(158 days)
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
| Acceptance Criteria & Test Categories | Reported Device Performance |
|---|---|
| Non-Clinical Testing: | |
| - Performance to design input specifications (via Side-by-Side bench testing compared to predicate device K092186) | - "The VPAP Tx met the predetermined pass/fail criteria as defined in the VPAP Tx System Verification Report." |
| - ASVAuto algorithm performance to specification (via closed-loop and open-loop test scripts from patient models, including Adaptive servo-ventilation tests and EPAP response tests) | - "The bench test results demonstrated that the VPAP Tx met the predetermined pass/fail criteria." |
| Clinical Testing: | |
| - Non-inferiority of Enhanced ASV in suppressing respiratory events compared to predicate ASV treatment for central sleep apnea/periodic breathing. | - "Enhanced ASV is clinically non-inferior in terms of suppressing respiratory events in patients who are treated for central sleep apnea/periodic breathing." (Implied acceptance based on the study objective and the overall 510(k) clearance) |
| - Absence of complications or adverse events during the clinical trial. | - "There were no complications or adverse events recorded, as a result of this clinical trial." |
| Compliance: | |
| - Adherence to applicable regulations and guidance documents (e.g., FDA Guidance for Ventilators, FDA Guidance for Software in Medical Devices, IEC 60601-1-2, IEC 60601-1). | - "The VPAP Tx complies with the applicable requirements." (Explicitly stated for the listed standards.) |
Study Details:
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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.
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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.
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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.
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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.
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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.").
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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.
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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.
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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.
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).