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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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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 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. It is intended for home and hospital use.

S9 VPAP Adapt System (S9 VPAP Adapt with H5i) is similar to the predicate device(s), using a blower based positive pressure system with an integrated heater controller. The device platform is similar to the S8 Aspen with H4i Plus (K091947) 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 S9 VPAP Adapt is a flow generator device designed to provide adaptive servo-ventifation 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 S9 VPAP Adapt are CPAP, CPAP with EPR, and Auto Servo Ventilation (ASV). Therapy modes come from the VPAP Tx system (K092186) and VPAP Adapt (K051364).

The functional characteristics of the S9 VPAP Adapt system includes all the dinician and user friendly features of the predicate devices.

The S9 VPAP Adapt is a non-continuous ventilator indicated for the treatment of patients weighing over 30 kg with obstructive sleep apnea (OSA), central and/or mixed apneas, or periodic breathing. It is intended for home and hospital use.

The provided document describes a 510(k) submission for the S9 VPAP Adapt, focusing on demonstrating substantial equivalence to predicate devices rather than a standalone clinical study with detailed performance metrics against specific acceptance criteria.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly provide a table of acceptance criteria with corresponding performance results for the S9 VPAP Adapt. Instead, it states that "All tests (predicate bench testing) confirmed the product met the predetermined acceptance criteria." However, specific quantitative criteria or performance values are not listed.

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

The document mentions "predicate bench testing and clinical studies" were used to show substantial equivalence. However, it does not provide any details regarding the sample size used for the test set or the data provenance (e.g., country of origin of the data, retrospective or prospective) for these studies.

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

There is no information provided in the document about experts used to establish ground truth for any test set or their qualifications. The evaluation primarily relies on "predicate bench testing and clinical studies" for substantial equivalence.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1, none) for a test set.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size of how much human readers improve with AI vs. without AI assistance. The S9 VPAP Adapt is described as a device that provides adaptive servo-ventilation therapy, not an AI-based diagnostic or assistive tool for human readers.

6. Standalone Performance Study (Algorithm Only)

While the device includes a "Micro-processor controlled blower system" and "adjusts the degree of pressure support to servo-control the patient's ventilation," the document does not describe a standalone performance study for an algorithm in isolation without human interaction. The device's operation is inherently integrated into a patient's breathing cycle.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used in the "clinical studies" mentioned. Given the nature of the device (ventilator for sleep apnea), it is most likely that ground truth would be established through polysomnography (PSG) or other objective measures of respiratory events and ventilation effectiveness, but this is not specified.

8. Sample Size for the Training Set

The document does not provide information on the sample size used for any training set.

9. How Ground Truth for the Training Set Was Established

The document does not provide information on how ground truth was established for any training set.

Summary of Evidence Regarding Acceptance Criteria and Studies:

The submission for the S9 VPAP Adapt focuses on demonstrating substantial equivalence to pre-existing predicate devices (VPAP Tx, S8 Aspen with H4i Plus, VPAP Adapt). The core argument for meeting acceptance criteria is that "All tests (predicate bench testing) confirmed the product met the predetermined acceptance criteria" and that "predicate bench testing and clinical studies were used to show substantial equivalence." However, the abstract does not provide the detailed quantitative acceptance criteria, the specific results against those criteria, or the methodology and sample sizes of the mentioned "clinical studies." The document primarily affirms that the new device has "not altered the safety and effectiveness of CPAP treatment" and complies with relevant FDA guidance documents.

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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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