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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.

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.

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