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The Nihon Kohden NKV-550 Series Ventilator System is intended to provide continuous ventilation for adult, pediatric and neonatal patients who require invasive or noninvasive respiratory support. The NKV-550 offers mandatory and spontaneous ventilation modes as well as respiratory monitoring. The NKV-550 is intended for use in hospitals and hospital-type facilities, as well as, for in-hospital transportation.

The Nihon Kohden NKV-550 Series Ventilator System consists of a graphic user interface (GUI) and a breath delivery unit (BDU). The GUI allows clinicians to set ventilator control parameters such as tidal volume and inspiratory pressure, to set alarm limits such as high inspiratory pressure alarm, to view monitored numeric values, to view waveform and loops, and to operate various features through the apps. The BDU contains a microprocessor that receives inputs from the electronic system and controls the pneumatic system for breath delivery to the patient. It also provides various alarms, a safety valve, and other design features to maximize patient safety.

I am unable to extract specific acceptance criteria for the Nihon Kohden NKV-550 Series Ventilator System or details of a study proving it meets them. The provided text from the FDA 510(k) Summary primarily focuses on establishing substantial equivalence to predicate devices, rather than detailing a specific performance study with acceptance criteria.

The document states:

• "Performance of the Nihon Kohden NKV-550 Series Ventilator System was demonstrated by the following testing performed in compliance with Design Controls: Software Verification, Device Functionality Testing, Human Factors/Usability Testing, Bench Test Comparison with Reference Device, Risk Management."
• "Summary of Clinical Performance Data: Not Applicable – Clinical performance data was not required to demonstrate substantial equivalence."
• "Performance: Met ISO 80601-2-12 requirements on essential performance of critical care ventilator"

This indicates that the device's performance was evaluated against the general requirements of the ISO 80601-2-12 standard for critical care ventilators and through internal design control processes like software verification and functionality testing, but a standalone study with explicit acceptance criteria and performance metrics for the device itself (beyond meeting the ISO standard) is not detailed in this summary.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, expert involvement, adjudication methods, or MRMC studies, as this information is not present in the provided text.

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The Nihon Kohden NKV-550 Series Ventilator System is intended to provide continuous ventilation for adult, pediatric and neonatal patients who require invasive or noninvasive respiratory support. The NKV-550 offers mandatory and spontaneous ventilation modes as well as respiratory monitoring. The NKV-550 is intended for use in hospitals and hospital-type facilities, as well as, for in-hospital transportation.

The Nihon Kohden NKV-550 Series Ventilator System consists of a graphic user interface (GUI) and a breath delivery unit (BDU). The GUI allows clinicians to set ventilator control parameters such as tidal volume and inspiratory pressure, to set alarm limits such as high inspiratory pressure alarm, to view monitored numeric values, to view waveform and loops, and to operate various features through the apps. The BDU contains a microprocessor that receives inputs from the electronic system and controls the pneumatic system for breath delivery to the patient. It also provides various alarms, a safety valve, and other design features to maximize patient safety.

This document, K192307, is a 510(k) premarket notification for a medical device (Nihon Kohden NKV-550 Series Ventilator System). It asserts substantial equivalence to a predicate device. As such, the FDA does not require a clinical study with human patients to demonstrate device performance against specific acceptance criteria for a new AI/ML algorithm. Instead, the focus is on demonstrating that the revised device meets the same performance and safety standards as the predicate device.

Therefore, the requested information about "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/ML algorithm (including sample sizes, ground truth establishment, expert adjudication, MRMC studies, and standalone performance) is not applicable to this submission. This submission is for a ventilator, not an AI/ML diagnostic or therapeutic device.

The document discusses non-clinical performance data and states that clinical performance data was not required to demonstrate substantial equivalence.

Here's a breakdown of why the specific questions about an AI/ML study can't be answered from this document:

• 1. A table of acceptance criteria and the reported device performance: The document does not provide a table of performance acceptance criteria in the context of an AI/ML algorithm's output. It mentions "Met ISO 80601-2-12 requirements on essential performance of critical care ventilator," which refers to international safety and performance standards for ventilators, not an AI's diagnostic accuracy.
• 2. Sample sizes used for the test set and the data provenance: Not applicable. There is no AI/ML test set.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications: Not applicable. There is no AI/ML ground truth establishment.
• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
• 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: Not applicable. This is not an AI-assisted device.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
• 8. The sample size for the training set: Not applicable. There is no AI/ML training set.
• 9. How the ground truth for the training set was established: Not applicable.

