Software contained in medical devices, dated May 11 2005, as a guidance and per internal company requirements."

The modification in this 510(k) is the addition of the capability to set tidal volumes in volume-targeted modes down to 5 ml, compared to the previous lower limit of 10 ml.

Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria and study details based on the provided text. The document confirms that testing was performed to demonstrate substantial equivalence, but it does not specify the quantitative acceptance criteria, the study design, or the results in the level of detail requested.

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The Inspiration ™ Ventilator System with Smart Positive Airway Pressure (SPAP) and Volume Targeted Ventilation (VTV) options is indicated for use with a wide range of patients from infant through adult, requiring respiratory support for a wide range of clinical conditions in hospital, hospital-type facilities and intra-hospital transport.

The Inspiration™ Ventilator System with Smart Positive Airway Pressure (SPAP) and Volume Targeted Ventilation (VTV) options provides continuous ventilation to patients requiring respiratory support by means of pressure-based and volume-based mandatory and spontaneous breaths. The device is identical to the cleared device, the Inspiration™ Ventilator System, with the addition of two new software options: 1) The Smart Positive Airway Pressure (SPAP) modification provides the Inspiration™ Ventilator System with a biphasic pressure mode that allows for spontaneous breathing at two separate PEEP baselines. 2) The Volume Targeted Ventilation (VTV) modification provides the Inspiration™ Ventilator System with a pressure based breath mode that targets tidal volume by adjusting the delivered pressure targets on a breath-to-breath basis. This modification includes Pressure Regulated Volume Control (PRVC) and Volume Support (VS). This option also includes Automode which allows patients the backup safety support of mandatory breaths if they stop breathing and transition back to their spontaneous mode when they are again breathing spontaneously. These modifications are implemented on the Inspiration™ Ventilator through additional functionality in software only. The existing modalities, pneumatic design, breath delivery control algorithms, electrical circuitry and user interface have remained unchanged from the cleared Inspiration™ ventilator device.

The provided text describes a 510(k) premarket notification for the eVent Medical Ltd. Inspiration™ Ventilator System with Smart Positive Airway Pressure (SPAP) and Volume Targeted Ventilation (VTV) options. This submission focuses on demonstrating substantial equivalence to predicate devices rather than directly presenting acceptance criteria and a detailed study outcome to prove achievement of those criteria in the format typically used for AI/ML device evaluations.

Therefore, many of the requested elements (like sample sizes for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance metrics, and detailed ground truth establishment for training) are not explicitly present in the provided document, as it predates the common structured evaluation reporting for these types of technologies.

However, based on the information available, here's a breakdown of what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a formal table of quantitative acceptance criteria with specific performance metrics (e.g., accuracy, sensitivity, specificity, or error rates) and corresponding device performance values. Instead, it relies on demonstrating substantial equivalence to existing, legally marketed predicate devices.

The "acceptance criteria" are implied to be that the new software modifications (SPAP and VTV) function similarly to the predicate devices' equivalent modes without introducing new questions of safety or effectiveness. The "reported device performance" is the conclusion that:

• The SPAP feature is "substantially equivalent to the BiVent mode on the Siemens Servoi ventilator (K022132)."
• The VTV modification (including PRVC and VS) is "substantially equivalent to PRVC and VS and on the Siemens Servoi Ventilator (K022132)."
• The Automode feature is "substantially equivalent to Automode on the Siemens Servoi Ventilator (K022132)."
• Overall, the device "meets its specifications and is safe and effective for its intended use."

This is a qualitative assessment of equivalence, not a quantitative performance measurement against predefined thresholds.

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

Not explicitly stated. The document refers to "verification and validation testing" and "combined testing and analysis of results," but no specific sample sizes for a "test set" (in the context of AI/ML evaluation) are provided. The testing would have been conducted on the device itself, likely involving various simulated patient conditions and scenarios to verify correct functionality of the new software modes.

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

Not applicable in the context of this submission. The "ground truth" here is the expected mechanical and physiological response of the ventilator under various settings and patient conditions, and its equivalence to the predicate devices. This would typically be assessed by engineers, respiratory therapists, and physicians through functional testing, not by a panel of experts establishing a consensus ground truth for image interpretation or diagnosis as seen in AI/ML studies.

4. Adjudication Method for the Test Set

Not applicable. There's no mention of an adjudication method, as the evaluation is not based on expert review of ambiguous cases.

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 not an AI/ML clinical decision support device. It is a continuous ventilator with new software-driven ventilation modes. An MRMC study is not relevant to its evaluation.

