Search Results

EveryWare is indicated to support clinicians by managing data of patients who are prescribed compatible therapy devices in accordance with the intended use of those therapy devices. EveryWare provides remote patient data collection & viewing and is intended to be used by healthcare representatives in conjunction with compatible non-life support therapy devices to adjust prescription and/or performance settings. EveryWare is intended to be used in hospital, institutional, provider, and home care settings.

EveryWare is a platform that gathers treatment information from Breas respiratory devices in a secure cloud-based system. The data from ventilator is sent over a cellular modem through a cellular network to a cloud-hosted secure data storage system. The authenticated users access this cloud hosted system from a browser in their computer.
EveryWare securely connects compatible medical devices located at the point of patient care to the cloud, and provides authorized healthcare representatives the means to manage patient and device information and settings. EveryWare does NOT alter the intended use of connected medical devices or provide functions to automate diagnosis or therapy.

This document is a 510(k) clearance letter for the medical device "EveryWare." It focuses on establishing substantial equivalence to previously cleared predicate devices. Therefore, it does not contain the detailed study information typically found in a clinical trial report or a performance validation study for a novel device.

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

• Acceptance Criteria: Not explicitly stated as quantifiable metrics (e.g., "sensitivity $\ge 90%$"). The document primarily focuses on demonstrating that EveryWare's functionalities and technical characteristics are similar to its predicates, and that its differences "do not raise new questions of safety and effectiveness."
• Reported Device Performance: Instead of performance metrics, the document lists functional and technological characteristics and states their similarity or difference compared to predicates. Performance is broadly assessed through "non-clinical testing" listed below.

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

This information is not provided in the clearance letter. The document mentions "performance testing" and adherence to various standards but does not detail a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective nature). The focus is on software and system validation rather than clinical dataset performance.

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

This information is not provided. As the device is primarily a data management and remote settings platform aiming for "substantial equivalence" based on functional and technical characteristics, and not for diagnostic or therapeutic AI, there is no mention of experts establishing a clinical ground truth for a test set.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the device and the presented documentation, it's unlikely an adjudication method for a clinical test set would be applicable or detailed here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

A MRMC study was not performed nor mentioned. EveryWare is a data management and settings adjustment platform, not an AI-assisted diagnostic or therapeutic tool that would typically involve human readers interpreting AI output.

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

The device itself is a "platform that gathers treatment information from Breas respiratory devices in a secure cloud-based system" and allows "authorized healthcare representatives the means to manage patient and device information and settings." It does not involve a "standalone algorithm" in the typical sense of a diagnostic or predictive AI. Its performance is tied to its functionality in securely collecting, displaying, and allowing modification of therapy data, which relies on system integrity rather than algorithmic output interpretation. Therefore, a standalone algorithmic performance study in the context of AI was not done or reported.

7. The Type of Ground Truth Used

For EveryWare, the "ground truth" relates to:

• The accurate and secure transmission, storage, and display of patient data from compatible devices.
• The correct implementation of remote prescription/performance settings onto compatible devices.
• Compliance with various software, cybersecurity, human factors, and electromagnetic compatibility standards.

This is fundamentally different from a clinical ground truth (e.g., pathology, outcomes data, or expert consensus for disease detection). The ground truth for this type of device would be defined by technical specifications, data integrity, security protocols, and successful functional validation against a known correct behavior.

8. The Sample Size for the Training Set

This information is not provided. EveryWare is described as a data management platform rather than a machine learning model that would require a "training set" in the context of AI. The development would involve software engineering and validation practices.

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

This information is not applicable as there is no "training set" mentioned in the context of an AI/ML model for this device. The development process would have involved establishing requirements and validating the software against those requirements, rather than training against a ground-truth dataset.

Ask a specific question about this device

Clearo is indicated for use on adult or pediatric patients unable to cough or clear secretions effectively. It may be used either with a facemask or mouthpiece, or with an adapter to a patient's endotracheal or tracheostomy tube. The device is intended to be used in the hospital, institutional environment or in the home.

