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The Nihon Kohden NKV-330 Ventilator is intended to provide ventilation and oxygen concentration for patients who are breathing spontaneously but need partial ventilation support due to respiratory failure or chronic respiratory insufficiency. It is intended for children weighing 12.5 kg or greater to adult patients. It offers noninvasive ventilation, invasive ventilation, and respiratory monitoring. The NKV-330 is intended for use in hospital-type facilities, and in-hospital transportation by qualified and trained users under the directions of a physician.

The NKV-330 is a servo-controlled ventilator that is designed to meet the gas delivery and performance requirements for pediatric through adult patients. The NKV-330 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.

The provided document is a 510(k) summary for the Nihon Kohden NKV-330 Ventilator System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific acceptance criteria through a clinical study or detailed performance metrics.

Therefore, the document does not contain the specific acceptance criteria, reported device performance in those terms, details of a specific study proving it, sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth details as requested.

The document primarily states that the device's technical characteristics are "substantially equivalent" to a predicate device (Philips/Respironics V60 Ventilator) and lists various non-clinical performance data and standards compliance to support this claim. It explicitly states "Clinical performance data was not required to demonstrate substantial equivalence."

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The Servo-u Ventilator System is:

• intended for respiratory support, monitoring and treatment of neonatal, pediatric and adult patients
• to be used only by healthcare providers
• to be used only in professional healthcare facilities and for transport within these facilities

The Servo-n Ventilator System is:

• intended for respiratory support, monitoring and treatment of neonatal and pediatric patients
• to be used only by healthcare providers
• to be used only in professional healthcare facilities and for transport within these facilities

The Servo-u MR Ventilator System is:

• intended for respiratory support, monitoring and treatment of neonatal, pediatric and adult patients
• to be used only by healthcare providers
• to be used only in professional healthcare facilities and for transport within these facilities
• to be used in MR environment according to specified conditions
• with 1.5 T or 3 T MR scanners
• outside magnetic fields >20 mT/200 Gauss

The Servo-u/n/u MR Ventilator Systems 4.1 consist of a Patient Unit where gases are mixed and administered, and a User Interface where the settings are made and ventilation is monitored.

The Servo-u/n/u MR Ventilator Systems 4.1 are based on the cleared predicate device Servo-u/n Ventilator Systems 2.1 (K180098) with some improvements. The ventilation modes in the Servo-u/n/u MR 4.1 are the same as the predicate device. Standard configurations of available modes and optional modes do differ between the devices, i.e. Servo-u/n/u MR 4.1.

The ventilators deliver controlled or supported breaths to the patient, with constant flow, constant pressure, using a set oxygen concentration. The ventilators can also deliver High Flow therapy with a constant flow.

The Electrical activity of the diaphragm (Edi) is a measurement of the patients own breathing efforts. The Edi functionality makes it possible to monitor Edi activity in all ventilation modes, High Flow therapy as well as in Standby.

NAVA stands for Neurally Adjusted Ventilatory Assist and is a supported mode of ventilation based on the Edi, delivering assist in proportion to and synchronized with the patient's respiratory drive. NAVA is available as an invasive and a non-invasive mode. The included parts related to this mode, such as Edi module and Edi catheters are identical to the cleared predicate devices Servo-u/n 2.1 (K180098).

Servo-u/n contain a dedicated controller circuit for the Aerogen Solo nebulizer (included as standard). It is identical to the cleared predicate devices Servo-u/n 2.1 (K180098). Not available on Servo-u MR.

Accessories for CO2 monitoring and flow and pressure measurements at the Y piece (Y sensor) are integrated as options. It is identical to the cleared predicate devices Servo-u/n 2.1 (K180098).

The Servo-u/n/u MR Ventilator Systems will produce visual and audible alarms if any parameter varies beyond pre-set or default limits and log alarm recordings. The alarm handling is similar to the one used in the cleared predicate devices Servo-u/n 2.1 (K180098).

The Servo-u/n/u MR Ventilator Systems contain provisions for battery modules to supply the system in the case of mains power failure or during intra-hospital transport. The batteries are identical to the one used for the cleared predicate devices Servo-u/n 2.1 (K180098).

Based on the provided text, the device in question is the "Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1". This document is a 510(k) premarket notification to the FDA, asserting substantial equivalence to previously cleared predicate devices.

*Crucially, this document does not contain any information regarding clinical studies, acceptance criteria, or performance data in the context of an AI/human reader study. It focuses on the technical modifications, safety, and regulatory compliance of a medical device (ventilator systems) to demonstrate substantial equivalence to a predicate device.

Therefore, I cannot provide the requested information for the following reasons:

• No AI component or human reader study: The document describes hardware and software updates to ventilator systems. There is no mention of an Artificial Intelligence (AI) component or any study involving human readers or expert consensus on clinical images/data.
• Focus on Substantial Equivalence: The primary goal of this 510(k) submission is to demonstrate that the updated ventilator systems are "substantially equivalent" to previously cleared predicate devices, primarily through engineering testing, software verification, and adherence to performance standards, not through clinical comparative effectiveness trials in the way an AI diagnostic tool would be evaluated.
• Type of Testing: The non-clinical testing listed (code review, static code analysis, unit tests, integration tests, specification and system-level verification testing, waveform testing, biocompatibility, human factors validation testing) are typical for medical device development to ensure functionality and safety, not AI model performance.

