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1. Ventilation - The RTX Respirator is indicated for external ventilation of the lungs resulting in gas exchange. 2) Secretion Clearance - Also for use in assisting patients with secretion clearance management as indicated by standard medical convention. The RTX Respirator is for use in adult and pediatric patient populations. The RTX is not for use in out-of-hospital transport. For prescription use only.

The RTX Respirator is an external high and low frequency respirator, which controls both phases of respiration. It consists of a lightweight flexible cuirass, tubing with a keypad and display screen. The Cuirass is available in eleven (11) sizes for various patient populations and sizes. The Cuirass contains a disposable seal and is attached to the patient via Velcro and nylon straps. The RTX Respirator ventilates by decreasing and then increasing the pressure within the cuirass. The negative pressure creates expansion of the chest bringing about inspiration. The positive phase creates positive pressure on the chest and therefore creates expiration.

Here's an analysis of the provided 510(k) summary for the RTX Respirator, focusing on acceptance criteria and the supporting study:

The provided document, a 510(k) summary for the RTX Respirator, focuses on demonstrating substantial equivalence to predicate devices, not on proving that the device meets specific performance acceptance criteria through a standalone study with detailed metrics. The summary describes an equivalence study rather than a study defining and meeting acceptance criteria for a novel device.

Therefore, many of the requested data points (like sample size for test sets, number of experts, adjudication methods, MRMC studies, specific ground truth types, training set details) are not applicable or not provided in this type of submission which primarily addresses substantial equivalence for a medical device.

However, I can extract the information that is present and indicate where requested information is absent.

Acceptance Criteria and Device Performance (Based on Substantial Equivalence Claim)

The submission doesn't define explicit performance acceptance criteria in numerical terms that the RTX Respirator must meet. Instead, the "acceptance criteria" can be inferred as demonstrating substantial equivalence to a predicate device, meaning it performs similarly and is as safe and effective.

Study Details

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

   • Sample Size: Not explicitly stated. The summary refers to "A comparative clinical study was performed" but does not give patient numbers.
   • Data Provenance: Not specified (e.g., country of origin). The study involved a "comparative clinical study" and a "review of recent publications on the RTX Respirator," implying a mix of directly collected data and published literature. It doesn't state if it was retrospective or prospective.

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

   • Not Applicable/Not Provided. The clinical evaluation focuses on comparative outcomes to a predicate device. "Ground truth" in the context of device performance metrics (like accuracy for a diagnostic device) is not the focus here. The clinical results observed in the comparative study essentially served as the "truth" for demonstrating similar performance to the predicate.

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

   • Not Applicable/Not Provided. This method is typically used in image interpretation or diagnostic studies where expert consensus resolves discrepancies. The described clinical study is a comparative performance study of a therapeutic device.

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. This is a therapeutic device (ventilator), not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and "human readers improving with AI assistance" are not relevant to this submission.

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

   • Not Applicable/Not Provided. The RTX Respirator is a medical device, not an algorithm. Its performance is inherent to the device's function, not a computational output.

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

   • Clinical Outcomes/Performance Data: The study relied on "clinical results" to demonstrate a "similar pattern" between the RTX Respirator and the predicate Hayek Oscillator. This would involve physiological measurements and patient well-being outcomes, but specific metrics are not detailed.

7. The sample size for the training set:

   • Not Applicable/Not Provided. This is not an AI/machine learning device that requires a training set.

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

   • Not Applicable/Not Provided. As it's not an AI/ML device, there is no training set.

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The New Negavent Ventilator DA-3 Plus Pegaso V is a timed-cycled, pressure ventilator that is intended to support a patient's ventilation by alternately applying and releasing external negative pressure over the diaphragm and upper trunk of the patient. The ventilator works with a cuirass, poncho, or a ventilating chamber (Porta-Lung).

The Pegaso V is an assisted/controlled non-invasive ventilation system. It can work with a cuirass, poncho, or a ventilating chamber (Porta-Lung). An optional Trigger can be installed, sensing the spontaneous demands of the patient and permitting the use in Synchro/Timed, Spontaneous/Timed and Spontaneous with Plateau modes. If the Triggers are installed, the Autoparameters Function is enabled too, permitting the evaluation of the Respiratory Frequency and I/E Ratio of the patient in automatic mode. The negative pressure ventilation is a mechanical kind of ventilation similar to the human spontaneous ventilation. The Pegaso V is designed around a blower, used as pressure and flow generator, and a mechanical valve, commanding the sign and the air pressure intensity outing to the patient. The blower takes air from the atmosphere, compresses it in order to generate a pressure/depressure controlled by electronic sensors. Leaks are compensated cycle by cycle. The Inspiratory/Expiratory cycles are determined by the blower rotation and the mechanical valve positioning. This valve is connected to a step-motor, whose position is detected through an optical sensor. The valve lets the compressed flow go toward the patient and the depressed flow toward the atmosphere or, instead, the compressed flow to the atmosphere and the depressed flow toward the patient. The working parameters are displayed on an LCD and controlled through a touch keyboard.

The provided text describes a 510(k) premarket notification for the Pegaso V ventilator, asserting its substantial equivalence to a predicate device, the Lifecare NEV-100. The document primarily focuses on demonstrating this equivalence through a comparison of features, technical specifications, and safety standards, rather than detailing a specific study designed to meet quantitative acceptance criteria for device performance.

Therefore, many of the requested details about acceptance criteria, study sample sizes, ground truth establishment, and expert involvement are not explicitly stated in this document. The "acceptance criteria" appear to be satisfied by demonstrating substantial equivalence to the predicate device and meeting relevant electrical and safety standards.

Here's an attempt to extract and infer the information based on the provided text:

Acceptance Criteria and Reported Device Performance

The "acceptance criteria" are implied to be meeting various safety standards and demonstrating comparable performance parameters to the predicate device. The device performance is reported through a comparison table.

Study Details

The provided document is a 510(k) summary, which is a premarket notification for a medical device. It aims to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than providing detailed results of a clinical study or a standalone performance study as might be expected for an AI/CADe device.

As such, for many of the requested points, the answer is "Not applicable" or "Not provided in this document" within the context of a typical AI/CADe diagnostic device performance study.

1. Sample size used for the test set and the data provenance: Not applicable. This document does not describe a performance study with a test set of patient data. The "test" here refers to demonstrating compliance with engineering and safety standards, and comparing technical specifications to a predicate device.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" establishment in the context of diagnostic interpretation is described. The "truth" is established by engineering specifications and compliance with standards.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. The device is a ventilator, not a diagnostic imaging aid.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. Its performance is evaluated against engineering specifications and predicate device characteristics, not clinical algorithm performance.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" or basis for evaluation is the engineering specifications of the device, its function, and compliance with recognized safety and performance standards (IEC, EN standards). For substantial equivalence, the "ground truth" is the established characteristics and safety profile of the predicate device.
7. The sample size for the training set: Not applicable. The device is a hardware ventilator, not an AI model requiring a training set of data.
8. How the ground truth for the training set was established: Not applicable.

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