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The Respironics Heated Humidifier is an accessory for CPAP and Bi-level systems to provide moisture to the patient circuit. It is intended for use with adult patients, in the home or hospital/institutional environment, who use maskapplied CPAP or Bi-level therapy for the treatment of Obstructive Sleep Apnea.

The Respironics Heated Humidifier is a Respiratory Gas Humidifier (heated Passover type) according to 21 CFR 868.5450. Heat is used to provide an evaporated water content to dry breathing gases. The Respironics Heated Humidifier has a thermoplastic enclosure with dimensions of 5.5 in. high x 6.5 in. wide x 5.25 in. deep and weighs 1.24 lbs. (without the chamber fitted), 1.63 lbs. (with the chamber fitted), and 2.5 lbs. (with the chamber fitted and filled with water). The unit is compromised of a metal heater plate that is controlled from control electronics, contained in a plastic enclosure that is directly supplied with AC power. The heater plate is positioned in the front of the unit. The humidification chamber slides onto the heater plate and is held in place by a rim on the enclosure. The unit controls are located on the top panel.

This document describes a 510(k) submission for the Respironics Heated Humidifier, a respiratory gas humidifier.

Here's an analysis of the provided text with respect to acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a structured table or numerical targets for device performance. Instead, it relies on demonstrating equivalence to a predicate device and compliance with general safety and performance standards.

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

• Test Set Sample Size: Not applicable. This submission is for a medical device (humidifier), not an AI algorithm evaluated on a 'test set' of data in the typical sense. Performance was assessed through non-clinical laboratory testing of the device itself and comparison to a predicate.
• Data Provenance: Not applicable in the context of clinical trial data. The data refers to the results of engineering and functional tests conducted on the physical device. The country of origin for these tests is implied to be within the company's (Respironics, Inc. in Murrysville, PA) testing facilities, or by certified third-party testing labs for standards compliance. The data is prospective for this specific device, meaning the tests were performed on the newly designed humidifier.

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

Not applicable. "Ground truth" in the context of expert consensus on diagnostic images or patient outcomes is not relevant for this type of device submission. Ground truth for device performance would be established by validated measurement equipment and adherence to defined engineering and medical device standards.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not applicable. No adjudication method involving multiple experts for a test set is mentioned or relevant for this type of device submission.

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. This is a submission for a physical medical device (respiratory gas humidifier), not an AI-powered diagnostic or assistive technology where MRMC studies would be relevant.

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

Not applicable. This is not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the device's performance is established by:

• Compliance with recognized international and national safety standards (IEC 60601-1, UL 2601-1).
• Functional verification against design specifications.
• Comparison of technological characteristics and performance to the legally marketed predicate device (Fisher & Paykel HC100 Respiratory Humidifier), demonstrating substantial equivalence.
• The intended function of warming and adding moisture to breathing gases is physically measurable.

8. The Sample Size for the Training Set

Not applicable. There is no AI algorithm being trained. Performance is based on physical device testing and comparison to a predicate.

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

Not applicable. There is no AI algorithm being trained, and therefore no training set or ground truth for it.

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The Respironics Solo CPAP System is intended to deliver Continuous Positive Airway Pressure (CPAP) therapy for the treatment of adult Obstructive Sleep Apnea (OSA) only. The Solo CPAP System may be used in clinical settings (hospitals & sleep labs) and in home environments, and must be prescribed by a physician. It is not intended for life support or life sustaining applications. The device is used in conjunction with a mask (various styles and sizes available), headgear, and a combination of breathing circuit accessories.

