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The REMstar Auto A-Flex HT delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea in spontaneously breathing patients weighing over 30kg (66 lbs). It is for use in the home or hospital/institutional environment.

The REMstar Auto A-Flex HT is a microprocessor controlled blower based positive pressure system which is comprised of the therapy device, a heated humidifier and patient tubing (15mm, 22mm, or heated tubing).

The REMstar Auto A-Flex HT delivers CPAP and Auto CPAP therapy. With CPAP therapy, the device provides a continuous positive airway pressure throughout the entire therapy session. With Auto CPAP therapy, the device provides a positive airway pressure that automatically adjusts to the patient's needs as various breathing events, such as apneas and hypopneas, are detected.

In addition to the CPAP and Auto CPAP therapy, the REMstar Auto A-Flex HT incorporates several optional features to aid with patient comfort. These features include ramp, adjustable pressure relief (FLEX technologies), and humidification. Two ramp options are available, ramp and GPAP, in which therapy pressure gradually increases (ramps) to the prescription pressure. The therapy pressure increases to the prescription pressure over minutes with the standard ramp feature and over days with the GPAP extended duration ramp feature. Humidification options include both a heated humidifier and heated tubing. The heated humidifier adjusts the level of humidification by varying the temperature of a heated plate used to heat up a chamber of water. Optional heated tubing can then be used to maintain that air at a desired temperature until it reaches the patient's mask.

The REMstar Auto A-Flex HT is intended for use with a patient circuit that connects the device to a patient interface device (mask). A typical patient circuit consists of patient tubing (15mm, or heated tubing) and an exhalation device (if one is not present in the mask). When a heated humidifier is attached to the therapy device, the patient circuit connects to the air outlet port of the heated humidifier.

The provided text describes modifications to an existing device (REMstar Auto A-Flex HT) and seeks substantial equivalence to the predicate device (REMstar Auto A-Flex HT K113068). The submission focuses on non-clinical testing and standard compliance to demonstrate safety and effectiveness.

Here’s a breakdown of the information requested, based on 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 modified device. Instead, it states:

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

• Sample Size: Not applicable. The testing described is non-clinical design verification testing, not clinical studies with patient test sets. Therefore, there is no mention of a "test set" in the context of patient data.
• Data Provenance: Not applicable. The testing is internal design verification rather than data from human subjects.

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

• Not applicable. As described above, there was no clinical test set requiring expert ground truth establishment. The "ground truth" for the non-clinical tests would be the established engineering specifications and regulatory standards.

4. Adjudication Method for the Test Set

• Not applicable. There was no clinical test set to adjudicate.

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. The document explicitly states: "Clinical tests were not required to demonstrate the safety and effectiveness of the REMstar Auto A-Flex HT." Therefore, no MRMC study was performed, and there is no mention of AI assistance or human reader improvement.

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

• Not applicable. This device is a CPAP system, not an AI algorithm. Its performance is assessed through its mechanical and functional operation, not as an algorithm, and it's designed for use by patients, not directly by "human-in-the-loop" readers in the context of image interpretation or similar AI applications.

7. The Type of Ground Truth Used

• For the non-clinical tests, the "ground truth" would be the design specifications, performance requirements, and regulatory standards (e.g., ISO, IEC standards) that the device was tested against. The tests verified that the modifications did not alter the safety or effectiveness or the device's ability to meet these established engineering and regulatory benchmarks.

8. The Sample Size for the Training Set

• Not applicable. This device is a hardware and software system, not an AI model requiring a training set in the machine learning sense. The "training set" equivalent here would be the accumulated engineering knowledge, design principles, and previous device iterations used in the development process, not a distinct dataset for algorithm training.

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

• Not applicable, as there is no training set in the context of an AI algorithm. The "ground truth" for the device's development and verification is established through a combination of:
  • Regulatory standards: As listed (e.g., ISO 14971, IEC 60601-1).
  • Internal product requirements and specifications: Developed based on the intended use, risk analysis, and engineering principles.
  • Performance of the predicate device: The modified device's performance is compared to its substantially equivalent predicate.

