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The iVent101 ventilator [with single or dual limb configuration] is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for infants from 5 kg through adult patients who require invasive or non-invasive support via the following ventilatory modalities:

• Assist/Control and SIMV with either Volume, Pressure, or Pressure Regulated . Volume Control (PRVC)
• CPAP with Pressure Support .
• Adaptive Bi-Level for either NIV or invasive ventilation. ●
  The iVent101 ventilator is suitable for use in institution, home and portable settings.

The iVent101 is a compact, portable, microprocessor-controlled ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation .A turbine-powered air source and a rechargeable internal battery provide freedom from wall air and power outlets . Internal flow and pressure are read through flow/pressure sensors. Clinical data [Tidal Volume, Rate, PIP, FiO2, Peak Flow, Inspiratory Time, I:E Minute Volume] are presented on machine screen.
All the operator actions are performed on the LCD touch-screen on the front panel, allows, rapid control and continuous real-time monitoring of patient ventilation. · Alarm settings are fully adjustable. Optional Waveform and Diagnostic Software package displays pressure and flow waveform data, loops, trends, and logged totals in a full array of time slices and presentation modes.
The iVent101 can use external AC or DC power supply and contains an integrated battery.
The iVention is equipped with two configurations, which differs in the patient circuit type that connects to the machine. One configuration is to be used with a standard one limb patient circuit, and the second configuration is to be used with a standard dual limb patient circuit. The two configurations are incorporating the same infrastructure and can be easily replaced by the user.
The iVent101 is capable of providing the following types of ventilatory support:

• Assist/Control and SIMV with either Volume, Pressure, or Pressure Regulated . Volume Control (PRVC)
• CPAP with Pressure Support
• Adaptive Bi-Level for either NIV or invasive ventilation. .

The iVent101 is a continuous ventilator intended to provide continuous or intermittent ventilatory support for patients requiring mechanical ventilation, including infants (from 5 kg) through adults. It supports various ventilatory modalities and can be used in institutional, home, and portable settings.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

   The document explicitly states: "No performance standards have been established for such devices under Sections 514 of the Federal Food, Drug, and Cosmetic Act." Therefore, there are no specific, quantitative acceptance criteria provided in the document in terms of performance metrics (like accuracy, sensitivity, or specificity for a diagnostic device, or specific flow/pressure tolerances for a ventilator). Instead, the device's conformance to established voluntary standards is used as evidence of its safety and effectiveness.

   Acceptance Criteria (Voluntary Standards met)	Reported Device Performance
   ASTM F 1100-90 (Critical Care Ventilators)	Complies with standard
   ASTM F 1246-91 (Home Care Ventilators)	Complies with standard
   Draft Reviewer guidance for ventilators (July 1995)	Complies with standard
   ISO 10651-2 (Home Care Ventilators)	Complies with standard
   ISO 10651-6 (Usability of Medical Electrical Equipment)	Complies with standard
   IEC 60601-1 (General Safety for Medical Electrical Equipment)	Complies with standard
   IEC 60601-2-12 (Safety of Lung Ventilators)	Complies with standard
   IEC 60601-1-2 (Electromagnetic Compatibility)	Complies with standard
   IEC 60601-1-8 (Alarm Systems)	Complies with standard
   UL 60601-1 (General Safety for Medical Electrical Equipment)	Complies with standard

   The overall reported device performance conclusion is: "The iVent101 performs as intended according to its performance specification. The iVent101 is substantially equivalent to the predicate devices."

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

   No human or animal test set data is described or used. The evaluation relies on compliance with engineering and safety standards.

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

   Not applicable. No ground truth was established by experts for a test set in the context of clinical performance data.

4. Adjudication method for the test set:

   Not applicable.

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 medical device (ventilator), not an AI-powered diagnostic or assistive tool.

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

   Not applicable. This is a medical device (ventilator), not an algorithm for diagnosis or interpretation.

7. The type of ground truth used:

   Not applicable. Clinical ground truth (e.g., pathology, outcomes data) was not used as there were no clinical studies. The "ground truth" for the device's performance in this context is its adherence to the specified technical requirements and voluntary industry standards.

