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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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The bellavista 1000/1000e ventilator is intended to provide positive pressure ventilatory support to adult and pediatric patients and optionally infant and neonatal patients by qualified, trained personnel under the direction of a physician.

Environment of use: hospitals, sub-acute care facilities and intra-hospital transfer

When used on neonatal patients: The environment of use is the Neonatal Intensive Care Unit (NICU).

bellavista is an electronically controlled pneumatic ventilation system. It is powered by AC or DC and also provided with an internal battery. The bellavista pneumatic system supplies respiratory gas whilst the electrical systems control the pneumatics and provides the power supply.

The user can enter values or parameters in the bellavista via the touch screen. These inputs entail instructions for bellavista's pneumatic system to ventilate the patient with a precisely controlled gas mixture. bellavista gathers readings from the proximal flow sensor within the ventilator.

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter and summary for a medical device (ventilator). It describes the device, its intended use, a comparison to predicate devices, and the basis for substantial equivalence.

However, it does not include details about acceptance criteria, specific device performance numerical results, sample sizes for test or training sets, data provenance, expert qualifications, ground truth establishment, or any details about a multi-reader multi-case (MRMC) study or standalone algorithm performance, as these are typically part of a clinical validation study and not usually found in a 510(k) summary for a ventilator.

The document discusses the ventilatory support capabilities and patient populations for which the device is intended, but not the kind of detailed performance metrics usually required for AI/algorithm-based diagnostic devices.

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The HAMILTON-C3 ventilator is intended to provide positive pressure ventilatory support to adults, pediatrics, infants, and neonates.

Intended areas of use:

• In the intensive care ward or in the recovery room.
• During transfer of ventilated patients within the hospital.

The HAMILTON-C3 ventilator is a medical device intended for use by qualified, trained personnel under the direction of a physician and within the limits of its stated technical specifications.

The HAMILTON-C3 has been designed to ventilate adult and pediatric patients in the critical care environment. With optional support, the HAMILTON-C3 is also able to ventilate infants and neonates. The HAMILTON-C3 ventilator uses the same graphical user interface (GUI) used by the predicate HAMILTON-C2, which features a touchscreen "Ventilation Cockpit". This provides the exact information that the user needs and helps focus on what is important. In addition, the HAMILTON-C3 includes the ASV ventilation-mode, which automatically applies lung-protective strategies, reduces the risk of operator error, and promotes early weaning.
The HAMILTON-C3 has been designed with built-in batteries and a turbine thereby giving the user maximum independence and flexibility to accompany a patient everywhere. The HAMIL-TON-C3 offers the same ventilation modes as the HAMILTON-C2, which provides for both full and partial ventilatory support.

1. The HAMILTON-C3 offers all the conventional modes, as well as advanced invasive and non-invasive ventilation modes: ASV, (S)CMV+, SIMV+, PCV+, SPONT, APRV, DuoPAP, NIV, NIV-ST, nCPAP-PS, PSIMV+, and PSIMV+ with IntelliSync.
2. All 41 monitoring parameters can be trended over 1, 6, 12, 24, and 72 hours.
3. The ability to turn off the Apnea alarm in the nCPAP-PS mode.
4. The HAMILTON-C3 includes a 12.1" wide-screen monitor.

The Hamilton-C3 is a continuous ventilator. The provided text outlines its characteristics, intended use, and a comparison with a predicate device and other FDA-cleared ventilators. However, it does not include detailed acceptance criteria or a study that specifically "proves the device meets the acceptance criteria" in the way one might expect for a diagnostic or AI-driven device with performance metrics like sensitivity, specificity, or F1-score.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel performance. The "acceptance criteria" discussed are primarily related to safety, effectiveness, and adherence to recognized standards, rather than specific performance metrics for a novel diagnostic function.

Here's a breakdown based on the information provided, and where information is not present:

1. Table of acceptance criteria and the reported device performance

Based on the document, "acceptance criteria" are inferred from the demonstration of substantial equivalence and adherence to recognized standards. The "reported device performance" is largely presented as meeting the same functional capabilities as the predicate device (HAMILTON-C2) and adhering to various medical device standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable in the traditional sense for this submission type. This is a 510(k) submission based on substantial equivalence, not a clinical trial with a "test set" of patient data to evaluate a diagnostic algorithm's performance. The "testing" referred to is non-clinical verification and validation of the device's functionality and adherence to standards. There is no mention 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. As per point 2, there is no "test set" with ground truth in the context of diagnostic performance presented in this document.

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

• Not Applicable. See point 3.

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. This document describes a continuous ventilator, not an AI-assisted diagnostic device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or mentioned.

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

• No. This is a medical device (ventilator), not a standalone algorithm. While it contains software, the evaluation in this document focuses on the integrated system's safety and effectiveness and its equivalence to a predicate device, not on the performance of a standalone algorithm or AI.

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

• Not Applicable. As per point 2, there is no "test set" requiring ground truth for diagnostic performance evaluation. The "ground truth" for the device's functionality is its design specifications and compliance with recognized standards.

8. The sample size for the training set

• Not Applicable. This document does not describe the development or evaluation of an AI/ML algorithm that would require a "training set" of data.

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

• Not Applicable. See point 8.

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