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The Vivo 45 LS ventilator (with or without the SpO2 and CO2 sensors) is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for pediatric through adult patients weighing more than 5 kg (11 lbs.), however, the mouthpiece ventilation modes are for adult patients only.

The Vivo 45 LS with the SpO2 sensor is intended to measure functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate.

The Vivo 45 LS with the CO2 sensor is intended to measure CO2 in the inspiratory and expiratory gas.

The device is intended to be used in home, institution, hospitals and portable applications such as wheelchairs and gurneys. It may be used for both invasive and non-invasive ventilation. The Vivo 45 LS is not intended to be used as an emergency transport or critical care ventilator.

The Viyo 45 LS Ventilator is a portable, microprocessor controlled turbine based pressure support, pressure control or volume controlled ventilator intended for the care of individuals who require mechanical ventilation.

Flow and pressure are read using flow and pressure sensors. Essential parameters such as pressure, flow and volume are presented on the ventilator screen, both in the form as graphs and numbers.

Operator actions are performed via the front panel where the buttons and an LCD screen are located (and two dedicated buttons on the top of the ventilator control starting/stopping treatment and pausing the alarm audio). There are dedicated LEDs and buttons for managing alarm conditions and an Information button which provides integrated user support.

The Vivo 45 LS can be operated by external AC or DC power supply and contains an integrated battery as well as an optional click in battery.

The Vivo 45 LS can be used with two types of patient circuits: single limb patient circuits including an active exhalation valve and single limb patient circuits including a passive leakage port.

The Vivo 45 LS can be operated in the following combinations of ventilation and breath modes:

• PSV-Pressure Support Ventilation
• PSV(TgV)-Pressure Support Ventilation with Target Volume ●
• PCV-Pressure Controlled Ventilation
• PCV(TgV)-Pressure Controlled Ventilation with Target Volume ●
• PCV(A)-Assisted Pressure Controlled Ventilation
• PCV(A+TgV)-Assisted Pressure Controlled Ventilation with Target Volume ●
• PCV-SIMV-Pressure Controlled Ventilation with Synchronized Intermittent Mandatory Ventilation
• PCV-MPV-Pressure Controlled Ventilation with MouthPiece Ventilation ●
• . VCV-Volume Controlled Ventilation
• VCV(A)-Assisted Volume Controlled Ventilation
• VCV-SIMV-Volume Controlled Ventilation with Synchronized Intermittent Mandatory ● Ventilation
• VCV-MPV- Volume Controlled Ventilation with MouthPiece Ventilation ●
• CPAP-Continuous Positive Airway Pressure, with optional features for HFNT-High Flow ● Nasal Therapy

High flow nasal therapy (HFNT) may be prescribed for spontaneously breathing patients undergoing non-invasive ventilatory therapy using a small, medium or large nasal cannula interface. The user may prescribe a flow rate setting in the range of 4 to 60 liters per minute. It is recommended to use an external humidifier, the Fisher & Paykel MR 850, during HFNT, due to possibly higher humidification output requirements of the patient. The Vivo 45 LS automatically disables the internal humidifier when the HFNT feature is being used.

Conditioning of the breathing air's temperature and humidity level may be prescribed for noninvasively ventilated patients using the integrated humidifier and heated wire patient circuit of the Vivo 45 LS at the clinician's discretion to enhance patient comfort and compliance. The humidification function is enabled by the Vivo 45 LS only when the device is powered by AC Mains and is automatically disabled including power to the heating plate when the device is powered by battery. The humidifier heating level can be selected by the user by setting the heating level (1-5) on the device user interface.

The Vivo 45 LS provides the user with available settings that determine the power delivered to the heater wire. This setting is in terms of a patient-end temperature in the range of 16 to 30° C. The heated wire patient circuit contains a temperature sensor located at the patient connection port, and the firmware of the Vivo 45 LS continuously monitors the temperature and automatically adjusts the power delivered to the heater wire to maintain the temperature at the user set point.

The provided text is a 510(k) summary for the Breas Medical AB Vivo 45 LS ventilator. It details the device's characteristics, comparisons to predicate devices, and performance data to demonstrate substantial equivalence to legally marketed devices.

