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The New Aera Tidal Assist™ Ventilator, with accessories, is a volume assist ventilator intended to aid adult patients with respiratory insufficiency. It is designed for patients who are capable of spontaneously breathing a minimum tidal volume of 3.5cc/kg of predicted body weight. The device is designed for continuous applications such as patient ambulation, physical therapy, occupational therapy, respiratory therapy, and other rehabilitation efforts in an institutional or home care environment. The device is intended for operation by trained personnel, patients or caregivers under the direction of a physician.

The New Aera Tidal Assist Ventilation (TAV) system comprises a small, lightweight, wearable, battery-powered ventilator, TAV-C100, and a nasal pillow interface, TAV-NP10. The system is intended to connect to an air or oxygen source and supports three modes of delivery:

• Tidal Assist mode, a breath-activated ventilation assist mode in which the delivered gas from the source entrains additional room air at the nasal pillows interface, delivering it under positive pressure during the patient's inhalation to assist breathing;
• Conserve mode, a breath-activated delivery mode used to conserve oxygen consumption when using a cylinder with regulator; and
• Constant mode, presenting a continuous 1 – 5 LPM flow of oxygen to the patient.
  For the Tidal Assist mode, the user may select one of five flow delivery settings, corresponding to a delivered minute volume of approximately 1 - 5 LPM.
  For the Conserve mode, the user may select one of five pulse delivery settings, corresponding to an equivalent gas flow rate of approximately 1 - 5 LPM.
  For the Constant mode, the user may select one of five flow delivery settings, corresponding to a delivered gas flow rate of approximately 1 - 5 LPM.
  The TAV system is battery operated, running from a single AA alkaline battery. Under typical usage, battery life is ~ 14 days; a low battery alert activates when battery life is less than 2 days under typical usage.
  The system has a simple user interface, comprising:
• a mode selection button;
• buttons to increase or decrease the delivered flow rate;
• a button to turn the device on and off, and to temporarily silence any alarms;
• LED indicators for the current delivery mode, flow setting, and low battery and alarm conditions; and
• an audible buzzer used to alert the user to an alarm condition.
  The device has two pneumatic ports:
• an inlet port, used to connect the regulated gas source to the device, and
• an outlet port, used to connect the device to the patient interface.
  Lastly, the device has a bypass valve, used to deliver a constant 2 LPM gas flow rate to the patient in the event of a system failure.

The provided text describes the New Aera Tidal Assist™ Ventilator (TAV™) System and its substantial equivalence to a predicate device, the Breathe Technologies – NIOV Ventilator (BT-V2S).

Here's the breakdown of the acceptance criteria and the study information based on the provided document:

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

The document does not explicitly present a table of "acceptance criteria" for performance metrics with specific numerical targets. Instead, it compares the proposed device's features and performance to a predicate device (BT-V2S) and a reference device (Chad Evolution Model OM-900) to demonstrate substantial equivalence. The "acceptance criteria" are implied by the similarity to the predicate device and meeting general performance specifications and standards.

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The NIOV Ventilator, with accessories; is a volume assist ventilator intended to aid adult patients with respiratory insufficiency. It is designed for patients that are capable of spontaneously breathing a minimum tidel volume of 3.5 ml/kg of predicted body weight. The device is designed for continuous applications such as patient ambulation, physical therapy, respiratory therapy, and other rehabilitation efforts in an institutional or home care environment. The device is intended for operation by trained personnel, patients or their caregivers under the direction of a physician.

The Breathe Technologies NIOV Ventilator System is a battery powered, wearable, volume ventilator that augments the patient's spontaneous breathing. The NIOV Ventilator administers this physician-prescribed volume to the patient via the attached Breathe Technologies Patient Circuit (BT-PC) which inserts into the patient's tracheostomy tube, or via the Breath Technologies NIOV Pillows Interface, a type of nasal mask. The ventilator is small and light enough to be worn on a patient's belt, or slung over their shoulder. It is connected to a separate, third party, air or oxygen gas supply. The Ventilator is cleared for Institutional or Home Use.

The provided text describes the Breathe Technologies NIOV Ventilation System and its substantial equivalence to a predicate device, but it does not contain the specific information required to answer all parts of your request regarding acceptance criteria and a study proving those criteria.

Specifically, the text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed study results against specific, quantified acceptance criteria.

However, I can extract what is available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a quantified, pass/fail manner. Instead, it refers to compliance with recognized standards and guidelines. The "reported device performance" is a general statement of compliance.

The study that proves the device meets the (implied) acceptance criteria:

The study referenced is "bench testing of the device" and "Software Design and Validation process."

