(90 days)
The ESPRIT ventilatory 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 Speaking Mode software option allows tracheostomized adult and pediatric patients who meet the assessment criteria to vocalize without the need of a speaking valve.
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 and pediatric patients as prescribed by a physician. The ESPRIT Ventilator is intended for use in either invasive or non-invasive applications. The Speaking Mode software option allows tracheostomized adult and pediatric patients who meet the assessment criteria to vocalize without the need of a speaking valve.
The provided document, K071212, describes the Esprit Ventilator Speaking Mode Option. It outlines the device's indications for use and demonstrates substantial equivalence to a predicate device through performance testing.
Here's the requested information structured around acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The document provides a table titled "Substantial equivalence was established by performance testing. The Table describing the performance testing follows:". This table outlines specific parameters and their purpose, with all outcomes reported as "Pass." This indicates that the device met the pre-defined acceptance criteria for each tested parameter.
| Parameter | Purpose | Reported Device Performance (Pass/Fail) |
|---|---|---|
| Speaking Mode (SM) operability | SM operates with VCV with A/C, SIMV, and CPAP; is not functional with NPPV; operates with Flow-Trak; operates with Pressure Support; operates on both adult and pediatric patient types | Pass |
| Speaking Mode operability | SM is not available for Neonatal patients; is not active after power cycling; is not available when specific alarms are active | Pass |
| Speaking mode and I-trigger | I-trigger will automatically adjust to pressure triggering if flow triggering is the current trigger type; that only pressure triggering is allowed while in SM; test the accuracy of pressure triggering | Pass |
| Speaking Mode graphical user interface | Test the ventilator behavior when SM is not installed; confirm the SM related dialogs; test the ventilator behavior when SM is deactivated; confirm that PEEP is always set to zero when SM is active | Pass |
| Speaking Mode alarms and settings | Confirm alarm performance, including patient disconnect | Pass |
| Speaking Mode alarms and settings | Confirm alarm performance, including occlusion alarm | Pass |
| Apnea alarm | Confirm that if apnea alarm occurs while in SM, exhalation valve opens during exhalation | Pass |
| Maneuvers not available | Confirm that Respiratory Mechanics and expiratory Hold Maneuvers are not available when SM is active | Pass |
| Displayed patient data | Confirm that data displays are appropriate | Pass |
| Trending | Confirm that trending values are trended/not trended when SM is active | Pass |
| Breath delivery | Confirm that exhalation valve is closed during inhalation and exhalation while in SM | Pass |
| Communications | Confirm that RS 232 and Vuelink communications are operable | Pass |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the sample size used for the performance testing. The provenance of the data is not specified (e.g., country of origin, retrospective or prospective). The testing appears to be a series of functional and alarm verification tests performed on the device itself, rather than a clinical study with patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
The document does not mention the use of experts to establish a "ground truth" for the test set, as the testing described focuses on functional aspects and alarm performance of the device's software option rather than subjective interpretation of medical data. The "Pass" results likely reflect objective verification against a documented set of design specifications or engineering requirements.
4. Adjudication Method for the Test Set
No adjudication method is described. Given the nature of the tests (functional verification of software and hardware interaction), results would likely be directly observable and measurable against specifications, without the need for expert adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not conducted or described in this document. The focus is on the substantial equivalence of a new software feature for an existing ventilator, not on the comparative effectiveness of human readers with or without AI assistance. Therefore, no effect size for human reader improvement with AI is applicable or stated.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Yes, the performance testing described appears to be a standalone assessment of the Esprit Ventilator's Speaking Mode Option. The tests verify the algorithm's functional behavior, alarm performance, and interaction with the ventilator's existing systems, without explicit human-in-the-loop performance evaluation beyond potentially operating the device during testing.
7. The Type of Ground Truth Used
The "ground truth" for the described performance testing appears to be the device's functional specifications, design requirements, and intended operational behavior. The tests confirm that the ventilator's Speaking Mode Option operates as designed and meets the established safety and performance parameters. This is not
expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
This document does not describe a training set. The "Speaking Mode Option" is a software feature for an existing ventilator, and the testing outlined is a verification of its functionality and integration, not an algorithm developed using machine learning or data-driven training.
9. How the Ground Truth for the Training Set Was Established
As no training set is described or implied by the document, the establishment of ground truth for a training set is not applicable.
§ 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).