However, the document does not contain the kind of information requested in your prompt regarding acceptance criteria and a study proving a device meets a specific acceptance criteria table. Instead, it discusses:

• Substantial Equivalence: The primary goal of this submission is to demonstrate that the modified Vivo 45 LS is substantially equivalent to a previously cleared predicate device (K193586) and reference devices. This is done by showing similar intended use, technological characteristics, and performance data.
• Performance Testing: It lists various performance tests conducted according to relevant standards (e.g., electrical safety, EMC, usability, alarm systems, biocompatibility, accuracy of controls and monitored values, cybersecurity, software verification/validation, human factors). The text states that "all tests passed" or "met all specifications," implying that the device did meet internal acceptance criteria for these tests, but these specific criteria are not explicitly detailed in a table for most categories.
• Human Factors Study: A summative human factors study was performed to assess user safety and effectiveness, including specific findings related to critical tasks and risk mitigation.

Therefore, I cannot generate the requested table of acceptance criteria and reported device performance from the provided text, nor can I provide specific details on sample sizes, ground truth establishment, or MRMC studies in the manner you've outlined, as that level of detail is not present for quantitative performance metrics tied to specific acceptance thresholds.

Based on the provided text, here's what can be extracted regarding the types of studies and the nature of the performance assessment:

The document focuses on demonstrating substantial equivalence for a modified medical device. This is a regulatory pathway where the new device is shown to be as safe and effective as a legally marketed predicate device. The "proof" is largely comparative and based on meeting recognized standards and internal specifications, rather than a standalone clinical trial proving a specific performance target against a pre-defined acceptance criterion.

Here's a breakdown of the information that is available or implicitly stated, addressing your points where possible, and noting what is missing:

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

   • Not explicitly provided in the document for the overall device.
   • The document presents tables comparing the subject device's features and performance specifications (e.g., accuracy of controls, accuracy of monitored values, alarm settings) to the predicate device. It then broadly states that "testing confirmed that the Vivo 45 LS meets its accuracy specifications," implying acceptance criteria were met but not detailing them in a distinct "acceptance criteria vs. reported performance" table.
   • For example, under "Accuracy of Controls," it lists "Inspiratory Pressure: max of ±0.5cmH2O, ±5%" for both subject and predicate device, and notes "Same." This implies this was an acceptance criterion, and performance matched it. However, actual reported device performance (e.g., "The device demonstrated an inspiratory pressure accuracy of ±0.3cmH2O, ±4%") is not provided.

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

   • Human Factors Testing: The only specific sample size mentioned is for the summative human factors study:
     • Sample Size: 15 Respiratory Therapists (RTs), 15 Registered Nurses (RNs), and 15 Lay Caregivers (LCGs). Total = 45 participants.
     • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). It's a "summative human factors testing" which is typically prospective.

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

   • Not applicable directly in the context of setting "ground truth" for diagnostic accuracy, as this is a ventilator, not a diagnostic imaging device.
   • For Human Factors: The experts involved would be the human factors professionals designing and performing the study, and potentially clinicians involved in scenario review. Their number and specific qualifications are not detailed.

4. Adjudication method for the test set:

   • Not applicable directly for diagnostic accuracy.
   • For Human Factors: Errors and difficulties observed during the human factors study were subject to "root cause analysis." The method of adjudication for identifying these errors or classifying them (e.g., by multiple observers) is not specified.

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 addressed. This type of study (MRMC for AI assistance) is relevant for AI-powered diagnostic aids, not for the core function of a mechanical ventilator.
   • The "human factors testing" evaluated user interaction and safety with the device, not the device's diagnostic performance in assisting human "readers."

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

   • Not detailed for the AI (if any). The device is a ventilator, a mechanical and software-controlled device. Its "standalone performance" refers to its ability to meet specifications for delivering ventilation, controlling parameters, and managing alarms.
   • The document states: "Performance testing included testing to the standards and procedures listed below:" and then lists many standards, followed by "The Vivo 45 LS with humidifier and heated wire patient circuit met all specifications, and the comparative waveforms testing demonstrated equivalence to the cleared Vivo 45 LS device." and "Testing of the Vivo 45 LS was performed to confirm accuracy of controls and monitored values. The testing confirmed that the Vivo 45 LS meets its accuracy specifications." This implies rigorous standalone testing.

