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The Humidifier Heater Base PMH7000PLUS/PMH7000 is intended to add moisture and to warm the breathing gases for administration to the patient.

The Humidifier Heater Base, PMH7000PLUS/PMH7000 is intended for use on adult at hospital and home.

The Humidifier Heater Base, PMH7000PLUS/PMH7000 is a humidifier incorporating with ventilator and provides respiratory humidification through patient breathing circuit for adult at hospital and home.

This heater base features a dual temperature servo control system which regulates the temperature of the gas delivered to the patient and the gas at outlet of humidifying chamber. It continuously monitors temperatures by a dual temperature probe. The heater base warms and humidifies the gas through the humidifier chamber and in addition a heater wire in the patient breathing circuit further controls same gas temperature. The operator is allowed to set the temperature of two locations: temperature of the chamber outlet gas and the gas immediately before delivered to the patient.

The Humidifier Heater Base PMH7000PLUS/PMH7000 is equipped with alarms which activate audible and visual indicators to alert the operator of adverse conditions. Alarms are provided for high and low airway temperature, high and low chamber outlet temperature probe disconnect or fault condition, heater wire fault connection, and the light identifies the area of alarm.

The Humidifier Heater Base PMH7000PLUS/PMH7000 includes several safety features such as prevention of excessive heating which can be harmful to the patient or can cause damage to the heater base itself. To ensure patient safety, the heater base will shut down under any alarm conditions if it continues for 10 minutes.

The Humidifier Heater Base are available in two models, PMH7000PLUS and PMH7000. PMH7000PLUS/PMH7000 has both inspiratory and expiratory heater wires for use in the inspiratory and expiratory limbs of breathing circuit. The use of the expiratory heater wire with PMH7000PLUS/PMH7000 is to control humidity in the expiratory limb and to reduce moisture returned to the ventilator.

The provided text is a 510(k) summary for a medical device (Humidifier Heater Base PMH7000PLUS/PMH7000). It describes the device, its modifications, and its substantial equivalence to a predicate device. However, this document does not contain explicit acceptance criteria tables, detailed study designs with sample sizes, information on ground truth establishment with expert qualifications, adjudication methods, or MRMC comparative effectiveness studies typically found for AI/ML device submissions.

The documentation focuses on demonstrating substantial equivalence to a predicate device based on non-clinical testing and design modifications. The modifications mainly concern changes to the front and side panel design and the heater wire connector interface to improve maneuverability and connectivity. The core technological characteristics, intended use, operating principle, and performance (temperature and humidity output) are stated to be equivalent to the predicate device.

Therefore, many of the requested data points (especially those related to AI/ML device evaluation) are not present in this type of submission.

Here's an attempt to extract the available information:

• Acceptance Criteria and Reported Device Performance: Explicit acceptance criteria in a table format with specific performance metrics are not detailed in this 510(k) summary. The document states that "Non-clinical testing of Humidifier Heater Base PMH7000PLUS/ PMH7000 has been carried out covering mechanical, electrical and thermal safety, environmental conditions and electromagnetic compatibility, functional verification, and performance capacity and accuracy." It also states, "PMH7000PLUS/ PMH7000 meets the requirements of the IEC 60601-1 and IEC 60601-1-2 electro medical and EMC standards" and "complies with performance and safety requirements of the ISO 8185 particular standard for Humidification Systems." This implies the acceptance criteria were compliance with these specific standards for safety and performance, but the numerical target values are not provided. The reported device performance is that it meets these requirements.

• Sample Size for Test Set and Data Provenance: Not applicable. This device is not an AI/ML device tested with a "test set" of patient data. The evaluation was based on non-clinical engineering and performance testing.
• Number of Experts and Qualifications for Ground Truth: Not applicable. No experts were used to establish ground truth in the context of diagnostic performance for patient data, as this is not an AI/ML diagnostic device.
• Adjudication Method: Not applicable.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No, this type of study was not conducted as this is not an AI/ML device that assists human readers.
• Standalone Performance: A standalone performance evaluation was done in the sense of the device's electrical, mechanical, and thermal safety and its ability to meet performance standards (e.g., temperature and humidity output) independently. The testing was "non-clinical."
• Type of Ground Truth Used: The "ground truth" here refers to compliance with recognized consensus standards (IEC 60601-1, IEC 60601-1-2, ISO 8185, ANSI/AAMI ES60601-1) and the functional specifications of the device itself (e.g., set temperature, humidity output).
• Sample Size for Training Set: Not applicable. This is not an AI/ML device that requires a training set.
• How Ground Truth for the Training Set was Established: Not applicable.

