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The SV600, SV800 Ventilator is intended to be used in intensive care situations for long-term or during transport within a professional healthcare facility. The SV600, SV800 Ventilator is intended to provide ventilation assistance and breathing support for adult, pediatric and neonate patients with a minimum body weight of 0.5 kg. The SV600, SV800 Ventilator should be operated by properly-trained and authorized medical personnel. This equipment is not suitable for use in an MRI environment.

The SV600 and SV800 Ventilators are pneumatically-driven and electronically-controlled ventilators. The Ventilators consists of a main unit (including pneumatic circuit, electronic system, mechanical structure, display, CO2 module, SpO2 module), trolley and support arm. The device also includes a neonatal flow sensor and neonatal flow sensor cable, which are used to measure the patient inspiration/expiration flow in neonatal ventilation modes.

The provided FDA 510(k) Clearance Letter for the SV600, SV800 Ventilator describes modifications to an existing device, primarily the addition of neonatal ventilation capabilities and updated monitoring modules. However, the document does not contain the level of detail typically found in a clinical study report for evaluating acceptance criteria and device performance in the way you've requested for studies involving AI algorithms, image analysis, or expert consensus with specific metrics like sensitivity, specificity, or AUC.

This document focuses on providing evidence of substantial equivalence to predicate devices through technical comparisons and various forms of bench testing, software verification, and compliance with consensus standards. It does not present a performance study with acceptance criteria specific to an AI device's output (e.g., accuracy against ground truth, reader performance improvements).

Therefore, I cannot fill out your requested table and answer many of your specific questions as the information is not present in the provided text.

Here's what can be extracted based on the document's content:

Acceptance Criteria and Device Performance (Based on available information)

The document doesn't define "acceptance criteria" in terms of specific performance metrics (like sensitivity, specificity, accuracy) that would be typically found for an AI or diagnostic device. Instead, "acceptance criteria" are implied by compliance with various technical specifications and international standards. Device performance is generally reported as "meets specifications" or "is equivalent to the predicate."

Study Details (Based on available information in the 510(k) Summary)

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

   • The document does not specify sample sizes for test sets in the context of clinical performance evaluation (e.g., number of patients, number of readings). The "testing" mentioned refers to engineering, software, and standards compliance evaluations.
   • Data provenance is not provided, as this is not a clinical study report.

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

   • Not applicable. The document describes engineering and standards compliance testing, not a clinical study involving expert-established ground truth for performance evaluation of an AI component or diagnostic output.

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

   • Not applicable. This is not a clinical study with an adjudication process for ground truth.

4. 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 MRMC comparative effectiveness study was done. This document describes a ventilator, not an AI diagnostic or assistance tool in that context. While it includes "Intellicycle" and "Lung Recruitment (SI)" features, these are not presented as AI assistance augmenting human reader performance in a diagnostic capacity.

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

   • The document implies standalone performance testing for various technical aspects of the ventilator and its integrated modules (CO2, SpO2 sensors) against their respective specifications and standards. For example, SpO2 sensor accuracy is stated as "Measurement accuracy: 70 to 100%: ±2% (adult/pediatric mode)" for the Mindray SpO2 module. However, this is for sensor performance, not a complete "algorithm only" evaluation in the context of AI diagnostic output as typically measured.

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

   • For the technical and performance testing, the "ground truth" would be established by reference standards, calibrated equipment, and design specifications. For example, a flow sensor's accuracy would be tested against a known, precise flow rate. For biocompatibility, the ground truth is defined by the toxicological profiles dictated by the ISO standards. For software, the ground truth is the functional requirements and design specifications.
   • There is no mention of expert consensus, pathology, or outcomes data being used to establish ground truth for clinical performance evaluation of an AI component.

7. The sample size for the training set:

   • Not applicable. This document does not describe the development or validation of an AI algorithm with a training set. The "Intellicycle" feature is mentioned, but no details regarding its development, training data, or validation as an AI algorithm are provided.