What the document does provide regarding device performance:

The document states that the performance of the Nihon Kohden NKV-550 Series Ventilator System was demonstrated by various non-clinical tests performed in compliance with Design Controls:

• Software Verification
• Electrical Safety & EMC Testing
• Device Functionality Testing
• Performance of Therapy Types and Ventilation Modes
• Environmental Testing
• Cleaning & Disinfection
• Risk Management
• Accessory Compatibility
• Regression Testing

The key "performance" criterion mentioned is meeting ISO 80601-2-12 requirements on essential performance of critical care ventilators. This is a general safety and effectiveness standard for the device's physical and functional operation, not related to an AI's analytical accuracy.

In summary, this 510(k) submission is for a conventional medical device (a ventilator) with minor modifications, and as such, the detailed clinical study and AI/ML-specific acceptance criteria information requested is not part of this type of regulatory submission.

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The Nihon Kohden NKV-550 Series Ventilator System is intended to provide continuous ventilation for adult, pediatric and neonatal patients who require invasive or noninvasive respiratory support. The NKV-550 offers mandatory and spontaneous ventilation modes as well as respiratory monitoring. The NKV-550 is intended for use in hospitals and hospital-type facilities, as well as, for in-hospital transportation.

The Nihon Kohden NKV-550 Series Ventilator System consists of a graphic user interface (GUI) and a breath delivery unit (BDU). The GUI allows clinicians to set ventilator control parameters such as tidal volume and inspiratory pressure, to set alarm limits such as high inspiratory pressure alarm, to view monitored numeric values, to view waveform and loops, and to operate various features through the apps.

The BDU contains a microprocessor that receives inputs from the electronic system and controls the pneumatic system for breath delivery to the patient. It also provides various alarms, a safety valve, and other design features.

The Nihon Kohden NKV-550 Series Ventilator System's acceptance criteria and the study proving it meets these criteria are described below.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

The document does not explicitly state a "test set" in the context of clinical data for performance evaluation. Instead, the performance was demonstrated through non-clinical testing against various standards and comparisons to a predicate device. Therefore, a specific sample size for a test set of patient data is not applicable here as clinical performance data was not required for substantial equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable, as clinical performance data was not required, and thus, no ground truth established by experts on patient data was utilized for the device's clearance. The "ground truth" for the non-clinical testing was established by the requirements and thresholds set by the relevant international standards (e.g., ISO 80601-2-12, ANSI AAMI ES60601-1, etc.).

4. Adjudication method for the test set:

Not applicable, as clinical performance data and expert-established ground truth were not used for the device's clearance.

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:

Not applicable. This device is a ventilator system, not an AI-assisted diagnostic or interpretation tool that would involve human readers or MRMC studies.

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

The device's performance was evaluated in a standalone manner by testing against established international standards. The listed "Summary of Non-Clinical Performance Data" includes:

• Software Verification
• Electrical Safety & EMC Testing
• Agency Testing to Applicable Standards
• Device Functionality Testing
• Performance of Therapy Types and Ventilation Modes
• Product Endurance
• Power Performance
• Environmental
• Cleaning & Disinfection
• Gas Path Biocompatibility
• Human Factors/Usability Testing
• Risk Management
• Waveform Comparison with Predicate
• Accessory Compatibility

These tests assess the device's intrinsic functions and compliance with safety and performance requirements, which can be considered standalone performance.

7. The type of ground truth used:

For the non-clinical performance evaluation, the "ground truth" was derived from:

• International Standards: e.g., ISO 80601-2-12 (essential performance of critical care ventilators), ANSI AAMI ES60601-1 (general requirements for basic safety and essential performance), IEC 60601-1-2 (electromagnetic compatibility), IEC 60601-1-6 (usability), IEC 60601-1-8 (alarm systems), IEC 62133 (batteries), ISO 80601-2-55 (respiratory gas monitor), ISO 10993-1 (biological evaluation), ISO 18562-1 to 3 (biocompatibility of breathing gas pathways).
• Predicate Device Characteristics: The Nihon Kohden NKV-550 Series Ventilator System was compared to the predicate device (Draeger Evita Infinity V500) based on its documented technical characteristics and performance, aiming for substantial equivalence.

8. The sample size for the training set:

Not applicable, as this device does not appear to involve machine learning or AI models that would require a training set of data. Its performance is based on engineering design and meeting pre-defined physical and functional specifications.

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

Not applicable, as there is no mention of a training set or machine learning components in the provided documentation.

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