8. The sample size for the training set:

   Not applicable. This is a medical device (ventilator), not a machine learning algorithm that requires a training set.

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

   Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" demonstrating the device meets its "acceptance criteria" (which are defined by adherence to voluntary standards and substantial equivalence to predicate devices) is a series of non-clinical performance tests.

The document states: "Due to comprehensive scientific literatures, performance tests per ASTM 1246-91, ASTM 1100-90, IEC and ISO standards, VersaMed believes that clinical studies are not required to determine the safety and efficacy of the device."

Therefore, the proof consists of:

• Engineering and Performance Testing: The device underwent internal performance tests to ensure it met its own engineering specifications and complied with the listed voluntary international and national standards (ASTM, ISO, IEC, UL). These tests would verify aspects like air delivery accuracy, pressure control, alarm functionality, electrical safety, electromagnetic compatibility, and usability, all as specified in those standards.
• Substantial Equivalence Argument: The core of the submission relies on demonstrating substantial equivalence to four predicate devices (LTV1200, iVent201, PLV Continuum II, Legendair XL2). This argument posits that because the iVent101 has the same intended use, environment for use, patient population, and employs the same technology (internal compressor, software algorithms for breath delivery) as legally marketed, safe, and effective devices, it is also safe and effective. No specific data from the predicate devices is provided beyond their identification.

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The iVent™ 201 MR Conditional is a portable, computer controlled, electrically powered intensive care ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for use with adult through pediatric patients, who require invasive or non-invasive assistance via the following general modes of ventilatory support, as prescribed by an attending physician:

• Assist/Control (Pressure Controlled or Volume Controlled)
• SIMV (Pressure Controlled or Volume Controlled)
• CPAP/PSV

The iVent™ 201 MR Conditional ventilator is suitable for use in the ICU and all other hospital areas, including Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field, in all hospital-type facilities, alternate care sites, transport, emergency and in the home environment. The iVent™ 201 MR Conditional ventilator is MR Conditional.

The optional non-invasive Pulse Oximeter is intended for non-invasive monitoring of oxygen saturation and pulse rate and is suitable for use in all above mentioned areas, excluding MR environments.

The iVent™ 201 MR Conditional ventilator is a restricted medical device intended for use by qualified, trained personnel under the direct supervision of a physician.

The iVent™ 201 MR Conditional is a compact, portable, fully featured, microprocessorcontrolled ventilator offering the versatility and capability of larger and costlier ventilators. A turbine-powered air source and a rechargeable internal battery provide freedom from wall air and power outlets. An intuitive turn and click control knob, quick choice push buttons, and a bright, well-organized, easy-to-read screen allow rapid control and continuous real-time monitoring of patient ventilation. Alarm settings are fully adjustable. Optional Waveform and Diagnostic Software package displays pressure and flow waveform data, loops, trends, and logged totals in a full array of time slices and presentation modes.

Optional equipment:

• Non-invasive pulse oximeter (not to be used in MR environments) .
• . Remote Alarm Adapter

Testing has been performed according to ASTM F2052-06-e1 in 1.5 and 3.0 Tesla environments.

The provided text describes a 510(k) submission for the VersaMed iVent™ 201 MR Conditional ventilator. This document focuses on demonstrating substantial equivalence to predicate devices, particularly regarding its functionality within a Magnetic Resonance (MR) environment.

Here's an analysis of the acceptance criteria and the study information present in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly present a table of "acceptance criteria" in the format of specific performance metrics with target values and actual results for a clinical study on a disease. Instead, the focus is on the device's MR Conditional status and equivalence to predicate devices. The key "performance" aspect is the device's safe operation in MR environments, which is confirmed through a specific standard.

