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The TBird VELA Ventilator is intended to provide continuous or intermittent mechanical ventilatory support for individuals who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 10 kg (22 lbs.), who require the following general types of ventilatory support, as prescribed by an attending physician:

• Positive pressure ventilation .
• Assist/Control, SIMV, CPAP modes of ventilation .
  The ventilator is suitable for use in institutional and transport settings. It is not intended for use as an emergency medical transport ventilator.

The TBird VELA Ventilator employs a turbine gas delivery system along with microprocessor control to provide support for pediatric to adult patients. Capable of delivering clinically advanced modes of ventilation like Pressure Support with an internal battery or AC power the TBird VELA Ventilator has an extensive patient range.
The TBird VELA Ventilator ventilator pneumatic system is an electromechanical system comprised of four major subsystems, each containing several components. These systems include the flow delivery system, the exhalation system, the safety system and the inspiratory hold valve.
This electromechanical system controls all inspiratory flow to the patient. The exhalation system controls the flow of gas from the patient's lungs during the exhalation phase. The mechanical safety system ensures that the patient can breath spontaneously from room air and that the patient pressure is limited to a maximum value in the event of a ventilator malfunction. When activated, the inspiratory hold valve blocks flow between the flow delivery system and the patient.
The TBird VELA Ventilator ventilator electronic system is comprised of several subsystems, each containing numerous components. These subsystems include the Graphical User Interface System, the Power System, the Main Controller System, Exhalation, and Flow Delivery systems. The Display System is comprised of SVGA and Touchscreen. The Main Controller System is comprised of three Pressure Transducers, an Analog-to-Digital Converter, two Digital-to-Analog Converters, the Input-Output Processor, Solenoid Valves, and the Watchdog and Hardware Fault Monitors. The Power System conditions and controls energy from the AC input, the internal battery, and the option of external battery pack. The ventilator operates from this source, as well as recharging the internal battery.

The provided document, K032451, is for a medical device (TBird VELA Ventilator) and details modifications to an already cleared device. It primarily focuses on demonstrating substantial equivalence to predicate devices and verifying performance requirements.

Therefore, the requested information regarding acceptance criteria, study details, expert involvement, and specific ground truth methodologies for an AI device is not applicable to this submission. This document describes a ventilator, which is a hardware medical device, not an AI/ML-driven software device.

Specifically:

1. A table of acceptance criteria and the reported device performance: Not applicable. The document states "Performance testing verified that the TBird VELA Ventilator meets its performance requirements," but does not present a table of specific acceptance criteria or quantitative performance metrics in the way one would for an AI model. The verification is at a system level for a hardware device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This refers to a clinical study for an AI algorithm, not the engineering performance verification of a ventilator.
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): Not applicable. This pertains to AI model evaluation, not hardware device performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This pertains to AI model evaluation.
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 pertains to AI model evaluation, specifically human-in-the-loop performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This pertains to AI model evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. This pertains to AI model evaluation.
8. The sample size for the training set: Not applicable. This pertains to AI model training.
9. How the ground truth for the training set was established: Not applicable. This pertains to AI model training.

The document indicates that "Performance testing verified that the TBird VELA Ventilator meets it's performance requirements and that this device is substantially equivalent to medical devices currently legally marketed in the United States." This implies that internal engineering and functional tests were conducted to ensure the device performs as intended and meets relevant safety and effectiveness standards for a ventilator, likely against established benchmarks for similar devices. However, the specific details of these performance requirements and test outcomes are not provided in this summary.

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The AVEA is intended to provide continuous respiratory support in an institutional health care environment (e.g. hospitals). It may be used on adult, pediatric, and neonatal patients. It should only be operated by properly trained clinical personnel, under the direction of a physician. The AVEA is indicated for the delivery of air, oxygen or a helium-oxygen combination (Heliox).

The AVEA is a servo-controlled, software-driven ventilator. It has a dynamic breathing gas delivery that provides for neonatal through adult patients. Its module provides maximum flexibility with simple operator interaction. It has a range of user interface interaction, membrane keys and a dial for changing settings and operating parameters. It also has an internal gas delivery system with servo controlled active inhalation and exhalation functions. The AVEA may be configured as a conventional ventilator or noninvasive positive pressure ventilator (NPPV). It has been designed to function using most commonly available accessories.