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The Humidifier Heater Base PMH7000 is intended to add moisture and to warm the breathing gases for administration to a patient. The Humidifier Heater Base, PMH7000 is intended for use on adult at hospital and home.

The Humidifier Heater Base, PMH7000 is a humidifier incorporating with ventilator and provides respiratory humidification through patient breathing circuit for adult at hospital and home.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Humidifier Heater Base, PMH7000:

Device: Humidifier Heater Base, PMH7000

This document is a 510(k) summary for a medical device. For such submissions, the primary "study" proving acceptance is typically a demonstration of substantial equivalence to an already legally marketed (predicate) device, rather than a clinical trial with specific performance metrics and acceptance criteria in the same way a novel AI algorithm might have. Therefore, many of the requested fields will reflect this type of submission.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission based on substantial equivalence, the "acceptance criteria" are generally that the new device (PMH7000) is as safe and effective as the predicate device (PMH5000) and that any differences do not adversely affect safety or effectiveness. The "reported device performance" is a direct comparison to the predicate.

Overall Acceptance: The PMH7000 is concluded to be "as safe and effective (therefore substantially equivalent)" as the predicate device, the PMH5000 (K020700).

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

• Sample Size: Not applicable in the context of a substantial equivalence submission based on documentary comparison. No specific "test set" of patient data or device performance data from a clinical study is mentioned for the direct comparison. The "test" is the comparison of specifications and design features with the predicate device.
• Data Provenance: The data provenance comes from the design specifications and technical characteristics of the Pacific Medico PMH7000 and its predicate device, the Pegasus Research PMH5000 (K020700). The context is Japan-based manufacturing (Pacific Medico Co., Ltd., Tokyo Japan). It is a descriptive comparison of technical specifications rather than a data-driven clinical study.

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

• Number of Experts: Not explicitly stated as a formal panel for ground truth establishment. For a 510(k) submission, the "ground truth" for substantial equivalence is primarily established by the manufacturer (Pacific Medico Co., Ltd.) through their technical assessment and comparison to the predicate device. The FDA then reviews this assessment.
• Qualifications of Experts: The submission was prepared by Yukio Tomisawa (Official Contact) and Mr. Yoshio Toyama (Manager of Regulatory Affairs), who can be considered the subject matter experts from the manufacturer’s side regarding the device design and regulatory comparison. The FDA's Division of Anesthesiology, General Hospital, Infection Control and Dental Devices (Director: Chiu Lin, Ph.D. and reviewer for the letter: Samith J. Michels D.M.D.) are the regulatory experts who reviewed and accepted the claim.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable in the sense of a clinical test set with adjudicated outcomes. The "adjudication" in a 510(k) is the FDA's regulatory review process, where they determine if the manufacturer's claim of substantial equivalence is valid based on the submitted documentation comparing the new device to the predicate device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging devices or AI algorithms where human readers' performance with and without AI assistance is evaluated on a set of cases. This submission is for a respiratory gas humidifier, which is a physical device, and its safety and effectiveness are established through technical specifications and comparison to a predicate, not through reader studies.
• Effect Size of Human Readers: Not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone Study: Not applicable. The device is a physical medical device (humidifier heater base), not an algorithm or AI system. Its performance is inherent in its design and operation, not through algorithmic output without human interaction.

7. The Type of Ground Truth Used

• Ground Truth Type: Not applicable in the clinical sense of pathology or outcome data. The "ground truth" for this 510(k) submission is the established safety and effectiveness of the legally marketed predicate device (Pegasus Research PMH5000, K020700). The PMH7000 aims to demonstrate that it is equally safe and effective by comparing its technical characteristics, intended use, and operational principles to this predicate. The manufacturer's declaration that "there is no difference in the technology applied in both PMH5000 and PMH7000 which may affect the safety and effectiveness of the subjective devices" serves as the basis for this ground truth in the context of substantial equivalence.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This is not an AI or machine learning device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

• Training Set Ground Truth Establishment: Not applicable. As there is no training set, there is no ground truth to establish for it.

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