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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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