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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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