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The BAROnova Insufflation System is designed to use air as a distention media in the gastrointestinal tract when used in conjunction with the BAROnova TPS Delivery Device.

The BAROnova Accessory Kit, consisting of the BAROnova Insufflation System, TPS Stand, and Hook Tool is designed to facilitate use of the BAROnova TPS Delivery Device.

The BAROnova Accessory Kit includes the following products:

• BAROnova Insufflation System
• BAROnova Transpyloric Shuttle (TPS) Stand
• Hook Tool

The BAROnova Insufflation System is designed to provide pressure-controlled air to the stomach for insufflation within the gastric space during endoscopic procedures for placement of the BAROnova Transpyloric Shuttle (TPS) device. The Insufflation System is used in conjunction with the BAROnova TPS Delivery Device to facilitate TPS skin expansion during deployment once the Delivery Device is inserted. Prior to initiating TPS coil advancement with the handle controls, the TPS Delivery Device is connected to the reusable Insufflation System using the disposable tubing set provided within the TPS Delivery Device Kit. The reusable components of the Insufflation System are composed of a portable air Compressor, a Power Adapter, and Pressure Regulator Box. The air Compressor and Power Adapter are the identical components as utilized in the PARI Trek S nebulizer (K060357). The Pressure Regulator Box includes a precision low-pressure regulator and redundant pressure relief valves to limit system output pressure. The Box also includes a calibrated pressure gauge for testing and monitoring the performance of the system. The BAROnova Insufflation System allows the physician to deliver pressure-controlled air to the patient in a manner consistent with that being done currently in a routine endoscopic procedure with room air which is supplied by an air pump in the console of the endoscopic equipment.

The TPS Stand (Class I, regulated under 878.4800 – Manual surgical instrument for general use) and Hook Tool (Class I, regulated under 876.4730 - Manual Gastroenterology-Urology Surgical Instrument and Accessories), are optional accessories included in the Accessory Kit for use with the BAROnova TPS Delivery Device. The TPS Stand is a non-sterile, reusable plastic stand with a weighted aluminum base provided for the convenience of the operator, and can be used to support the TPS Delivery Device handle during TPS deployment. The Hook Tool is a stainless steel reusable tool which may be used to facilitate cutting of tension lines for deployment troubleshooting.

The provided text describes the BAROnova Insufflation System and BAROnova Accessory Kit, and the FDA's 510(k) clearance. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document is a 510(k) summary for a medical device (BAROnova Insufflation System and Accessory Kit), which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed performance studies with acceptance criteria, sample sizes, and ground truth information as requested.

Therefore, I cannot provide the requested information based on the input text. The text only states:

• "Non-clinical testing of the subject device for functional and simulated use has been performed, as well as testing to applicable standards. The subject device was found to meet all requirements." This is a general statement and does not provide specific acceptance criteria, reported performance, or details of the study.
• "The results of the testing performed demonstrate that the BAROnova Insufflation System is safe and effective when used in accordance with its intended use and labeling." Again, this is a concluding statement without the underlying data or criteria.

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