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The S9 VPAP Adapt is indicated for the treatment of patients weighing more than 66 lb (30 kg) with obstructive sleep apnea (OSA), central and/or mixed apneas, or periodic breathing. The S9 VPAP Adapt is intended for home and hospital use.

The AirCurve 10 ASV device is indicated for the treatment of patients weighing more than 66 lb (30 kg) with obstructive sleep apnea (OSA), central and/or mixed apneas, or periodic breathing. It is intended for home and hospital use. The humidifier is intended for single patient use in the home environment and re-use in a hospital/institutional environment.

The VPAP Adapt is indicated for the treatment of patients weighing more than 66lb (30kg) with obstructive sleep apnea (OSA), central and/or mixed apneas, or periodic breathing. The VPAP Adapt is intended for home and hospital use.

The S9 VPAP Adapt is identical to the predicate device S9 VPAP Adapt (K102586), using a blower based positive pressure system with an integrated heated humidfier and heater controller. The device platform is identical to the S9 VPAP Adapt (K102586) and contains a Micro-processor controlled blower system that generates controlled positive airway pressure between 3-25 cmHJO 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 ADAPT is a flow generator device designed to provide adaptive servo-ventilation therapy (ASV) to stabilize a patient's ventilation during sleep. The device continually measures instantaneous ventilation, and calculates a target ventilation based on to the patient's recent average. It then adjusts the degree of pressure support to servo-control the patient's ventilation to at least equal the target ventilation.

The VPAP Adapt is identical to the predicate device (K113801), using a blower based positive pressure system with an integrated heated humidifier and heater controller. The device platform is identical to the VPAP Adapt (K113801) and contains a Micro-processor controlled blower system that qenerates 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 VPAP Adapt is a flow generator device designed to provide adaptive servo-ventilation therapy (ASV) to stabilize a patient's ventilation during sleep. The device continually measures the patient's instantaneous ventilation, and calculates a target ventilation based on to the patient's recent average. It then adjusts the degree of pressure support to servo-control the patient's ventilation to at least equal the target ventilation.

The AirCurve 10 ASV is identica to the predicate device, S9 Greenhills (K140279), using a blower based positive pressure system with an integrated heated humidifier and heater controller. The device platform is identical to the S9 Greenhills (K140279) and contains a Micro-processor controlled blower system that generates controlled positive airway pressure between 3-25 cmH2O. The system comprises the flow generator, patient tubing, mask (patient interface) and humidifier. The AirCurve 10 ASV is a flow generator device designed to provide adaptive servo-ventilation therapy (ASV mode) or (ASVAuto mode) to stabilize a patient's ventilation during sleep. The device continually measures the patient's instantaneous ventilation, and calculates a target ventilation based on to the patient's recent average minute ventilation. It then adjusts the degree of pressure support to servo-control the patilation to at least equal the target ventilation. The same is true for ASVAuto mode except the EPAP is adjusted to address any obstructive apneas detected.

The provided text describes a 510(k) premarket notification for several ResMed devices (S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV). The submission is a labeling change only to include a contraindication related to Adaptive Servo-Ventilation (ASV) therapy.

Therefore, the acceptance criteria and device performance information typically associated with a medical device study (e.g., diagnostic accuracy metrics like sensitivity, specificity, AUC) are not applicable or provided in this document. The purpose of this 510(k) is to demonstrate substantial equivalence to predicate devices based on the absence of changes to the device's fundamental safety and effectiveness despite the new contraindication.

The study referenced, SERVE-HF, is not a study proving the device meets acceptance criteria in the traditional sense of validating a device's performance metrics. Instead, it is a clinical trial that informed the contraindication for the ASV therapy provided by the devices.

Here's an breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

As this submission is for a labeling change and asserts that the "new device has not altered the safety and effectiveness" compared to the predicate, traditional performance acceptance criteria (e.g. sensitivity, specificity for a diagnostic device) are not detailed as they were not required to be re-evaluated for the 510(k). The "acceptance criteria" here implicitly refer to demonstrating that the device itself (hardware, underlying software logic for therapy delivery) remains functionally identical and equally safe and effective as its predicate before the new contraindication.

The document essentially states:

The justification for substantial equivalence for all three devices (S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV) explicitly states:

• "Same intended use"
• "Same operating principle"
• "Similar technologies"
• "Same manufacturing process"

And crucially: "As this was a labelling change only, no further clinical testing was required to show substantial equivalence to the predicate device..."

2. Sample size used for the test set and the data provenance

The document does not describe a "test set" for validating the device's technical performance in the current submission. The SERVE-HF study, which informed the contraindication, acted as the primary data provenance.

• Sample Size (SERVE-HF): 1325 patients
• Data Provenance (SERVE-HF): "randomized, parallel, event-driven, international multicenter study." This implies a prospective, multi-country study. Specific countries are not detailed in this document.

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

Not applicable for this 510(k) submission, as it's a labeling change based on a clinical trial (SERVE-HF) rather than a de novo device performance study requiring expert ground truth in a test set. The SERVE-HF study's outcomes (survival and cardiovascular events) were the 'ground truth' for establishing the contraindication, validated via standard clinical trial methodologies rather than expert consensus on individual cases for a device's performance.

4. Adjudication method for the test set

Not applicable. For the SERVE-HF study, clinical trial protocols would typically include adjudication methods for primary and secondary outcomes, often by an independent committee. This level of detail is not present in the 510(k) summary.

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 device is a therapeutic ventilator, not an AI-assisted diagnostic tool.

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

Not applicable. This is a therapeutic device. The "algorithm" for ASV therapy operates as part of the device's function, not as a standalone diagnostic. The SERVE-HF study assessed the clinical outcome of the therapy delivered by such devices.

7. The type of ground truth used

The "ground truth" for the new contraindication derived from the outcomes data of the SERVE-HF study. These outcomes included "survival and cardiovascular outcomes" rather than expert consensus, pathology, or specific diagnostic accuracy.

8. The sample size for the training set

Not applicable. The SERVE-HF study's data was used to establish a clinical contraindication for the device's therapy, not to train a machine learning model. The device itself (S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV) is established technology, and the 510(k) asserts its functional identity to predicate devices.

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

Not applicable, as no training set for a machine learning model is described. The "ground truth" for the contraindication came from the clinical trial results of the SERVE-HF study: patients randomized to ASV therapy (compared to optimal medical management alone) showed an increased risk of cardiovascular mortality.

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