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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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