The provided text describes the 510(k) summary for the AVEA Ventilator. It focuses on the device's intended use, its substantial equivalence to predicate devices, and a brief description of testing.

Here's an analysis of the available information regarding acceptance criteria and the study that proves the device meets them:

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

The submission does not explicitly provide a table of acceptance criteria with corresponding performance metrics. Instead, it states:

• Same indicated use
• Similar indication as heliox predicate
• Same operating principle
• Same basic ventilator design (except for heliox connector)
• Manufactured and packaged utilizing the same basic processes. |

Missing Information:

• Specific numerical performance requirements for "alarms, controls, and monitors" are not detailed. For example, acceptable ranges for pressure, volume, flow, response times for alarms, accuracy of delivered gas mixes, etc., are not provided.
• The actual measured performance values from the testing are not presented.

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

This information is not provided in the given text.

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 information is not provided in the given text. The device is a ventilator, not an imaging or diagnostic device requiring expert interpretation for ground truth. The "ground truth" (or functional verification) would be against engineering specifications and physical measurements, rather than expert consensus on medical images or diagnoses.

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

This information is not provided in the given text. As this is a ventilator and not a diagnostic device relying on expert interpretation, an adjudication method in the traditional sense (e.g., for medical image reading) would not be applicable. The "adjudication" would be against engineering standards and test pass/fail criteria.

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

No, a multi-reader, multi-case comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices where human readers interpret medical images or data. The AVEA Ventilator is a treatment device, not a diagnostic one involving human interpretation of AI output.

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

The device itself is a standalone medical device (a ventilator), but it's not an AI algorithm in the context typically discussed for standalone performance studies (e.g., deep learning models making diagnoses). The "performance testing" described involved the device functioning independently, but it's not an AI algorithm in the modern sense. The device does provide "continuous respiratory support," implying its operation without constant direct human intervention once set up, which could be considered "standalone" in its functional capacity.

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

Given the nature of the device (a ventilator), the "ground truth" for performance testing would likely be:

• Engineering specifications and standards: The device's output (e.g., delivered volume, pressure, flow rates, alarm functionality, response times) would be compared against predefined engineering and medical device standards.
• Physical measurements: Using calibrated equipment to measure the actual performance parameters (e.g., gas flow, pressure, oxygen concentration) produced by the ventilator.

The text does not explicitly state the type of ground truth, but implicitly it relates to verifying compliance with performance requirements for "alarms, controls, and monitors."

8. The sample size for the training set

This information is not applicable and not provided. The AVEA Ventilator, described as a "servo-controlled, software-driven ventilator," from 2002, predates the widespread use of machine learning/AI models that would require "training sets" in the modern sense. Its software likely operates based on programmed logic and control algorithms rather than learned patterns from a "training set."

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

This information is not applicable and not provided, as there is no indication of a training set being used in the context of machine learning/AI for this device.

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The AVEA is intended to provide continuous respiratory support in an institutional health care environment. It may be used on adult, pediatric, and neonatal patients. Properly trained clinical personnel, under the direction of a physician should only operate it.

The AVEA is a servo-controlled, software-driven ventilator. It has a dynamic range of breathing gas delivery that provides for neonatal through adult patients. Its user interface module provides maximum flexibility with simple operator interaction. It has a flat panel color LCD with real time charting and digital monitoring capabilities, a touch screen for interaction, membrane keys and a dial for changing settings and operating parameters. It also has an internal gas delivery system with servo controlled active inhalation and exhalation functions. The AVEA may be configured as a conventional ventilator or non-invasive positive pressure ventilator (NPPV). It has been designed to function using most commonly available accessories.

The provided text is a 510(k) summary for the AVEA Ventilator. It describes the device, its intended use, and states that performance testing and analysis verified the device meets its requirements and is substantially equivalent to legally marketed predicate devices. However, it does not contain the specific details required to complete your request: acceptance criteria, reported device performance metrics, and the specifics of a study proving those criteria were met.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or details about the study, as that information is not present in the provided document.