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

The device itself is a standalone system with new software algorithms for ventilation control. Its performance was evaluated as such. There is no "human-in-the-loop" component in the sense of an AI assisting a human in a diagnostic task; the human (clinician) operates the device, and the device's algorithms control ventilation. The entire testing would, by definition, be "standalone" performance of the machine.

7. The Type of Ground Truth Used

The ground truth used for evaluating the ventilator's performance would be:

• Engineering specifications and expected physiological responses: The modes (SPAP, VTV) should control pressure and volume as designed and as observed in the predicate devices. This involves mechanical testing, simulations, and possibly animal or human subject testing (though not detailed here) to confirm that the delivered ventilation parameters (e.g., tidal volume, pressure) match the set parameters and physiological models within acceptable tolerances.
• Predicate device behavior: The "ground truth" for substantial equivalence is the established safe and effective performance of the predicate ventilators (Siemens - Elma AB. Servoi Ventilator with BiVent, K022132). The new device's modes are compared to the predicate's modes to ensure similar function.

8. The Sample Size for the Training Set

Not applicable. As a traditional medical device (ventilator) with software modifications, there is no "training set" in the context of machine learning. The software was developed and validated, but not "trained" on a dataset like an AI algorithm would be.

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

Not applicable, as there is no training set in the AI/ML sense. The "ground truth" for the software development would be the engineering requirements, clinical specifications, and intended functionality derived from established medical knowledge and predicate device capabilities.

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The InspirationTM Ventilator System is indicated for use with a wide range of patients from infant through adult, requiring respiratory support for a wide range of clinical conditions in hospital, hospital-type facilities and intra-hospital transport.

The Inspiration™ Ventilator System is housed in a metallic enclosure, comprising clear anodized aluminum with painted finish and is mounted on a mobile stand. User controls and display screen are located on the front face of the Ventilator. Display and controls operation is described in the Ventilator Settings and Controls section of the User Manual (See Section 14 of this Submission). Ventilation parameters are programmed by the operator, using the function and navigation keys plus the Push & Turn control device on the Ventilator front panel, in conjunction with selectable display screens. The programmed data from the User Interface is processed by the main microprocessor and stored in ventilator non-volatile memory. The microprocessor uses the stored data in the control of breath delivery. Oxygen and air supply connections are located on the back of the Ventilator. The patient breathing circuit connection is located below the front face of the unit, together with a pneumatic outlet for driving an optional accessory jet nebulizer. The Ventilator stand serves to support the main Ventilator unit, breathing circuit tubing and accessory equipment, facilitating connection to the Ventilator. The Inspirations Ventilator System incorporates three communications interfaces, namely, a Nurse Call interface, an RS-232 and an Ethernet interface. The Nurse Call interface comprises normally open and normally closed relay contacts (changeover switch) acting simultaneously with an alarm condition. Both the RS232 and Ethernet interfaces enable the same data transmission to receiving terminals such as nurse and physician workstations and PC equipment. The Inspiration ... Ventilator System consists of two major systems, the pneumatic system and the electrical/electronic system, which combine under software control to deliver respiratory support at operator-determined parameters. The pneumatic system, under microprocessor control, supplies air and oxygen to the patient system, external to the device. The electricallelectronic system inputs and supervises one of three alternative power sources to the unit and provides electronic control of the ventilator's pneumatic system components. The Inspiration™ Ventilator System can operate with a range of standard ventilator accessories, such as breathing circuits, nebulizer and humidifier.

I am sorry, but the provided text does not contain any information about acceptance criteria for a device, a study that proves the device meets acceptance criteria, or any of the detailed study parameters you've requested.

The document is a 510(k) summary for the "Inspiration™ Ventilator System" from eVent Medical Ltd. It covers:

• Company Information: Manufacturer, contact person.
• Device Name: Proprietary, common, and classification.
• Equivalent Devices: Predicate devices used for substantial equivalence comparison.
• Device Description: Physical layout, user interface, communication interfaces.
• Intended Use: Broad patient range (infant to adult), clinical conditions, environment of use (hospital, intra-hospital transport).
• Technological Characteristics: How it provides ventilation (pressure/volume-based), power sources, integral compressor, available ventilation modes.
• Certification Statement: Affirmation of truthfulness and accuracy of submitted data.
• FDA Clearance Letter: Official letter from the FDA stating substantial equivalence and allowing marketing.
• Indications for Use Statement: Formal statement of the device's intended use.

This document focuses on regulatory clearance based on substantial equivalence to predicate devices, rather than presenting a performance study with detailed acceptance criteria and results. Such detailed study information would typically be found in a separate section of a 510(k) submission, often within performance testing reports, which are not included in this summary.

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