7. The type of ground truth used:

   • For ventilator performance (pressure, flow, volume, etc.): "Ground truth" would be established by reference measurement devices/standards in a laboratory setting. The specific reference standards used are implied to be those within the listed IEC and ISO standards that the device was tested against.
   • For Biocompatibility: "Ground truth" is established by laboratory analyses against specified chemical and biological endpoints (e.g., absence of VOCs above threshold, non-cytotoxic results, non-sensitizing results), based on ISO standards.
   • For Human Factors: "Ground truth" for safe and effective use is established by the pre-defined critical tasks that users must perform successfully without errors that lead to harm. "Root cause analysis" was performed on observed errors.

8. The sample size for the training set:

   • Not applicable. This document describes the testing and regulatory submission for a physical medical device (ventilator) with integrated software, not an AI/ML algorithm that undergoes "training."

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

   • Not applicable for the same reason as above.

In summary, while the document confirms rigorous testing against various standards and specifications, it does not present the specific acceptance criteria and detailed reported performance in a structured comparative table as requested for an AI/ML driven diagnostic device. The focus is on demonstrating compliance with regulatory standards and substantial equivalence to a predicate device, rather than proving a statistical performance metric against clinical ground truth for a novel AI indication.

Ask a specific question about this device

The Vivo 45 LS ventilator (without the SpO2 and CO2 sensors) is intended to provide continuous or internittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for pediatric through adult patients weighing more than 5 kg (1 1bs.), however, the mouthpiece ventilation modes are for adult patients only.

The Vivo 45 LS with the SpO2 sensor is intended to measure function of arterial hemoglobin (% SpO2) and pulse rate.

The Vivo 45 LS with the CO2 sensor is intended to measure CO2 in the inspiratory and expiratory gas.

The device is intended to be used in home, institution, hospitals applications such as wheelchairs and gurneys. It may be used for both invasive and non-invasive ventilation. The Vivo 45 LS is not intended to be used as an emergency transport or critical care ventilator.

The Vivo 45 LS Ventilator is a portable, microprocessor controlled turbine based pressure support, pressure control or volume controlled ventilator intended for the care of individuals who require mechanical ventilation.

Flow and pressure are read using flow and pressure sensors. Essential parameters such as pressure, flow and volume are presented on the ventilator screen, both in the form as graphs and numbers.

Operator actions are performed via the front panel where the buttons and an LCD screen are located (and two dedicated buttons on the top of the ventilator control starting/stopping treatment and pausing the alarm audio). There are dedicated LEDs and buttons for managing alarm conditions and an Information button which provides integrated user support.

The Vivo 45 LS can be operated by external AC or DC power supply and contains an integrated battery as well as an optional click in battery.

The Vivo 45 LS can be used with two types of patient circuits: single limb patient circuits including an active exhalation valve and single limb patient circuits including a passive leakage port.

The provided FDA 510(k) summary (K193586) describes the Breas Medical AB Vivo 45 LS ventilator. This document primarily focuses on demonstrating substantial equivalence to predicate devices rather than deeply detailing an independent clinical study with acceptance criteria in the way a de novo device might.

Based on the document, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of acceptance criteria with corresponding performance metrics for the device for a standalone clinical study. Instead, performance testing focused on verifying conformance with requirements specifications and applicable standards, and comparative testing with predicate devices. The acceptance criteria are implicitly tied to meeting these standards and demonstrating substantial equivalence.

Here's an attempt to infer and summarize the performance goals and how they were met based on the provided text:

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

The document does not specify a "test set" in terms of patient data or clinical samples. The performance testing described is primarily bench testing against engineering specifications and industry standards, and comparative testing against predicate devices (Vivo 60 and Trilogy Evo). Therefore, concepts like country of origin or retrospective/prospective data provenance are not applicable in the context of this device's testing as described.

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

Not applicable in the typical sense. The "ground truth" for the engineering performance tests is derived from established engineering principles, international standards, and the performance characteristics of the predicate devices.

However, for summative usability/human factors testing, the document mentions the involvement of:

• Respiratory therapists
• Registered nurses
• Lay caregivers

Their collective feedback and performance in simulated use scenarios would have served as the "ground truth" for assessing the device's usability and human factors safety. The exact number of each type of professional is not specified.