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

The document does not specify a "test set" sample size in the context of clinical or performance data for the device itself. It mentions "bench testing," which implies laboratory-based tests on the device, but details on the number of units tested or specific scenarios are not provided. There is no mention of data provenance like country of origin or whether it was retrospective/prospective.

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

This information is not provided. The bench testing and software validation would likely rely on engineering and technical expertise to establish "ground truth" (i.e., correct device function or output), but no details on expert numbers or qualifications are given.

4. Adjudication method for the test set

This information is not provided.

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 such study is mentioned. The device is a ventilator, not an AI-powered diagnostic imaging tool that would typically involve human readers.

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

This concept is not relevant to a mechanical ventilator like the Breathe Technologies NIOV. The device itself operates "standalone" in the sense that it performs its function (ventilation) without direct human intervention in each breath cycle, but it is operated by trained personnel, patients, or caregivers. The document indicates that "bench testing of the device" demonstrated its operation.

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

For the bench testing and software validation, the ground truth would likely be based on:

• Engineering specifications and design requirements.
• Measurements against calibrated standards for parameters like volume, pressure, flow, and timing.
• Expected behavior defined by the referenced industry standards (e.g., ASTM, IEC).

8. The sample size for the training set

This information is not provided. The device relies on embedded software and control algorithms, but the document does not discuss machine learning or "training sets" in the context of AI.

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

Not applicable, as no training set for AI is mentioned.

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The Breathe Technologies™ Ventilator, with accessories, is a volume assist ventilator intended to aid adult patients with respiratory insufficiency. It is designed for patients who are capable of spontaneously breathing a minimum tidal volume of 3.5cc/kg of predicted body weight. The device is designed for continuous applications such as patient ambulation, physical therapy, occupational therapy, respiratory therapy, and other rehabilitation efforts in an institutional or home care environment. The device is intended for operation by trained personnel, patients, or caregivers under the direction of a physician.

The Breathe Technologies Ventilator with Accessories (BT-V2S) is a small, wearable, ventilator that interfaces with proprietary nasal and tracheostomy breathing circuits.

The provided text describes the Breathe Technologies Ventilator (BT-V2S) and its accessories, and a 510(k) submission for expanded indication to include use in the Home Care Environment. The information focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed acceptance criteria or a study design in the way you've outlined for a typical AI/software device.

Specifically, the document discusses general standards and guidelines the device complies with, and "Human Factors Studies" to demonstrate proper operation by intended users. It does not provide quantitative performance metrics, sample sizes, ground truth establishment, or expert-based evaluations in the context of an AI/algorithm-driven device.

Therefore, many of the requested fields cannot be directly extracted from the provided text. I will fill in the available information and indicate where data is not present.

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

The document does not specify quantitative acceptance criteria or performance metrics directly from a study in the format typically seen for AI/diagnostic devices. Instead, it states that the device is compliant with various industry standards and guidelines, and that "Human Factors Studies" demonstrated proper operation.

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

The document mentions "three Human Factors Studies" but does not provide sample sizes for these studies or their data provenance (e.g., country of origin, retrospective/prospective nature), beyond stating "The first study was with clinicians, and the second was with respiratory therapy patients."

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

Not applicable. This device is a mechanical ventilator, and the studies mentioned are Human Factors studies focused on usability and proper operation, not diagnostic accuracy requiring expert ground truth in the traditional sense of medical image analysis. The "experts" would likely be the clinicians and patients participating in the Human Factors studies.

4. Adjudication method for the test set

Not applicable. Adjudication methods are typically relevant for establishing ground truth in diagnostic studies, which is not the type of study described here.

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 not an AI-driven device, and no MRMC study is mentioned.

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

Not applicable. This is not an AI-driven device.

7. The type of ground truth used

For the Human Factors studies, the "ground truth" was likely defined by observational data and user feedback demonstrating the ability of users (clinicians, patients, caregivers) to safely and effectively operate the device according to its instructions and design, and to identify and address any usability issues. This is not a pathology or outcomes data ground truth in the diagnostic sense.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The "training" here refers to the actual training of users on how to operate the device.

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

Not applicable. See point 8.

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The Breathe Technologies Ventilator (BT-V2S), with Accessories, is a volume assist ventilator intended to aid adult patients with respiratory insufficiency. It is designed for patients, with or without a tracheostomy, that are capable of spontaneously breathing a minimum tidal volume of 3.5cc/kg of predicted body weight. The device is designed for continuous applications such as patient ambulation, physical therapy, occupational therapy, respiratory therapy, and other rehabilitation efforts in an institutional environment. The device is intended for operation by trained personnel under the direction of a physician.

This application is being filed to allow a new breathing circuit for the Breathe Technologies Ventilator (BT-V2). The Ventilator is fundamentally unchanged. The only difference between the predicate and application submissions is that the application requests clearance to market the BT-NT nasal interface with the BT-V2S ventilator.

