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The VPAP ADAPT SV is intended to provide non-invasive ventilatory support to treat adult patients with obstructive sleep apnea (OSA) and Respiratory Insufficiency caused by central and/or mixed apneas and periodic breathing.

The VPAP TX is indicated for the treatment of patients weighing more than 66 lb (> 30 kg) with obstructive sleep apnea (OSA), respiratory insufficiency, central or mixed apneas, or periodic breathing. The VPAP TX is intended to be used in a clinical environment.

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 VPAP Adapt SV is identical to the predicate device VPAP Adapt SV (K051364), using a blower based positive pressure system. The device platform is identical to the VPAP Adapt SV (K051364) and contains a blower (motorfan assembly), flow and pressure sensors, and processing electronics. The blower supplies pressurized air to the patient via a mask and air tubing. The VPAP Adapt SV is a non-invasive flow generator device designed to provide adaptive servo-ventilation therapy to stabilize a patient's ventilation. The device continually measures instantaneous ventilation, and calculates a target ventilation equal to 90% of the patient's recent average ventilation (time constant 100 seconds). It then adjusts the degree of support to servo-control the patient's ventilation to at least equal the target ventilation.

The VPAP Tx is identical to the predicate device VPAP Tx (K092186), using a blower based positive pressure system. The device platform is identical to the VPAP Tx (K092186) and contains 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 VPAP Tx system comprises the flow generator, patient interface) and optional humidifier.

The S9 VPAP Tx is identical to the predicate device S9 VPAP Tx (K123511), using a blower based positive pressure system. The device platform is identical to the S9 VPAP Tx (K092186) and contains 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 comprises the flow generator, patient interface) and optional humidifier.

This document is primarily a 510(k) summary for three ResMed devices (VPAP Adapt SV, VPAP Tx, and S9 VPAP Tx), indicating that the submission is for a labeling change to include a contraindication. It states that no further clinical testing was required to show substantial equivalence to the predicate devices because it was a labeling change only. Therefore, the document does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in a performance study for a new device or software.

However, the contraindication is supported by a large-scale clinical study:

SERVE-HF Study Information (relevant to the contraindication):

• Study Design: Randomized, parallel, event-driven, international multicenter study.
• Sample Size: 1325 patients.
• Patient Population: Chronic, symptomatic heart failure (NYHA 2-4) with reduced left ventricular ejection fraction (LVEF ≤ 45%) and moderate to severe predominant central sleep apnea.
• Intervention: Addition of ASV (Adaptive Servo-Ventilation) to guideline-based medical management.
• Outcome Investigated: Effects on survival and cardiovascular outcomes.
• Finding: The addition of ASV did not improve outcomes and showed an increased risk of cardiovascular mortality despite effective control of central sleep apnea. This finding supports the need for a contraindication rather than demonstrating the device's performance against specific acceptance criteria for its intended use outside of this specific high-risk patient group.

Given the nature of the submission (a labeling change based on a clinical trial that identified a contraindication), the following points from your request cannot be directly extracted from the provided text for the device's performance meeting acceptance criteria:

1. A table of acceptance criteria and the reported device performance: Not available, as no new performance study was conducted. The tables provided compare characteristics of the new device to the predicate, stating they are "Equivalent," which is about substantial equivalence, not acceptance criteria performance.
2. Sample size used for the test set and the data provenance: For the contraindication study (SERVE-HF), the sample size was 1325 patients, from an international multicenter study. Data provenance for the device's original clearance is not detailed here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for this submission's context, as it's a labeling change based on a large clinical trial, not a performance study compared to expert ground truth for a diagnostic AI.
4. Adjudication method: Not applicable here.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the SERVE-HF study, the "ground truth" was clinical outcomes data (survival and cardiovascular mortality).
8. The sample size for the training set: Not applicable, as this is a device and a labeling change, not an AI/ML algorithm development with a training set.
9. How the ground truth for the training set was established: Not applicable.

Summary in relation to your request:

The document describes a labeling change for three continuous ventilators (VPAP Adapt SV, VPAP Tx, S9 VPAP Tx). This change is to add a contraindication for ASV therapy in patients with chronic, symptomatic heart failure (NYHA 2-4) with reduced left ventricular ejection fraction (LVEF ≤ 45%) and moderate to severe predominant central sleep apnea.

This contraindication is directly supported by findings from the SERVE-HF study, a large-scale, randomized, parallel, event-driven, international multicenter study involving 1325 patients. The study found that adding ASV to guideline-based medical management in this specific patient population did not improve outcomes and led to an increased risk of cardiovascular mortality. The "ground truth" for the SERVE-HF study was clinical outcomes data (survival and cardiovascular outcomes).

The document explicitly states that no further clinical testing was required for this 510(k) submission because it was only a labeling change, and the device itself (its operating principle, technology, manufacturing process) remains substantially equivalent to its respective predicate devices (K051364, K092186, K123511). Therefore, there are no new acceptance criteria or device performance data against them presented in this document for the device's efficacy in its cleared indications.

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The 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. It is intended for home and hospital use.

VPAP Adapt System (VPAP Adapt with H5) is similar to the predicate device(s), 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 cmHzO as required to maintain an "air splint" for effective treatment of OSA. The system comprises the flow generator, 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. Therapy modes contained in the VPAP Adapt are CPAP, ASV, and ASVAuto. CPAP and ASV therapy modes come from the S9 VPAP Adapt (K102586).

The functional characteristics of the VPAP Adapt system includes all the clinician and user friendly features of the predicate device.