The Solo CPAP System is an electromechanical device that produces Continuous Positive Airway Pressure (CPAP) and delivers it to a patient. As shown in Figure 12-1, the system consists of the Solo CPAP device and a patient circuit that is used to direct the air to the patient. The Solo CPAP device consists of a blower assembly and a microprocessor control system. The blower assembly generates positive airway pressures from 4 to 15 cm H2O. The level of pressure is dependent on motor speed. Two control buttons (Pressure ON/OFF and Ramp) and an LED are located on the control panel at the top of the unit. Motor speed is controlled by a microprocessorcontrolled feedback system. The device can operate on either 115 or 230 Volts AC, or 12 volts DC using the DC accessories included with the system. The Solo CPAP System offers DC power as an alternative power source; it is not intended to be used as a battery back-up source. The Solo CPAP System is not intended to be used in a mobile environment. Pressurized air travels from the Solo CPAP device to the patient via 22 mm flexible tubing. The flexible tubing connects with an exhalation port to exhaust carbon dioxide from the circuit, which in turn connects to a mask. The tubing, exhalation port, and mask are referred to as the patient circuit.

The provided document is a 510(k) premarket notification for the Solo CPAP System. It states that the submission demonstrates the system's substantial equivalence to predicate devices (Respironics Aria CPAP System and Nellcor Puritan-Bennett Companion 314 Nasal CPAP System) through performance-related testing.

Here's an analysis based on your request, highlighting the limitations of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table of acceptance criteria with corresponding performance metrics for the Solo CPAP System in terms of diagnostic accuracy or clinical outcomes. Instead, it broadly states:

"Testing was performed to demonstrate that the performance of the Solo CPAP System in its intended environment is as safe and effective as that of the legally marketed predicate devices. The safety and effectiveness of the Solo CPAP System were verified through performance-related testing that consisted of Electrical Safety, Electromagnetic Compatibility, Mechanical and Environmental Testing. The Solo CPAP System was tested and found compliant with the standards referenced in the "Draft FDA Reviewer Guidance for Premarket Notifications," November 1993."

This indicates that the "acceptance criteria" were compliance with established safety and performance standards for these types of electromechanical devices, rather than clinical efficacy metrics.

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

The document does not mention any clinical test set involving patients or human subjects. The testing described is focused on the device's engineering performance (electrical, EMC, mechanical, environmental). Therefore, there is no sample size for a "test set" in the context of clinical data, nor is there information about data provenance (country of origin, retrospective/prospective).

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

Since there was no clinical study described with a test set requiring ground truth established by experts, this information is not applicable and not present in the document.

4. Adjudication Method for the Test Set

As no clinical test set is described, there is no adjudication method mentioned.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or described in this document. The submission focuses on demonstrating substantial equivalence through technical performance testing, not direct comparison of human reader performance with or without AI assistance. The device is a CPAP machine, not an AI diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The Solo CPAP System is an electromechanical device with an embedded software control system that regulates pressure. It's not an "algorithm" in the sense of an AI model making diagnostic or prescriptive decisions that would require a "standalone" performance evaluation against human performance. The software controls motor speed and monitors functions, which are integral to the device's operation. Its performance is assessed as part of the overall device's electrical, mechanical, and safety testing. Therefore, this question is not applicable in the context of this device.

7. The Type of Ground Truth Used

The "ground truth" for the testing described is primarily engineering specifications and regulatory standards for electrical safety, electromagnetic compatibility, mechanical integrity, and environmental performance. For example, a "ground truth" for electrical safety would be meeting specific current leakage limits or insulation resistance values.

8. The Sample Size for the Training Set

The document discusses an "embedded software control system" and assembly language routines. This software controls motor speed and monitors various conditions. There is no mention of a training set in the context of machine learning or AI models. The software is likely developed using traditional programming and control systems engineering, not a data-driven training approach.

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

Since there is no training set mentioned in the context of machine learning, there is no information on how ground truth for a training set was established. The software's "ground truth" would be its functional specifications and correct execution of control logic, verified through software testing and validation processes. The document states: "Its software has been designed and developed in accordance with the FDA Reviewer's Guidance for Computer Controlled Medical Devices." This implies adherence to established software development and verification principles, rather than a data-driven ground truth for a training set.

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