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

• Test Set Sample Size: The document does not specify a "test set" in terms of patient data or clinical cases. The testing mentioned (ASTM F2052-06-e1) is a physical and electromagnetic compatibility standard for medical devices in MR environments. This standard typically involves testing the device itself, not a patient population. Therefore, there is no sample size of patients or images.
• Data Provenance: Not applicable, as the testing is for device safety in an MR environment rather than a clinical data set.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: Not applicable. The "ground truth" for MR Conditional status is established by adhering to an industry standard (ASTM F2052-06-e1) and demonstrating that the device meets its requirements for safe operation in specified MR environments. This does not involve expert readers or clinical ground truth.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The testing is based on objective measurements against a standard, not on subjective interpretations requiring adjudication.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or interpretive AI devices where the performance of human readers with and without AI assistance is compared. The iVent™ 201 MR Conditional is a ventilator, a life-support device, and its safety in an MR environment is assessed through engineering and physical standards, not through clinical reader studies.
• Effect Size of Human Readers Improvement: Not applicable.

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

• Standalone Performance: Not applicable. This device is a physical medical device (ventilator), not an algorithm or AI software intended for standalone diagnostic performance. Its "standalone performance" relates to its mechanical and electrical operation, and its ability to function within an MR field without causing harm or malfunction, which is covered by the ASTM testing.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for this submission is adherence to the ASTM F2052-06-e1 standard for testing medical devices in MR environments. This standard specifies test methods to evaluate potential hazards and effects (e.g., magnetic force, induced heating, artifact generation) when a medical device is exposed to MR fields. The device demonstrating compliance with this standard against predetermined thresholds effectively establishes its "MR Conditional" ground truth.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

• Ground Truth for Training Set: Not applicable.

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The iVenf™ 201 is a portable, computer controlled, electrically powered intensive care ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for use with adult through pediatric patients, who require the following general modes of ventilatory support, as prescribed by an attending physician:

• Assist/Control (Pressure Controlled or Volume Controlled) .
• SIMV (Pressure Controlled or Volume Controlled) .
• . CPAP/PSV

The iVently 201 ventilator (with or without the non-invasive Pulse Oximeter option) is suitable for use in the ICU and all other hospital areas. in all hospital-type facilities. alternate-care sites, transport, emergency and in the home environment. The non-invasive Pulse Oximeter is intended for non-invasive monitoring of oxygen saturation and pulse rate and is suitable for use in all above mentioned areas.

The iVent™ 201 ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician

The iVent201 is a compact, portable, fully featured, microprocessor-controlled ventilator offering the versatility and capability of larger and costlier ventilators. A turbine-powered air source and a rechargeable internal battery provide freedom from wall air and power outlets. An intuitive turn-and-click control knob, quick-choice pushbuttons, and a bright, well-organized, easy-to-read screen allow rapid control and continuous real-time monitoring of patient ventilation. Alarm settings are fully adjustable. Optional Waveform and Diagnostic Software package displays pressure and flow waveform data, loops, trends, and logged totals in a full array of time slices and presentation modes.

Description of Non- invasive Pulse Oximeter: The Non-invasive Pulse Oximeter connects to sensors and provides oxygen saturation, pulse rate, pulse waveform, and other output information via a serial digital interface. The iVent 201 systems provide isolated DC power.

The Non-invasive Pulse Oximeter board is mounted internal to the iVent 201 unit and is part of the electronic configuration of the unit. Connection of the Pulse Oximeter accessories is via a connector on the back panel of the unit.

Description of remote Alarm Adaptor: The adapter connects between a Remote Alarm outlet on the iVent 201 Ventilator and the Central Remote Alarm unit of the Hospital. The adapter consists of a relay circuit, which meets activating requirements of the Central Remote Alarm unit.The iVent 201 Ventilator with Remote Alarm Adapter will activate the Central Remote Alarm unit for any major or medium priority alarm event that occurs on the unit.

This document is a 510(k) premarket notification for a medical device, the iVent™ 201 Portable Ventilator. It focuses on demonstrating substantial equivalence to a previously cleared device, rather than providing a detailed study proving the device meets specific acceptance criteria through clinical trials or comprehensive performance testing against numerical targets.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes, expert involvement, and ground truth establishment, typically found in a clinical study report for AI/CADe devices, is not present in this submission.

