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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.

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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.

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