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

   • Not applicable, as no AI training set is described.

Summary Limitations:

The provided text is a 510(k) summary, which aims to demonstrate substantial equivalence to legally marketed predicate devices. It details technical changes, compliance with regulatory standards (e.g., biocompatibility, electrical safety, EMC, software V&V), and functional testing results. It does not outline a clinical performance study with the types of metrics and methodologies commonly associated with evaluating AI-driven diagnostic devices or those requiring expert consensus for ground truth. Therefore, many of your specific questions are not addressed by the provided document.

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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.

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The HFT750U ventilator is intended to provide ventilation and oxygen concentration for patients who are breathing spontaneously but need partial ventilation support due to respiratory failure or chronic respiratory insufficiency.

The device provides heated and humidified gas to the patient.

The device is intended for pediatric patients weighing 12.5 kg or greater to adult patients in non-invasive respiratory therapy. Patients with their upper airways bypassed are included.

The High Flow mode has a flow range from 1 to 60 lpm.

The HFT750U is intended for use in hospitals, hospital-type facilities, and in hospital transportation by qualified and trained users under the directions of a physician.

It is not intended for life support.

This HFT750U is a Continuous Ventilator, intended to provide the patient with a high flow of gas that contains a constant amount of oxygen in a non-invasive method, thereby assisting or regulating the patient's respiration use in a hospital or medical institutions.

It can be used by the upper airways bypassed patients. Equipped with various alarm and safety functions, High flow (HF), the Continuous Positive Airflow Pressure (CPAP) and Bilevel Positive Airway Pressure (bilevel) modes regulate the patient's respiration, but for correct diagnosis it should be used together with clinical information.

The provided FDA 510(k) clearance letter for the HFT750U Continuous Ventilator does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the study that proves the device meets them.

The document is primarily a clearance letter and a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device based on similar indications for use, technological characteristics, and safety and performance standards. It lists types of performance testing conducted (e.g., Software Verification, Performance of Ventilation Modes), but it does not provide:

• Specific quantifiable acceptance criteria for device performance.
• Reported device performance data against those criteria.
• Details about the test set (sample size, provenance).
• Information on expert involvement in ground truth establishment or adjudication for performance studies.
• Details of any MRMC studies, standalone AI performance, or ground truth types used in specific performance evaluations.
• Training set information for any AI/ML component (which isn't explicitly mentioned as a core feature of this ventilator model, but could be implied by "Software Verification").

Given the limitations of the provided text, I will answer what can be inferred and highlight what information is missing.

Inferred Acceptance Criteria and Reported Device Performance (Table)

Based on the general nature of a continuous ventilator and the standards it claims to comply with, the acceptance criteria would revolve around meeting the specifications and a lack of hazardous function or failure. However, specific numerical acceptance criteria and direct performance metrics are not explicitly stated in the provided text.

The document implies that the device met acceptance criteria because it was cleared by the FDA and states "The sponsor has demonstrated through performance testing, design and non-clinical testing that the proposed device and predicates have been found to be substantially equivalent."

Here's an attempt to structure a table based on the types of performance aspects mentioned, acknowledging that specific data and criteria are absent:

Missing Information from the Provided Document:

1. Sample size used for the test set and the data provenance: Not mentioned. The document only lists types of tests, not the datasets or sample sizes for those tests.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not mentioned. This device is a ventilator, not an AI diagnostic tool requiring expert ground truth for image or signal interpretation. Performance is typically assessed against engineering specifications and physiological models.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/not mentioned. Adjudication methods are typically used for establishing ground truth in human-in-the-loop or standalone AI studies for diagnostic/interpretive tasks, which is not the primary function of this device's "performance testing" as described.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI diagnostic or assistive device in the context of "human readers" interpreting medical images or signals. Its "performance testing" would involve engineering and software validation, not human reader studies.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document mentions "Performance of Ventilation Modes and Control Settings" and "Software Verification" which are forms of standalone testing for the device's core functionality and software. However, no specific metrics or study design for "standalone performance" (as it relates to AI algorithm performance) are provided.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a ventilator, "ground truth" would typically be established by:
   • Engineering specifications: The device's output (flow, pressure, oxygen concentration) is measured against the design specifications.
   • Standardized test lung models: Simulation of patient physiology (e.g., lung compliance, resistance) to assess how the ventilator responds in different scenarios.
   • Reference measurement devices: Highly accurate external sensors to verify the device's internal measurements and deliveries.
   • Compliance with recognized standards: Adherence to standards like ISO 80601-2-12 for basic safety and essential performance of ventilators.
     The document does not explicitly state the specific "ground truth" methods used, but these are the common practices for such devices.
7. The sample size for the training set: Not applicable/not mentioned. The document describes a traditional medical device (ventilator) and its conformity to engineering and safety standards. There is no indication of a machine learning model that would require a "training set" in the context of an AI/ML device submission. The software verification refers to traditional software development and testing.
8. How the ground truth for the training set was established: Not applicable, for the same reason as point 7.

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The AVEA Disposable Expiratory Filter/ Water Trap is an expiratory filter and water trap for use with the AVEA Ventilator.

It would be used in an institutional healthcare environment (e.g., hospitals). It may be used on adult, pediatric, and neonatal patients.

It should be operated by properly trained clinical personnel, under the direction of a physician.

The AVEA disposable expiratory filter/water trap is designed to be used exclusively with the AVEA Ventilator.

This document is a 510(k) clearance letter for the AVEA Disposable Expiratory Filter/Water Trap. It declares the device substantially equivalent to a predicate device and provides the regulatory information. Crucially, it does not describe a clinical study of the device against acceptance criteria for performance; instead, it relies on demonstrating identicality to a previously cleared predicate device.

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, and expert details for a test set.
• Ground truth establishment and adjudication methods.
• MRMC comparative effectiveness study results.
• Standalone AI algorithm performance (as this is a physical medical device, not an AI software).
• Training set sample size or ground truth establishment for a training set.

The document explicitly states:

• "The subject and predicate devices are identical in all ways."
• "The subject device and the predicate – AVEA disposable expiratory filter/water trap – K081837 is substantially equivalent based upon identicality."

This means that the study proving the device meets acceptance criteria for this specific 510(k) relies purely on the fact that it is a direct copy of a previously cleared device. The "acceptance criteria" here are essentially "be identical to the predicate device."

Here's what can be extracted from the document related to performance, based on the predicate device's listed performance:

1. Table of Acceptance Criteria (as per predicate device's listed performance) and Reported Device Performance (by virtue of identicality)

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Respiration Data Management Software is installed in a computer to perform patient management by treatment data viewing, treatment data reporting and remotely adjusting the prescribed compatible BMC CPAP and BPAP devices' settings. It is intended for healthcare professionals in healthcare facilities use only.

The Respiration Data Management Software is a softwareonly device, which allows physicians and other clinical staff to transmit, analyze and review respiration data from the compatible CPAP and BPAP devices (non-life support systems), thus to assist the users in patient management and follow-up work. This also includes remote modification of the treatment parameters of the compatible devices. It can also store patient data, upload data to the cloud platform, generate and print reports.

The provided text is a 510(k) Summary for the "Respiration Data Management Software." It highlights the device's indications for use and its substantial equivalence to a predicate device, but it does not contain acceptance criteria for device performance or a study demonstrating that the device meets such criteria.

The document focuses on:

• Software Verification and Validation: Stating that it was conducted according to FDA guidance.
• Cybersecurity: Stating that it was considered and evaluated according to FDA guidance.
• Comparison to Predicate Device: Detailing similarities and differences in functionality, compatible devices, and communication mediums, and asserting that differences do not raise new questions of safety or effectiveness.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them because this information is not present in the provided text. The document is a regulatory submission demonstrating substantial equivalence, not a detailed performance study.