The Breas Medical Clearo is an airway clearance device that provides Mechanical Insufflation-Exsufflation (MI-E) therapy. Clearo is indicated for use on adult or pediatric patients who are unable to cough or clear secretions effectively. It may be used either with a facemask or mouthpiece, or with an adapter to a patient's endotracheal or tracheostomy tube. The device is intended to be used in the hospital, institutional environment or in the home.

The Clearo device is not intended to be used in line with a ventilator.

Clearo must be prescribed by a licensed physician and must be used only as directed by a physician or healthcare provider.

Clearo must be used with a single-limb patient circuits fitted an anti-bacterial filter.

Clearo functions by delivering ambient air at a defined positive pressure to the patient's airways (insufflation), followed by a rapid shift to negative pressure (exsufflation). This quick transition—known as "time through zero" – creates a high expiratory flow that stimulates or simulates a natural cough.

Optional oscillatory vibrations may further aid in loosening and mobilizing secretions. The continued rapid transition to negative pressure helps generate sufficient expiratory flow from the central airways, supporting the clearance of respiratory secretions.

Clearo achieves its intended use through a blower, which compresses air, a solenoid-controlled valve to manage air flow and pressure, and microcontroller electronics to control and monitor the operation. Clearo is powered from either a mains source or an internal battery.

Clearo includes the following device modes to accommodate both clinical and patient use:

• Unlocked (Clinical) Mode: Provides full access to all treatment settings and mode configurations, intended for use by healthcare professionals. Clinicians can enable specific modes for patient use and customize treatment protocols.
• Locked (Patient) Mode: Restricts access to pre-selected modes as set by the clinician. Patients cannot modify treatment parameters but may view compliance data and alarm history.

Clearo provides the following Treatment Modes:

• Manual Mode: The user controls the cycling between insufflation and exsufflation via a manual switch. This mode supports "Insufflation Rise" to control pressure ramp-up. Sessions can be recorded and stored for repeated use using the Treat-Repeat feature.
• Basic Auto Mode: Provides repeated, automatic cycling of insufflation, pause, and exsufflation, with configurable recruitment breaths, pause intervals, rise time, and optional patient-triggered breaths. Optional Stepped Insufflation Breaths gradually increases insufflation pressure across breaths for comfort.
• Program Auto Mode: Similar to Basic Auto but with a customizable, repeatable sequence of multiple insufflations followed by one exsufflation. Includes all features of Basic Auto Mode.

This FDA 510(k) clearance letter and summary primarily focus on demonstrating substantial equivalence through technical comparisons and compliance with relevant standards rather than a typical clinical study with acceptance criteria and reported device performance metrics in a tabular format. The document emphasizes performance testing which verifies conformance with requirements, but these are primarily engineering-level tests, not direct clinical performance metrics.

Therefore, many of the requested points regarding sample size, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for clinical data are not explicitly detailed in this provided text because the clearance relies on non-clinical performance and substantial equivalence to a predicate device.

However, I can extract and infer information about the acceptance criteria and study proving device meets them based on the provided text, focusing on the engineering and non-clinical aspects:

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

Based on the provided text, the "acceptance criteria" discussed are primarily adherence to specified technical characteristics and performance within defined ranges, as well as compliance with various medical device standards. The "reported device performance" is framed as the device meeting these specifications and showing comparable waveforms to the predicate.

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

• Test Set Sample Size: Not explicitly stated as a number of patients or cases. The testing described is primarily non-clinical performance testing (e.g., pressure, flow, timing, oscillation measurements on the device itself, EMC, electrical safety) and waveform comparison against a predicate device.
• Data Provenance: Not applicable in the context of geographical origin or retrospective/prospective study for clinical data, as this filing relies on engineering performance tests and comparative technological characteristics. It's safe to assume the testing was conducted in a laboratory/engineering environment.