Here's a breakdown of what can be extracted and what cannot based on the provided text:

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

• Not Available. The document does not provide a table of numerically defined acceptance criteria for device performance (e.g., accuracy, sensitivity, specificity, latency) or corresponding reported performance metrics from a specific study. Instead, it references compliance with voluntary standards and general specifications.

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 / Not Available. This document describes a traditional medical device (ventilator) and its components, not an AI/CADe device. Therefore, there is no "test set" in the context of algorithm evaluation with patient data. The non-clinical testing mentioned is likely engineering verification and validation against design specifications and voluntary standards, not a data-driven performance evaluation.

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. As above, there is no "test set" or "ground truth" establishment in the context of expert review for an AI/CADe system.

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

• Not Applicable / Not Available. No such adjudication method is mentioned or relevant for this type of device 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

• Not Applicable / Not Available. This device is a ventilator, not an AI-assisted diagnostic or CADe device. Therefore, MRMC studies and "human readers" are not relevant to its evaluation.

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

• Not Applicable / Not Available. There is no standalone algorithm in the context of an AI device being evaluated. The device itself is a standalone medical device.

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

• Not Applicable / Not Available. No "ground truth" in the AI/CADe sense is established or used for this type of device. Performance is generally verified against engineering specifications, simulated physiological models, and recognized standards.

8. The sample size for the training set

• Not Applicable / Not Available. This device does not involve a "training set" as it is not an AI/machine learning product.

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

• Not Applicable / Not Available. As there is no training set, this question is not relevant.

Summary of Relevant Information from the Document:

While the document does not fit the structure of an AI/CADe device submission, it does discuss device performance in terms of compliance with standards and equivalence:

• Performance Standards: The iVent™ 201 portable ventilator complies with several voluntary standards: ASTM F 1100-90, ASTM F 1246-91, MIL-STD-810E, ISO 10651-112/3, IEC 60601-1, IEC 60601-2-12, IEC 60601-1-2, CAN/CSA-C22.2 No.601.1, ISO 9919, EN 865 (section 6).
• Statement on Performance: "The non clinical testing results provides assurance that the device meets it's specifications and is safe and effective for its intended use."
• Substantial Equivalence: The primary "proof" of meeting safety and effectiveness is through demonstration of substantial equivalence to a predicate device (iVent™ cleared under K053270). This equivalence is based on having the same intended use, environment for use, patient population, similar design, same technology, and identical materials, with only a "clarification to the indications statement without changing the scope."

Essentially, for this device, the "acceptance criteria" are the relevant voluntary standards and the ability to demonstrate substantial equivalence to a predicate device already deemed safe and effective by the FDA. The "study" proving it meets these "criteria" is the non-clinical testing mentioned and the formal argument for substantial equivalence presented in the 510(k) submission.

Ask a specific question about this device

The iVent™ 201 is a portable, computer controlled, electrically powered ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 10 kg (22 lb.), who require the following general modes of ventilatory support, as prescribed by an attending physician:

• Assist/Control (Pressure Controlled or Volume Controlled)
• SIMV (Pressure Controlled or Volume Controlled)
• CPAP/PSV

The iVent™ 201 ventilator with Non-invasive Pulse Oximeter is suitable for intra-hospital use, home and alternate-site use, transport and emergency use. The Non-invasive Pulse Oximeter is intended for non-invasive monitoring of oxygen saturation and pulse rate.

The iVent™ 201 ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician and within the technical specification limits.

The iVent201 is a compact, portable, fully featured, microprocessor-controlled ventilator offering the versatility and capability of larger and costlier ventilators. A turbine-powered air source and a rechargeable internal battery provide freedom from wall air and power outlets. An intuitive turn-and-click control knob, quick-choice pushbuttons, and a bright, well-organized, easy-to-read screen allow rapid control and continuous real-time monitoring of patient ventilation. Alarm settings are fully adjustable. Optional Waveform and Diagnostic Software package displays pressure and flow waveform data, loops, trends, and logged totals in a full array of time slices and presentation modes.

Description of Non- invasive Pulse Oximeter: The Non-invasive Pulse Oximeter connects to sensors and provides oxygen saturation, pulse waveform, and other output information via a serial digital interface. The iVent 201 systems provide isolated DC power.

