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Model: Advance
Intended to provide continuous ventilation to patients requiring respiratory support. The devices are intended for patients from neonate/infant to adult. The devices are intended to be used in hospital and hospital-type facilities and during hospital and hospital-type transport provided that electrical power and compressed gas are supplied.

Model: Neumovent GraphNet TS
Intended to provide continuous ventilation to patients respiratory support. The devices are intended for patients from pediatric to adult with an option for neonate/infant patients. The devices are intended to be used in hospital-type facilities and during hospital and hospital-type transport provided that electrical power and compressed gas are supplied.

Model: Neumovent GraphNet NEO
Intended to provide continuous ventilation to patients requiring respiratory support. The devices are intended for neonate/infant patient. The devices are intended to be used in hospital and hospital-type facilities and during hospital and hospital-type transport provided that electrical power and compressed gas are supplied.

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This document is a 510(k) premarket notification FDA clearance letter for a continuous ventilator, the Neumovent GraphNet. It indicates that the device has been found substantially equivalent to predicate devices, but it does not contain any information regarding acceptance criteria, device performance studies, or clinical trial data.

Therefore, I cannot provide the requested information. The prompts about "acceptance criteria," "reported device performance," "sample sizes," "expert ground truth," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," and "training set details" are not addressed in this regulatory document.

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The Neumovent GraphNet is intended to provide continuous ventilation to patients requiring respiratory support. The device is intended for patients from neonatelinfant to adult and for a wide variety of clinical conditions. The device is intended to be used in hospital and hospitaltype facilities and during hospital and hospital-type transport provided that electrical power and compressed gas are supplied.

Not Found

I am sorry, but the provided text from the FDA letter primarily concerns the substantial equivalence determination for the "Ventilator Model Neumovent GraphNet" (K101401). It does not contain information about acceptance criteria for a study, reported device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, types of ground truth, or how ground truth was established for training sets.

The letter explicitly states that the FDA "reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...to legally marketed predicate devices." This means the review focused on comparing the new device to existing, legally marketed devices, rather than a detailed study proving performance against specific acceptance criteria.

To answer your request, I would need a document that describes a specific study conducted for the device, including the methodology, acceptance criteria, and results.

Ask a specific question about this device