(88 days)
The Respironics Trilogy 200 system provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Trilogy200 is intended for pediatric through adult patients weighing at least 5 kg (11 lbs.).
The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation.
The Respironics Trilogy 200 Ventilatory Support System is a microprocessor controlled blower based pressure support, pressure control or volume controlled ventilator intended for the care of individuals who require mechanical ventilation. The ventilator is suitable for use in the institutional/hospital, home and transport settings and is applicable for adults and pediatric patients weighing at least 5 kg (11 lbs) who require the following types of ventilatory support.
- CPAP Continuous Positive Airway Pressure
- S Spontaneous Ventilation
- S/T Spontaneous and Timed Ventilation
- T Timed Ventilation
- PC Pressure Control Ventilation
- PC-SIMV Pressure Controlled Synchronized Intermittent Mandatory Ventilation
AC – Assist Control Ventilation
CV - Control Ventilation
SIMV - Synchronized Intermittent Mandatory Ventilation
A user interface displays clinical data and enables the operator to set and adjust certain clinical parameters.
The Trilogy 200 Ventilator is fitted with alarms to alert the user to changes that will affect the treatment. Some of the alarms are pre-set (fixed), others are user adjustable.
The Trilogy 200 Ventilator can deliver therapy to patients > 5kg (11 Ibs), invasively (via ET tube) or noninvasively (via masks that are cleared for use with this patient population including small child, pediatric and adult sizes).
Here's a breakdown of the acceptance criteria and study information for the Respironics Trilogy 200, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not contain a specific table of acceptance criteria with corresponding performance metrics. However, it states:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Performance and functionality of the Trilogy was unaffected as result of changes. | "extensive waveform performance, triggering and alarm functionality testing was performed. All tests were verified to meet the required acceptance criteria." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance. It generally refers to "extensive waveform performance, triggering and alarm functionality testing."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish ground truth for a test set. This appears to be a technical and functional performance verification, rather than a clinical study requiring expert interpretation.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method. Given it's a technical performance verification, this would likely not be applicable in the same way it would be for a clinical trial.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. The submission is for a modified device (Trilogy 200) demonstrating substantial equivalence to a predicate device (Trilogy 100) through performance and functionality testing, not a clinical trial evaluating human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not directly applicable to the device described. The Trilogy 200 is a ventilator, a mechanical device providing ventilatory support. It doesn't rely on an "algorithm only" or AI in the sense of image analysis or diagnostic support. The "testing" referred to is about the ventilator's mechanical and electronic performance.
7. The Type of Ground Truth Used
The ground truth for this device's performance verification would be defined by the pre-established engineering and performance specifications for a ventilator. For example, specific waveform characteristics, triggering thresholds, and alarm activation points would be the "ground truth" against which the device's performance was measured. It's not clinical "ground truth" in the sense of pathology or outcomes data.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable here. This is a medical device (ventilator) undergoing performance verification, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
As above, the concept of a "training set" and establishing ground truth for it is not applicable to this type of device submission.
§ 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).