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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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Medium and Large Size: The AF531 Oro-Nasal SE Face Mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators which have adequate alarms and safety systems for ventilation failure, and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure, respiratory insufficiency, or obstructive sleep apnea. The mask is for single use in the hospital/institutional environment only. The mask is to be used on patients (>30 kg) who are appropriate candidates for noninvasive ventilation.

Small Size: The AF531 Oro-Nasal SE Face Mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators which have adequate alarms and safety systems for ventilation failure, and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure, respiratory insufficiency, or obstructive sleep apnea. The mask is for single use in the hospital/institutional environment only. The mask is to be used on patients 7 years or older (>20 kg) who are appropriate candidates for noninvasive ventilation.

The AF531 Oro-Nasal SE Face Mask is designed for single-patient use in the hospital or institutional environment. AF531 Oro-Nasal SE Face Mask covers the nose and mouth while avoiding the eye region. The mask is available in three (3) sizes: Small, Medium, and Large.

The headgear options for the AF531 Oro-Nasal Masks include the four-point headgear and a CapStrap headgear.

The AF531 Oro-Nasal SE Face Mask requires use of a separate exhalation device. The mask utilizes a click-style elbow that secures to the mask hub yet can be removed by pressing the release tabs.

The document describes a medical device, the AF531 Oro-Nasal SE Face Mask, and its substantial equivalence to predicate devices, rather than a study on an AI/ML powered device. Therefore, it does not contain the information required to answer your query regarding acceptance criteria and performance studies for an AI/ML device.

Specifically, the document does not provide:

1. A table of acceptance criteria and reported device performance for an AI/ML model.
2. Sample sizes used for a test set (in the context of AI/ML).
3. Data provenance (country of origin, retrospective/prospective) for AI/ML data.
4. Number of experts or their qualifications for establishing ground truth for AI/ML.
5. Adjudication method for AI/ML ground truth.
6. Details of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
7. Results of a standalone (algorithm only) performance study.
8. Type of ground truth used (expert consensus, pathology, outcomes data) for AI/ML.
9. Sample size for a training set in an AI/ML context.
10. How ground truth for a training set was established for an AI/ML model.

The document is a 510(k) summary for a physical medical device (a face mask for ventilation) and focuses on demonstrating substantial equivalence based on intended use, design, materials, and performance specifications relevant to a physical component. The "Non-Clinical Data Submitted" section lists engineering and biological performance tests (e.g., total mask leak, pressure drop, sound testing, biocompatibility), not AI/ML model performance metrics.

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Each model of the ZOLL 731 Series of Ventilators is indicated for use in the management of infant through adult patients weighing greater than or equal to 5 kg with acute or chronic respiratory failure or during resuscitation by providing continuous positive-pressure ventilation. ZOLL Ventilators are appropriate for use in hospitals, outside the hospital, during transport and in severe environments where they may be exposed to rain, dust, rough handling, and extremes in temperature and humidity. With an appropriate third-party filter in place, they may be operated in environments where chemical and/or biological toxins are present. When marked with an "MRI conditional" label, ZOLL ventilators are suitable for use in an MRI environment with appropriate precautions. ZOLL ventilatiors are intended for use by skilled care providers with knowledge of mechanical ventilation, emergency medical services (EMS) personnel with a basic knowledge of mechanical ventilation, and by first responders under the direction of skilled medical care providers.

The ZOLL Ventilator pulse oximeter with Masimo SET technology is intended for use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), and pulse rate. The pulse SpO2 oximeter and accessories are indicated for use on adult, pediatric, and neonatal patients during both no motion conditions, and for patients who are well or poorly perfused, in hospitals, hospital-type facilities, or in mobile environments.

