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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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