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The DreamStation 2 CPAP/DreamStation 2 Auto CPAP system delivers positive airway for the treatment of Obstructive Sleep Apnea in spontaneously breathing patients weighing over 30 kg (66 lbs). It is for use in the home or hospital/institutional environment.

The DreamStation 2 System uses a microprocessor-controlled blower to treat patients with Obstructive Sleep Apnea (OSA). There are 2 models: DreamStation 2 and DreamStation 2 Advanced. Both aforementioned models will be available in two therapy modes: CPAP only and Auto CPAP. 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 are detected, such as apneas and hypopneas. In addition to the therapy modes, the DreamStation 2 System provides several optional features to aid with patient comfort. These patient comfort features include: Ramp Plus, adjustable pressure relief (FLEX), EZ-Start, Opti-Start, and humidification (adaptive and adaptive with heated tube). Note: some of the features are only available in the DreamStation 2 Advanced model. The DreamStation 2 device also features integrated Bluetooth and cellular technology for the transfer of patient management data between the therapy device and Respironics proprietary compliance software, Care Orchestrator.

This document describes the 510(k) premarket notification for the DreamStation 2 System, a noncontinuous ventilator (CPAP system) for treating Obstructive Sleep Apnea. It does not contain information about a study proving the device meets acceptance criteria from clinical trials involving human subjects, nor does it provide a table of acceptance criteria and reported device performance from such a study.

The document primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing, software testing, biocompatibility testing, general safety and electrical compatibility testing, and human factors/usability testing.

Therefore, I cannot fulfill the request for information regarding clinical acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, standalone performance, or training set specifics, as this information is not present in the provided text.

The document explicitly states: "Clinical tests were not required to demonstrate the safety and effectiveness of the DreamStation 2 System. Safety and efficacy of the DreamStation 2 System has been established via nonclinical tests."

The only "acceptance criteria" presented are related to technical specifications (e.g., pressure accuracy) and compliance with various international standards, which is then demonstrated through the completion of non-clinical testing.

Here's a breakdown of what is available in the document regarding performance and testing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides a comparison of technical characteristics between the DreamStation 2 System and its predicate devices in Table 5-1 (pages 5-6) and Table 5-2 (page 8). While it doesn't explicitly state "acceptance criteria" for clinical outcomes, it does list performance specifications for pressure accuracy and notes whether the subject device's performance is "Same" or "Similar" to the predicates.

Note: The "Acceptance Criteria" column is inferred from the document's claim of "Same" or "Similar" performance to the predicates, which is the basis for substantial equivalence. The document does not specify exact acceptance criteria values for new features, but rather demonstrates that the new device meets or exceeds the performance of existing legally marketed predicate devices for similar functionality.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not Applicable. The document explicitly states that clinical tests were not required. The testing performed was non-clinical. Therefore, no "test set" of patient data or data provenance information is provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. As no clinical "test set" was used, there was no need for experts to establish ground truth in a clinical context. Product requirement and specification experts within the company would have been involved in defining the non-clinical testing parameters.

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

• Not Applicable. This refers to clinical data adjudication, which was not performed.

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:

• Not Applicable. No MRMC study involving human readers or AI assistance was performed or described. This device is a CPAP system, not an AI-driven diagnostic tool.

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

• Not Applicable. This refers to AI algorithm performance. The DreamStation 2 System is a hardware device for delivering airway pressure, not primarily an AI algorithm. Its software is for controlling the device and managing patient data, not for making diagnostic or treatment recommendations independently in an "algorithm only" sense beyond its intended function.

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

• Not Applicable (for clinical ground truth). For the non-clinical and software testing, the "ground truth" would be the device's technical specifications, design requirements, and adherence to recognized international standards (e.g., ISO, IEC).

8. The sample size for the training set:

• Not Applicable. No clinical training set was used or described.

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

• Not Applicable. No clinical training set was used or described.

Summary of the Study that Proves the Device Meets the (Non-Clinical) Acceptance Criteria:

The DreamStation 2 System demonstrated that it meets acceptance criteria through a series of non-clinical performance tests which include:

• Performance Testing: To address device requirements, risk mitigations, show substantial equivalence, and assure safety and efficacy. (Details not provided in terms of specific tests, but performance characteristics like pressure accuracy are compared to predicates).
• Software Testing: Developed according to IEC 62304:2015 ("Medical Device Software - Software Life Cycle Processes"). Software verification and validation were performed based on product requirements, following FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software was deemed to have a "Moderate" level of concern.
• Biocompatibility Testing: Conducted in accordance with FDA Guidance and international standards ISO 10993-1:2018 and ISO 18562-1:2017, proving the device to be biocompatible.
• General Safety, Electrical Safety, and Electromagnetic Compatibility (EMC) Testing: The system complies with AAMI/ANSI/ES 60601-1:2005/A1:2012, IEC 60601-1-2:2014, IEC 60601-1-6:2013, IEC 60601-1-11:2015, ISO 80601-2-61: 2011, ISO 80601-2-70: 2015, and ISO 80601-2-74: 2017.
• Human Factors/Usability Testing: Aligned with IEC 62366-1: 2015 and FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices." A human factors validation study indicated safe and effective operation by intended users with acceptable residual risk.

The conclusion drawn from these non-clinical tests is that the DreamStation 2 System is substantially equivalent to its predicate devices, and that modifications do not raise new questions of safety and effectiveness. Clinical tests were not deemed necessary.

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