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The REMstar Auto A-Flex HT delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea in spontaneously breathing patients weighing over 30kg (66 lbs). It is for use in the home or hospital/institutional environment.

The REMstar Auto A-Flex HT is a microprocessor controlled blower based positive pressure system which is comprised of the therapy device, a heated humidifier and patient tubing (15mm, 22mm, or heated tubing).

The REMstar Auto A-Flex HT includes CPAP and Auto CPAP therapy modes. While in CPAP mode, the device delivers a continuous positive airway pressure throughout the entire therapy session. While in Auto CPAP mode, the device delivers a positive airway pressure that automatically adjusts to the patient's needs as various breathing events, such as apneas and hypopneas, are detected.

In addition to CPAP and Auto CPAP therapy modes, the REMstar Auto A-Flex HT incorporates several optional features to aid with patient comfort. These features include ramp, adjustable pressure relief (FLEX technologies), and humidification options include both a heated humidifier and heated tubing. The heated humidifier adjusts the level of humidification by varying the temperature of a heated plate used to heat up a chamber of water. Optional heated tubing can then be used to maintain that air at a desired temperature until it reaches the patient's mask. This is accomplished through a resistive-wire heating element embedded in the tubing wall.

The submission describes the REMstar Auto A-Flex HT, a CPAP system, and outlines verification activities performed to ensure its safety and effectiveness following modifications to include optional heated tubing. The study provided focuses on non-clinical tests to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The provided document describes non-clinical verification activities rather than a traditional clinical study with a "test set" in the sense of patient data. The tests focus on device performance, materials, and compliance with standards.

• Sample Size for Test Set: Not applicable in the context of patient data. The "test sets" would refer to the physical devices and components subjected to engineering and safety tests. The specific number of units tested for each verification activity is not provided.
• Data Provenance: Not applicable in the context of patient data. The provenance for the testing is internal to the manufacturer (Respironics, Inc.), performing engineering, safety, and performance evaluations of the device modifications. The tests are "retrospective" in the sense that they assess the final design.

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

Not applicable. The ground truth for these non-clinical tests is established by industry standards (e.g., ISO 10993-1, IEC 60601-1) and internal product specifications. The "experts" would be the engineers and regulatory affairs personnel at Respironics, Inc. responsible for designing the tests and evaluating the results against these pre-defined standards and specifications. Their specific number and qualifications are not detailed but are assumed to be appropriate for device development and regulatory submission.

4. Adjudication Method for the Test Set:

Not applicable in the context of expert adjudication. The "adjudication" for these non-clinical tests would involve assessing whether the device's performance meets the pre-defined acceptance criteria and standards. This is typically a pass/fail determination based on objective measurements and compliance documents, rather than human expert consensus on ambiguous data.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical tests were not required to demonstrate the safety and effectiveness of the REMstar Auto A-Flex HT. Product functionality has been adequately assessed by non-clinical tests." Therefore, there is no effect size of human readers improving with or without AI assistance.

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

The device is a medical apparatus (CPAP system) that includes microprocessor-controlled functionality. The "standalone" performance refers to the device itself operating according to its design specifications. All the non-clinical tests described are evaluations of the device's standalone performance, including software, electrical, and mechanical aspects. There is no "algorithm only" context separate from the device for this type of product.

7. The Type of Ground Truth Used:

The ground truth used for these non-clinical tests is based on:

• Product Specifications: Internal technical requirements defined by Respironics, Inc. for the device's functionality and performance.
• International Standards: Recognized medical device standards such as ISO 10993-1 (Biological evaluation) and IEC 60601-1 (Electrical safety).
• FDA Guidance Documents: Guidance for Premarket Notification Submissions regarding electromagnetic compatibility and mechanical stress testing.

8. The Sample Size for the Training Set:

Not applicable. This submission describes verification of a modified physical device, not an AI/ML algorithm that requires a "training set" of data.

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

Not applicable, as there is no training set for an AI/ML algorithm involved in this submission.

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