In summary, the provided text does not contain the information necessary to answer your request about acceptance criteria and a study proving an AI device meets those criteria. The document pertains to the clearance of ventilator systems, not an AI diagnostic or assistive device.

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The HAMILTON-C1 ventilator is intended to provide positive pressure ventilatory support or continuous flow of respiratory gases to adults and pediatrics, and optionally infants and neonates.

Intended areas of use:

· In the intensive care ward, intermediate care ward, emergency ward, long term acute care hospital or in the recovery room

· During transfer of ventilated patients within the hospital

The HAMILTON-C1 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-T1 ventilator is intended to provide positive pressure ventilatory support or continuous flow of respiratory gases to adults and pediatrics, and optionally infants and neonates.

Intended areas of use:

· In the intensive care ward, intermediate care ward, emergency ward, long term acute care hospital or in the recovery room

• · For emergency medical care
• · During transport within and outside the hospital
• · During transfer by rescue vehicles, fixed wing aircraft, helicopter or ship

The HAMILTON-T1 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-C1 and HAMILTON-T1 ventilators are designed for adults, pediatrics, infants and neonatal patients requiring invasive or non-invasive ventilation support. All ventilators cover a range of clinical requirements, including invasive ventilation, automated ventilation with Adaptive Support Ventilation (ASV), and Non-Invasive Ventilation.

The previously cleared ventilators, HAMILTON-C1 and HAMILTON-T1 (both K140939), have been bundled together in this 510(k) submission in order to add the following new features:

A modification to the software allows compatibility with the Nihon Kohden -SpO2 sensors to be used with HAMIILTON-C1 and HAMILTON-T1 ventilators. These ventilators are already compatible and cleared for use with Masimo SpO2 sensors (K140939).

• cFlow was added, which continuously delivers an air/gas mixture.
• -A modification to the software, which allows HAMILTON-C1/T1 ventilators to be compatible for use with speaking valves. A speaking valve allows tracheostomized adult and pediatric patients to communicate verbally.

The provided text describes the Hamilton-C1 and Hamilton-T1 ventilators and their clearance by the FDA. The submission focuses on adding new features to already cleared devices.

Here's an analysis of the provided information regarding acceptance criteria and study details:

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

The document does not explicitly present a table of acceptance criteria for the new features (cFlow, Speaking Valve, and Nihon Kohden SpO2 sensor compatibility) and their reported performance. Instead, it states that "the data provided from these tests was shown to be equivalent to the legally marketed devices." This implies that the acceptance criterion was equivalence to predicate/reference devices, and the reported performance met this criterion.

However, the "SUMMARY OF THE TECHNOLOGY AND PERFORMANCE SPECIFICATIONS COMPARISON WITH THE PREDICATED DEVICES" (Table 1 on pages 5-6) compares various parameters of the proposed HAMILTON-C1/T1 with the predicate HAMILTON-C1/T1 (K140939). For all listed parameters (Indications of Use, Control settings, Modes of ventilation, Alarms), the comparison states "Substantially Equivalent" or "Equivalent". While this table doesn't detail performance metrics for the new features, it confirms that the device, with its existing features, is considered equivalent to its predicate.

For the new features, the text mentions:

• cFlow: "cFlow was added, which continuously delivers an air/gas mixture." It later states, "The Nihon Kohden NKV-550 Series Ventilator System is used as a reference device for the proposed HAMILTON-C1/T1 as both the reference device and the proposed device are intensive care ventilators which have the O2 therapy/cFlow feature." This implies the cFlow feature in HAMILTON-C1/T1 is equivalent to that in the Nihon Kohden NKV-550.
• Nihon Kohden SpO2 sensors: "A modification to the software allows compatibility with the Nihon Kohden -SpO2 sensors to be used with HAMIILTON-C1 and HAMILTON-T1 ventilators." The document states, "The HAMILTON-C3 is used as a reference device for the proposed HAMILTON-C1/T1 as both the reference device and the proposed device are intensive care ventilators which can be used with Nihon Kohden SpO2 sensors and accessories." This suggests compatibility and performance with these sensors are equivalent to the HAMILTON-C3.
• Speaking Valve: "A modification to the software, which allows HAMILTON-C1/T1 ventilators to be compatible for use with speaking valves." "The Esprit Ventilator V200 with Speaking mode Option is used as a reference device for the proposed Speaking valve compatibility on the modified HAMILTON-C1/T1..." This indicates equivalence to the Esprit Ventilator V200's speaking mode.

Implicit Acceptance Criteria and Reported Performance for New Features:

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

The document does not specify exact sample sizes (e.g., number of patients, number of test cases) used for the comparison testing of the new features. It only states that "Testing of the modified HAMILTON-C1/T1, with the new features, was conducted."
The provenance of the data (country of origin, retrospective/prospective) is also not mentioned. The non-clinical performance tests are generally bench testing and software validation, not human studies.

