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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.

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.

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The Performax SE Total Face Mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators which have adequate alarms and safety systems for ventilator failure, and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure, respiratory insufficiency or obstructive sleep apnea.

The mask is for multi-patient reuse on patients weighing > 30 kg, who are appropriate candidates for noninvasive ventilation, in the hospital/institutional environment only.

The Respironics Performax SE Total Face Mask consists of a polycarbonate faceplate with silicon cushion seal for the face. Like the device predicate, Image 3SE full face mask (K023135), the interface to the patient circuit is a polycarbonate standard elbow. The design of the standard elbow (SE) is the same as the SE used on the Image 3SE Full Face mask. The mask when used with the standard elbow has one integrated exhalation feature, which includes one port on the faceplate. Similar to the device predicate, Total Face Mask (K992969), the mask faceplate contains headgear hooks upon which the premium headgear is attached. The mask is available in two sizes - small and large.

The Respironics Performax SE Total Face Mask is intended for use with a patient circuit that is used to connect the device to the patient interface device (mask). A typical patient circuit consists of a six-foot disposable or reusable smooth lumen 22mm tubing, a method of venting exhaled gases.

The provided document is a 510(k) summary for a medical device (Respironics Performax SE Total Face Mask). It is a regulatory submission demonstrating substantial equivalence to a predicate device, rather than a clinical study report with detailed acceptance criteria and performance metrics.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information cannot be extracted from this document.

This document focuses on:

• Device Description: What the device is, its components, and how it's designed.
• Intended Use: For what purpose and with what patients the device is meant to be used.
• Substantial Equivalence: How the new device is similar to previously cleared predicate devices (Respironics Total Face Mask K992969 and Image 3 SE Face Mask K023135). The submission discusses design modifications and states that "Based on the testing performed, none of the design modification affect the safety or effectiveness of the device."

The document does not provide details on the specific "testing performed" in terms of acceptance criteria, study design, or quantitative performance results relevant to the questions asked. It's a high-level summary for regulatory clearance, not a detailed scientific study publication.

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