4. Adjudication method for the test set

Not explicitly stated for the engineering and comparative tests. The passing of tests against specifications and standards implies adherence to predefined pass/fail criteria. For the usability testing, "was found to be safe and effective" suggests a consensus or evaluation against usability requirements, but a specific adjudication method (e.g., 2+1) is not detailed.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted as this device is a ventilator, not an AI-assisted diagnostic tool for "human readers." The comparative testing performed was between the Vivo 45 LS and its predicate devices (Vivo 60 and Trilogy Evo) to demonstrate technological equivalence, not to evaluate human performance with or without AI assistance.

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

This refers to the performance of the device itself (the "algorithm only" being the device's operational logic and hardware). The document describes extensive standalone performance testing of the Vivo 45 LS against various standards and specifications. This includes:

• Waveform performance (flow, pressure, volume)
• Triggering performance
• Accuracy of controls and monitored values
• Performance of specific ventilation modes (MPV, SIMV)
• Alarm system operation
• Power management
• Cybersecurity
• RFID immunity
• Software verification and validation
• Biocompatibility

These tests evaluate the device's inherent function without human intervention during the measurement or operation for the test itself, thus representing its standalone technical performance.

7. The type of ground truth used

The ground truth for the various performance tests was primarily based on:

• International and National Standards: e.g., ANSI/AAMI ES60601-1, IEC 60601 series, ISO 80601 series, ISO 18562 series. The criteria within these standards define what constitutes acceptable performance.
• Device Specifications: The manufacturer's own predefined accuracy specifications and operational parameters.
• Predicate Device Performance: For comparative testing, the performance of the legally marketed predicate devices (Vivo 60 and Trilogy Evo) served as a benchmark for demonstrating substantial equivalence.

8. The sample size for the training set

Not applicable. This document describes the premarket notification for a medical device (ventilator), not a machine learning or AI algorithm that requires a "training set" of data.

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

Not applicable, as there is no mention of a training set or AI algorithm for which ground truth would be established.

Ask a specific question about this device

The Vivo 60 ventilator (with or without the iOxy and CO2 sensor) is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for pediatric through adult patients weighing more than 5 kg (11 lbs.)

The Vivo 60 with the iOxy is intended to measure functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate.

The Vivo 60 with the CO2 sensor is intended to measure CO2 in the inspiratory and expiratory gas.

The device is intended to be used in home, institution, hospitals and portable applications such as wheelchairs and gurneys. It may be used for both invasive and non-invasive ventilation. The Vivo 60 is not intended to be used as a transport or critical care ventilator.

The Vivo 60 Ventilator is a portable, microprocessor controlled turbine based pressure support, pressure control or volume controlled ventilator intended for the care of individuals who require mechanical ventilation.

Flow and pressure are read through flow and pressure sensors. Essential parameters such as pressure, flow and volume are presented on the ventilator screen, both as graphs and numbers.

Operator actions are performed via the front panel where the buttons and an LCD screen are located. There are dedicated LEDs and buttons for managing alarm conditions and an Information button which provides integrated user support.

The Vivo 60 can be operated by external AC or DC power supply and contains an integrated battery as well as an additional click on battery.

The Vivo 60 can be used with three types of patient circuits: single limb patient circuits including an active exhalation valve, single limb patient circuits including a passive leakage port, and dual limb patient circuits.

This document describes the regulatory submission for the Vivo 60 ventilator and its substantial equivalence to predicate devices (Vivo 50 and Astral 110/150). It outlines various performance tests conducted to demonstrate compliance with specifications and recognized standards.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a single, consolidated table of acceptance criteria (i.e., specific numerical or qualitative thresholds that the device had to meet) alongside the reported device performance in the format you requested. Instead, it lists numerous recognized standards to which the device was tested and then broadly states that the device "conforms with all requirements specifications and applicable standards" and "meets its accuracy specifications."

Here's a partial summary of the performance testing mentioned, but without explicit acceptance criteria or detailed quantitative results:

2. Sample Size for the Test Set and Data Provenance

The document does not explicitly state the sample size for any specific test set for the performance testing. For most tests, it mentions "the Vivo 60" or "comparative testing with the Vivo 50 and Astral predicate devices" without specifying the number of devices or number of tests performed.