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

• Not applicable/Not mentioned, as the "ground truth" for this submission are the engineering specifications, relevant IEC and ISO standards, and the performance of the predicate device (CoughAssist T70). Expert opinion on clinical efficacy/diagnosis is not the basis for this 510(k) clearance documentation.

4. Adjudication method for the test set:

• Not applicable/Not mentioned. Adjudication methods are typically associated with clinical studies involving reader-based interpretations (e.g., radiology images). This submission focuses on objective engineering measurements and compliance with standards.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No, an MRMC comparative effectiveness study was not conducted or described. This type of study is relevant for AI/radiology devices where human interpretation is assisted by AI. The Clearo device is a therapeutic device (mechanical insufflation-exsufflation device), not an AI diagnostic imaging tool.

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

• Not applicable. This device is a mechanical medical device, not an AI algorithm. While it has software and microcontroller electronics, its "performance" is its mechanical function, regulated by its design parameters and confirmed through physical measurements and standard compliance.

7. The type of ground truth used:

• The "ground truth" for this submission is primarily:
  • Engineering Specifications and Design Requirements: The device's internal design parameters for pressure, flow, timing, oscillation, etc.
  • International Standards: Conformance to standards like IEC 60601 series, ISO 18562 series, etc., which define safety and performance benchmarks.
  • Predicate Device Performance: The established, legally marketed performance of the Respironics CoughAssist T70 provides the benchmark for "comparable waveforms" and technological characteristics.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device that requires a "training set" of data in the typical sense for algorithm development.

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

• Not applicable, as there is no "training set" as understood in the context of AI/machine learning.

Ask a specific question about this device

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

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

The Vivo 40 is an assist ventilator intended to augment the breathing of spontaneously breathing adult patients >66 lbs (>30 kg) suffering from respiratory failure, respiratory insufficiency, or obstructive sleep apnea.

The Vivo 40 is not intended to provide the total ventilatory requirements of the patient.

The Vivo 40 is intended to be used for both invasive and non-invasive applications.

The Vivo 40 is intended to be operated by qualified and trained personnel.

The Vivo 40 is intended for use in clinical settings (e.g., hospitals, sleep laboratories, sub-acute care institutions) and home environments.

The Vivo 40 must always be prescribed by a licensed physician.

The Vivo 40 is a pressure-supported and pressure-controlled ventilator with a CPAP function intended for spontaneously breathing patients to augment the breathing.

In the treatment of chronic respiratory failure, positive airway pressure ventilation is well established and common practice as a mean to assure sufficient gas exchange. There are a number of devices legally marketed in the United States for this application.

The therapy delivered by the Breas Vivo 40 System can be either:

• 1. Pressure Controlled Ventilation (PCV) or
• 2. Pressure Support Ventilation (PSV) or
• 3. Constant Positive Airway Pressure (CPAP)

The Vivo 40 airflow is delivered via a single lumen outlet tube that may be connected to various non-invasive and invasive patient interfaces, such as nasal masks. To minimize CO2 rebreathing, masks or other interfaces permitting a leak flow of at least 12 liters/minute at the output pressure setting of 4 cmH20 are recommended.

The Vivo 40 has an auto-switching power supply that facilitates use in conjunction with international travel (100 - 240 VAC). It can also be used with an external 12.5/ 24 VDC power source when AC mains line voltage is not available.

The outer dimensions of the Vivo 40 housine are 7.2 × 9.1 × 8.9 inches, and the device weighs 8.9 pounds.

This document describes the Breas Vivo 40 ventilator with a new "Target Volume" feature, seeking 510(k) clearance from the FDA. The submission largely relies on predicate device comparison and bench testing rather than extensive clinical studies.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

• Pressure stability
• Dynamic pressure regulation
• Waveform performance
• Target volume feature | Bench testing confirmed substantial equivalence for:
• Wave-form performance
• Work of Breathing
• Pressure Dynamic regulation
• Target Volume feature |
  | Safety and Effectiveness | As safe and effective as therapy without the Target Volume feature. | Clinical article attached (Appendix 12) supporting the use of volume-controlled ventilation in combination with pressure-controlled ventilation. |

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

• Test Set Sample Size: Not applicable. The primary evidence presented is bench testing and a single clinical article, not a clinical study with a defined patient test set for the device itself.
• Data Provenance:
  • Bench Testing: Performed by Breas Medical AB (Sweden). This is retrospective as it's testing a modification to an existing device.
  • Clinical Article: Referencing "one clinical article" provided in Appendix 12. The provenance (country of origin, retrospective/prospective) of this article's data is not specified in the provided text.