The BT-NT is a nasal mask style patient circuit which attaches to the patients nose. It connects to the BT-V2S ventilator.

The BT-NT is approximately 12cm wide and 2cm thick at its thickest point under the patient's nose. These dimensions do not include the 231 cm dual tubing that connects to the Ventilator. It is composed of various plastics.

The provided document is a 510(k) Summary for a medical device modification (BT-V2S Ventilator and accessories). It states that the device is substantially equivalent to a predicate device, meaning it does not claim to offer superior performance or new functionalities that require extensive studies to prove acceptance criteria. Instead, the focus is on demonstrating that the modification (a new nasal interface breathing circuit, BT-NT) does not introduce new safety or efficacy concerns and that the device remains compliant with existing standards.

Therefore, the document does not contain the information requested in points 1-9 regarding the acceptance criteria, sample sizes, ground truth establishment, or expert involvement for a study proving device performance against specific acceptance criteria in the way one would expect for a novel AI/Diagnostic device.

Here's a breakdown of what is available and why most of the requested information is absent:

Explanation of Missing Information:

This document describes a "Special 510(k): Device Modification" for a ventilator. The core claim is "substantial equivalence" to a predicate device (BT-V2). This means the manufacturer is asserting that the modified device is as safe and effective as the previously cleared device, not that it is a new device with novel performance claims requiring rigorous clinical trials or AI performance evaluations. The modification here is specifically a "new breathing circuit for the Breathe Technologies Ventilator (BT-V2S)."

Therefore, the study performed is primarily bench testing and biocompatibility to prove that the modification does not negatively impact the existing performance and safety of the ventilator. This is fundamentally different from a study to establish novel performance metrics for AI or diagnostic accuracy where many of your questions would be highly relevant.

Information from the Document (and limitations):

1. Table of acceptance criteria and the reported device performance:

   • Acceptance Criteria (Implied): Compliance with
     • ISO 10993 (Biocompatibility)
     • FDA Draft Reviewer Guide for Ventilators (July 1995)
     • ASTM F1100 90 (1997), Standard Specification for Ventilators Intended for Use in Critical Care
     • IEC 60601 1 (1988), Amendment 1 (1991-11), Amendment 2 (1995): Medical electrical equipment - General Requirements for Safety
     • IEC 60601 2- 12 (2001-10): Medical electrical equipment - Particular requirements for the safety of lung ventilators - Critical care ventilators.
   • Reported Device Performance:
     • Biocompatibility data demonstrates that the device is in compliance with ISO 10993.
     • Bench testing, including a lung model, has demonstrated that the BT-V2S remains in compliance with the expectations of the medical community, the product labeling, and the listed Standards and Guidances.
     • The document states: "The testing described below demonstrates that the differences in the devices do not raise any unresolved issues of safety or efficacy."

2. Sample size used for the test set and the data provenance: Not applicable. The "study" was bench testing (likely involving physical units of the ventilator and the new breathing circuit). There is no "test set" in the context of patient data, nor is there data provenance (e.g., country of origin, retrospective/prospective) for a bench test.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in this context, refers to the compliance with established engineering and medical device standards, which are evaluated by accredited labs and engineers, not typically by clinical experts establishing diagnostic "ground truth."

4. Adjudication method for the test set: Not applicable. There is no "adjudication" in the sense of resolving disagreements among experts on a test set. Compliance is determined by objective measurements against specified standard thresholds.

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 AI-powered diagnostic tool, and no MRMC study was performed or needed for this type of modification.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-only device.

7. The type of ground truth used: "Ground truth" was compliance with established engineering and medical device standards (ISO, ASTM, IEC) and the "expectations of the medical community" for ventilator performance, as verified through bench testing.

8. The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established: Not applicable, as there is no training set for this type of device.

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The Breathe Technologies™ Ventilator BT-V2S, with accessories, is a volume assist ventilator intended to aid adult patients with respiratory in u vouln'is assist patients with a tracheostomy that are capable of spontaneously breathing a minimum tidal volume of 3.5cc/kg of predicted body weight. The device is designed for continuous applications such as patient ambulation, physical therapy, occurational therapy, respiratory therapy, and other rehabilitation efforts in an institutional environment. The device is intended for operation by trained personnel under the direction of a plysician

The Breathe Technologies™ Ventilator (BT-V2S) is a battery powered (which may be charged during use) wearable, volume ventilator that augments the patient's spontaneous breathing. The BT-V2S administers this physician-prescribed volume to the patient via the attached Breathe Technologies Patient Circuit (BT-PC). The end of the BT-PC is inserted into the patient's tracheostomy tube. The ventilator is small and light enough to be worn on a patient's belt, or slung over their shoulder.