Data provenance is not mentioned (e.g., country of origin, retrospective or prospective). The testing appears to be primarily lab-based engineering verification and validation testing rather than clinical study data from patients.

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

This information is not provided in the document. The testing described is largely engineering and technical conformance, which would typically rely on calibrated instruments and defined standards rather than expert medical interpretation for "ground truth" as it would be for an AI diagnostic device.

4. Adjudication Method

This information is not provided. Given the nature of the tests outlined (e.g., electrical safety, waveform comparison, accuracy of controls), expert adjudication as seen in clinical studies for diagnostic accuracy would not be applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC study was not done. This device is a ventilator, not an AI-powered diagnostic system where human readers would be assessing cases with and without AI assistance. The performance testing focuses on the device's technical and safety specifications.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone study in the context of an AI algorithm was not explicitly described for diagnostic performance. However, the numerous performance tests listed (e.g., waveform performance, triggering, accuracy of controls, software V&V) can be considered "standalone" in the sense that they evaluate the device's inherent function against its specifications and standards, independent of direct human operational impact during the test. The ventilator's control algorithms were tested, but not as a "standalone AI" for diagnostic purposes.

7. Type of Ground Truth Used

The ground truth for the performance testing appears to be based on:

• Recognized Standards: e.g., IEC 60601-1, ISO 80601-2-72, EPA PM2.5.
• Manufacturer's Specifications: The device was tested to confirm it "meets its accuracy specifications" and "conform to specifications."
• Predicate Device Performance: Waveform comparisons were made to predicate devices (Vivo 50 and Astral).
• Expected Functionality: For triggering, the "ground truth" was detecting patient efforts without false triggers, as "intended."

8. Sample Size for the Training Set

This information is not applicable/provided. The Vivo 60 is a conventional mechanical ventilator, not an AI/machine learning device that requires a training set in the typical sense of AI algorithm development for diagnostic or predictive tasks. Its "algorithms" refer to control logic, not learned models.

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

This information is not applicable/provided for the same reason as #8. The control algorithms of the ventilator are based on engineering design and physiological principles, not on "ground truth" established from data used to train a machine learning model.

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The Vivo 50 ventilator (with or without the iOxy and CO2 sensor) is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for pediatric through adult patients weighing at least 10 kg (22 lbs.).

The Vivo 50 with the iOxy is intended to measure functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate.

The Vivo 50 with the CO2 sensor is intended to measure CO2. in the inspiratory and expiratory gas.

The device is intended to be used in home, institution, hospitals and portable applications such as wheelchairs and gurneys. It may be used for both invasive and non-invasive ventilation. The Vivo 50 is not intended to be used as a transport and critical care ventilator.

The Vivo 50 Ventilator is a portable, microprocessor controlled turbine based pressure support, pressure control or volume controlled ventilator intended for the care of individuals who require mechanical ventilation.

Internal flow and pressure are read through flow/ pressure sensors. Essential parameters such as pressure, flow and volume are presented on the ventilator screen, both as graphs and numbers.

All the operator actions are performed via the front panel where clear buttons and screen are located. There are dedicated LEDs and buttons for managing alarm conditions and an Information button which provides integrated user support.

The Vivo 50 can be operated by external AC or DC power supply and contains an integroted battery as well as an additional click on battery.

The Vivo 50 can be used with both single limb patient circuits including an active exhalation valve and single limb patient circuits including a leakage port.

The Vivo 50 can be operated in 9 different ventilation modes:

• . PSV - Pressure Support Ventilation
• PSV(TgV) Pressure Support Ventilation with Target Volume .
• PCV Pressure Controlled Ventilation
• PCV(TgV) Pressure Controlled Ventilation with Target Volume
• PCV(A) Assisted Pressure Controlled Ventilation
• PCV(A+TaV) Assisted Pressure Controlled Ventilation with Taraet Volume ●
• VCV Volume Controlled Ventilation
• VCV(A) Assisted Volume Controlled Ventilation ●
• CPAP Continuous Positive Airwav Pressure ●

The internal memory data of the Vivo 50 can be downloaded to a PC, printed out, and analysed via the Vivo 50 PC Software. The Vivo 50 PC Software is the support software for follow-up on patient treatment. The PC Software can communicate with the ventilator in two ways, either using an USB cable or a Compact Flash memory card.

