FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The S9 Elouera self-adjusting device is indicated for the treatment of Obstructive Sleep Apnea (OSA) in patients (female patients with mild to moderate OSA when using AfH treatment mode) weighing more than 66 lb (30 kg).

It is intended for home and hospital use.

Device Description

The S9 Elouera retains all the same hardware and performance features of the predicate device(s). Key features include in-line power supply, fully integrated humidifier, tubing, colour LCD and simplified controls which provides improved usability. The S9 Elouera contains a Micro-processor controlled blower 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, mask (patient interface) and humidifier.

The S9 Elouera 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.
t AutoSet for Her mode - the device automatically adjusts pressure in response to female-specific OSA characteristics.

The functional characteristics of the S9 Elouera 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Criteria Category	Acceptance Criteria	Reported Device Performance
Clinical Efficacy (AfH Mode)	The modified AutoSet algorithm (AfH) should effectively treat female OSA patients and demonstrate non-inferiority to the standard AutoSet algorithm (predicate device S8 Aspen K091947). Outcomes of interest include Apnea-Hypopnea Index (AHI) and Oxygen Desaturation Index (ODI). No adverse events or complications should occur. The AfH algorithm should deliver therapeutic responses tailored to female OSA characteristics (slower pressure rise and decay in response to Flow Limitations).	A single-blind, randomized, cross-over non-inferiority clinical study demonstrated that the modified AutoSet algorithm (AfH) performed as expected in treating female patients. The trial showed that the AfH algorithm effectively treated female OSA patients as reflected by AHI and ODI outcomes. No adverse event or complications occurred as a result of the trial. The device incorporates modified responses to Flow Limitations, resulting in a slower pressure rise and decay when compared to the standard AutoSet algorithm, which is intended for female OSA patients.
CSR Detection and Reporting	The S9 Elouera's Cheyne-Stokes Respiration (CSR) detection and reporting feature should be equivalent to ResMed's ApneaLink Plus (K083575). This equivalence should be assessed through sensitivity and specificity compared to human scoring. The device should accurately report one of the following for each patient script file (scenario): No CSR, CSR, CSR + OSA, or OSA. A patient should be reported as having CSR once the CSR duration reaches 15 minutes. The device must meet predefined Clinical Pass/Fail criteria for CSR detection.	Side-by-side bench testing was performed using the same digitized breathing patterns. The S9 Elouera's CSR detector results were compared to human scoring, and sensitivity and specificity were assessed. The S9 Elouera met the predefined Clinical Pass/Fail criteria. In this test, a patient was reported as having CSR once the CSR duration on the Flow Generator reached 15 minutes. If it didn't reach 15 minutes, the script ran to completion.
Device Performance (General)	The S9 Elouera must meet the requirements of the S9 Elouera System Specification and the performance of the predicate devices (S8 Aspen K091947 and ApneaLink Plus K083575) for all therapy modes. This includes pressure stability, response to apneas, response to flow limitations and snore, and reporting of Closed Airway Detection (CAD). The device should provide CPAP pressure from 4-20 cmH2O.	Side-by-side bench testing verified that the S9 Elouera met the requirements of the S9 Elouera System Specification when compared to the predicate devices. This testing included performance of each therapy mode (CPAP and self-adjusting). The tests covered pressure stability, response to apneas, response to flow limitations and snore, and reporting of CAD. The breathing machine simulated patient breathing patterns, and the Flow Generator responded consistently with maintaining CPAP treatment pressure or adjusting pressure in real-time. The S9 Elouera offers a pressure range of 4-20 cmH2O for all modes.
Biocompatibility	Materials contacting the heated humidified gas pathway (permanent "external communicating devices") must pass biological tests in accordance with FDA guidance #G95-1 (ISO 10993-3 Genotoxicity, ISO 10993-5 Cytotoxicity, ISO 10993-6 Implantation, ISO 10993-10 Sensitization & Irritation). Testing for particulate matter and volatiles must demonstrate compliance to EPA requirements.	The appropriate biological tests were conducted and passed for these components, in accordance with FDA guidance #G95-1. These included ISO 10993-3 Genotoxicity, ISO 10993-5 Cytotoxicity, ISO 10993-6 Implantation, and ISO 10993-10 Sensitization & Irritation. Testing for particulate matter and volatiles demonstrated compliance to EPA requirements.
Safety and Electrical	The S9 Elouera and integrated heated humidifier must comply with IEC 60601-1:2005 (General requirements for safety and essential performance) and IEC 60601-1-2:2007 (Electromagnetic compatibility).	The S9 Elouera with integrated heated humidifier was designed and tested according to IEC 60601-1:2005 and IEC 60601-1-2:2007.
Usability	The S9 Elouera should retain clinician and user-friendly features of the predicate device, verified through usability studies in accordance with IEC 62366.	The functional characteristics of the S9 Elouera system include 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.

