(154 days)
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.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Product met predetermined acceptance criteria based on design and verification activities. | "All tests confirmed the product met the predetermined acceptance criteria." |
| Compliance with applicable standards and FDA guidance documents. | "The new device complies with the applicable standards and requirements referenced in the FDA guidance documents." |
| Substantial Equivalence to predicate devices in intended use, operating principle, technologies, and manufacturing process. | "The new device has the following similarities to the previously cleared predicate devices... ResMed has determined that the new device is Substantially Equivalent to the predicate devices." |
| Biocompatibility requirements met for air path materials. | "The materials used in the air path are either predicate materials... or have been tested and found compliant with the biocompatibility requirements." |
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.
§ 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).