Here's a breakdown of what can be extracted and what cannot:

A. Information NOT present in the document:

1. A table of acceptance criteria and the reported device performance: The document states "Performance testing and analysis will have verified that the AVEA Ventilator meets its performance requirements," but it does not list these specific requirements or the results.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there's no mention of a diagnostic AI component requiring ground truth from experts. The device is a ventilator.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not mentioned, and generally not applicable for a device like a ventilator.
6. If a standalone study (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned, and not a typical study for a ventilator.
7. The type of ground truth used: Not applicable in the context of a ventilator's performance validation.
8. The sample size for the training set: Not applicable as no AI/algorithm training is explicitly described for a diagnostic purpose.
9. How the ground truth for the training set was established: Not applicable.

B. Information that can be inferred or stated from the document:

• Study type: The document generally refers to "Performance testing and analysis" and "Validation" which are typical for medical device clearance processes to ensure the device performs as intended and is safe and effective. It's not a diagnostic AI study.
• Purpose of the study: To demonstrate that the AVEA Ventilator meets its performance requirements and is substantially equivalent to predicate devices.
• Predicate Devices: A list of 7 predicate ventilators from Puritan Bennett, Drager, SIEMENS, Bear Medical Systems, Bird Products Corporation, and DATEX-OHMEDA is provided.

In summary, the provided 510(k) summary for the AVEA Ventilator does not contain the detailed study results, acceptance criteria, or methodological specifics typically found in a clinical study report for an AI/diagnostic device that would allow me to populate your request. It primarily focuses on the regulatory submission process and substantial equivalence to existing devices.

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The Orion Nasal CPAP System is intended for treatment of Obstructive Sleep Apnea (OSA). Obstructive Sleep Apnea is defined as the absence of air movement in ten seconds during sleep. Obstructive Sleep Apnea is usually diagnosed through a sleep study. The study obtains the optimum level of pressure required to maintain airway pressure to the obstructed airway. The positive pressure allows the airway to stay open. The Orion Nasal CPAP System is intended only for spontaneously breathing patients.

The Orion Nasal CPAP System is intended to provide continuous positive airway pressure for the care and treatment of individuals suffering from obstructive sleep apnea. The positive pressure is clinician-adjustable within the designed operating range, and a clinicianadjustable time allows at timed rise to the set pressure. The user controls are limited to an On/Off switch and the optional pre-set time rise to the set pressure. This device is designed to be used with a 22-millimeter, smooth-bore air delivery hose and user-selected nasal or face mask. The Orion consists of a plastic enclosure that surrounds a power supply, impeller and motor, microprocessor, motor controller, display and switch inputs.

Here's an analysis of the provided text regarding the Orion Nasal CPAP System's acceptance criteria and studies, organized according to your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not specify a sample size or data provenance (e.g., country of origin, retrospective/prospective) for any test set involving patients or clinical data. The performance testing described is limited to laboratory verification of device functions and compliance with engineering and safety standards.

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

Given that the performance testing was laboratory-based and focused on engineering specifications and safety standards, there is no mention of experts establishing a "ground truth" in a clinical sense for a test set. The "ground truth" here would be the engineering specifications and international standards, which are evaluated through direct measurement and compliance testing.

4. Adjudication Method for the Test Set

As the testing was primarily laboratory-based and focused on objective measurements against engineering specifications and international standards, an adjudication method is not applicable in the context of clinical evaluation or expert consensus. Compliance was determined by direct measurement and verification.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or reported. The provided information solely pertains to the device's functional performance, electrical safety, and EMC in a laboratory setting, and its substantial equivalence to a predicate device. There is no mention of human readers or AI assistance in the context of this submission.

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

No, a standalone study describing the performance of an algorithm without human-in-the-loop interaction was not done or reported. The Orion Nasal CPAP System is a hardware device, not an AI or algorithmic diagnostic tool.

7. The Type of Ground Truth Used

The "ground truth" used for the reported performance testing was primarily engineering specifications and internationally accepted standards for electrical safety and electromagnetic compatibility. This is demonstrated by statements like "all functions were verified to operate as designed and intended, and measured parameters met required ranges and accuracies" and "the Orion complied with the requirements of these standards."

