(112 days)
The ESPRIT ventilator is a microprocessor controlled, electrically powered, mechanical ventilator. It is intended for use by qualified medical personnel in providing continuous or intermittent ventilatory support for adult, pediatric and neonatal patients as prescribed by a physician. The ESPRIT Ventilator is intended for use in either invasive or noninvasive applications. The Auto-Trak option is intended for adult and pediatric patients, and automatically adjusts I-Triggers and E-Cycles breathing without the need for user adjustment of I-trigger (sensitivity) and E-cycle thresholds under changing leak conditions. The Auto-Trak option provides leak-compensated ventilation for leaks up to 60L/min.
The Respironics Esprit Ventilator is unchanged from K072450. The only change is to include the Respironics Performax Youth SE mask as an option for use by its pediatric users. This mask is the same mask design as is used by the small size of the cleared Respironics Performax SE Total Face Mask (K072588). The mask consists of a silicon cushion, polycarbonate faceplate with an elbow that contains the exhalation feature. The anthropometric profile of the Respironics Performax Youth SE mask was designed to meet the 90" percentile for pediatrics age 7 and older and > 40 lbs.
The provided text describes a Special 510(k) submission for the Esprit Ventilator, primarily focusing on adding the Respironics Performax Youth SE mask as an option. As such, the study described is a compatibility test rather than a typical clinical performance study for an AI-powered device.
Here's an analysis based on the provided information, addressing your points where applicable:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "mask compatibility testing was performed. This testing included pressure performance, waveform performance, triggering, cycling and alarm functionality testing. All tests were verified to meet the required acceptance criteria." However, the specific quantitative acceptance criteria or detailed numerical performance results are not provided in this document excerpt.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Pressure performance | Verified to meet required acceptance criteria (details not provided) |
| Waveform performance | Verified to meet required acceptance criteria (details not provided) |
| Triggering functionality | Verified to meet required acceptance criteria (details not provided) |
| Cycling functionality | Verified to meet required acceptance criteria (details not provided) |
| Alarm functionality | Verified to meet required acceptance criteria (details not provided) |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: The document indicates "mask compatibility testing was performed" but does not specify the sample size (e.g., number of test sessions, number of masks tested, duration of tests).
- Data Provenance: The testing was "performed" by Respironics, Inc. ("This testing is provided in Tab 8 of this submission"). This implies the data is prospective and generated specifically for this submission, likely within a controlled lab or testing environment. The country of origin of the data is not explicitly stated beyond Respironics being based in the US (Monroeville, Pennsylvania).
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable in this context. The study is a compatibility test for a medical device (ventilator and mask), not an AI diagnostic tool requiring expert interpretation to establish ground truth for a test set. The "ground truth" here would be the established functional specifications and performance characteristics of the ventilator and mask system, evaluated against engineering and physiological standards.
4. Adjudication Method for the Test Set
This information is not applicable. Since it's a compatibility test, not an expert-based diagnostic study, there's no need for adjudication of expert opinions.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a MRMC study was not done. This submission is for a ventilator and mask, not an AI system where human readers would interpret results.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
No, this is not an AI algorithm. The device, the Esprit Ventilator, is a "microprocessor controlled, electrically powered, mechanical ventilator." The "Auto-Trak option" automatically adjusts parameters, which involves an algorithm, but the study described is about the physical compatibility of a new mask with the existing ventilator, not a performance study of the Auto-Trak algorithm itself.
7. The Type of Ground Truth Used
The ground truth used for this compatibility testing would be the engineering specifications, recognized standards, and physiological performance requirements for a ventilator and its compatible components (like a mask). The verification would be against these predefined technical and performance standards, not against "expert consensus, pathology, or outcomes data" in the typical sense of diagnostic AI studies. The statement "All tests were verified to meet the required acceptance criteria" implies testing against these pre-established standards.
8. The Sample Size for the Training Set
This information is not applicable. This is not an AI model requiring a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable. This is not an AI model requiring a training set with established ground truth.
§ 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).