(287 days)
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.
| Feature | Acceptance Criteria (Implied from Predicate/Standards) | Reported Device Performance (Pegaso V) |
|---|---|---|
| Indications for Use | Equivalent to Lifecare NEV-100: Support patient's ventilation by alternately applying and releasing external negative pressure over the diaphragm and upper trunk; works with cuirass, poncho, or ventilating chamber. | 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; works with a cuirass, poncho, or ventilating chamber (Porta-Lung). (Stated as equivalent) |
| Voltage | Comparable to Lifecare NEV-100 (120-240Vac) | 110-230Vac |
| Frequency | Comparable to Lifecare NEV-100 (50/60 Hz) | 50/60 Hz |
| Power | Comparable to Lifecare NEV-100 (500W/600W) | 400W |
| Use settings | Comparable to Lifecare NEV-100 (Home, hospital, institution) | Home, hospital, institution |
| Patient Use | Comparable to Lifecare NEV-100 (Adult) | Adult |
| Negative Pressure I | Comparable to Lifecare NEV-100 (Adjustable -5 to -100 cm H2O) | Variable from 0 to -99 cm H2O |
| Positive/Negative Pressure E | Not specified for predicate | Variable from +99 to -25 cm H2O |
| Frequency (bpm) | Comparable to Lifecare NEV-100 (4 to 60 bpm) | Variable from 5 to 50 bpm |
| I/E Ratio | Comparable to Lifecare NEV-100 (Adjustable 1:0.5 to 1:29.1) | Variable from 1/0.5 to 1/99 (based on present frequency and adjustable to clinician's selected setting) |
| Controls | Comparable to Lifecare NEV-100 (Menu driven, software controlled) | Menu driven, software controlled |
| Inspiratory Time (Ti) | Comparable to Lifecare NEV-100 (0.5 to 5.0 seconds) | 0.1 to 5.0 seconds |
| Modes | Comparable to Lifecare NEV-100 (Controlled ventilation, Assisted controlled ventilation) | Controlled ventilation, Assisted controlled ventilation, Continuous negative, Assisted with Plateau |
| Alarms | Comparable to Lifecare NEV-100 (High and Low respiratory pressure, Power Failure, Constant Pressure, Internal failure) | High and Low respiratory pressure, Power Failure |
| Weight | Comparable to Lifecare NEV-100 (31 pounds) | 14.3 pounds |
| Electrical Safety | Meet IEC 60601 standards (e.g., UL, TUV, CSA for predicate) | EN 60601 |
| Standards | Meet UL 747Y (for predicate cough assist) | EN 60601-1, EN 60601-1-2, EN 60601-1-4 |
| EMC | Meet UL, TUV, FCC Part 15, CSA, Class B (for predicate) | EN 60601-1-2, FCC Part 15, Class B |
| Environmental Temperature | Comparable to Lifecare NEV-100 (41° F to 104° F) | 50° F to 122° F |
| Safety | Device Safety is demonstrated through meeting device safety standards IEC, EN 60601-1-2, EN ISO 9703-3, EN 794-1, and EN 794-2. (This is stated directly as how device safety is demonstrated). Compliance with these specific standards constitutes the acceptance criteria for safety. | "Device Safety is demonstrated through meeting device safety standards IEC, EN 60601-1-2, EN ISO 9703-3, EN 794-1, and EN 794-2." The document states this directly, indicating compliance with these standards as the performance. |
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.
- 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.
- 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.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- 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.
- 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.
- 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.
- How the ground truth for the training set was established: Not applicable.
§ 868.5935 External negative pressure ventilator.
(a)
Identification. An external negative pressure ventilator (e.g., iron lung, cuirass) is a device chamber 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.(b)
Classification. Class II (performance standards).