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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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When used with a Neptune Heated Humidifier and Hudson RCI ventilator circuits, the ConchaSmart Column provides heated humidification for patients with and without an artificial airway in place.

The ConchaSmart Column is an accessory to the Neptune Heated Humidifier (K063758 and K131912). It is a single use, disposable humidifier cartridge which is intended for neonatal, infant, pediatric, and adult patients requiring heated humidification. The ConchaSmart Column is used by inserting the column into the center of the Neptune Heated Humidifier.

The provided document is a 510(k) summary for the ConchaSmart Column, a respiratory gas humidifier. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific acceptance criteria in the context of an AI/algorithm-based medical device.

Therefore, the requested information categories related to acceptance criteria, device performance, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies are largely not applicable to this type of regulatory submission. This document describes a medical device, but not an AI-powered one that would typically undergo the kind of performance evaluation requested.

However, I can extract the information that is present and indicate where the requested information is not applicable (N/A) or not provided in this document.

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

The document presents a comparison to a predicate device based on technological characteristics and performance specifications rather than explicit acceptance criteria and a study proving device performance against those criteria in the way an AI device would be evaluated. The "reported device performance" in this context refers to its specifications alongside those of the predicate.

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The Fisher & Paykel HC550 System is designed for use with artificial ventilation systems. Portable volume ventilation systems, pressure support ventilation and Continuous Positive Airway Airway Pressure (CPAP) systems may incorporate an HC550 to provide therapeutic levels of warm humidified air to adult patients with artificial airways or through mask ventilation.

The operating flow range is 5 to 120L/min depending on the patient interface.

The HC550 is designed for use in long term care facilities or the home under the prescription of a qualified medical professional.

The Fisher & Paykel Healthcare HC550 System is designed to condition gases for patients by raising the delivered water vapor content (humidity) and temperature of the gases.

The HC550 System consists of the following components:

• . HC550 Respiratory Humidifier
• . Accessories:
  • a) Breathing circuit (compatible adult breathing circuits as cleared in K983112, K020332, K034026, K103767, K122432)
  • b) Humidification Chamber (as cleared in K9341401 and K913368)
  • c) Heaterwire Adaptor (as cleared in K073706)
  • d) Temperature/Flow Probe (as cleared in K983112)
  • RT008 Air Entrainer (optional oxygen therapy accessory) (as cleared in K953711) e)

The device consists of an electrically powered heat controller, utilizing a microprocessor with embedded software, to control a heating element that transfers heat to the water in a humidification chamber.

A dryline tube (part of the breathing circuit) transports respiratory gases from a flow source (e.g. ventilator) to the humidification chamber where the gases are heated and humidified.

The inspiratory limb of the breathing circuit transports the heated and humidified gases from the humidification chamber to the patient. The inspiratory tube may be electrically heated by means of a heater-wire placed internally to the tube, which is controlled by the HC550 respiratory humidifier.

The expiratory limb of the breathing circuit transports expired gas from patient. In the case of a dual-heated breathing circuit, this limb may also be heated in the same manner as the inspiratory limb.

If a heated breathing circuit is used, the heaterwire adaptor provides electrical energy from the respiratory humidifier to the heaterwire in the breathing circuit.

Temperature probes in the gas path provide feedback on temperature and flow of the gas to regulate temperature and humidity to the patient.

HC550 System Acceptance Criteria and Study Details

This document describes the acceptance criteria and corresponding study results for the HC550 System, a respiratory gas humidifier. The information is extracted from the provided 510(k) Notification K132017.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the HC550 System are based on compliance with the ISO 8185:2007 standard for humidification systems. The device's performance is compared to these requirements.

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