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The SV600, SV800 Ventilators are intensive care situations for long-term or during transport within a professional healthcare facility. The SV600, SV800 Ventilators are intended to provide ventilation assistance and breathing support for adult and pediatric patients with a minimum body weight of 10 kg (all pediatric subgroups except newborns (neonates)). The SV600, SV800 Ventilators should be operated by properly-trained and authorized medical personnel. This equipment is not suitable for use in an MRI environment.

The SV600 and SV800 Ventilators are pneumatically-driven and electronically-controlled ventilators. The Ventilators consists of a main unit (including pneumatic circuit, electronic system, mechanical structure, display, CO2 module, SpO2 module), trolley and support arm.

This document outlines the substantial equivalence of the Mindray SV600 and SV800 Ventilators to a predicate device (Evita XL Ventilator K083050) and reference devices. The submission focuses on technical comparisons and various types of performance testing to demonstrate safety and effectiveness.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly provide a table of acceptance criteria with corresponding device performance for specific thresholds. Instead, it states that "The functional and system level testing showed that the devices continue to meet specifications and the performance of the device is equivalent to the predicate." It also notes that the device "meets its accuracy specification and is substantially equivalent to the predicate device."

The closest to "acceptance criteria" are the technical characteristics compared to the predicate and reference devices, and the standards the device was tested against. The "reported device performance" is implied by the statement of compliance with these standards and equivalency to the predicate.

Here's an example of how one might infer "acceptance criteria" from the technical characteristics table:

2. Sample sized used for the test set and the data provenance

The document mentions "functional and system level testing" and "bench testing" but does not specify the sample sizes for these tests. It also does not specify the data provenance (e.g., country of origin of the data, retrospective or prospective) for any of the testing. The nature of these tests (bench, functional, system level) generally implies laboratory or simulated environments, rather than patient data from a specific country or clinical setting.

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. The testing described (biocompatibility, software, EMC, electrical safety, bench testing) does not typically involve "experts establishing ground truth" in the way a clinical study would. These are generally engineering and performance evaluations against defined specifications and standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided. Adjudication methods are typically relevant in clinical studies (e.g., for image interpretation or diagnosis) to resolve discrepancies between multiple evaluators. The types of testing described here (functional, system, bench, safety, EMC) do not involve such adjudication.

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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study. This document describes a ventilator (hardware and software for life support), not an AI-assisted diagnostic or interpretative device that would typically involve human "readers" or "AI assistance" in that context.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The document does not explicitly use the term "standalone" in the context of an algorithm. However, the majority of the testing described (software verification and validation, electromagnetic compatibility, electrical safety, bench testing) are inherently evaluations of the device's performance without continuous human intervention during the test itself, focusing on the device's adherence to specifications and standards. The "human factors testing" mentioned relates to the usability and user interface, ensuring safe and effective interaction for the intended users (medical personnel), rather than a "human-in-the-loop" performance study of an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The concept of "ground truth" as typically understood in clinical or AI performance studies (e.g., pathology for a biopsy, expert consensus for an image diagnosis) is not directly applicable or explicitly stated for the types of testing described. For this device (ventilator), the "ground truth" for its performance is its adherence to:

• Engineering specifications (e.g., flow range, pressure range accuracy)
• Consensus standards (e.g., ISO, IEC for safety, EMC, performance characteristics)
• Functional requirements (e.g., does it deliver the correct ventilation modes)

These are verified through various physical and software tests against known engineering principles and standardized test methods.

8. The sample size for the training set

This information is not applicable/not provided. Ventilators are not typically "trained" using data sets in the way AI/ML algorithms are. This is a traditional medical device whose functionality is based on pre-programmed logic, control algorithms, and pneumatic/electronic design.

9. How the ground truth for the training set was established

This information is not applicable/not provided for the same reason as point 8.

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