The Non-invasive Pulse Oximeter board is mounted internal to the iVent 201 unit and is part of the electronic configuration of the unit. Connection of the Pulse Oximeter accessories is via a connector on the back panel of the unit.

Description of remote Alarm Adaptor: The adapter connects between a Remote Alarm outlet on the iVent 201 Ventilator and the Central Remote Alarm unit of the Hospital. The adapter consists of a relay circuit, which meets activating requirements of the Central Remote Alarm unit.The iVent 201 Ventilator with Remote Alarm Adapter will activate the Central Remote Alarm unit for any major or medium priority alarm event that occurs on the unit.

The provided text describes a 510(k) premarket notification for the iVent™ 201 Portable Ventilator, seeking to establish substantial equivalence to predicate devices. It states that the device complies with voluntary performance standards and mentions "non clinical testing results provides assurance that the device meets its specifications and is safe and effective for its intended use." However, it does not provide specific quantitative acceptance criteria or detailed study results for device performance.

Therefore, many of the requested sections about acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies cannot be extracted from the provided text.

Here's a summary of what can be inferred:

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

The document does not explicitly state quantitative acceptance criteria or provide a table of reported device performance against such criteria. It generally states: "The non clinical testing results provides assurance that the device meets it's specifications and is safe and effective for its intended use."

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

Not mentioned in the document. The testing described is "non-clinical," implying bench testing rather than studies involving 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, as the testing described is non-clinical.

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

Not applicable, as the testing described is non-clinical.

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

Such a study was not performed or mentioned. This device is a ventilator, not an AI-assisted diagnostic tool.

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

This concept is not applicable to a ventilator. The document describes the device's functionality as a standalone ventilator.

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

For "non clinical testing," the ground truth would typically be established by engineering specifications, calibration standards, and established mechanical/electrical measurement techniques. No details are provided.

8. The sample size for the training set

Not applicable, as this is a medical device, not an AI/machine learning model that typically has "training sets." The assessment is based on non-clinical testing of the device itself.

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

Not applicable for the same reason as above.

Summary of available information related to performance and standards:

The document states that a "non-clinical testing" was performed and that the device complies with several voluntary performance standards. These standards implicitly set performance criteria that the device must meet.

Voluntary Performance Standards the iVent™ 201 portable ventilator complies with:

• ASTM F 1100-90
• ASTM F 1246-91
• MIL-STD-810E
• ISO 10651-1/2/3
• IEC 60601-1
• IEC 60601-2-12
• IEC 60601-1-2
• CAN/CSA-C22,2 No.601.1
• ISO 9919
• EN 865 (section 6)

Study proving the device meets acceptance criteria:

The document broadly states: "The non clinical testing results provides assurance that the device meets it's specifications and is safe and effective for its intended use." No specific study name, methodology, or detailed results are provided beyond this general statement. The 510(k) submission relies on demonstrating substantial equivalence to predicate devices and compliance with recognized voluntary standards rather than providing detailed clinical study results in this particular summary.

Ask a specific question about this device

The iVent™ 201 is a portable, computer controlled, electrically powered ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 10 kg (22 lb.), who require the following general modes of ventilatory support, as prescribed by an attending physician:

• · Assist/Control (Pressure Controlled or Volume Controlled)
• · SIMV (Pressure Controlled or Volume Controlled)
• · CPAP/PSV
  The iVent™ 201 ventilator with Non-invasive Pulse Oximeter is suitable for intra-hospital use, home and alternate-site use, transport and emergency use. The Non-invasive Pulse Oximeter is intended for non-invasive monitoring of oxygen saturation and pulse rate.
  The iVeur™ 201 ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician and within the technical specification limits.

