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The Servo-i ventilator with NAVA option is intended for treatment and monitoring to improve synchromy between the ventilator and patients. The Servo-i with NAVA option is suitable for patient ranges of neonates, infants and adults with respiratory failure or respiratory insufficiency. Servo-i is a ventilator system to be used only by healthcare providers in hospitals or healthcare facilities and for in-hospital transport. The added indications for use of the NAVA option is when the brain to the brain to the diaphragm is intact; NAVA will improve synchrony between the ventilator and patients with no contraindication for insertion/exchange of a Naso Gastric tube.

The predicate device Servo-i is a ventilator, which gives, ventilation (Invasive and Non Invasive) to critical care patients in the weight range 0.5 to 250 Kg's The modified device is an option, called NAVA option (Neurally Adjusted Ventilatory Assist) which is a HW module with SW for Servo-i integration, which are added to the predicate device. The Nava option uses an amplifier which in conjunction with a nasogastric feeding tube with microelectrodes detects signals to the diaphragm (Edi). The Edi is used as an additional detector to improve the synchrony between the patient and the ventilator and to give the patient corresponding ventilatory support.

This document is a 510(k) summary for the Maquet Servo-i ventilator with the NAVA (Neurally Adjusted Ventilatory Assist) option. It focuses on demonstrating substantial equivalence to predicate devices and does not contain detailed acceptance criteria and performance data for a clinical study in the format requested.

The document indicates that "Clinical and non clinical data is submitted to verify that the safe performance is substantial equivalent to the Servo-i ventilator with NAVA option" (Section-Page 13 (55)), but it does not provide the acceptance criteria or results of a specific study to prove the device meets those criteria.

Therefore, I cannot populate the table or answer most of the questions as the information is not present in the provided text.

Here's what can be extracted based on the limitations:

1. Table of acceptance criteria and the reported device performance:
This information is not provided in the document. The document states that clinical and non-clinical data were submitted to verify safe performance and substantial equivalence, but it does not detail specific acceptance criteria or performance metrics and results.

2. Sample size used for the test set and the data provenance:
This information is not provided in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document.

4. Adjudication method for the test set:
This information is not provided in the document.

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:
No information about an MRMC study or AI assistance is provided. The NAVA option is described as a module to improve synchrony between the patient and the ventilator by detecting signals to the diaphragm (Edi), not an AI-assisted diagnostic or interpretive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
The NAVA option is an integral part of a ventilator system, assisting in ventilation. It's not a standalone algorithm in the typical sense of a diagnostic tool that produces an output without human intervention for review. Its function is to modulate the ventilator's output based on physiological signals, which implies continuous operation within the human-in-the-loop context of patient ventilation.

7. The type of ground truth used:
This information is not provided in the document. The general claim is about verifying "safe performance" and "substantial equivalence," but the specific ground truth for any underlying studies is not detailed.

8. The sample size for the training set:
This information is not provided in the document.

9. How the ground truth for the training set was established:
This information is not provided in the document.

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The Servo' Ventilator System is intended for treatment and monitoring of patients in the range of I ne or re Fentually with respiratory failure or respiratory insufficiency. Servo' is a ventilator neonales, thanks and datas will respiratery gain. I o realthcare facilities and for in-hospital transport.

The ventilator is a platform with several selectable ventilation modes which monitor patients whom need respiratory assistance. The Non-Invasive Ventilation Option is a software controlled feature available on the Servo-i ventilator. The microprocessor control of this feature allows a larger range of flow capabilities designed to meet patient needs safely in a non-invasive application.

The provided text does not contain detailed acceptance criteria for a device, nor does it describe a study explicitly proving that the device meets such criteria. The document is primarily a 510(k) summary for a Special 510(k) submission regarding a "NIV option for Servo-i" ventilator and concerns its substantial equivalence to predicate devices.

Therefore, I cannot provide a response filling the requested table and sections as the information is not present in the provided text.

Specifically, the document focuses on:

• Identifying the device and its manufacturer.
• Listing predicate devices.
• Briefly describing the device as a software-controlled feature for the Servo-i ventilator, designed to handle non-invasive ventilation with features like disconnect/leakage detection.
• Stating that the intended uses and indications are largely the same as the unmodified Servo-i, with a minor change in the lower range for infant use with the NIV option.
• The FDA letter confirms the substantial equivalence determination but does not delve into detailed performance acceptance criteria or study results demonstrating compliance with such criteria.

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The Servo' Ventilator System is intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory failure or respiratory insufficiency. Servo' is a ventilator system to be used only by health care providers in hospitals or health care facilities and for in-hospital transport.

The ventilator is a ventilator with several selectable modes to individually monitor and treat patients whom needs respiratory assistance. The ventilator is the same as described in the notification K010925 and K022132 (addition of BiVent mode and CO2 module).

The provided text is a 510(k) summary for a Special 510(k) submission for the Servo-i Ventilator System. It focuses on a minor modification to the device, specifically changing the low minute volume alarm for infants. Crucially, the document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested.

The 510(k) submission is for a modification to an existing device (Servo-i Ventilator System) and claims substantial equivalence to previously cleared devices (K010925 and K022132 for Servo-i, and K970839 for Servo Ventilator 300 A). The core of this particular submission is that the low minute volume alarm for infants has been changed from 0.10 l/min to 0.06 l/min, to match that of the predicate device, the SV300 ventilator.

Therefore, I cannot provide the requested information from the given text.

This document is a regulatory submission for a minor device change, not a detailed study report on novel device performance or AI/algorithm effectiveness. Such a document would typically not contain the robust clinical study data requested.

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