The ZOLL 731 Series Ventilators family consists of AEV, EMV+, Eagle II and Z Vent models which are small, durable, full-featured portable mechanical ventilators which provide ventilatory support for infants (≥ 5 kg), pediatric and adult patients. 731 Series ventilators are designed to operate in hospitals, prehospital, and field hospital settings. The ventilators can be operated from an AC or DC external power source, or from an integrated battery system, and support the following pressure and volume ventilation modes: Assist/Control (AC), Synchronized Intermittent Mandatory Ventilation (SIMV) with or without Pressure Support (PS), Continuous Positive Airway Pressure (CPAP) with or without PS, with and without Noninvasive Positive Pressure ventilation (NPPV) Positive Pressure Ventilation (PPV).

The provided document is a 510(k) premarket notification letter and summary for the ZOLL 731 Series Ventilator. It details the device, its intended use, and the comparisons made to a predicate device to establish substantial equivalence.

However, the request asks for information about acceptance criteria and a study that proves a device meets those criteria, specifically in the context of an AI/algorithm-driven medical device. The document provided does not describe an AI/algorithm-driven device. Instead, it is for a ventilator (a mechanical device with updated software), and the "study" referred to is primarily non-clinical evidence (software verification and validation testing, safety testing per international standards, electrical safety, EMC, and usability testing with no changes to the UI). There is no mention of an algorithm or AI that generates outputs requiring ground truth, expert adjudication, or MRMC studies for evaluation.

Therefore, I cannot fulfill the request with the provided input because the input document does not contain the necessary information about acceptance criteria and studies for an AI/algorithm-driven device.

The document explicitly states:

• "Clinical evidence was not necessary to show substantial equivalence."
• The primary change is a "software revision 5.25, which updates the ventilator alarm logic." This is a rule-based or programmatic change, not an AI/ML model.
• The comparison is based on "Alarm System, Functions and Features, Indications for Use, Intended Use, Labeling, Pulse Oximeter Specifications, Ventilator Specifications." These are typical for traditional medical device updates, not AI.

If the request refers to general device acceptance criteria and testing (not specific to AI/algorithms), then the relevant parts of the document are the "Substantial Equivalence - Non-Clinical Evidence" section, which details the various tests and standards met:

• Software Verification and Validation Testing: This is the primary "study" proving the device meets its software-related acceptance criteria. The document states this testing "ensured that the 731 Series Ventilators performs as well as the indicated predicate devices and met all its functional requirements and performance specifications."
• Safety Testing per International Standards: Compliance with a long list of international standards (IEC 60601-x, ISO 15223-1, EN 1789, etc.) serves as the acceptance criteria for safety and effectiveness in various aspects. The "Table 1: 731 Series Ventilator Compliance Standards" lists these.
• Usability Testing: The document states "No usability validation is included in this plan. The user interface remains unchanged." This implies that the acceptance criterion for usability was "no change from predicate" and thus no new testing was needed.
• Electrical Safety and Electromagnetic Compatibility (EMC): Tested to meet applicable standards listed in Table 1.

However, the request is very specific about AI-related evaluation elements (MRMC, standalone algorithm, ground truth methods, training set, etc.), which are entirely absent from the provided document.

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The Ventoux is intended to provide continuous or intermittent mechanical ventilation support for the care of individuals who require mechanical ventilation. Specifically, the Ventoux is applicable for adult and pediatric (i.e., infant, child and adolescent) patients who weigh at least 5 kg (11 lbs).

The Ventoux is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician; it is suitable for use in hospital environments.

The Ventoux Ventilator is an electrically powered, microprocessor-controlled multi-parameter ventilator, which can be: Time, Pressure, Flow or Volume triggered; Volume or Pressure controlled; Time or Flow cycled.

Manual inflation is allowed, and the Ventoux supports the emergency intake of ambient air which permits the patient to pull ambient air into the breathing circuit in the event of a complete loss of air/gas supply.

Volume triggered is based on Inspiratory trig response time ≤100 ms from pressure drop/flow rise to PEEP level.

Ventilation is possible in both Invasive and Noninvasive settings.

The system can be expanded to include additional parameter monitoring to allow for Sp02, etC02 and Cuff Pressure Control.