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

• Not applicable. As no clinical study with a patient test set for the device was performed by Breas Medical, there were no experts used to establish ground truth for such a test set. The bench testing relies on engineering standards and measurements, not expert human assessment. The cited clinical article would have its own ground truth establishment methods, but these are not for the device's specific performance in this submission.

4. Adjudication Method for the Test Set

• Not applicable. No human-involved test set requiring adjudication was conducted by Breas Medical for this submission.

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

• No. An MRMC comparative effectiveness study was not done. The submission explicitly states: "No clinical testing has been performed by Breas Medical."

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

• Yes, in a sense, standalone performance testing was done in the form of "bench testing." The "Target Volume" feature is a software-based algorithm that adjusts pressure. The bench tests evaluated the performance of this algorithm (and the integrated device) in a controlled environment, without human intervention in the device's operation during the tests.

7. The Type of Ground Truth Used

• Bench Testing: The ground truth for bench testing is established by engineering specifications, physical principles, and measurement standards for ventilator performance (e.g., precise pressure and flow measurements, waveform analysis, tidal volume delivery).
• Clinical Article: The ground truth for the cited clinical article (not part of Breas Medical's direct testing) would depend on the study's design, but typically in clinical ventilation studies, it could involve physiological measurements (e.g., blood gas analysis, lung mechanics), patient outcomes, or expert clinical assessment.

8. The Sample Size for the Training Set

• Not applicable. The Vivo 40 with the Target Volume feature is a medical device, not an AI/ML algorithm that is "trained" on a dataset in the conventional sense. Its "training" or development would involve engineering design, simulation, and iterative hardware/software development and testing, not a labeled training dataset.

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

• Not applicable, as there is no "training set" in the context of AI/ML for this device. The development of the device's control algorithms would be based on established physiological models, control theory, and engineering principles, with validation through simulations and bench testing.

Ask a specific question about this device

The Breas Vivo 40 is an assist ventilator intended to augment the breathing of spontaneously breathing adult patients (>30 kgs) suffering from respiratory failure, respiratory insufficiency, or obstructive sleep apnea. It is not intended to provide the total ventilatory requirements of the patient. It is intended to be used for both invasive and non- invasive applications. The Breas Vivo 40 is intended to be operated by qualified and trained personnel. The Breas Vivo 40 is intended for use in clinical settings (e.g., hospitals, sleep laboratories, sub-acute care institutions) and home environments. The Breas Vivo 40 must always be prescribed by a licensed physician.

The Vivo 40 is a pressure-supported and pressure-controlled ventilator with a CPAP function intended for spontaneous breathing patients who require long-term support by mechanical ventilation during night and part of the day. In the treatment of chronic respiratory failure, positive airway pressure ventilation is well established and common practice as a mean to assure sufficient gas exchange. There are a number of devices legally marketed in the United States for this application. The Vivo 40 can be used in clinical settings (e.g., hospitals, sleep laboratories, sub-acute care institutions) and home environments. It must always be prescribed by a licensed physician. It is not intended for life support applications or for transport of critical care patients. The therapy delivered by the Breas Vivo 40 System can be either: 1) Pressure Controlled Ventilation (PCV) or 2) Pressure Support Ventilation (PSV) or 3) Constant Positive Airway Pressure (CPAP). The Vivo 40 airflow is delivered via a single lumen outlet tube that may be connected to various invasive and non-invasive patient interfaces, such as nasal masks. To minimize CO2 rebreathing, masks or other interfaces permitting a leak flow of at least 12 liters/minute at the output pressure setting of 4 cmH20 are recommended. The Vivo 40 has an auto-switching power supply that facilitates use in conjunction with international travel (100 - 240 VAC). It can also be used with an external 12.5/ 24 VDC power source when AC mains line voltage is not available. The outer dimensions of the Vivo 40 housing are 7.2 × 9.1 × 8.9 inches, and the device weighs 8.9 pounds.

