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The HC604 CPAP Humidifier is used to assist with patient breathing while sleeping, for the purpose of treating Obstructive Sleep Apnea (OSA). This is by the delivery of Continuous Positive Airway Pressure (CPAP) in order to prevent airway obstruction. The addition of heated respiratory humidification to this therapy relieves the drying and irritating effects on the patient airways, which may arise from use of a CPAP system.

The HC604 CPAP Humidifier is for use on adult, spontaneously breathing (non-ventilator dependant) patients at home or in the sleep laboratory.

The HC604 CPAP Humidifier is a non-invasive Continuous Positive Airway Pressure flow generator, incorporating a Heated Respiratory Humidifier and a heated respiratory breathing circuit.

The HC604 is comprised of two main functional units. One is a motorised fan assembly that provides positive air pressure, which can be adjusted from 4 to 20cm H₂O as prescribed by a physician. The fan speed is directly related to air pressure, and is controlled by software. The blower assembly output connects directly to a humidification chamber at the front of the device.

The second functional unit of the HC604 is a heated passover humidifier. The water is contained in a humidification chamber positioned on a heaterplate at the front of the unit. The chamber connects directly to the blower assembly via a port at the back of the chamber. Ambient temperature is monitored in order to reduce breathing tube condensation in cooler operating conditions. Condensation is further reduced by the heated breathing tube which connects to the outlet port on the fop of the unit.

Here's an analysis of the provided text regarding the HC604 CPAP Humidifier's acceptance criteria and studies, organized according to your request:

Acceptance Criteria and Device Performance Study

The provided document describes the substantial equivalence of the HC604 CPAP Humidifier to a predicate device (HC234 CPAP Humidifier) for 510(k) clearance. It does not present a study with specific acceptance criteria metrics and numerical results for that device's performance. Instead, it relies on demonstrating compliance with recognized standards and similarity to a legally marketed predicate.

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, specific numerical acceptance criteria and a table of direct performance for the HC604 CPAP Humidifier are not provided in the document. The document states that the device "meets the requirements" of various standards and that its "technological characteristics... are equivalent" to the predicate.

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

• The document does not specify a sample size for any clinical test set because it explicitly states: "Clinical verification studies on the HC604 CPAP Humidifier were not required in order to demonstrate the safety, effectiveness, and performance of the device."
• Data provenance for non-clinical tests is implicitly from the manufacturer, Fisher & Paykel Healthcare, but no specific country of origin for the data or whether it was retrospective/prospective is mentioned.

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

• Not applicable. No clinical test set requiring expert ground truth assessment was performed. The evaluation was based on non-clinical testing and comparison to a predicate device.

4. Adjudication Method for the Test Set

• Not applicable. No clinical test set requiring adjudication was performed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. An MRMC comparative effectiveness study was not done, as no clinical studies were performed or deemed necessary.

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

• Not applicable. This device is a physical medical device (CPAP Humidifier), not an AI algorithm. Its performance is intrinsic to the device's function, not an algorithm that operates independently or with a human in the loop in the context of interpretation or diagnosis.

7. The Type of Ground Truth Used

• For the non-clinical tests (mechanical, electrical, thermal safety, EMC, functional verification, performance), the "ground truth" was established based on compliance with recognized international and national standards (IEC 60601-1, UL 60601-1, IEC 60601-1-2, ISO 8185, ASTM F1690) and demonstrated equivalence to the predicate device's technological characteristics and intended use.

8. The Sample Size for the Training Set

• Not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.

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

• Not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.

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