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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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The S9 VPAP Tx is indicated for the treatment and titration of patients with obstructive sleep apnea (OSA), respiratory insufficiency, central or mixed apneas, or periodic breathing. CPAP, S, ST, T and PAC modes are indicated for patients weighing more than 30lb (13 kg); all other modes are indicated for patients weighing more than 66lb (30 kg).

The S9 VPAP Tx is intended to be used in a clinical environment.

The S9 VPAP Tx is similar to the predicate devices VPAP ST-A (K113288), VPAP ST (K102513), S9 VPAP Adapt (K113801) and S8 Aspen (K091947).

The S9 VPAP Tx provides CPAP, Auto-titrating, Bilevel, VAuto and ASV modes to treat OSA and/or respiratory insufficiency, central or mixed apneas or periodic breathing. This is achieved through the use of a micro-processor controlled blower system that generates airway pressures as required to maintain an "air splint" for effective treatment of OSA and/or respiratory insufficiency.

The S9 VPAP Tx system comprises the flow generator, patient tubing, mask (patient interface) and optional H5i humidifier.

The performance and functional characteristics of the S9 VPAP Tx includes all the clinician and user friendly features of the predicate devices, VPAP ST-A (K113288), VPAP ST (K102513), S9 VPAP Adapt (K113801) and S8 Aspen (K091947).

Here's an analysis of the ResMed S9 VPAP Tx 510(k) submission based on the provided text, focusing on the absence of information regarding "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the traditional sense of an AI/ML medical device submission.

The provided document is a 510(k) summary for the ResMed S9 VPAP Tx, a continuous ventilator. It does NOT describe an AI/ML device or any study that would typically be associated with performance criteria for an algorithmic diagnostic or prognostic tool. Instead, it describes a hardware medical device and its substantial equivalence to previously cleared predicate devices.

Therefore, many of the requested points, such as "acceptance criteria and reported device performance" related to an AI/ML algorithm, sample sizes for test sets, data provenance, expert ground truth, MRMC studies, or standalone algorithm performance, are not applicable to this submission.

The submission focuses on demonstrating compliance with recognized standards for medical electrical equipment and biocompatibility, as well as the substantial equivalence of the new device to existing predicate devices based on intended use, operating principle, technology, and manufacturing process.

Summary regarding Acceptance Criteria and Study for ResMed S9 VPAP Tx (K123511):

This 510(k) submission is for a continuous ventilator (S9 VPAP Tx), which is a hardware medical device, not an AI/ML device. As such, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" within the context of AI/ML performance (e.g., sensitivity, specificity, AUC) is not applicable to this submission.

The document states:

• "Design and Verification activities were performed on the S9 VPAP Tx as a result of the risk analysis and design requirements. All tests confirmed the product met the predetermined acceptance criteria."
• "The S9 VPAP Tx has been tested to appropriate FDA consensus standards and other applicable requirements passing all test protocols."

This indicates that internal design verification and validation activities were conducted based on engineering specifications and compliance with relevant safety and performance standards for hardware medical devices. These are not performance metrics for an AI algorithm.

Addressing the specific points based on the provided text, noting irrelevance where appropriate for an AI/ML context:

1. A table of acceptance criteria and the reported device performance

   • Not Applicable in an AI/ML context. The document does not provide a table of performance metrics (like sensitivity, specificity) for an AI/ML component. The "acceptance criteria" here refers to the passing of various engineering and safety standards.
   • Relevant information from document: The device was tested according to:
     • IEC 60601-1-2:2007 (Electromagnetic compatibility)
     • IEC 60601-1:2005 (General requirements for safety and essential performance)
     • IEC 60601-1-8:2006 (Alarm systems)
     • ISO 10993 series (Biocompatibility)
   • Reported Device Performance: The document states "All tests confirmed the product met the predetermined acceptance criteria" and "passing all test protocols." No specific numerical performance results (e.g., for pressure delivery accuracy, flow rates) are provided in this summary, as these would typically be detailed in the full submission, not the summary.

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

   • Not Applicable. This device is a hardware ventilator. There is no "test set" of patient data for evaluating an AI/ML algorithm as described in the prompt. The testing involved bench testing of the physical device. The document states: "Clinical data for the S9 VPAP Tx is not required as the predicate devices have been subjected to clinical trial requirements or validated patient simulation models have been used during the bench testing phases." This refers to physical models or simulated patient conditions, not patient data for algorithm training/testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • Not Applicable. This is not an AI/ML device. Ground truth as typically understood for AI/ML validation (e.g., expert consensus on image interpretation) is not relevant here.

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

   • Not Applicable. This is not an AI/ML device.

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. This is not an AI/ML device and therefore no MRMC study involving human readers and AI assistance was conducted or would be relevant.

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

   • Not Applicable. This device is a hardware ventilator, not an algorithm.

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

   • Not Applicable in an AI/ML context. The "ground truth" for this device's testing would be established by the functional specifications and performance standards (e.g., a pressure sensor correctly measures the output pressure, the device delivers a specified flow rate). The "validated patient simulation models" mentioned refer to physical or mathematical models representing patient physiology for bench testing, not clinical ground truth derived from patients for an AI.

8. The sample size for the training set

   • Not Applicable. This device does not have a "training set" in the context of AI/ML.

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

   • Not Applicable. This device does not have a "training set" or associated ground truth in the context of AI/ML.

In conclusion, the ResMed S9 VPAP Tx 510(k) submission is for a conventional medical device (ventilator) and does not contain information pertinent to the performance criteria or studies typically associated with AI/ML-enabled devices. The "predetermined acceptance criteria" and "test protocols" refer to engineering and safety standards, not AI algorithm performance metrics.