The iVent201 is a compact, portable, fully featured, microprocessor-controlled ventilator offering the versatility and capability of larger and costlier ventilators. A turbine-powered air source and a rechargeable internal battery provide freedom from wall air and power outlets. An intuitive turn-and-click control knob, quick-choice pushbuttons, and a bright, well-organized, easy-to-read screen allow rapid control and continuous real-time monitoring of patient ventilation. Alarm settings are fully adjustable. Optional Waveform and Diagnostic Software package displays pressure and flow waveform data, loops, trends, and logged totals in a full array of time slices and presentation modes.
Description of Non- invasive Pulse Oximeter: The Non-invasive Pulse Oximeter connects to sensors and provides oxygen saturation, pulse rate, pulse waveform, and other output information via a serial digital interface. The iVent 201 systems provide isolated DC power.
The Non-invasive Pulse Oximeter board is mounted internal to the iVent 201 unit and is part of the electronic configuration of the unit. Connection of the Pulse Oximeter accessories is via a connector on the back panel of the unit.
Description of remote Alarm Adaptor: The adapter connects between a Remote Alarm outlet on the iVent 201 Ventilator and the Central Remote Alarm unit of the Hospital. The adapter consists of a relay circuit, which meets activating requirements of the Central Remote Alarm unit.The iVent 201 Ventilator with Remote Alarm Adapter will activate the Central Remote Alarm unit for any major or medium priority alarm event that occurs on the unit.

This document is a 510(k) premarket notification for a medical device (Ventilator). These types of submissions typically focus on demonstrating substantial equivalence to a predicate device rather than presenting detailed studies with acceptance criteria, ground truth, and statistical analyses of algorithm performance, as would be common for AI/ML device submissions.

Therefore, much of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not explicitly available within the provided text.

Based on the provided text, here's what can be extracted and what is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of acceptance criteria and reported device performance in the way an AI/ML submission would. Instead, it states compliance with voluntary performance standards and highlights modifications that indicate improved capabilities or ranges compared to the predicate.

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

• Sample Size (Test Set): Not applicable. This is a ventilator, not an AI/ML diagnostic device with a "test set" in the context of imagery or other data. The "testing" referred to is non-clinical performance and safety testing against engineering specifications and voluntary standards. No specific sample sizes for such tests are provided in this summary.
• Data Provenance: Not applicable in the context of "data" for a test set. The non-clinical testing would have been conducted by the manufacturer, VersaMed Medical Systems Inc., likely at their facilities or certified labs.

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

• Not applicable. There is no "ground truth" establishment in the AI/ML sense for this type of device. The verification of the device's performance against specifications would be done through engineering tests, calibration, and safety assessments.

4. Adjudication method for the test set

• Not applicable. No adjudication method is mentioned, as there is no "test set" requiring human interpretation or consensus.

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 hardware medical device (ventilator), not an AI-assisted diagnostic or therapeutic system. Therefore, an MRMC study is not relevant and was not performed or described.

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

• Not applicable. This device is a ventilator, which is a standalone machine. Its performance parameters are assessed directly (e.g., airflow, pressure, tidal volume delivery accuracy) rather than through separate algorithm-only performance. It operates with human input (setting parameters) but its core function is mechanical ventilation, not an algorithm providing diagnostic output.

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

• Not applicable. For a ventilator, the "ground truth" for performance would be its physical output and functional accuracy compared to its specified engineering parameters and relevant performance standards (e.g., "does it deliver 50ml tidal volume when set to 50ml?" This is measured directly, not compared to human labels or pathology).

8. The sample size for the training set

• Not applicable. This device does not use machine learning, so there is no "training set."

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

• Not applicable. As there is no training set, there is no ground truth to establish for it.

Ask a specific question about this device

The Went™ 201 is a portable, computer controlled, electrically powered ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for adult and pediatric putients weight 10 kg (22 lb.), who require the following general modes of ventilatory support, as prescribed by an attending physician:

• Assist/Control (Pressure Controlled or Volume Controlled) .
• SIMV (Pressure Controlled or Volume Controlled) .
• CPAP/PSV .
  The iVent™ 201 ventilator with Non-invasive Puise Oximeter is suitable for intra-hospital use, home and alternate-site use, transport and emergency use. The Non-invasive Pulse Oximeter is intended for non-invasive monitoring of oxygen saturation and pulse rate.
  The iVent™ 201 ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician and within the technical specification limits.