The Vivo 50 PC Software provides presentation features of logged data by 24 hours, 30 days and 365 days resolution. The Vivo 50 PC Software presents treatment parameters such as pressure, volume, flow, leakage but also events such as alarms and change of settings. Further, the hours of usage is presented.

The Vivo 50 with the iOxy kit , consisting of an SpO2 (blood oxygen saturation) Nonin sensor, an electronic unit and cable, is intended to be connected to ventilator for logging SpO2 and pulse rate data and, when applicable, for real time monitoring. The SpO2 and pulse rate measurements are stored in the Vivo 50 internal memory log which can be downloaded to a PC and viewed in the Vivo 50 PC software. The SpO2 sensors are manufactured by Nonin Medical Inc.

The Vivo 50 with the CO2 sensor can be connected with the purpose to measure and display End Tidal CO2 (EtCO2) as well as Inspired CO2 (InspCO2). The EtCO2 displays the end-tidal carbon dioxide, measured on the last portion of the exhaled volume. The InspCO2 displays the inspired carbon dioxide.

The CO2 sensor can be connected to the patient breathing circuit and to the Vivo 50 in order to monitor and store CO2 measurements. The CO2 measurements will be stored in the Vivo 50 data memory which can be downloaded to a PC and viewed in the Vivo 50 PC software.

The CO2 sensor used with the Vivo 50 is manufactured by PHASEIN AB and is in used with PHASIEN AB carbon dioxide gas analyser cleared device under K081601 & K123043.

The Vivo 50 Remote Alarm Unit enables care providers and clinical personnel to monitor the Vivo 50 alarms remotely. The Remote Alarm unit is connected to the ventilator via a 10. 25 or 50 meter cable and powered by the ventilator. The Remote Alarm repeats alarms from the Vivo 50. The alarm signal sound level may be adjusted by the user. The actions or adjustments on the Remote Alarm unit do not, in any way, affect the alarm indications, alarm sound level, or audio pause on the Vivo 50.

This device is a ventilator, and the provided document is a 510(k) summary for its clearance. For ventilators, acceptance criteria and associated "studies" typically refer to compliance with recognized standards and internal verification/validation testing rather than clinical performance studies measuring accuracy metrics like sensitivity/specificity against ground truth. The document explicitly states that no clinical studies were required or performed to support substantial equivalence for the Vivo 50.

Therefore, the "acceptance criteria" for this device are its compliance with various medical device standards and the internal non-clinical testing performed by the manufacturer.

Here's the information extracted and formatted as requested, with explanations where direct answers are not applicable due to the nature of the device and submission:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not applicable. The submission explicitly states "The subject of this premarket submission, Vivo 50 did not require clinical studies to support substantial equivalence." The testing described is non-clinical (verification and validation against specifications and standards), not a clinical 'test set' with patient data.
• Data Provenance: Not applicable, as there was no clinical test set using patient data. All testing mentioned is internal, non-clinical lab/bench testing.

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

• Not applicable. There was no clinical test set requiring ground truth established by experts.

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

• Not applicable. There was no clinical test set requiring adjudication.

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. No MRMC study was mentioned or performed. This device is a standalone ventilator, not an AI-assisted diagnostic tool that would involve human readers.

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

• The performance testing and standards compliance outlined in "Summary of Non-Clinical Tests" represent the standalone performance of the device against its specifications and relevant standards. This is not a specific "algorithm-only" study in the sense of a diagnostic AI, but rather the integrated system's performance. The device's functionality (e.g., controlling ventilation modes, displaying parameters, managing alarms) is intrinsically "standalone" in its operation.

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

• Not applicable. For non-clinical verification and validation of a medical device like a ventilator, the "ground truth" equates to the established engineering specifications for the device, and the requirements outlined in the applicable medical device standards (e.g., IEC 60601 series, ISO 9919, ISO 21647, ASTM F1246-91, ASTM F1100). Performance is measured against these objective, predefined criteria.

