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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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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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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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FAMILY OF DIMAR DIMAX NIV MASKS 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 ventilator failure, and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure, respiratory insufficiency.

For single patient use in the Hospital environment

The mask is to be used on patients who are appropriate candidates for noninvasive ventilation.

The small size is intended to be used for children (from 7 years and > 20kg) while the sizes medium/large/ extra-large/ extra-extra-large are intended to be used for adolescents or adults >30 kg

FAMILY OF DIMAR DIMAX NIV MASKS consists of two main types of a patient interface:

• DIMAX ZERO
• DIMAX

The DIMAX ZERO MASK is a "total face" MASK that totally covers eyes, nose and mouth. The DIMAX ZERO MASK is provided for SINGLE USE.

Below a short summary of the technical features of the DIMAX ZERO MASK:

• The MASK can be connected to 2 different connectors: 1 for gas inlet and the other one for ● the exhaust gas outlet (the mask can also work with 1 connector, with the hole for the second connector - gas outlet- capped);
• The MASK is fixed to the head of the patient through a 5 fixing points headgear;
• A silicon gasket allows the mask to adapt to the patient's face and avoid air leaks;
• 2 specific luer ports are available for the control of the pressure through a manometer;
• The DIMAX ZERO MASK is provided not sterile in a plastic pouch. In each pouch are included the following connectors (22 mm connectors conforming to ISO 5356-1) and components:
  • 22F Non-Vented connector; O
  • 22F Vented connector with flop; O
  • 22F Non-Vented connector with FBS port; O
  • 22M-22M adapter; O
  • o 22F-22F adapter;
  • о 22F сар.

The DIMAX MASK is a "Total Face" MASK that totally covers eyes, nose and mouth. The DIMAX MASK is provided for SINGLE USE.

Below a short summary of the technical features of the DIMAX MASK:

• The MASK can be connected through the same connector for both gas inlet and exhaust gas ● outlet;
• The MASK is fixed to the head of the patient through a 5 fixing points headgear;
• A silicon gasket allows the mask to adapt to the patient's face and avoid air leaks;
• 2 specific luer ports are available for the control of the pressure through a manometer;
• The DIMAX MASK is provided not sterile in a plastic pouch. In each pouch are included the following connectors (22 mm connectors conforming to ISO 5356-1) and components:
  • O 22F Non-Vented connector;
  • O 22F Vented connector with flop;
  • O 22F Non-Vented connector with FBS port.

The provided text describes the acceptance criteria and performance data for the "FAMILY OF DIMAR DIMAX NIV MASKS" (subject device) in comparison to predicate devices, primarily the Performax SE Total Face Mask (K072588) and Respironics Total Face Mask (K992969).

Here's the breakdown of the requested information:

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample size for the test sets. The performance data presented (e.g., resistance to flow, rebreathing) are quantitative measurements.
The data provenance (country of origin, retrospective/prospective) is not mentioned. The submitter is DIMAR S.P.A. located in Italy, which might suggest the testing was conducted in Italy, but this is not explicitly stated.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is a medical device (NIV mask), not an AI/software device that requires expert ground truth for classification or diagnosis. The performance tests are based on physical and functional measurements against established standards (e.g., ISO 17510:2015, ISO 5356-1, ISO 10993 series, ISO 18562 series). Therefore, there is no mention of experts establishing a "ground truth" in the diagnostic sense. The "truth" is determined by compliance with the referenced standards.

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

Not applicable. The tests performed are objective measurements against recognized standards for medical device performance (e.g., resistance to flow, rebreathing, biocompatibility). There is no "adjudication" in the context of expert review or consensus for this type of device testing.

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

Not applicable. This is a hard-good medical device (NIV mask), not an AI/software device. No human reader or AI assistance studies are mentioned or relevant to its performance evaluation for market clearance.

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

Not applicable. This is a hard-good medical device (NIV mask), not an AI/software device.

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

The "ground truth" for this device's performance is compliance with established international standards for medical devices, specifically:

• Physical and Functional Performance: ISO 17510:2015 (Medical devices – Sleep apnea breathing therapy - Masks and application accessories), ISO 5356-1 (Anaesthetic and respiratory equipment — Conical connectors), and internal working pressure/filter connection/construction requirements.
• Biocompatibility: ISO 10993 series (Biological evaluation of medical devices) and ISO 18562 series (Biocompatibility evaluation of breathing gas pathways).

8. The sample size for the training set

Not applicable. This is a hard-good medical device and does not involve a training set as would be used for an AI/software algorithm.

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

Not applicable. There is no training set for this type of medical device.

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The VM-2000 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation in emergency and transport situations. The ventilator is a medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult patients, who require the following types of ventilatory support:

• Positive Pressure Ventilation, delivered invasively (via endotracheal tube or trach tube) or non-invasively (via mask).
• Assist/Control, SIMV, CPAP and NPPV modes of ventilation.
  The ventilator is suitable for use in institutional or transport settings.

The VM-2000 allows for rapid initiation of emergency ventilation based on default parameters. An operator can quickly begin ventilation by connecting the patient to the breathing circuit, and if necessary, adjusting ventilatory settings using the touch screen input before selecting start.
Once the therapy is initiated, breaths are delivered to the patient based on the configured settings. If the situation allows, qualified operators can adjust desired Mode, Tidal Vol, Respiratory Rate, PEEP, PIP, T Insp, P Insp and Sensitivity. Operators can monitor patients closely through a graphical breath-by-breath display to deliver highquality care. Audio and visual alarm indicators help troubleshoot issues.
The VM-2000 uses a single-patient-use breathing circuit with a Pressure Monitoring Line, and Flow Sensor to deliver air to patients using a motor-blower system. The unit has a Type BF Applied Part, which is the breathing circuit. The device can run on AC wall power and / or batteries. To support use in environments where compressed Oxygen is unavailable or ill-advised, the device does not require compressed Oxygen. The VM-2000 is compatible with low pressure oxygen sources and blenders but will function without supplemental FiO2.

This document does not contain the specific information required to complete the requested table and study description regarding acceptance criteria and performance data for a device, particularly an AI-powered one.

The provided text is an FDA 510(k) clearance letter and a summary for the Ventis Medical VM-2000 ventilator. This device is a continuous ventilator, not an AI-powered diagnostic or therapeutic device that would typically have acceptance criteria presented as sensitivity, specificity, or other performance metrics against a "ground truth" established by experts.

Instead, the document details a comparison of the VM-2000 to predicate ventilator devices (Cardinal Health LTV 1200 and Respironics Trilogy EVO) to establish substantial equivalence. The "performance testing" mentioned refers to compliance with various safety and performance standards for medical devices (e.g., IEC 60601 series, ISO 80601 series, MIL-STD-810G), not a study demonstrating AI performance on a test set.

Therefore, I cannot extract the requested information such as:

• A table of acceptance criteria and reported device performance related to AI.
• Sample size used for an AI test set or data provenance.
• Number of experts for ground truth establishment or their qualifications.
• Adjudication method for an AI test set.
• MRMC comparative effectiveness study results.
• Standalone AI performance.
• Type of ground truth (expert consensus, pathology, outcomes data).
• Sample size for an AI training set.
• How ground truth for a training set was established.

The "Performance Testing" section (page 13) simply lists the standards the device was tested against and states that the "non-clinical performance testing included testing of a set of ventilation modes... The data demonstrates that the technological characteristics of the VM-2000 ventilator are substantially equivalent with the predicate device." This refers to engineering and safety performance, not AI-driven diagnostic accuracy.

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