The iVent201 is a compact, portable, fully featured, microprocessor-controlled ventilator offering the versatility and capability of larger and coptivessor vontilators. A turbine-powered air source and a rechargeable internal battery provide freedam from wall air and power outlets. An intuitive turn-and-click control knob, quick-choice pushbuttons, and a bright, well-organized, easy-to-read screen allow rapid control and continuous real-time monitoring of patient ventilation. Alam settings are fully adjustable. Optional Waveform and Diagnostic Software package displays pressure and flow waveform data, loops, trends, and logged totals in a full array of time slices and presentation modes.
Description of Non- invasive Pulse Oximeter (Cleared under K 021981): The Noninvasive Pulse Oximeter connects to sensors and provides oxygen saturation, pulse rate, pulse waveform, and other output information via a serial digital interfor. The iVent 201 systems provide DC power and isolation to the board from the mains power and ground.
The Non-invasive Pulse Oximeter board is mounted internal to the iVent 201 unit and is part of the electronic configuration of the unit. Connection of the Pulse Oximeter accessories is via a connector on the back panel of the unit.
Description of remote Alarm Adaptor (cleared under K 011957): The adapter connects between a Remote Alarm outlet on the iVent 201 Ventilator and the Central Remote Alarm unit of the Hospital. The adapter consists of a relay circuit, which meets activating requirements of the Central Remote Alarm unit.The iVent 201 Ventilator with Remote Alarm Adapter will activate the Central Remote Alarm unit for any major or medium priority alarm event that occurs on the unit.

The provided text is a Fragment of a 510(k) premarket notification and an FDA clearance letter for a medical device (iVent™ 201 Portable Ventilator). It does not contain the kind of detailed study information (acceptance criteria, specific performance metrics, sample sizes, expert qualifications, etc.) that would typically be found in a clinical study report or a more comprehensive technical summary.

The document focuses on demonstrating substantial equivalence to predicate devices and adherence to voluntary performance standards, rather than providing the results of a specific performance study against defined acceptance criteria for the device itself.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer most of the requested questions based on the provided text. The document states that "No performance standards have been established for such devices under Sections 514 of the Federal Food, Drug, and Cosmetic Act," but it does mention compliance with voluntary standards like ASTM and ISO. However, it doesn't specify what the acceptance criteria derived from these standards were, nor does it provide the results of testing against those criteria in a format suitable for the requested table.

Here's what can be extracted and what cannot:

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

• Cannot provide. The document states "No performance standards have been established for such devices under Sections 514 of the Federal Food, Drug, and Cosmetic Act." While it lists voluntary standards (e.g., ASTM F 1100-90, ISO 10651-1/2/3), it does not detail specific acceptance criteria derived from these standards or present test results against them. Compliance with these standards is mentioned as a general statement rather than specific performance data.

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

• Cannot provide. The document does not describe a specific performance test or clinical study with a test set. It focuses on substantial equivalence based on design, intended use, and technology rather than clinical performance 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 / Cannot provide. No test set or ground truth establishment process is described in the provided text.

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

• Not applicable / Cannot provide. No test set or adjudication process is described in the provided text.

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 device is a ventilator, not an AI-assisted diagnostic tool for human readers. No MRMC study is mentioned.

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 (ventilator), not an algorithm or AI. Performance would be assessed through engineering and bench testing, as well as potentially clinical trials for safety and effectiveness, but not in the "standalone algorithm" sense. The document does not detail specific performance studies.

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

• Not applicable / Cannot provide. No ground truth establishment is described as part of a performance study.

8. The sample size for the training set

• Not applicable. This device is a mechanical ventilator; there is no "training set" in the context of machine learning or AI models with the provided information.

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

• Not applicable. See point 8.

In summary, the provided document is a regulatory submission focused on demonstrating substantial equivalence to predicate devices and compliance with voluntary standards for a physical medical device (ventilator). It does not contain the detailed performance study data, acceptance criteria, or ground truth information typical of a submission for an AI/algorithm-based device.

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