8. The sample size for the training set:

• Not applicable. This document describes a medical device (ventilator) that underwent traditional engineering verification and validation, not a machine learning or AI algorithm development process that typically involves a "training set."

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

• Not applicable. As there was no training set (see point 8), no ground truth was established for it.

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The intended use of the PLV Continuum II ventilator is to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The intended patient population includes pediatric and adult patients who weigh at least 5 kg (11 lbs). The PLV Continuum II ventilator is intended for use in home, institutional and portable settings and may be used for invasive as well as non-invasive ventilation.

The PLV Continuum ventilator is a microprocessor controlled, compressor-based, ventilator that provides ventilatory support by delivering room air to the patient. PLV Continuum utilizes an internal compressor to generate compressed air for delivery to the patient. Breath delivery is controlled by software. The PLV Continuum has a membrane keypad with indicator Light Emitting Diodes (LED) for the selection and acceptance of patient settings. The PLV Continuum is capable of providing the following types of ventilatory support:

• Positive Pressure Ventilation, delivered either invasively (via endotracheal or tracheostomy tube) or non-invasively (via mask or mouthpiece).
• Assist Control, Synchronized Intermittent Mandatory Ventilation (SIMV) or Spontaneous Pressure (CPAP) modes of ventilation.
• Volume-Controlled (VC). Available in A/C and SIMV.
• Pressure-Controlled (PC). Available in A/C and SIMV.
• Pressure Support (PS). Available in SIMV and SPONT.

The provided document is a 510(k) Premarket Notification for a modification to the PLV Continuum Ventilator, now referred to as the PLV Continuum II Ventilator. This document concerns a medical device (ventilator) and its regulatory approval process, rather than a clinical study evaluating an AI/ML powered device. As such, many of the requested fields (e.g., sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance) are not applicable to this type of submission.

The document primarily focuses on establishing substantial equivalence to predicate devices rather than proving the performance against specific acceptance criteria in the context of an AI/ML algorithm.

However, I can extract information related to the performance testing conducted for the device.

Here's a summary of the information that can be extracted, with notes for the fields that are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is described as a series of performance tests, rather than a single clinical study.

• Study Name/Description: "Summary of Performance Testing" (Section 16.5)
• Study Objective: To demonstrate that all design and system requirements for the modified PLV Continuum have been met and to support substantial equivalence to predicate devices.
• Key Finding: "The results of all testing demonstrate that all design and system requirements for the modified PLV Continuum have been met." (Section 16.5) and "The technological characteristics of the modified PLV Continuum ventilator and the results of the performance testing do not raise new questions of safety and effectiveness when compared to the legally marketed predicate devices." (Section 16.6)

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. This is a hardware/software medical device modification submission, not an AI/ML study with a distinct "test set" of patient data. The "testing" refers to engineering and regulatory compliance testing of the device itself.

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. Ground truth, in the context of patient data adjudicated by experts, is not relevant to this type of device submission. Performance was assessed against engineering standards and specifications.

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

• Not Applicable. See point 3.

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-powered device, nor is it a diagnostic device being evaluated with human readers.

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

• Not Applicable. While the device is microprocessor-controlled with software algorithms, the "standalone" performance requested typically refers to the performance of an AI algorithm in isolation from a human user, which is not the subject of this document. The device's performance was evaluated as a complete system.

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

• Not Applicable as traditionally defined for AI/ML studies. The "ground truth" here is adherence to engineering specifications and regulatory standards (e.g., flow rates, pressure delivery, safety alarms, EMC compliance).

8. The sample size for the training set

• Not Applicable. There is no "training set" in the context of an AI/ML algorithm development described in this document. The software algorithms are described as "equivalent to those used on the currently marketed Respironics PLV Continuum ventilator (K022750)".

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

• Not Applicable. See point 8.

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The intended use of the PLV Continuum ventilator is to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The intended patient population includes pediatric and adult patients who weigh at least 5 kg (11 lbs). The PLV Continuum ventilator is intended for use in home, institutional and portable settings and may be used for invasive as well as non-invasive ventilation.

