(32 days)
The VPAP Malibu is indicated for the treatment of adult patients with Obstructive Sleep Apnoea (OSA). It is intended for use in the hospital and home.
The VPAP Malibu System is similar to the predicate devices, VPAP III (K030843) and AutoSet Spirit (K013843). The VPAP Malibu provides CPAP, Bilevel and Vset therapy modes to adult patients with OSA. 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. The system comprises the Flow Generator, HumidAire 2i (K013843), patient tubing, mask (patient interface) and ResLink with Smart Media Card (K024191). The performance and functional characteristics of the VPAP Malibu system includes all the clinician and user friendly features of the predicate devices, VPAP III (K030843) and AutoSet Spirit (K013843).
This document, K062291, is a 510(k) premarket notification for the RESMED VPAP Malibu, a noncontinuous ventilator (IPPB) intended for the treatment of adult patients with Obstructive Sleep Apnea (OSA). The submission focuses on demonstrating substantial equivalence to predicate devices (VPAP III and AutoSet Spirit) rather than presenting a de novo study with detailed acceptance criteria and performance data for a new, novel device.
As such, the provided text does not contain the detailed information requested for a study proving device performance against specific acceptance criteria. The submission focuses on substantial equivalence based on similar intended use, operating principle, technologies, and manufacturing processes, supported by design and verification activities.
Here's an analysis of what is and isn't available based on your request:
1. A table of acceptance criteria and the reported device performance:
The document does not provide a public table of specific acceptance criteria or detailed reported device performance data in the format you requested. The submission states: "Design and Verification activities were performed on the VPAP Malibu as a result of the risk analysis and product requirements. All tests confirmed the VPAP Mailbu met the predetermined acceptance criteria." However, the exact criteria and corresponding performance metrics are not disclosed in this 510(k) summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
No information is provided regarding the sample size used for any test set or the data provenance (country of origin, retrospective/prospective nature) in the provided text. The "Design and Verification activities" are mentioned generically, without specifics about the subjects or data involved.
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 device is a medical device (ventilator) whose performance would typically be evaluated against engineering specifications and clinical endpoints, not against expert-established ground truth for diagnostic accuracy, which is common for AI/imaging devices. The concept of "ground truth" and expert adjudication as described in your request is not relevant to the type of device and submission presented here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. As with point 3, adjudication methods for expert-established ground truth are not relevant to this type of device and submission.
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 physical medical device (ventilator) and does not involve AI assistance for human "readers" or diagnostic interpretation. Therefore, an MRMC study and AI-assisted improvements are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This device is a physical medical device. The concept of a "standalone algorithm" is not relevant here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For a noncontinuous ventilator, "ground truth" would generally refer to engineering specifications, physiological measurements (e.g., pressure, flow, volume, respiratory rate), and potentially clinical outcomes related to OSA treatment (e.g., AHI reduction). The document implicitly states that internal design and verification activities confirmed the device met predetermined acceptance criteria, which would be based on these types of "ground truth" or specifications, but it does not elaborate on them.
8. The sample size for the training set:
Not applicable. This device is a physical medical device and is not described as involving machine learning or AI models that would require a "training set."
9. How the ground truth for the training set was established:
Not applicable. As with point 8, the concept of a training set and its associated ground truth is not relevant to this traditional medical device submission.
Summary of what the document provides regarding acceptance criteria and study:
The 510(k) submission for the VPAP Malibu asserts that "Design and Verification activities were performed... All tests confirmed the VPAP Mailbu met the predetermined acceptance criteria." This statement is the primary evidence provided in the summary regarding performance validation. However, the details of these activities, the specific acceptance criteria, or the performance data are not included in the public-facing 510(k) summary document provided. The submission relies on demonstrating substantial equivalence to existing predicate devices (VPAP III and AutoSet Spirit) rather than presenting a detailed de novo clinical or performance study.
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).