8. The Sample Size for the Training Set

The provided text does not mention a training set sample size. This is because the device described is a physical medical device (CPAP machine) and not an AI or machine learning model that would require a "training set" in the conventional sense.

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

Since there is no mention of a training set, the question of how its ground truth was established is not applicable to this device submission.

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The TBird VELA Ventilator is intended to provide continuous or intermittent mechanical ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 10 kg (22 lbs.), who require the following general types of ventilatory support, as prescribed by an attending physician:

• Positive pressure ventilation .
• Assist/Control, SIMV, CPAP modes of ventilation .

The ventilator is suitable for use in institutional and transport settings. It is not intended for use as an emergency medical transport ventilator.

The TBird VELA Ventilator employs a turbine gas delivery system along with microprocessor control to provide support for pediatric to adult patients. Capable of delivering clinically advanced modes of ventilation like Pressure Support with an internal battery or AC power the TBird VELA Ventilator has an extensive patient range.

The TBird VELA Ventilator ventilator pneumatic system is an electromechanical system comprised of four major subsystems, each containing several components. These systems include the flow delivery system, the exhalation system, the safety system and the inspiratory hold valve.

This electromechanical system controls all inspiratory flow to the patient. The exhalation system controls the flow of gas from the patient's lungs during the exhalation phase. The mechanical safety system ensures that the patient can breath spontaneously from room air and that the patient pressure is limited to a maximum value in the event of a ventilator malfunction. When activated, the inspiratory hold valve blocks flow between the flow delivery system and the patient.

The TBird VELA Ventilator ventilator electronic system is comprised of several subsystems, each containing numerous components. These subsystems include the Graphical User Interface System, the Power System, the Main Controller System, Exhalation, and Flow Delivery systems. The Display System is comprised of three Alarm Setpoint Displays, seven Control Setpoint Displays, up to forty-eight Message Display characters, up to twentyfive Discrete Indicators, and a bargraph style Manometer. The Main Controller System is comprised of three Pressure Transducers, an Analog-to-Digital Converter, two Digital-to-Analog Converters, the Input-Output Processor, Solenoid Valves, and the Watchdog and Hardware Fault Monitors. The Power System conditions and controls energy from the AC line input, the internal battery, and the optional external battery pack. When energy is available from the AC line, the ventilator operates from this source, as well as recharging the internal battery.

The manufacturer states that "Performance testing verified that the TBird VELA Ventilator meets it's performance requirements and that this device is substantially equivalent to medical devices currently legally marketed in the United States."

However, this submission does not provide any specific acceptance criteria or detailed results of the performance testing. It only makes a general statement about meeting performance requirements and substantial equivalence.

Therefore, many of the requested details cannot be extracted from the provided text.

Here is a summary of what can and cannot be provided based on the given document:

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):

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).

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):

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

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

• Adjudication Method: 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:

• MRMC Study: Not mentioned or implied. The device is a ventilator, not an AI-assisted diagnostic tool for human readers.

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

• This question is not entirely applicable in the context of a ventilator. The "performance testing" would likely refer to the device's functional performance in delivering ventilation according to its specifications, rather than an algorithm's diagnostic performance. No details are given about the methodology of this testing.

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

• Ground Truth: Not specified. For a ventilator, "ground truth" would generally refer to established engineering standards, physiological measurements, and clinical outcomes for evaluating its performance. However, no details on how "performance requirements" were assessed are provided.

8. The sample size for the training set:

• Sample Size for Training Set: Not applicable/not specified. Ventilators do not typically have "training sets" in the same way AI algorithms do. Their development involves engineering design, prototyping, and testing against specified performance criteria.

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

• Ground Truth for Training Set: Not applicable/not specified. (See point 8).

In summary, the provided document is a 510(k) summary for a ventilator, focusing on its description, intended use, and substantial equivalence to predicate devices. It states that performance testing was conducted to verify that the device meets its requirements, but it does not provide any specific details about the acceptance criteria, study design, sample sizes, or results of that testing.

