(103 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 useradjustment 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 ESPRIT ventilator is a microprocessor controlled, electrically powered, mechanical ventilator.
Here's a breakdown of the acceptance criteria and study information for the Respironics Esprit Ventilator Auto-Trak Sensitivity Option, based on the provided 510(k) summary:
Acceptance Criteria and Reported Device Performance
The document presents software testing results and performance testing results. The acceptance criteria for the software tests appear to be a simple "Pass/Fail" determination, where all listed parameters must pass. The performance testing section mentions a clinical trial for Auto-Trak performance and evaluation of other parameters, but it doesn't explicitly state quantitative acceptance criteria for these. The overall conclusion for the clinical investigation is qualitative: "at least equivalent performance and patient preference and no increase in adverse events over the predicate device."
| Acceptance Criteria / Software Parameter | Reported Device Performance |
|---|---|
| Software Testing | |
| Flow Triggering: Validate accuracy of flow-triggered breaths during Auto-Trak triggering | Pass |
| Auto-Trak Triggering - Bias Flow: Validate accuracy of bias flow used during Auto-Trak triggering; check for Auto-Trak triggering with constant and changing leaks | Pass |
| Auto-Trak Triggering - Back up Pressure Trigger: Validate that breaths can also be triggered using the back up pressure trigger when Auto-Trak is active | Pass |
| Auto-Trak Triggering - Mask Off Test: Validate that in CPAP or non-invasive modes, breaths will not auto-cycle if a patient's mask is taken off, then returned to the patient, when Auto-Trak is active | Pass |
| Auto-Trak Triggering - High Leak Test: Validate that when Auto-Trak is active, and a large leak is suddenly blocked, the ventilator will not truncate more than one breath | Pass |
| Exhalation Sensitivity with and without Auto-Trak active: Validate the Auto-Trak performance when Auto-Trak is active and not active | Pass |
| Exhalation Sensitivity decreasing with Auto-Trak active: Validate Auto-Trak sensitivity when Exhalation is not detected, compensating by decreasing exhaled flow sensitivity for the next breath | Pass |
| Exhalation Sensitivity Increasing with Auto-Trak: Validate Auto-Trak performance when Auto-Trak is active and not active | Pass |
| Clinical Investigation (Primary Efficacy Objective) | |
| Equivalence in the proportion of subjects in Auto-Trak (test) and Flow Triggering (control) treatment groups | Shown to be substantially equivalent in performance |
| Clinical Investigation (Primary Safety Objective) | |
| Evaluate the rate of adverse events during the intervention | No increase in adverse events over the predicate device |
| Patient Preference (Clinical Investigation) | |
| Not explicitly stated as a separate criterion, but included in the overall conclusion. | Substantially equivalent in patient preference |
Study Information
Due to the nature of the 510(k) summary, specific details about sample size for test and training sets, and expert qualifications are limited.
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Sample Size and Data Provenance (Test Set):
- Sample Size: The document does not explicitly state the sample size (number of patients) for the clinical trial. It refers to "the proportion of subjects."
- Data Provenance: Not specified, but generally, clinical trials submitted for U.S. FDA 510(k) clearance are often conducted in the U.S. or international sites adhering to GCP. The document does not specify if the data was retrospective or prospective, but clinical investigation implies prospective.
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Number of Experts and Qualifications (Ground Truth for Test Set):
- The document does not provide information on the number or qualifications of experts used to establish the ground truth for the clinical trial.
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Adjudication Method (Test Set):
- The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the clinical trial data.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC study was not explicitly described as such. The clinical investigation was a comparison between the "Auto-Trak (test)" and "Flow Triggering (control)" treatment groups to show equivalence. This is more of a comparative clinical trial of two device functionalities rather than an MRMC study assessing human reader improvement with AI assistance.
- Effect Size: Not applicable, as an MRMC study was not described. The study aimed for equivalence rather than an effect size of human improvement with AI.
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Standalone Performance (Algorithm Only without Human-in-the-loop):
- Yes, a standalone study was done in the form of "Software testing" and "Performance Testing Results" tables (Table 1 and Table 2). These tests evaluated the device's algorithmic and mechanical functions independently of direct human interaction with the real-time AI. The "Auto-Trak Sensitivity option automatically triggers and cycles breathing without the need for user-adjustment of I-trigger (sensitivity) and E-cycle thresholds," which indicates its autonomous operation in those aspects.
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Type of Ground Truth Used:
- For the Software Testing and Performance Testing Results (mechanical parameters): The ground truth was based on pre-defined engineering and software specifications, and measured directly from the device's output against expected values (e.g., accuracy of flow-triggered breaths, bias flow).
- For the Clinical Investigation: The ground truth for efficacy would be patient breathing patterns, comfort levels, and ventilator performance metrics (triggering, cycling). The ground truth for safety would be the occurrence and rate of adverse events. These would be derived from clinical observations and patient outcomes.
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Sample Size for Training Set:
- The document does not provide any information on the sample size used for the training set (if any explicit machine learning 'training' was involved beyond deterministic algorithm development). The "Auto-Trak" option likely relies on rule-based algorithms or pre-programmed logic derived from extensive engineering and physiological knowledge, rather than a machine learning model trained on a large dataset in the modern sense.
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How Ground Truth for Training Set Was Established:
- As with the training set size, the document does not describe how ground truth was established for a training set. Given the context of a 2007 510(k) for a ventilator option, it's highly probable that the "training" involved:
- Physiological models and simulations: Using established respiratory mechanics and patient models to design and refine the algorithms for triggering and cycling.
- Bench testing & phantom lungs: Extensive testing with artificial lungs and leak generators to validate the algorithms' responses across various scenarios.
- Clinical experience and expert input: The design of the algorithms would have incorporated extensive knowledge from respiratory therapists and physicians on effective ventilation strategies and patient interaction.
- As with the training set size, the document does not describe how ground truth was established for a training set. Given the context of a 2007 510(k) for a ventilator option, it's highly probable that the "training" involved:
§ 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).