The provided text describes a 510(k) premarket notification for the Breathe Technologies BT-V2S Ventilator. This submission focuses on demonstrating substantial equivalence to a predicate device (BT-VS) rather than presenting a de novo study with acceptance criteria and performance metrics for a new, unclassified device.

Therefore, the input document does not contain the acceptance criteria and study data typically associated with proving a device meets specific performance criteria through a clinical or rigorous standalone study. It primarily states that "Bench testing has demonstrated that the device is in compliance with the medical community's expectations, the product labeling and pertinent sections of the guidance's and standards."

Without a separate study report or detailed performance data, it's not possible to populate the requested table or answer most of the questions.

However, I can extract the information provided:

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

The document explicitly states: "Bench testing has demonstrated that the device is in compliance with the medical community's expectations, the product labeling and pertinent sections of the guidance's and standards." This implies that the 'acceptance criteria' were likely defined by those standards and expectations, and the 'reported device performance' was that it met them. However, the specific quantitative criteria and results are not provided in this document.

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. The document refers to "bench testing," not a test set with patient data or a clinical study.

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. No test set with ground truth established by experts is mentioned. The "medical community's expectations" are a general reference, not a specific expert panel.

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

Not applicable. No test set with adjudication is mentioned.

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 not an AI-assisted device, and no MRMC study is mentioned.

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

Not applicable. This is not an algorithm-only device. The ventilatory function is directly interacting with the patient. The statement "Bench testing has demonstrated that the device is in compliance..." refers to the device's physical and functional performance, which is inherently "standalone" in the sense that it's the device's performance being assessed against engineering and medical standards.

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

For the bench testing, the "ground truth" would be the engineering specifications, relevant industry standards (e.g., ISO 10993 for biocompatibility), and "medical community's expectations" related to ventilator performance. The document doesn't provide specifics on how these were quantified for each test.

8. The sample size for the training set:

Not applicable. This is a ventilator device, not a machine learning algorithm requiring a training set.

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

Not applicable, for the same reason as point 8.

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The Breathe Technologies™ Ventilator, with accessories, is a volume assist ventilator intended to aid adult patients with respiratory insufficiency. It is designed for patients with a tracheostomy that are capable of spontaneously breathing a minimum tidal volume of 3.5cc/kg of predicted body weight. The device is designed for continuous applications such as patient ambulation, physical therapy, occupational therapy, respiratory therapy, and other rehabilitation efforts in an institutional environment. The device is intended for operation by trained personnel under the direction of a physician.

The Breathe Technologies™ Ventilator (BT-V) is a battery powered, wearable, volume ventilator that augments the patient's spontaneous breathing. The BT-V administers this physician-prescribed volume to the patient via the attached Breathe Technologies Transtracheal Tube (BT-TT). The end of the BT-TT is inserted into the patient's tracheostomy tube. The ventilator is small and light enough to be worn on a patient's belt, or slung over their shoulder, because it has only a subset of the features of a full-featured ventilator.

The document provided is a 510(k) summary for the Breathe Technologies Ventilator & Accessories, indicating FDA clearance, but it does not contain detailed information about specific acceptance criteria, device performance metrics, or the study that proves the device meets those criteria in the format requested.

The document primarily focuses on:

• Device Description and Intended Use: Explaining what the device is, who it's for, and how it's used.
• Comparison to Predicate Devices: Asserting substantial equivalence to existing ventilators.
• Summary of Supporting Data (High-Level): Mentioning biocompatibility and bench testing compliance with "medical community's expectations," "product labeling," and "pertinent sections of the guidance's and standards."

Therefore, I cannot populate the requested table or provide detailed answers to most of the study-related questions based on the provided text.

Here's what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size for the test set: Not specified in the provided document. The document mentions "bench testing" but does not give details about the size or nature of any test set used in a clinical or performance study.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not specified.

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

• This information is not available in the provided document. The document refers to "bench testing" and compliance with "medical community's expectations," but no details on expert involvement for ground truth establishment are given.

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

• 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 applicable/Not mentioned. This device is a ventilator, not an imaging or diagnostic device typically evaluated with MRMC studies or AI assistance in the context of "human readers."

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

• Not applicable/Not mentioned. This is a physical medical device (ventilator), not an algorithm or AI system. Its performance would be evaluated as a standalone device, as hinted by "bench testing."

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

• Not explicitly defined. For a ventilator, ground truth would typically relate to meeting physiological performance parameters, safety standards, and functional specifications. The document only references "compliance with the medical community's expectations, the product labeling and the pertinent sections of the guidance's and standards" and "bench testing."

8. The sample size for the training set

• Not applicable/Not mentioned. This device is not described as involving machine learning or AI models with training sets.

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

• Not applicable/Not mentioned. (See point 8)

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