The provided text is a 510(k) summary for the ResMed VPAP Adapt device, a non-continuous ventilator. The document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of the device's performance against specific acceptance criteria in a clinical setting.

Based on the information provided, here's a breakdown of the requested points:

Device: VPAP Adapt (Non-continuous ventilator)

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of clinical acceptance criteria (e.g., AHI reduction, oxygen saturation improvement) with corresponding device performance metrics. Instead, it refers to "predetermined acceptance criteria" for bench testing demonstrating the ASVAuto algorithm's specification and the device's adherence to safety and performance standards.

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

• Test Set Sample Size: Not applicable. The "tests" mentioned are bench tests using "closed-loop and open-loop test scripts from patient models," not human subjects or a clinical test set. Therefore, there's no patient sample size.
• Data Provenance: Not applicable, as no clinical data from human subjects is mentioned for the verification activities. The "patient models" used in bench testing would be simulated data or hardware models.

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

Not applicable. The "ground truth" for the bench tests was based on the device's own specifications and the performance of the predicate device (S9 VPAP Adapt K102586). No human experts were used to establish ground truth for a test set in the clinical sense.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring human adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or conducted. The document focuses on demonstrating substantial equivalence through bench testing to a predicate device, not on comparing human reader performance with and without AI assistance.

6. Standalone (Algorithm Only) Performance Study

Yes, in a way. The "Non-Clinical Testing" section describes "extensive bench testing using both closed-loop and open-loop test scripts from patient models designed to verify that the ASVAuto algorithm in the VPAP Adapt performs to specification." This is a form of standalone testing of the algorithm within the device against preset criteria. It's not a clinical standalone study, but an engineering verification.

7. Type of Ground Truth Used for the Testing

The ground truth for the bench testing was the design specification of the ASVAuto algorithm and the performance characteristics of the predicate device (S9 VPAP Adapt K102586). It's based on engineering requirements and existing device performance, not clinical pathology, expert consensus, or outcomes data from human subjects.

8. Sample Size for the Training Set

Not applicable. The document does not describe any machine learning training processes or a "training set" in the context of AI. The device's algorithm appears to be rule-based or pre-programmed, not learned from a dataset.

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

Not applicable, as no training set is mentioned for an AI/machine learning model. The algorithm's behavior is described as "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." This implies a deterministic, pre-defined control algorithm, not one developed through machine learning.

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The VPAP ADAPT is intended to provide non-invasive ventilatory support to treat adult patients with OSA and Respiratory Insufficiency caused by central and/or mixed apneas and periodic breathing.

The VPAP ADAPT is a non-invasive flow generator device designed to provide adaptive servo-ventilation therapy (ASV) to stabilize a patient's ventifation. The device continually measures the patient's instantaneous ventilation, and calculates a target ventilation equal to 90% of the patient's recent average ventilation (time constant 100 seconds). It then adjusts the degree of support to servo-control the patient's ventilation to at least equal the target ventilation.

The VPAP ADAPT is fitted with alarms to alert the user to changes that will affect the treatment. Some of the alarms are pre-set (fixed) whereas others are clinically selectable. Also, a graphic user interface displays clinical data and enables the user (patient/clinician) to set and adjust certain parameters.

Here's a breakdown of the acceptance criteria and study information for the VPAP ADAPT device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The text explicitly mentions "Predicate bench testing and clinical studies were used to show substantial equivalence." However, it does not specify the sample size for either the bench test or the clinical test set.

Regarding data provenance:

• The text does not explicitly state the country of origin.
• The text refers to the study as "clinical studies" and "equivalence study," which are typically prospective in nature.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth in the clinical study. It refers to "clinical studies" and "findings," implying expert interpretation of data like AHI and RAI, but no specifics are given.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method used for the test set in the clinical study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted in the typical sense for algorithm evaluation. Instead, a comparative clinical study was performed between the new device (VPAP ADAPT) and a predicate device (VPAP III ST-A) in human patients.

• Effect size of how much human readers improve with AI vs without AI assistance: This metric is not applicable as the study compares device performance on patients, not human reader performance with or without AI assistance. The study found that the VPAP ADAPT device itself was, in one aspect (non-equivalent AHI results), superior (statistically significant p=0.001) in providing effective therapy compared to the predicate device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The study described is a standalone device performance study, not an algorithm-only study. The device, VPAP ADAPT, is a physical medical device that provides "adaptive servo-ventilation therapy" and includes "processing electronics." The performance data relates to the device's ability to treat patients, rather than the isolated performance of an algorithm within it. The "servo-control" mechanism is essentially an algorithm embedded in the device.

7. Type of Ground Truth Used

The ground truth for the clinical study was based on clinical parameters such as:

• Apnea/Hypopnea Index (AHI)
• Respiratory-related Arousal Index (RAI)
  These are standard metrics used in sleep medicine to assess the severity of breathing disorders and the effectiveness of therapies. While not explicitly stated, these metrics are typically derived from polysomnography studies, which involve expert interpretation.

8. Sample Size for the Training Set

The document does not mention a separate training set or its sample size. This suggests that the device's "adaptive servo-ventilation therapy" mechanism might have been developed and refined using internal methods, but no external "training set" with ground truth is referenced in the context of this 510(k) submission. The device continually measures ventilation and calculates a target ventilation, which is inherent to its real-time operation, not a pre-trained model in the sense of modern AI.

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

As no separate training set is mentioned as part of the submission documentation, there is no information on how its ground truth would have been established. The device design and verification activities were performed based on risk analysis and product requirements, implying internal R&D processes rather than training on a specific external dataset with pre-established ground truth.

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