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The nasal CPAP unit is intended for treatment of adult Obstructive Sleep Apnea (OSA). Obstructive sleep apnea is defined as the absence of air movement for ten seconds during sleep. Obstructive sleep apnea is usually diagnosed by a sleep study. The study obtains the optimum level of pressure required to maintain an unobstructed airway, the positive pressure allows the is ve or prosuropen. The nasal CPAP unit is intended only for spontaneously breathing adult patients.

The SoftAire Nasal CPAP System is intended to provide continuous positive airway pressure for the care and treatment of individuals suffering from obstructive sleep apnea. The positive pressure is clinician adjustable within the designated operating range and a clinician adjustable timer will allow timed rise to pressure ("Ramp" mode). The user controls will be limited to an on/off switch and option of using the timed pressure rise. This product is designed to be used with a 22 millimeter (smooth bore) tube air delivery system and user selected nasal mask. This mask is not marketed by Bird. Power will be provided by AC to DC adapter s which accommodate a variety of input voltages and frequencies. This adapter will plug into a 12 VDC connector on the side of the unit. The SoftAire Nasal CPAP System does not utilize an actively controlled exhalation valve. The patient circuit consists of two essential parts: a large-bore tube from the ventilator to the patient and a required exhaust port. The exhaust is an orifice which may be part of the adapter between the tubing an the patient mask, or may be an orifice which is part of the patient mask.

Acceptance Criteria and Device Performance for SoftAire Nasal CPAP System

1. Table of Acceptance Criteria and Reported Device Performance

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The VIP Bird Gold and VIP Sterling are ventilators intended to treat respiratory failure or respiratory insufficiency, in neonatal, infant and pediatric patients. The ventilators are intended for institutional use only, and not for emergency medical transport or home use.

The V.I.P Bird ventilator is a self-contained unit, combining an advanced pneumatic system with microprocessor -based technology. The result is a state-of-the-art ventilator system capable of providing excellent patient monitoring. Packaged in a compact lightweight unit, the V.I.P. Bird Gold/Sterling will incorporate all previous function of the V.I.P. Bird and the addition of Pressure Control mode of ventilation with Variable Rise Time, Volume Assured Pressure Support, Flow Triggering in Volume modes and a decelerating waveform. Other enhancements include expanded control setting range for Tidal Volume, improved resolution for the Inspiratory Time and Peak Flow controls. These specifications also include the volume monitoring functions of the Partner IIi.

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, experimental studies, sample sizes, expert involvement, or ground truth establishment. The document is a 510(k) summary and an FDA clearance letter for a medical device (ventilator), primarily focused on declaring substantial equivalence to predicate devices and outlining regulatory compliance. It does not contain the kind of detailed technical study information that your request asks for.

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The Bird Monitor Interface (BMI) is a stand-alone unit providing a means of communicating information from Bird ventilators to patient monitoring systems. Specific interfaces to the Hewlett-Packard Merlin and SpaceLab's PDMS are provided. as well as a Bird proprietary interface for use with other systems. The purpose of BMI is to deliver ventilator settings, monitored values, alarm information and waveform data to the patient monitoring system.

