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The Gründler's HumiCare D900 system is intended to heat and humidify medical respiratory gases for patients. The device is for use during artificial ventilatory support (e.g. invasve ventilation via tracheal tube or cannula), non-invasive ventilation, or respiratory therapy by means of a mask or other patient interface.

Heated breathing circuits are intended to provide warmed and/or humidified breathing gases before entering the patient airway reducing or eliminating water. They are accessories for the Gründler's HumiCare D900. The heated breath or flow rates greater than 3L/min.

The system is for use in hospital/institutional environment or in the home environment by medically trained healthcare users.

The HumiCare D900 system is a respiratory gas humidifier according to 21 CFR §868.5450. A respiratory gas humidifier is identified by the Food and Drug Administration (FDA) as a therapeutic device that is intended to warm and add humidity.

The HumiCare D900 including heated air tubings is an active heated humidifier which employs a pass-over humidification via an enhanced surface area for gas/water. The huge gas/water surface area is resulting in an output of gas with a temperature almost identical to that of the water with a relative humidity of 100%.

The principle operation of the HumiCare D900 is to direct the gas mixture from the ventilator's outlet into the humidifier's water chamber via air tubing. There it is heated and humidified by means of heated water. A heated inspiratory tube is used to transport the conditioned gas from the water chamber's outlet to the patient.

Depending on the patient interface an inspiratory tube or inspiratory and expiratory tubes can be used for the humidification with HumiCare D900. The inspiratory limb can further include an antibacterial filter with filter heater to reduce condensation. In order to minimize condensation (rain out), both inspiratory and expiratory air tubing can be actively heated. Therefore a temperature sensor is included in the inspiratory air tubing to control the temperature regulation of the air tubing.

The provided text describes a 510(k) premarket notification for the HumiCare D900 respiratory gas humidifier, which is a modification of an already cleared device (K122705). The submission primarily focuses on demonstrating substantial equivalence to the predicate device through non-clinical bench testing.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly present a table of acceptance criteria and reported device performance in the format of specific numerical targets vs. achieved results. Instead, it indicates that the modified device was tested against the "predetermined pass/fail requirements of the HumiCare D900 System Specification".

However, some performance characteristics are mentioned and compared between the predicate and modified device, which can be inferred as meeting acceptance criteria due to the "Equivalent" or "Substantially Equivalent" comments.

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 primarily discusses non-clinical bench testing.

• Sample size: The document does not specify the exact sample size for the bench tests (e.g., number of devices tested, number of test runs). It generally refers to "Side-by-Side bench testing" and "Design and Verification activities."
• Data provenance: The testing was "Side-by-Side bench testing" and "Design and Verification activities" performed by the manufacturer, ResMed Corp., which is based in San Diego, California, USA (though the original submitter, Dr. Christoph Gründler, and the device name "Gründler's HumiCare D900" suggest a European origin for the base technology). The nature of the testing is non-clinical/laboratory, not human subject data. Therefore, the terms "retrospective" or "prospective" are not applicable in this context.

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 information is not applicable as the study did not involve human interpretation or subjective judgment to establish ground truth. The acceptance criteria were based on "predetermined pass/fail requirements of the HumiCare D900 System Specification" and international standards like ISO 8185 and ISO 10993. These are objective measurements and engineering specifications, not expert consensus.

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

This information is not applicable as the testing was non-clinical bench testing and did not involve human observers or interpretation 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

No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not done. This device is a respiratory gas humidifier, not an AI-powered diagnostic or assistive technology that would involve human readers.

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

The concept of "standalone algorithm only" is not applicable to this device. It is a physical medical device (humidifier) that performs its function directly, not through an algorithm interpretation. The device does contain software for control and monitoring, but its performance is assessed via its physical output (temperature, humidity), not through an inferential algorithm's output.

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

The "ground truth" or reference for evaluating performance was based on:

• Predetermined pass/fail requirements from the HumiCare D900 System Specification.
• International standards: ISO 8185 for system performance and ISO 10993 for biocompatibility.
• Objective physical measurements: Such as temperature accuracy, humidification output (mg/L), and absence of condensation.

8. The sample size for the training set

This information is not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

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

This information is not applicable as there is no training set for a machine learning model.

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The Gründler HumiCare D900 system is intended to heat and humidify medical respiratory gases for patients. The device is for use during artificial ventilation or ventilatory support (e.g. invasive ventilation via tracheal tube or cannula), non-invasive ventilation, or respiratory therapy by means of a mask or other patient interface.

