(91 days)
The 840 Ventilator with Volume Ventilation Plus™ Option is used to provide continuous ventilation to patients requiring respiratory support. This device is used for a wide range of patients from infant to adult and for a wide variety of clinical conditions.
The 840 Ventilator with Neomode and Volume Ventilation Plus™ Options provides continuous ventilation to patients requiring respiratoroy support. The Neomode Option, which is used on neonatal patients with Ideal Body Weights (IBW) as low as 0.5kg, is intended to cover a variety of clinical conditions. The 840 Ventilatory with Neomode and Volume Ventilation Plus Options is intended for use in hospitals and hospital-type facilities. It may be used during hospital and hospital-type facility transport provided that electrical power and compressed gas are supplied.
The VV+ modification provides the 840 Ventilator System with two new breath types, VC' and VS. The VV+ feature is implemented on the 840 Ventilator through additional functionality in software and by use of the existing User Interface panel. No hardware or firmware changes or additions were required. The 840 Ventilator is a dual-microprocessor controlled, critical care ventilator intended to provide continuous ventilation for neonate to adult (with NeoMode Option) or infant to adult (without NeoMode Option) patients who require either invasive ventilation or non-invasive ventilation (via face mask).
The provided document describes a 510(k) premarket notification for the 840 Ventilator System with Volume Ventilation Plus™ Option (VV+). However, it does not contain a table of acceptance criteria or a detailed study proving the device meets specific performance criteria outlined in the input request.
The document focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than presenting a performance study with detailed acceptance criteria, sample sizes, ground truth establishment, or expert adjudication.
Here's an analysis of the information that is available in relation to your request:
1. A table of acceptance criteria and the reported device performance:
- Not provided. The document does not define specific performance metrics or acceptance criteria (e.g., accuracy, precision, sensitivity, specificity for diagnostic devices) for the VV+ option. Instead, it asserts that "the technical characteristics of the device modification do not introduce new questions regarding safety or effectiveness of critical care ventilators" and that the device is "safe and effective for its intended use" based on substantial equivalence.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not explicitly mentioned. While the document states that "Software design and development (including verification testing, test and software quality procedures) were conducted," it does not specify the sample size of any test sets or the provenance of data used in these tests. The focus is on the development process, not a clinical or performance study with a dedicated test set of patient data.
3. 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):
- Not applicable/Not mentioned. Since no explicit "test set" and "ground truth" establishment are detailed in the context of a performance study, this information is not provided. The device is a ventilator with new breath types, not a diagnostic tool requiring expert interpretation of results.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not mentioned. No adjudication method is described as there's no mention of a diagnostic interpretation task requiring consensus among experts.
5. 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:
- Not applicable. This device is a ventilator, not a diagnostic AI-assisted tool meant to be used by human readers for interpretation. Therefore, an MRMC study is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not directly applicable. The device is an electro-mechanical ventilator with software-controlled breath types. Its "performance" would be assessed through engineering verification and validation testing, ensuring it delivers the intended ventilation parameters safely and accurately. The document states that "Software design and development (including verification testing, test and software quality procedures) were conducted," which implies standalone testing of the software's functionality, but no specific results or acceptance criteria for these tests are provided in the summary.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not explicitly defined in the context of a performance study. For a ventilator, "ground truth" would likely relate to objective physical measurements (e.g., delivered tidal volume, pressure, flow) against known standards or specifications, rather than clinical diagnoses or pathology. The document doesn't detail what specific "ground truth" was used for its verification testing.
8. The sample size for the training set:
- Not applicable/Not mentioned. This device is not an AI/ML device that requires a "training set" in the conventional sense. The software functionality for the new breath types is developed through traditional software engineering, programming, and testing.
9. How the ground truth for the training set was established:
- Not applicable/Not mentioned. As there is no "training set" for an AI/ML model, this information is not relevant.
In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence of the 840 Ventilator System with the Volume Ventilation Plus™ Option to existing predicate devices based on intended use, materials, design, and adherence to software development guidelines. It does not present a detailed performance study with explicit acceptance criteria, sample sizes, or ground truth methodologies as would be expected for a diagnostic device or a new technology requiring such extensive clinical validation.
§ 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).