The Bird Monitoring Interface (BMI) is a stand-alone unit providing a communications interface between the Bird ventilators, 8400STi, VIP and TBird, and patient monitoring systems. Specific interfaces to the Hewlett-Packard Merlin (via Hewlett-Packard's Vuelink proprietary interface) and SpaceLab's PDMS (via Spacelab's Universal Flexport proprietarv interface) are provided as well as a Bird proprietary interface, the General Purpose Computer Protocol (GPCP), for use with other systems. The purpose of the BMI is to deliver ventilator settings, monitored values, alarm information and waveform data to the patient monitoring system. The BMI has no user-operated controls or displays. This device is activated when it is attached to a 9 to 15 Volt power supply and fully functional when attached to the ventilator and patient monitoring system. Indicators are limited to a power indicator. The BMI is installed between the ventilator and the Patient Monitoring System. Connection between the ventilator and the BMI is Fiber Optic. Connection between the BMI and the Patient Monitoring System is RS-232 compatible. The BMI also contains a fiber optic feed-through for connection to Bird accessories, particularly the Bird Graphics Monitor and The Partner Volume Monitor. Serial data is received from the ventilator over the fiber optic interface. The fiber optic signal is converted to an electrical signal by a fiber optic receiver. The electrical signal then routes to a fiber optic driver for connection to an accessory device as described above. The electrical signal also routes to the serial input of the microprocessor where the serial data is converted to parallel data. The parallel data is then stored in random access memory (RAM) for future use. Program code for the microprocessor is contained in an electrically programmable read only memory (EPROM) and is accessed as necessary for program execution. Requests from the monitoring system are received as serial RS-232 signals. These signals are converted to logic levels by RS-232 receivers. These logic levels then are processed bv a universal asynchronous receiver transmitter (UART). The UART converts the serial data to parallel data and then notifies the microprocessor by using the interrupt signal. The microprocessor reads the data from the UART, forming a request packet from the monitor. Following receipt of a complete request packet from the monitor, the processor generates the appropriate response packet from the ventilator data stored in RAM. This data is written to the UART, which converts the data to serial form. The serial data is then converted to RS-232 signals and transmitted to the monitor.

The Bird Monitor Interface (BMI) is a communication device, not a diagnostic or AI-powered system that would typically undergo studies involving expert adjudication, MRMC, or training sets in the way more complex medical imaging or AI-driven diagnostic devices would. Its "performance" is based on its ability to accurately transmit data as designed.

Here's the information based on the provided text, recognizing the nature of this device:

Acceptance Criteria and Device Performance

The acceptance criteria for the Bird Monitor Interface (BMI) are derived from its design specifications and its ability to communicate specific data points between Bird ventilators and patient monitoring systems, as well as its compliance with various electrical, environmental, and safety standards. The study performed was focused on verifying that all these specified functions operated as designed.

1. Table of Acceptance Criteria and Reported Device Performance

Study Details:

The provided document describes a performance testing study conducted to verify the functionality and compliance of the Bird Monitor Interface.

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

• Sample Size: The document does not specify a numerical "sample size" in terms of number of devices tested or data points collected for the functional verification. Instead, it states that "All functions were verified to operate as designed and intended." This implies comprehensive testing against each listed function rather than statistical sampling of performance.
• Data Provenance: The testing was conducted "in the laboratory." Environmental, EMI/RFI, and Electrical Safety Standards testing were performed by "certified test facilities." This indicates a controlled, simulated environment, not clinical data from patients or specific geographical origins. The testing is retrospective in nature, verifying the device's adherence to its design specifications.

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

• Number of Experts/Qualifications: Not applicable for this type of device. The ground truth is the device's design specifications and accepted engineering and safety standards (e.g., IEC, CISPR, MIL-STD, FDA Reviewer's Guidance). The "experts" would be the engineers and technicians involved in the design and testing process, and the personnel at the certified test facilities who conduct the standard compliance tests. No clinical "expert" consensus was required as the device's function is data transmission, not clinical interpretation.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:

• Adjudication Method: Not applicable. Functional verification against engineering specifications and industry standards does not involve adjudication by multiple human observers as would be the case for diagnostic accuracy studies. The "adjudication" is essentially a pass/fail determination based on whether the device performs according to its predefined requirements.

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:

• MRMC Study: No. The Bird Monitor Interface is not an AI-powered diagnostic device or an assistive technology for human readers/clinicians, therefore, an MRMC comparative effectiveness study was not performed.

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

• Standalone Performance: Yes, in essence. The "performance testing" described is for the device operating independently to transmit data as specified. While it interfaces with other systems (ventilators and patient monitors), its functionality is standalone in terms of correctly handling and transmitting the data according to its programmed logic. The testing verified the algorithm's (microprocessor's) ability to process and transmit data as per design.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

• Type of Ground Truth: The ground truth for this device's performance is its design specifications and compliance with recognized national and international engineering, electrical safety, environmental, and electromagnetic compatibility standards (e.g., IEC601-1, CISPR11, MIL-5TD462D, IEC801-2, IEC801-4, IEC 68 series). The "truth" is whether the data transmitted matches the data received from the ventilator, and whether the device operates reliably and safely according to these standards.