Heated breathing circuits are intended to provide warmed and/or humidified breathing gases before entering the patient airway reducing or eliminating water. They are accessories for the Gründler's HumiCare D900. The heated breathing circuits are used for flow rates greater than 3L/min.

The system is for use in hospital/institutional environment or in the home environment by medically trained healthcare users.

The HumiCare D900 system is a respiratory gas humidifier according to 21 CER §868.5450. A respiratory gas humidifier is identified by the Food and Drug Administration (FDA) as a therapeutic device that is intended to warm and add humidity.

The HumiCare D900 including heated air tubings is an active heated humidifier which employs a passover humidification via an enhanced surface area for gas/water. The huge gas/water sufface area is resulting in an output of gas with a temperature almost identical to that of the water with a relative humidity of 100%.

The principle HumiCare D900 is to direct the gas mixture from the ventilator's outlet into the humidifier's water chamber via air tubing. There it is heated and humidified by means of heated water. A heated inspiratory tube is used to transport the conditioned gas from the water chamber's outlet to the patient.

Depending on the patient interface an inspiratory tube or inspiratory and expiratory tubes can be used for the humidification with HumiCare D900. The inspiratory limb can further include an antibacterial filter with filter heater to reduce condensation. In order to minimize condensation (rain out), both inspiratory and expiratory air tubing can be actively heated therefore temperature sensors are included in the inspiratory and expiratory air tubing,

The HumiCare D900 system consists of a heater base with external power supply, connector cables, a 30day disposable water chambers, heated tubes (inspiratory), connection tube, antibacterial filter and filter heater. The 30day disposable water chamber and air tubing circuits are intended for single patient use, with the exception of when an antibacterial filter is incorporated into the circuit allowing multi-patient use of the chamber. The HumiCare D900 heater base and filter heater are intended for multi-patient re-use.

The HumiCare D900 is a respiratory gas humidifier. The provided text from the 510(k) summary (K122765) states that various design and verification activities were performed to ensure the device met predetermined acceptance criteria. These tests confirmed that the product met these criteria, specifically highlighting side-by-side testing for humidification performance and resistance.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "All tests confirmed the product met the predetermined acceptance criteria. In particular side-by-side testing demonstrated that the HumiCare D900 essential performance specifications (humidification performance, resistance of the humidifier) are Substantially Equivalent to the predicate devices."

However, specific numerical acceptance criteria or detailed performance reports are not provided in this summary. The summary only generally states that the device met the criteria and was substantially equivalent to predicate devices for "humidification performance" and "resistance of the humidifier."

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

The document does not specify the sample size used for the test set. It also does not define the data provenance (e.g., country of origin, retrospective or prospective) for the performance testing.

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

The document does not mention the use of experts or a ground truth established by them for the performance validation of the HumiCare D900. The testing appears to be of a technical/engineering nature, comparing the device's technical specifications and performance against predicate devices and relevant standards.

4. Adjudication Method for the Test Set

Since an expert-based ground truth is not mentioned, there is no adjudication method described in the provided text.

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

No. The document describes a medical device (a respiratory gas humidifier) and its engineering and performance validation. It does not involve human readers interpreting data or a multi-reader multi-case comparative effectiveness study in the context of AI assistance.

6. If a Standalone Performance Study Was Done

Yes, a standalone performance study was done in the sense that the device's performance was evaluated against predetermined acceptance criteria and compared to predicate devices. The text states: "All tests confirmed the product met the predetermined acceptance criteria. In particular side-by-side testing demonstrated that the HumiCare D900 essential performance specifications (humidification performance, resistance of the humidifier) are Substantially Equivalent to the predicate devices." This implies that the device (algorithm/system) was tested on its own to demonstrate its functionality and equivalence.

7. The Type of Ground Truth Used

The "ground truth" for the HumiCare D900's performance appears to be based on:

• Engineering specifications and pre-determined acceptance criteria for device functionality.
• The performance characteristics of legally marketed predicate devices, against which the HumiCare D900 was deemed "substantially equivalent."
• Compliance with recognized standards (e.g., ISO 8185:2009 for humidifiers, ISO 10993 series for biocompatibility, IEC 60601-1 for safety).

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable here, as this device is a physical medical device (a humidifier) and not an AI/machine learning model that undergoes training on data.

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

As mentioned above, the concept of a "training set" is not applicable to this device. Therefore, no ground truth for a training set was established.

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