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The VPAP Tx is indicated for the treatment of patients weighing more than 66 lb (> 30 kg) with obstructive sleep apnea (CSA), respiratory insufficiency, central or mixed apneas, or periodic breathing.

The VPAP Tx is intended to be used in a clinical environment.

The modified VPAP Tx device has a similar operating principle, and the same technology and manufacturing process as the VPAP Tx (K092186). The hardware (electromechanical operation and materials) also remain unchanged from the predicate VPAP Tx (K092186). The therapy modes contained in the predicate VPAP Tx (K092186) provides CPAP, Auto-titrating, Bilevel, VAuto and ASV modes to treat OSA and/or respiratory insufficiency, central or mixed apneas or periodic breathing in patients weighing more than 66 lb, and remain unchanged. The device contains a micro-processor controlled blower system that generates as required to maintain an "air splint" for effective treatment of OSA and/or respiratory insufficiency, central or mixed apneas or periodic breathing.

The changes to the modified VPAP Tx device include the addition of the iVAPS therapy mode, from the predicate device Stellar 150 (K103167), the addition of SlimLine tubing as cleared in K091947, the addition of EasyBreathe in S-mode, the addition of Mirage FX (K102746) and Quattro FX (K091129) masks, and the removal of CAD (Closed Airway Detection) in CPAP mode.

The modified VPAP x system comprises the flow generator, patient interface) and optional HumidAire 2i humidifier.

The performance and functional characteristics of the modified VPAP Tx includes all the clinician and user friendly features of the predicate devices, VPAP Tx (K092186) and Stellar 150 (K103167).

The provided text is a 510(k) summary for the ResMed VPAP Tx device. It primarily focuses on demonstrating substantial equivalence to predicate devices and describes the device's intended use and technical specifications. It does not contain information about acceptance criteria, device performance metrics, or any specific study protocol involving test sets, ground truth establishment, sample sizes, or expert adjudication that is typically associated with proving a device meets acceptance criteria for an AI/ML medical device.

The document states: "As the VPAP Tx device is technologically identical to the VPAP Tx (K092186), predicate therapy performance ventication was directly applicable to the modified VPAP Tx device." This implies that the current submission relies on the performance data of the predicate device, rather than presenting new performance studies for the modifications.

Therefore, I cannot extract the requested information in the format provided because the document does not contain it.

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The S9 VPAP ST is indicated for the treatment of Obstructive Sleep Apnea.(OSA).in.patients.weighing. . more than 66 lb (30 kg). The S9 VPAP ST is intended for use in the hospital and home.

S9 VPAP ST System (S9 VPAP ST with H5i) is similar to the predicate device(s), using a blower based positive pressure system with an integrated heated humidifier and heater controller. The device platform, both hardware and firmware come from the S8 Aspen with H4i Plus (K091947) and contains a micro-processor controlled blower system that generates controlled positive airway pressure between 3-25 cmH2O 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 VPAP ST contains treatment modes that come from earlier versions of ResMed Bilevel devices, these modes are known as Spontaneous (S Mode), Timed (T Mode), Spontaneous/Timed (S/T Mode) and VAuto Mode. Therapy modes come from the VPAP Tx system (K092186), VPAP ST (K080131) for S, S/T, T and VAuto and CPAP Mode comes from the S8 Aspen (K091947).

This document is a 510(k) summary for the ResMed S9 VPAP ST, a non-continuous ventilator intended for the treatment of Obstructive Sleep Apnea (OSA). It outlines the device's substantial equivalence to predicate devices and the non-clinical testing performed.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly state quantitative acceptance criteria in a table format with specific performance metrics and their corresponding values for each test. Instead, it broadly states that "All bench tests confirmed the predetermined acceptance criteria." The performance is generally reported as meeting these criteria through various tests against predicate devices.

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

The document indicates that clinical data for the S9 VPAP ST is not required. Therefore, there is no human patient test set as the device's safety and effectiveness were established through comparison to predicate devices and bench testing.

• Sample Size: Not applicable for a human test set. Bench tests were performed on the device itself.
• Data Provenance: Not applicable for patient data. The tests were non-clinical (bench testing) and likely performed internally by ResMed.

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

As no clinical data was required and testing was done non-clinically, there was no expert adjudication process to establish ground truth for a patient test set. The "ground truth" for the non-clinical tests would have been the specifications and performance characteristics of the predicate devices and relevant engineering standards.

4. Adjudication Method for the Test Set

Not applicable, as there was no patient test set requiring expert adjudication.

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 data for the S9 VPAP ST is not required as the predicate devices have been subjected to clinical trial requirements or validated patient simulation models have been used during the bench testing phases."

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

The S9 VPAP ST is a physical medical device (a ventilator), not a software algorithm providing diagnostic or treatment recommendations. Therefore, the concept of "standalone performance" in the context of an algorithm's without-human-in-the-loop performance is not directly applicable. The device itself performs its intended function (delivering positive airway pressure). Its performance was evaluated through non-clinical bench testing.

7. The Type of Ground Truth Used

For the non-clinical testing, the "ground truth" was based on:

• The performance specifications and established safety/effectiveness of the predicate devices.
• Engineering parameters and requirements defined by international standards (IEC, ISO) and internal design requirements.
• Validated patient simulation models used during bench testing.

8. The Sample Size for the Training Set

The device is a hardware-based medical device with integrated software, not a machine learning algorithm that undergoes a "training phase" with a distinct "training set" of data in the typical AI/ML sense. Therefore, no specific sample size for a training set is applicable or mentioned. Its design and functionality are based on established engineering principles and prior device iterations, not statistical learning from a dataset.

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

As there is no "training set" in the context of machine learning, this question is not applicable. The device's functionality and "knowledge" are engineered into its design, operating principles, and firmware, validated against industry standards and predicate device performance.

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