(23 days)
The Esprit Ventilator with VCV Demand Flow Option is a microprocessor controlled, electrically powered, mechanical ventilator. It is intended for use by qualified medical personnel in providing continuous or intermittent ventilatory support to adult and pediatric patients as prescribed by a physician. The Esprit Ventilator is intended for use in either invasive or non-invasive applications.
The VCV Demand Flow Option is a software option for the currently marketed Esprit Ventilator. It represents an enhancement intended to provide additional flow/volume to patients when operator settings do not satisfy patient demand. VCV Demand Flow is available only in volume controlled mandatory and assist breaths. Once the software is enabled, the VCV Demand Flow feature is always available.
The provided text describes a 510(k) submission for a device modification (VCV Demand Flow Option) to an existing Esprit Ventilator. The document focuses on demonstrating substantial equivalence to predicate devices and does not contain detailed information about specific acceptance criteria, comprehensive performance metrics, or the specific study design typically associated with a complete clinical trial or a full standalone performance evaluation of a new device.
Therefore, many of the requested categories cannot be fully answered based on the provided text. However, I will extract all available information that aligns with your request.
Acceptance Criteria and Device Performance (Limited Information Available)
The document states: "The results of all verification and validation testing demonstrate that all design and system requirements for the Esprit ventilator with VCV Demand Flow have been met." However, it does not provide a table of specific acceptance criteria (e.g., specific thresholds for flow rate accuracy, response time, etc.) nor does it report detailed device performance against such criteria. The focus is on demonstrating that the new software option for demand flow provides additional flow/volume when operator settings do not satisfy patient demand, and that this does not raise new questions of safety and effectiveness.
| Performance Metric Category | Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance (Not Explicitly Stated) |
|---|---|---|
| Software Functionality | Implied: All design and system requirements met | "The results of all verification and validation testing demonstrate that all design and system requirements for the Esprit ventilator with VCV Demand Flow have been met." |
| Demand Flow Provision | Implied: Provides additional flow/volume to patients when operator settings do not satisfy patient demand. | "It represents an enhancement intended to provide additional flow/volume to patients when operator settings do not satisfy patient demand." |
| Safety and Effectiveness | Implied: No new questions of safety and effectiveness compared to predicate devices. | "The addition of this new feature does not raise new questions of safety and effectiveness for the Esprit." and "The technological characteristics of the Esprit ventilator with the VCV Demand Flow and the results of the performance testing do not raise new questions of safety and effectiveness when compared to the legally marketed predicate devices." |
Study Details (Limited Information Available)
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document mentions "Software validation testing was performed," but does not specify a sample size for a test set, nor does it provide information on data provenance (country of origin, retrospective/prospective). This typically refers to patient data, which is not mentioned in the context of this software modification.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This information is not provided. The testing described appears to be software verification and validation, not a study involving expert-adjudicated ground truth on patient data.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided, as the study described is not a clinical or image-based adjudication study.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC comparative effectiveness study is mentioned. The device is a ventilator, not an AI diagnostic tool primarily evaluated by human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The document implies standalone testing of the software modification ("Software validation testing was performed... The results of all verification and validation testing demonstrate that all design and system requirements for the Esprit ventilator with VCV Demand Flow have been met."). However, it does not isolate "algorithm only" performance from the overall system performance, nor does it quantify it explicitly. The VCV Demand Flow option is a software feature that enhances the ventilator's automatic response.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The concept of "ground truth" (in the sense of clinical accuracy against a definitive reference standard) is not explicitly discussed for this type of software modification. The ground truth for software validation would be defined by the design requirements and specifications themselves, against which the software's functionality is tested.
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The sample size for the training set:
- Not applicable. The document describes a software modification to an existing ventilator, not a machine learning or AI model trained on a dataset.
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How the ground truth for the training set was established:
- Not applicable, as there is no mention of a training set for a machine learning model.
Summary of Study Information Available in the Document:
The study described is primarily software verification and validation testing.
- Objective: To demonstrate that the VCV Demand Flow option, a software enhancement, meets all design and system requirements and does not raise new questions of safety and effectiveness compared to predicate devices.
- Methodology: "Software validation testing was performed in accordance with FDA's Guidance for the Content of Premarket Submissions for Software contained in Medical Devices (1998)."
- Outcome: "The results of all verification and validation testing demonstrate that all design and system requirements for the Esprit ventilator with VCV Demand Flow have been met." and "The technological characteristics... and the results of the performance testing do not raise new questions of safety and effectiveness."
This submission is a "Special 510(k): Device Modification," which typically focuses on demonstrating that the changes do not adversely affect safety or effectiveness, often through engineering analysis and in-house testing rather than extensive clinical trials or complex AI performance studies with broad datasets and expert adjudication.
§ 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).