The Ventoux can be powered by external power (100 – 240 VAC, 50-60 HZ or 10 – 30 VDC) and/or by its two swappable internal Li Ion rechargeable batteries, which provide full operating power the to the ventilator for a minimal operating time of 6 hours when operating on standard ventilation parameters.

A comprehensive alarm system is built-in to alert the user to violations of set safety limits. The alarm system alerts the care giver by activating the audible alarm, screen display and the LED indicator.

The electrical system is comprised of three primary boards: The main board (motherboard) which holds the majority of the electronics including the main CPU and the display CPU. the power board, which holds the power subsystems, and internal communication functions, and the Communication board, which holds internal communication and external communication connectors. The main component of the pneumatic system is an electrically controlled compressor (pump). This compressor provides a compressed gas source so no external air compressor is needed. Additionally, the exhalation valve is activated by an electrically controlled proportional solenoid that provides a built in PEEP.

The provided FDA 510(k) summary (K223120 for the Ventoux Ventilator) does not contain information about an AI/ML powered device. The document describes a traditional medical device (a continuous ventilator) and its comparison to predicate devices based on established engineering and performance standards.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, human reader improvement with AI assistance, or ground truth establishment for an AI/ML model. The 510(k) summary specifically states:

"No clinical testing was conducted or required in support of this premarket notification." and "The software design and validation process, together with the bench testing of the device, demonstrated Ventoux Ventilator performs as intended."

This indicates that the device's performance was validated through bench testing and compliance with recognized standards, not through studies involving AI/ML performance metrics, expert consensus, or multi-reader studies as would be typical for AI-powered diagnostic aids.

The document focuses on:

• Technological Characteristics Comparison: Showing the Ventoux has similar features and functionalities to predicate devices.
• Performance Data: Demonstrating compliance with various IEC and ISO standards related to electrical safety, EMC, basic safety and essential performance of ventilators, alarm systems, gas monitors, pulse oximeters, environmental testing (shock, rough handling, vibration), altitude, internal temperature, and battery validation.
• Software Design and Validation: Stating that this was performed and contributed to demonstration of intended performance.
• Bench Testing: Stating that bench testing was conducted to verify compliance with predefined specifications and internal procedures.
• Biocompatibility: Assessment of gas pathways.

To answer your request, an AI/ML-specific device submission would be needed, which would detail metrics like sensitivity, specificity, AUC, and studies with expert readers. This document does not provide such information.

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The RESPOND(R) Ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. The RESPOND(R) Ventilator is intended for pediatric through adult patients weighing at least 38 kg.

The RESPOND(R) Ventilator is intended for use in a hospital transport, and institutional environments such as long-term acute care, skilled nursing facilities, long-term care, and subacute care facilities.

The RESPOND(R) Ventilator is intended for use by qualified, trained personnel under the direction of a licensed clinician.

The RESPOND® Ventilator is a multi-patient continuous ventilator intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen/air to the breathing gas.

The ventilator provides both pressure control and volume modes of therapy and can provide both invasive and non-invasive ventilation. The device is compatible with both passive HME and heated humidification patient circuits, as well as nebulization with an ultrasonic nebulizer. The ventilator is equipped with an oxygen mixing module, which allows oxygen to be delivered to the patient within a range of 21% to 95% concentration.

The RESPOND® Ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. RESPOND® is intended for pediatric and adult patients weighing at least 38 kg (84 lbs.) and is intended for use in a hospital including intra-hospital transport, and institutional environments such as long-term acute care, skilled nursing facilities, long-term care, and subacute care facilities. The RESPOND® Ventilator is intended for use by qualified and trained personnel.

I am sorry, but the provided text does not contain the requested information about acceptance criteria, device performance, sample size, ground truth, or study details. The document is a 510(k) summary for a medical device (RESPOND® Ventilator), primarily focused on demonstrating substantial equivalence to a predicate device. It discusses the device's indications for use, technological characteristics, and a broad overview of non-clinical performance testing without providing specific acceptance criteria or detailed study results in the format you've requested.

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