The PLV Continuum ventilator is a microprocessor controlled, compressor-based, mechanical ventilator. It is intended to control or assist breathing by delivering room air to the patient. PLV Continuum utilizes an internal compressor to generate compressed air for delivery to the patient. Breath delivery is controlled by software algorithms. The user interface on PLV Continuum has a membrane keypad with indicator Light Emitting Diodes (LED) for the selection and acceptance of patient settings and for the display of alarm conditions. PLV Continuum is capable of providing the following types of ventilatory support:

• Positive Pressure Ventilation, delivered either invasively (via endotracheal or . tracheostomy tube) or non-invasively (via mask or mouthpiece).
• Assist/Control. Spontaneous Intermittent Mandatory Ventilation (SIMV) or . Continuous Positive Airway Pressure (CPAP) modes of ventilation.
• Volume-Controlled (VC). Available in A/C and SIMV. .
• Pressure-Controlled (PC). Available in A/C and SIMV. .
• Pressure Support (PS). Available in SIMV and SPONT. ●

Here's an analysis of the provided text regarding the acceptance criteria and study for the PLV Continuum Ventilator:

Acceptance Criteria and Device Performance for PLV Continuum Ventilator

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the results "demonstrate that all design and system requirements...have been met," implying successful adherence to the standards. Specific numerical performance data against acceptance thresholds from ASTM F 1100-90 and F 1246-91 are not explicitly detailed in this summary.

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

The provided summary does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The document refers to "Performance testing," "EMC testing," "Electrical, mechanical and environmental testing," and "Software validation testing" as being conducted, but typical details like the number of devices tested, number of patients, or specific test scenarios are not included in this high-level summary.

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 summary. Performance testing for a ventilator typically involves engineering and functional tests against specifications, rather than expert-established ground truth in the same way a diagnostic imaging AI might.

4. Adjudication Method for the Test Set

This information is not applicable or provided. The document describes performance testing against established standards and guidance, not an adjudication process of expert opinions.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is specifically relevant for diagnostic AI devices where human readers interpret medical images or data. The PLV Continuum Ventilator is a mechanical ventilator, and its evaluation focuses on its functional performance, safety, and equivalence to predicate devices, not on human-in-the-loop diagnostic accuracy.

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

Given that the device is a mechanical ventilator, the "standalone" performance would encompass the various performance tests mentioned (e.g., breath delivery accuracy, alarm functionality, power consumption) without direct human intervention in its core mechanical operation. The summary states: "Breath delivery is controlled by software algorithms." This implies algorithmic function is evaluated as part of the overall device performance. However, there isn't a separate "algorithm only" study specifically described as it would be for an AI diagnostic device. The performance testing evaluates the device's functions, which are driven by its algorithms.

7. The Type of Ground Truth Used

The "ground truth" for the PLV Continuum Ventilator's performance testing is based on established engineering standards and regulatory guidance. This includes:

• ASTM F 1100-90 and F 1246-91: These are standards for ventilators, providing the criteria against which the device's mechanical and functional performance (e.g., volume delivery, pressure control, alarm thresholds) would be measured.
• FDA Draft Reviewer Guidance for Premarket Notification Submissions (1993): This guidance dictates the requirements for electrical, mechanical, and environmental testing.
• FDA's Guidance for the Content of Premarket Submissions for Software contained in Medical Devices (1998): This guidance sets the "ground truth" for software validation.

Essentially, the "ground truth" is defined by compliance with these recognized safety and performance standards for medical devices.

8. The Sample Size for the Training Set

The concept of a "training set" is usually applicable to machine learning or AI models that learn from data. The PLV Continuum Ventilator is described as a "microprocessor controlled" device with "software algorithms" that are "equivalent to those used on the currently marketed Respironics Esprit ventilator." This suggests that the software algorithms were developed based on established engineering principles for ventilator function, possibly iteratively tested and refined, rather than being "trained" on a large dataset in the sense of a deep learning model. Therefore, a "training set" in the context of an AI model driven by data is not explicitly mentioned or directly applicable here.

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

As the device relies on established software algorithms and engineering principles rather than a data-driven AI model, the concept of a "training set" with established ground truth as it applies to AI/ML is not relevant here. The ground truth for the development of such a device's software would stem from physiological requirements for ventilation, mechanical engineering principles, and the performance characteristics of predicate devices, which were then codified into algorithms. The testing described then verifies that these algorithms, as implemented in the device, meet the specified performance and safety requirements.

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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 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).

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