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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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