8. The Sample Size for the Training Set:

• Training Set Sample Size: Not applicable. The Bird Monitor Interface is a hardware device with embedded software (firmware) that performs predefined functions. It does not utilize machine learning or AI that requires a "training set" to learn patterns or make predictions. The software is programmed deterministically.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for this device. The "ground truth" for the device's functionality is established during its design and engineering phases, based on functional requirements derived from the intended use and compliance standards.

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The TBird Homecare ventilator is intended to provide continuous or intermittent mechanical ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 10 kg (22 lbs.), who require the following general types of ventilatory support, as prescribed by an attending physician:

• Positive pressure ventilation .
• . Assist/Control, SIMV, CPAP modes of ventilation

The ventilator is suitable for use in institutional and home settings.

The TBird Homecare ventilator employs a revolutionary turbine gas delivery system along with sophisticated microprocessor control to provide support for pediatric to adult patients. Capable of delivering clinically advanced modes of ventilation like Pressure Support with an internal battery or AC power the TBird Homecare has an extensive patient range.

Here's an analysis of the provided text regarding the TBird Homecare Volume Ventilator, focusing on acceptance criteria and supporting studies:

It is important to note that the provided document is a 510(k) Summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive, detailed clinical study results in the same way a PMA (Premarket Approval) submission would. As such, direct "acceptance criteria" and detailed "study" information as one might expect for a new, novel device might not be explicitly present in this format. The "study" here largely refers to the verification testing against standards.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Study Details

Given that this is a 510(k) for a modification (intended use for home care) and claims substantial equivalence, the "study" described is primarily verification testing against recognized standards and comparison to predicate devices, rather than a clinical trial.

2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify a "test set" in the context of patient data or clinical samples. Instead, it refers to performance testing of the device itself.

• Sample Size: Not applicable in the context of patient data for this type of submission. Performance testing would involve multiple runs and measurements on the device, but specific numbers are not provided.
• Data Provenance: The device "has been verified to meet the requirements of ASTM F1246 (1991)." This implies engineering and bench testing data, rather than clinical data from a specific country. This type of data is internal to the manufacturer's testing and development process. It is "prospective" in the sense that the device was designed and tested to meet these standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable to this type of submission. The "ground truth" for verifying a device against a standard like ASTM F1246 is the standard itself and the objective measurements performed by engineers and technicians during verification testing. There were no "experts" establishing ground truth in the sense of clinical consensus on patient cases.

4. Adjudication Method for the Test Set
Not applicable. There was no clinical "test set" requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a ventilator, not an imaging or diagnostic device that would typically involve "human readers" or "AI assistance" in the way implied by an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device, a ventilator, which inherently has human interaction (healthcare provider setting parameters, patient use). The "standalone" performance here refers to the device's ability to meet its technical specifications independently, which is covered by the performance testing against standards.

7. The Type of Ground Truth Used
The "ground truth" for the device's performance is derived from:

• Technical Specifications and Design Requirements: The device was designed to achieve certain measurable performance characteristics (e.g., flow rates, pressure control, alarm ranges, battery life).
• Recognized Standards: ASTM F1246 (1991) served as a primary ground truth for homecare ventilator requirements.
• Predicate Device Performance: The functional capabilities and safety profiles of the already marketed TBird VS, Aequitron LP10, and Bear 33 Volume Ventilators served as benchmarks for demonstrating substantial equivalence.

8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm trained on data in the modern sense. The "training" for the device's control system would be the engineering design and software development, refined through iterative testing and calibration.

9. How the Ground Truth for the Training Set Was Established
Not applicable as there is no "training set" in the context of AI/ML. The "ground truth" for the ventilator's functional design and control algorithms would have been established through:

• Physiological Principles: Understanding of respiratory mechanics, gas exchange, and patient ventilation needs.
• Engineering Principles: Control theory, fluid dynamics, electrical engineering, materials science, and software development best practices.
• Clinical Requirements and Standards of Care: How ventilators are used clinically and the parameters necessary for effective and safe patient support. This informs the algorithms and control logic.

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