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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.

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 Portable Oximeter is suitable for intrahospital use, home and alternate-site use, transport and energy 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 speqification, limits.

The Non-invasive Pulse Oximeter board, MS-5, connects to sensors and provides oxygen saturation, pulse rate, pulse waveform, and other output information via a serial digital interface. The iVent201 provides DC power and isolates the board from the mains power and ground.

The provided text describes the regulatory filing for the iVent™ 201 Portable Ventilator with Pulse Oximeter, but it does not contain the detailed information required to fill out the table and answer all the questions regarding acceptance criteria and the study that proves the device meets them.

Specifically, the text mentions "Acceptance criteria for compliance with the standards is detailed in Section 3, part E (Compliance)" but this section is not provided. It also discusses risk analysis for hardware and software but doesn't explicitly link these to performance claims or specific studies with sample sizes, ground truth, or expert qualifications.

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

Information Present:

• Device Name: iVent™ 201 Portable Ventilator with Pulse Oximeter
• Predicate Device (for Pulse Oximeter): MASIMO CSD-1050, Masimo Set 2000, cleared under K990966
• Voluntary Standards:
  • ISO 9919 Pulse Oximeters for Medical Use Specifications
  • UL 544 Standard for Medical and Dental Equipment
  • Council Directive -93/42/EEC
  • IEC 601-1-4 Medical Electrical Equipment Programmable electrical medical systems
  • EN 865 Pulse Oximeters Particular Specifications
  • IEC 60601-1 (for medical safety)
• Risk Analysis Areas: Leakage current, SpO2 power source failure, SpO2 Alarms, EMC interference (ventilator on oximeter, oximeter on ventilator, integrated unit on external devices and vice versa), loss of communication, out of range inputs.
• Mention of Testing (but no details):
  • "interference of the Ventilator on the Pulse Oximeter, which is checked by Masimo"
  • "interference of the Pulse Oximeter on the Ventilator which is checked Versamed's software validation procedure"
  • "interference of the integrated unit on external devices and vise versa, which is checked by an independent accredited testing agent."
  • "The software risks addressed are loss of communication and out of range inputs. These are checked as part of Versamed's Software Test Procedure for validation of the software."
• Indications for Use (Pulse Oximeter): Non-invasive monitoring of oxygen saturation and pulse rate of adult and pediatric patients.

Missing Information (Crucial for the Request):

• Specific Acceptance Criteria: While standards are listed, the document does not provide specific numerical or qualitative acceptance criteria (e.g., SpO2 accuracy within +/-X%, pulse rate accuracy within +/-Y bpm).
• Reported Device Performance: No actual performance data (e.g., measured accuracy values) is given.
• Study Details:
  • Sample size for test set
  • Data provenance (country, retrospective/prospective)
  • Number of experts
  • Qualifications of experts
  • Adjudication method
  • MRMC study details (effect size)
  • Standalone algorithm performance
  • Type of ground truth used
  • Sample size for training set
  • How ground truth for training set was established

Table of Acceptance Criteria and Reported Device Performance:

• SpO2 accuracy within a certain % range (e.g., ±2% between 70-100% SpO2)
• Pulse rate accuracy within a certain BPM range (e.g., ±3 BPM)
• Alarm functionality testing
• Electromagnetic compatibility (EMC) compliance
• Safety standards (IEC 60601-1, UL 544) compliance | Not specified in the provided text. The document states "Acceptance criteria for compliance with the standards is detailed in Section 3, part E (Compliance)", but this section is not available here. No numerical performance results are provided. |

Answers to Specific Questions:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
* Information not provided. The document vaguely mentions "Versamed's software validation procedure" and "an independent accredited testing agent" for EMC, but no details on sample size or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
* Not applicable / Information not provided. For a pulse oximeter, ground truth for SpO2 and pulse rate is typically established through direct measurement or comparison with a gold standard device, not expert consensus on interpretations. No details are given on how the ground truth was established for any performance testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
* Not applicable / Information not provided. This method is typically used for subjective evaluations where multiple readers/experts interpret images or data. For objective measurements like SpO2 and pulse rate, it's not relevant.

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 comparative effectiveness study was not done. This type of study is for AI-assisted human interpretations, which is not relevant to a standalone medical device like a ventilator and pulse oximeter that provide direct measurements.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
* Yes, implicitly. A pulse oximeter is a standalone measurement device. However, the document does not provide the specific performance data from such a standalone evaluation. It references compliance with standards like ISO 9919, which would necessitate standalone performance testing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
* Information not provided. For pulse oximetry, the ground truth for oxygen saturation and pulse rate is typically obtained from a reference method (e.g., arterial blood gas analysis, electrocardiogram) for accuracy testing, but this is not explicitly stated.

8. The sample size for the training set
* Not applicable / Information not provided. The device described is a hardware medical device with integrated software for control and measurement. It's not an AI/machine learning device that would typically involve a "training set" in the common sense.

9. How the ground truth for the training set was established
* Not applicable / Information not provided. (See answer to #8).

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 is suitable for intra-hospital use, home and alternate-site use, transport and energy use.
  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 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. The ventilator is designed to treat a variety of clinical conditions. It can deliver oxygen-enriched air and may be used to administer nebulized medications by inhalation. The iVent™ 201 can use external AC or DC power supply and contains an internal battery. Its operation is controlled by the iVent™ 201 Software.

I am sorry, but the provided text is a 510(k) premarket notification letter and summary for a medical device (iVent™ 201 Portable Ventilator). This document confirms the device's substantial equivalence to a legally marketed predicate device, but it does not contain information about acceptance criteria, a specific study proving the device meets those criteria, or details regarding AI algorithms, ground truth establishment, or human reader performance.

Therefore, I cannot extract the information you requested about acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

The document primarily focuses on:

• Confirming the device's regulatory classification and substantial equivalence.
• Listing predicate devices.
• Specifying indications for use.
• Detailing compliance with voluntary performance standards (e.g., ASTM, ISO, EN).
• Describing the device and its remote alarm adapter.
• Stating that safety and performance testing were conducted to determine substantial equivalence.

It does not describe:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for specific tests.
3. Number or qualifications of experts for ground truth.
4. Adjudication methods.
5. MRMC comparative effectiveness studies or AI-related performance.
6. Standalone algorithm performance.
7. Type of ground truth used for performance evaluation (beyond general safety and performance testing for regulatory submission).
8. Sample size for a training set (as this is not an AI-enabled device validation).
9. How ground truth for a training set was established.

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