Here's an analysis of the provided text regarding the Breas Vivo 40 System, focusing on acceptance criteria and the study proving it meets those criteria:

Device: Breas Vivo 40 System (Bilevel system, Ventilator)
Intended Use: For spontaneous breathing adult patients (>30 kg) requiring long-term support by mechanical ventilation (night and part-day), and for CPAP therapy for obstructive sleep apnea. Not for life support or transport of critical care patients.

1. Acceptance Criteria and Reported Device Performance

The provided document describes the device's adherence to various regulatory and performance standards rather than specific quantitative acceptance criteria with numerical targets. The "reported device performance" is essentially a statement of compliance or "passed all tests."

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

The document explicitly states that "Non-clinical testing was conducted" and "Comparative testing... was performed." These refer to bench-testing and device-level verification.

• Sample Size for Test Set: Not specified in the provided text, but it pertains to physical units of the ventilator and possibly components, not patient data.
• Data Provenance: The tests were conducted on the device itself, likely within a laboratory or manufacturing setting. No patient data (e.g., country of origin, retrospective/prospective) is associated with this testing as it was non-clinical.

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

This question is not applicable in the context of the provided information. The testing was non-clinical bench-testing, comparing the device to pre-established standards and a predicate device. "Ground truth" in this context would be the performance characteristics of the standards or the predicate device, not established by human experts for a test set of medical cases.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (e.g., 2+1, 3+1) typically refer to expert review processes for clinical data or imaging, which were not part of this submission's testing. The "adjudication" for the bench-tests would be whether the device passed the specified criteria, which is a binary outcome based on measurement, not expert consensus.

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

No, an MRMC comparative effectiveness study was not done.

The document explicitly states: "Clinical studies were not required to support a substantial equivalence determination."

Therefore, there is no information on:

• Effect size of how human readers improve with AI vs without AI assistance. (This is an AI-specific question, and this device is a ventilator, not an AI diagnostic tool.)

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

This question is not applicable in the context of this device. The Breas Vivo 40 is a mechanical ventilator, not an AI algorithm or a diagnostic software. Its performance is inherent to its hardware and controlling software, which directly delivers therapy. There isn't a separate "algorithm only" performance to be evaluated outside of the device's functional operation. The software testing mentioned was for compliance with FDA guidance, not for standalone diagnostic performance.

7. The Type of Ground Truth Used

For the non-clinical and comparative bench testing, the "ground truth" was established by:

• Engineering Specifications / Pre-defined Measurement Criteria: For meeting its own "stated performance specifications" (e.g., pressure delivery accuracy, flow rates).
• International Standards: Compliance with standards like IEC 601-1, ISO 10651-6, ISO 17510-1 for safety and performance.
• Predicate Device Performance: For the comparative testing (Wave-form performance, Work of Breathing, Pressure Dynamic regulation), the performance of the legally marketed predicate devices (Respironics Vision, Breas Vivo 40 (K053607)) served as the benchmark for substantial equivalence.

No pathology, expert consensus on clinical cases, or outcomes data were used as ground truth for this submission, as no clinical studies were performed.

8. The Sample Size for the Training Set

This question is not applicable. The Breas Vivo 40 System is a mechanical ventilator, not a machine learning or AI-driven device that requires a "training set" of data in the typical sense for algorithm development. The software testing mentioned refers to verification and validation of the embedded control software, not training a predictive model.

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

This question is not applicable, as there was no "training set" for an AI algorithm.

Ask a specific question about this device