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The Nihon Kohden NKV-440 Ventilator System is intended to provide continuous ventilation for adult, pediatric and neonatal patients who require invasive or noninvasive respiratory support. The NKV-440 offers mandatory and spontaneous ventilation modes as well as respiratory monitoring. The NKV-440 is intended for use in hospitals and hospital-type facilities, as well as, for in-hospital transportation.

Device Description

The NKV-440 is a servo-controlled ventilator that is designed to meet the gas delivery and performance requirements for neonate through adult patients. The NKV-440 design is comprised of two major components, a Breath Delivery Unit (BDU) and a Graphic User Interface (GUI). The GUI allows clinicians to set ventilator control parameters such as PEEP and inspiratory pressure, to set alarm limits such as high inspiratory pressure alarm, to view monitored numeric values, and to view waveforms. The BDU assembly contains a blower and the electronics required to perform breath delivery. Ambient air is taken into the blower and mixed with oxygen which is flow rate controlled by a proportional valve. The mixed gas is provided to the patient. The microprocessor controls the blower and the proportional valve to deliver the pressure and oxygen concentration which are set by the user. It also provides various alarms and other design features to maximize patient safety.

AI/ML Overview

The provided document is an FDA 510(k) premarket notification for the Nihon Kohden NKV-440 Ventilator System. It details the device's indications for use, technological characteristics, and comparison to a predicate device (Nihon Kohden NKV-550 Ventilator System).

The document does not include information about AI/ML algorithm performance, acceptance criteria for such algorithms, or studies involving human readers or ground truth established by experts for image analysis. Therefore, I cannot address most of the specific points requested regarding acceptance criteria and the study proving the device meets them, as it relates to AI/ML device performance.

This 510(k) pertains to a physical medical device (a ventilator), and its substantial equivalence is demonstrated through engineering performance testing against established standards and comparison of technical characteristics with a legally marketed predicate device.

However, I can extract the general acceptance criteria for this type of device based on the information provided:

Summary of Acceptance Criteria and Device Performance (Based on the provided document for a Ventilator):

Since this is a ventilator and not an AI/ML diagnostic tool, the "acceptance criteria" discussed are related to performance against established engineering and safety standards, and functional equivalence to a predicate device, rather than diagnostic accuracy metrics.

Acceptance Criteria (General for Ventilators)	Reported Device Performance (Nihon Kohden NKV-440 Ventilator System)
Intended Use Equivalence: Provide continuous ventilation for adult, pediatric, and neonatal patients requiring invasive or noninvasive respiratory support, including mandatory and spontaneous ventilation modes and respiratory monitoring, for use in hospitals and hospital-type facilities, as well as in-hospital transport.	Met: "The Nihon Kohden NKV-440 Ventilator System is intended to provide continuous ventilation for adult, pediatric and neonatal patients who require invasive or noninvasive respiratory support. The NKV-440 offers mandatory and spontaneous ventilation modes as well as respiratory monitoring. The NKV-440 is intended for use in hospitals and hospital-type facilities, as well as, for in-hospital transportation." (Identical to predicate)
Clinical Conditions Equivalence: Use in hospitals, hospital-type facilities, and in-hospital transportation for patients needing ventilation therapy.	Met: "Hospitals, hospital-type facilities and in-hospital transportation for patients who need ventilation therapy." (Identical to predicate)
Anatomical Site Equivalence: Patient airways.	Met: "Patient airways." (Identical to predicate)
Target Population Equivalence: Adult, pediatric, and neonatal patients.	Met: "Adult, pediatric and neonatal patients." (Identical to predicate)
User Equivalence: Trained clinicians, not lay users.	Met: "Trained clinicians, not lay users." (Identical to predicate)
Compliance with ISO 80601-2-12 (Essential Performance of Critical Care Ventilator):	Met: "Met ISO 80601-2-12 requirements on essential performance of critical care ventilator." (Identical to predicate)
Waveform Comparison: Comparable waveform test result to predicate device.	Met: "Comparable waveform test result."
Chemicals Deployed to Patient Equivalence: Air and oxygen.	Met: "Air and oxygen." (Identical to predicate)
Delivery Method to Patient Equivalence: Positive pressure.	Met: "Positive pressure." (Identical to predicate)
Energy Used for Device Equivalence: AC Power and internal DC Power (Li-ion battery).	Met: "AC Power and internal DC Power (Li-ion battery)." (Identical to predicate, noting "Exactly same battery packs are used in both NKV-440 and NKV-550.")
Control Principle Equivalence: Time-cycled, volume-constant, pressure-controlled.	Met: "time-cycled, volume-constant, pressure-controlled." (Identical to predicate)
Breathing Modes Equivalence: All specified invasive and non-invasive modes (A/CMV-PC, A/CMV-VC, A/CMV-PRVC, SIMV-PC-PS, SIMV-VC-PS, SIMV-PRVC-PS, SPONT-CPAP, SPONT-PS, SPONT-VS, APRV, CPAP, O2 Therapy).	Met: All listed modes are identical to the predicate device.
Compliance with Relevant Standards: (e.g., ANSI AAMI ES 60601-1, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 62133, IEC 62304, IEC 62366-1, ISO 10993-1, ISO 14971, ISO 18562-1, ISO 80601-2-12, ISO 80601-2-55, ISO 80601-2-61).	Met: The device "has been tested in compliance with the following standards" (a comprehensive list is provided).
Other Non-Clinical Performance: Performance of Ventilation Modes and Control Settings, Device/Software Functionality, Power performance, Essential Performance and Worst Case VBS, Environmental, Product Endurance/Reliability, Biocompatibility, Cleaning & Disinfection, EMC and Electrical Safety, Human Factors/Usability, Risk Management, Compatibility with 3rd Party Devices.	Demonstrated: "Performance of the Nihon Kohden NKV-440 Ventilator was demonstrated by the following..." (followed by the list above).

Regarding the points specific to AI/ML device studies, the document states "Not Applicable" for clinical and animal performance data, and does not mention any AI/ML components inherent to the device or its assessment.

Therefore, the following points cannot be answered from the provided text:

Sample sizes used for the test set and the data provenance: Not applicable, as this is not an AI/ML clinical study. Performance is demonstrated through engineering tests and comparison to a predicate device.
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.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

In conclusion, the supplied document describes the regulatory clearance for a conventional medical ventilator by demonstrating substantial equivalence to a predicate device through non-clinical performance data and adherence to recognized standards. It does not involve AI/ML technology or human reader studies.

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