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The S9 Cronulla for Her self-adjusting system is indicated for the treatment of mild to moderate obstructive sleep apnea (OSA) in female patients weighing more than 66 lb (30 kg).

The S9 Cronulla for Her self-adjusting system is intended for home and hospital use.

The 'S9 Cronulla for Her' contains a Micro-processor controlled blower (flow generator) system that generates Continuous Positive Airway Pressure (CPAP) from 4-20 cmHzO as required to maintain an "air splint" for effective treatment of OSA. The system comprises the flow generator, patient tubing (standard, or heated), mask (patient interface) and humidifier. The 'S9 Cronulla for Her' System (S9 Cronulla for Her with HumidAire 5i) retains all the same hardware and performance features of the predicate device. Key features include in-line power supply, HumidAire 5i, tubing (heated and standard options) and colour LCD for better user interface.

The 'S9 Cronulla for Her' flow generator includes three therapy modes. These include:

• CPAP mode - the device delivers a continuous positive airway pressure throughout the entire therapy session
• AutoSet mode the device automatically adjusts pressure in response to inspiratory flow limitation, snore and apnea.
• AutoSet for Her mode -- the device automatically adjusts pressure in response female-specific OSA characteristics.

The functional characteristics of the S9 Cronulla for Her system includes all the clinician and user friendly features of the predicate device which have been verified during usability studies in accordance with IEC 62366 Medical devices - Application of usability engineering to medical devices.

This document describes the regulatory submission for the ResMed S9 Cronulla for Her, a non-continuous ventilator (IPPB) designed for the treatment of mild to moderate obstructive sleep apnea (OSA) in female patients. The submission aims to demonstrate substantial equivalence to a predicate device, the S8 Aspen (K091947), by incorporating a new treatment mode called AutoSet for Her (AfH).

Here's an analysis based on your requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not provide a formal table of specific, quantitative acceptance criteria for the clinical trial, nor does it explicitly list corresponding "reported device performance" against those criteria. Instead, it describes the primary endpoints and outcomes as "met" and generally discusses improvements and lack of significant differences.

However, based on the text, the implicit acceptance criteria for the clinical trial were demonstrating non-inferiority or efficacy in treating female OSA patients, with key outcomes being Apnea-Hypopnea Index (AHI) and Oxygen Desaturation Index (ODI). The non-clinical testing had "predetermined acceptance criteria" for pressure stability, response to apneas, and response to flow limitations and snore, which were reportedly met.

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

• Sample Size: The document does not specify the exact sample size for the clinical trial. It refers to "female OSA patients" without providing a number.
• Data Provenance: The clinical trial was a "single-blind, randomised, cross-over non-inferiority study." It does not explicitly state the country of origin, but ResMed Ltd is based in Australia, and their official contact for the submission is in the US, suggesting a multinational context or at least compliance with international standards. The study design is prospective.

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

This information is not provided in the submission. The clinical trial was a direct comparison of two algorithms in patients, with outcomes (AHI, ODI, sleep parameters) likely derived from polysomnography (PSG) data, which is objectively measured. The "ground truth" here would thus be the objective physiological measurements of OSA, rather than an expert interpretation of, for example, medical images.

4. Adjudication Method for the Test Set

This information is not explicitly provided. Given the nature of objective physiological measurements (AHI, ODI) as primary endpoints in a clinical trial, a complex adjudication method by multiple experts is less common than for subjective assessments or image interpretation. The study was single-blind, randomized, and cross-over.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This submission describes a clinical trial comparing two algorithms for a medical device (a ventilator), not an AI algorithm assisting human readers in interpreting medical data.

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

Yes, the clinical trial directly compared the performance of two algorithms: the new AutoSet for Her algorithm (AfH) against the standard AutoSet algorithm (predicate device's algorithm). This is a standalone comparison of the algorithms' effectiveness in treating OSA in female patients, without direct human intervention in the algorithm's diagnostic or therapeutic decision-making process. The device operates automatically based on these algorithms.

7. The Type of Ground Truth Used

The ground truth for the clinical trial was objective physiological measurements related to obstructive sleep apnea, specifically:

• Apnea-Hypopnea Index (AHI)
• Oxygen Desaturation Index (ODI)
• Other sleep parameters (e.g., flow limitation, REM sleep percentage, RERAs)

This data is typically derived from polysomnography (PSG), which directly measures these physiological events.

8. The Sample Size for the Training Set

The submission does not specify a "training set" size. The "AutoSet for Her" mode is an additional treatment software mode based on specific OSA characteristics in females. While algorithms are typically developed using data, the document does not detail the development or training process for this particular algorithm beyond stating it's a "modified AutoSet algorithm." The focus of the clinical trial is on validating its performance, not on describing its development data.

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

This information is not provided as the submission focuses on the clinical validation of the device and its new mode, not the detailed development of the algorithm itself. It's implied that the algorithm was designed to respond to "female-specific OSA characteristics," suggesting that development would have been based on clinical understanding and data related to these characteristics, likely derived from sleep studies and medical research.

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