Detailed Study Information:

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

Clinical Testing (AfH Mode): Not explicitly stated how many patients were in the "single-blind, randomized, cross-over non-inferiority study." Given the context of a 510(k) summary, specific sample sizes are often omitted in this section but would be detailed in the full submission.
- Data Provenance: Not explicitly stated, though ResMed is an Australian company, so studies could be international or domestic to Australia. The submission is to the FDA, implying relevance to the US market. The study design (clinical trial) implies prospective data collection.
Non-Clinical Testing (CSR Detection):
- Sample Size: The text mentions "patient script files," with each treated as an "individual scenario." The exact number of these scenarios (test cases for CSR) is not provided.
- Data Provenance: The text describes the use of "digitised breathing patterns." This suggests a retrospective dataset of breathing patterns, potentially derived from real patient data or generated synthetically to simulate various conditions. The origin of these patterns (e.g., country) is not specified.

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

Clinical Testing (AfH Mode):
- Number of Experts: Not specified. Clinical trials typically involve medical professionals (e.g., pulmonologists, sleep specialists) to diagnose OSA, monitor patients, and interpret results, but the experts specifically for ground truth establishment in this context (e.g., AHI/ODI scoring) are not quantified beyond the general conduct of a clinical trial.
- Qualifications: "Medical professionals" (implied for a clinical trial) are involved in patient assessment and data collection/interpretation.
Non-Clinical Testing (CSR Detection):
- Number of Experts: Not specified. The text refers to "human scoring" as the comparator for the CSR detector. This implies one or more human experts scored the breathing patterns.
- Qualifications: Not specified. These would likely be sleep specialists or trained sleep technologists with expertise in scoring sleep-disordered breathing events, including Cheyne-Stokes Respiration.

4. Adjudication Method for the Test Set:

Clinical Testing (AfH Mode): Not specified. Standard clinical trial practices for outcomes like AHI and ODI often involve blinded scoring by certified sleep technologists, potentially with adjudication processes for discrepancies, but this is not detailed in the summary.
Non-Clinical Testing (CSR Detection): Not specified. The text only mentions comparison to "human scoring." It doesn't indicate if multiple human scorers were used or if an adjudication process was in place.

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

No, an MRMC study was implicitly NOT conducted for the device performance itself.
- The primary clinical study for the AfH mode was a non-inferiority clinical trial comparing two device algorithms (AfH vs. standard AutoSet) in human patients, not a multi-reader study comparing human performance with and without AI assistance.
- The CSR detection testing involved bench testing against human scoring as ground truth, but not for assessing the improvement of human readers using the device.
Effect Size of Human Readers Improvement with AI vs. without AI: Not applicable, as an MRMC comparative effectiveness study involving human readers' performance with AI assistance was not described.

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

Yes, for the CSR Detection feature, a standalone evaluation was performed.
- The description of "Side-by-side testing using the same digitised breathing patterns was used. This test executes patient script files. Each patient script file is treated as an individual scenario, which the S9 Elouera reports either: No CSR, CSR, CSR + OSA, OSA. The S9 Elouera CSR detector results are then compared to human scoring where sensitivity and specificity are assessed." This clearly indicates an assessment of the algorithm's performance independent of a human operator, using human scoring as the ground truth.
For the main therapeutic algorithms (CPAP, AutoSet, AfH), these are inherently "standalone" in their operation. They automatically adjust pressure based on detected events. Their efficacy is evaluated in clinical trials (as described for AfH) where the device alone provides therapy.

7. The Type of Ground Truth Used:

Clinical Testing (AfH Mode): The ground truth for treatment effectiveness (non-inferiority) was established by patient outcomes data (AHI and ODI) collected during a clinical trial, likely based on polysomnography or other clinically accepted methods of measuring these indices.
Non-Clinical Testing (CSR Detection): The ground truth for the CSR detection algorithm was established by expert consensus / human scoring of the "digitised breathing patterns."

8. The Sample Size for the Training Set:

Not provided. The summary focuses on the validation/testing of the device's algorithms. It does not mention the training phase or the size of any training datasets used to develop the AutoSet or AfH algorithms or the CSR detector. This information is typically proprietary to the manufacturer and not always included in 510(k) summaries unless explicitly requested by the FDA for specific types of AI/ML devices depending on their risk and adaptive capabilities.

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

Not provided. Since the training set size is not mentioned, the method for establishing its ground truth is also absent from the summary.

Summary

Regulation Number and Section

§ 868.5905 Noncontinuous ventilator (IPPB).

(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).