(57 days)
The EvitaXL is a long-term ventilator for intensive care for adults, children, and infants with a body weight of at least 3 kg (6.6 lbs). With SmartCare™/PS the EvitaXL is intended to stabilize the patient's spontaneous breathing in a "comfortable zone" and to reduce inspiratory support for adults and children with a body weight of at least 15 kg (33 lbs). The patients should be haemodynamically stable with adequate oxygenation and spontaneous breathing. SmartCare can be used for intubated or tracheotomized patients. Patients must be endotracheally intubated and ventilated with active humidification. SmartCare™/PS is contraindicated in case of severe COPD and severe neurologic disorder that effects the cerebral control mechanism of the spontaneous breathing pattern.
The EvitaXL is a time-cycled microprocessor-controlled intensive care ventilator. For the EvitaXL a new system called SmartCare™ has been developed for assisting physicians and respiratory therapists with the standardization of the weaning process used in intensive care units. The system uses a strategy that gradually reduces the level of assistance, at a rate that is guided by a patient's tolerance, while measuring his/her capacity to breathe without mechanical assistance. The SmartCare / PS system refers to measured patient data and adjusts the pressure support provided by EvitaXL for intubated or tracheotomized patients. SmartCare / PS essentially uses three parameters measured by EvitaXL: respiratory rate, tidal volume, and expiratory CO2 concentration. It controls the level of pressure (PSupp. above PEEP) during ventilation in CPAP/PS mode. SmartCare / PS has three main functions: automatic adaptation of ventilatory assistance, automatic weaning strategy, automation of the weaning test. Physically, the SmartCare / PS system has been accomplished by adding a printed circuit board and software.
The provided text describes the SmartCare/PS option for the EvitaXL intensive care ventilator. However, it does not explicitly detail acceptance criteria in a quantitative table or the specific study that proves the device meets those criteria with performance metrics. It rather indicates that "Effectiveness of the SmartCare protocol has sufficiently been demonstrated by means of clinical studies on a comparison to current ventilator standard of care." and that Dräger Medical AG & Co. KGaA "has demonstrated the SmartCare system to be as safe and as effective as the referenced predicate devices."
Therefore, many of the requested details are not available in the provided document.
Here's a summary of what can be extracted based on the input:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table of acceptance criteria with specific quantitative performance metrics. It generally states that the device is "as safe and as effective as the referenced predicate devices."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in quantitative terms | Device is described as "as safe and as effective as the referenced predicate devices." |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified. The document only mentions "clinical studies."
- Data Provenance: Not specified (e.g., country of origin, retrospective or 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 in the document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided in the document.
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:
The document mentions "clinical studies on a comparison to current ventilator standard of care" but does not describe an MRMC study or an effect size for human reader improvement with AI assistance (as this is a ventilator, not an imaging AI device where "readers" would be applicable in the same sense). The SmartCare/PS system is designed to automatically adapt ventilatory assistance and weaning strategy, reducing the need for continuous human intervention.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The SmartCare/PS system essentially operates in a standalone (algorithm-only) capacity in terms of adjusting ventilation parameters, as it "refers to measured patient data and adjusts the pressure support." It is an automated system intended to "assist physicians and respiratory therapists" by standardizing the weaning process and automatically adapting ventilatory assistance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The document refers to "clinical studies" demonstrating effectiveness, implying that a form of clinical outcomes data related to patient stabilization and weaning success would have been used as ground truth, but specific details are not provided.
8. The sample size for the training set:
Not specified. The document only mentions "clinical studies."
9. How the ground truth for the training set was established:
Not specified. The document refers to "clinical studies" but does not detail how ground truth was established for any training data.
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).