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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 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 and titration of patients weighing more than 66 Ib (> 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 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. 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 change to the modified VPAP Tx device includes the addition of the ASVAuto therapy mode. The modified VPAP Tx system comprises the flow generator, patient tubing, mask (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 device VPAP Tx (K092186).

Here's an analysis of the provided text regarding the VPAP Tx device, focusing on acceptance criteria and study details.

It's important to note that the provided text describes a 510(k) premarket notification for a medical device. This process aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than to establish new safety and effectiveness through extensive, de novo clinical trials with predefined acceptance criteria for the new device's performance against a specific disease outcome. The "acceptance criteria" here refer more to meeting design specifications and demonstrating non-inferiority to the predicate device in terms of performance.

Acceptance Criteria and Reported Device Performance

Study Details:

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size (Clinical Trial): 21 subjects.
   • Data Provenance: Not explicitly stated, but it's a clinical trial comparing the enhanced device to a predicate, conducted by ResMed. It can be inferred as prospective, as it "documented the outcome" of the new feature. The country of origin is not specified, but ResMed Ltd is in Australia and ResMed Corp in the USA.

2. 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):

   • This document does not specify the number or qualifications of experts used to establish a "ground truth" for the clinical trial test set. The clinical trial focused on comparing the suppression of respiratory events between two ASV treatments, rather than evaluating an algorithm's performance against a manually adjudicated ground truth in a diagnostic context. The assessment of "respiratory events" would likely rely on standard polysomnography scoring, which itself involves trained technologists and/or physicians, but these details are not provided here.

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

   • Not specified. The clinical trial compared the outcomes of two different therapy modes (Enhanced ASV vs. Predicate ASV). The evaluation of respiratory events would typically follow established sleep study scoring guidelines, but the specific adjudication method for event scoring is not detailed.

4. 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:

   • No, an MRMC comparative effectiveness study involving human readers/interpreters with and without AI assistance was not performed. This study directly compared the performance of an "Enhanced ASV" algorithm (a software change) to a "predicate ASV" treatment in suppressing respiratory events in patients. It's a comparison of device performance, not an assessment of human reader improvement with AI.

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

   • Yes, the clinical trial essentially evaluated the "Enhanced ASV" algorithm as a standalone component within the device, comparing its therapeutic effect to the predicate ASV. The "Enhanced ASV" is described as a software change (ASVAuto algorithm), and its performance was directly assessed in suppressing respiratory events. The overall device operation (including the software) is independent once initiated.
   • The non-clinical bench testing also directly evaluated the ASVAuto algorithm alone ("ResMed conducted 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 Tx performs to specification.").

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

   • The term "ground truth" isn't directly applicable in the same way as it might be for a diagnostic AI device. In this context, the "ground truth" for evaluating the clinical effectiveness of ASV treatments would be the quantification of respiratory events (e.g., apneas, hypopneas, periodic breathing occurrences) as measured by standard clinical methods (presumably polysomnography or similar monitoring) in patients receiving treatment. The study's objective was to demonstrate non-inferiority in suppressing these events.

7. The sample size for the training set:

   • Not applicable / Not provided. This document describes a 510(k) submission for a device featuring an "ASVAuto algorithm" (a software change). It does not provide details about the development or training of this algorithm, including any potential "training set" of data that might have been used to develop the algorithm itself prior to verification and clinical testing. The focus is on the verification of the enhanced algorithm's performance.

8. How the ground truth for the training set was established:

   • Not applicable / Not provided. As mentioned above, details about the algorithm's development/training, and therefore the establishment of ground truth for any training data, are not included in this regulatory summary.

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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 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 VPAP Tx is similar to the predicate devices, VPAP Adapt (K051364), VPAP ST (K080131), VPAP III ST-A (K033276) and AutoSet Clinical (K952429). The VPAP Tx provides CPAP, Auto-itirating, Bilevel, VAuto and ASV modes to treat OSA and/or respiratory insufficiency in patients weighing more than 66 lb. This is achieved through the use of a micro-processor controlled blower system that generates 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 tubing, mask (patient interface) and optional HumidAire 2i humidifier.

The performance and functional characteristics of the VPAP Tx includes all the clinician and user friendly features of the predicate devices, VPAP Adapt (K051364), VPAP ST (K080131), VPAP III ST-A (K033276) and AutoSet Clinical (K952429).

This document describes a 510(k) premarket notification for the ResMed VPAP Tx, a respiratory therapy device. The submission claims substantial equivalence to previously cleared predicate devices.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly list specific numerical acceptance criteria or performance metrics for the VPAP Tx. Instead, it states a general conclusion about meeting predetermined criteria.

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

The document does not specify the sample size used for any test set related to direct device performance evaluation. It also does not mention data provenance (e.g., country of origin, retrospective/prospective). This is typical for a 510(k) summary focused on substantial equivalence rather than a clinical trial.

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

The document does not mention the use of experts to establish a "ground truth" in the context of a test set for performance evaluation. The substantial equivalence claim is based on engineering design, verification activities, and comparison to predicate devices, not on a clinical ground truth established by experts.

4. Adjudication Method for the Test Set

Since there is no mention of a test set requiring ground truth establishment by experts, there is no adjudication method described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document does not mention any MRMC comparative effectiveness study, nor does it discuss human reader improvement with or without AI assistance. This device is a ventilator, not an AI-powered diagnostic tool that would typically involve such studies.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device is a continuous non-life-supporting ventilator. Its performance is inherent in its electromechanical operation and software control, not an "algorithm only" in the sense of a diagnostic or interpretive AI. Therefore, the concept of "standalone performance" as it applies to AI algorithms is not directly applicable here. The device's performance itself is what was assessed in verification activities.

7. The Type of Ground Truth Used

For this type of device, the "ground truth" for its performance is typically established through engineering specifications, biomechanical models, and established clinical parameters for respiratory support. For example, pressure accuracy, flow delivery, and patient synchronization would be assessed against design requirements and recognized performance standards. The document indirectly refers to this by mentioning "design and verification activities" that confirmed the product met "predetermined acceptance criteria."

8. The Sample Size for the Training Set

The document does not mention any training set. This device uses a micro-processor controlled blower system with established control algorithms, not a machine learning model that would require a "training set."

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

As there is no mention of a training set, this question is not applicable.

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