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)

This section is not applicable as the document describes non-clinical performance tests for a ventilator, not diagnostic imaging or AI performance where human expert consensus would establish ground truth. The "ground truth" for these tests would be established through engineering specifications, validated test equipment, and established medical device standards.

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

Not applicable. The testing described is non-clinical performance and software validation, not a multi-reader clinical study requiring 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

Not applicable. This is a ventilation device, not a diagnostic AI tool, so no MRMC study or AI assistance improvement for human readers would be relevant.

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

This question is not entirely applicable in the context of a ventilator. However, the software validation and bench testing can be considered "standalone" in the sense that the device's technical performance and software functions were tested independently of a human operator making clinical decisions or interpreting results in a real patient scenario. The tests confirm the device operates as intended according to its design specifications and relevant standards.

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

The "ground truth" for the non-clinical performance tests and software validation would be based on:

• Engineering Specifications: The defined functional requirements and performance limits of the device.
• International and National Standards: Compliance with standards like ANSI/AAMI ES60601-1, IEC 60601-1-2, ISO 80601-2-12, etc. (listed in Section IX) which define acceptable ranges and behaviors for critical care ventilators, electromagnetic compatibility, alarm systems, and usability.
• Predicate/Reference Device Performance: The established, legally marketed performance of the predicate HAMILTON-C1/T1 and the reference devices (Nihon Kohden NKV-550, HAMILTON-C3, Esprit Ventilator V200) for the new features. Equivalence to these cleared devices serves as a form of "ground truth" for substantial equivalence.

8. The sample size for the training set

Not applicable. This device is not an AI/machine learning product that requires a training set. The changes described are software modifications for compatibility and feature additions to a pre-existing ventilator design.

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

Not applicable, as there is no training set for this type of medical device submission.

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The HAMILTON-G5 ventilator is designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients. The device is intended for use in the hospital and institutional environment where health care professionals provide patient care. The HAMILTON-G5 ventilator is intended for use by properly trained personnel under the direct supervision of a licensed physician. The HAMILTON-G5 ventilator may be used for transport within a hospital or hospital type facility provided compressed gas is supplied. The device is not to be used in the presence of flammable anesthetic agents or other ignition sources. The ventilator is not to be used in an environment with magnetic resonance imaging (MRI) equipment. The device is not intended for transportation outside the hospital or for use in the home environment.

The HAMILTON-G5 is designed for adult, pediatric, infant, and neonatal patients requiring invasive or noninvasive ventilation support. It covers a range of clinical modes, including invasive ventilation, Adaptive Support Ventilation (ASV), and noninvasive ventilation. The 510(k) submission intends to add the following new features to the previously cleared ventilator HAMILTON-G5: The following new feature for adult, pediatric, infant and neonatal patient group: cFlow

Based on the provided text, the acceptance criteria and study information for the HAMILTON-G5 ventilator are as follows:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific "sample size" for the test set in terms of patient data or case numbers. It refers to "bench testing of the device" and "comparison testing with legally marketed devices" for the cFlow feature.

The data provenance is implied to be retrospective in the sense that the device is being compared against already marketed devices (both predicate and reference devices) and established standards. There is no indication of prospective clinical trials in this 510(k) summary. The testing appears to be primarily laboratory/bench-based and validation of software and device performance against technical standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The document mentions "properly trained personnel under the direct supervision of a licensed physician" for its intended use, but not for the establishment of ground truth during testing. The "ground truth" for this device appears to be defined by adherence to recognized international technical standards and comparison to previously cleared devices.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the nature of the testing described (compliance with technical standards, bench testing, software validation, and comparison to predicate/reference devices), a formal adjudication method like 2+1 or 3+1 typically used in image-based diagnostic AI studies is not applicable or mentioned.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done and is not applicable to this device described. The HAMILTON-G5 is a medical ventilator, not an AI-assisted diagnostic tool for human readers.

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

This concept is not directly applicable as this is a medical ventilator. The device itself operates as a standalone system (an "algorithm only" analogy here would be the ventilator's internal software controlling ventilation parameters). The "human-in-the-loop" is the healthcare professional operating and monitoring the ventilator, as per its indications for use. The performance data refers to the device's technical compliance and functional equivalence.

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

The ground truth used for this submission is primarily:

• Compliance with recognized international technical standards (e.g., ISO, IEC, ANSI/AAMI standards for medical electrical equipment and ventilators).
• Functional equivalence to legally marketed predicate and reference devices (HAMILTON-G5 K131774 and Nihon Kohden NKV-550 Series Ventilator System K181695).
• Intended operation as designed as demonstrated through software design and validation processes and bench testing.

8. The sample size for the training set

The concept of a "training set" in the context of machine learning or AI is not applicable here. The HAMILTON-G5 is a traditional medical device (ventilator) with added features, not an AI/ML-driven model that undergoes training on a dataset. The software itself is validated, but not "trained" in the AI sense.

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

As explained above, there is no "training set" in the AI/ML context for this device. The verification and validation activities were based on established engineering principles, regulatory standards, and comparison to existing cleared devices.

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