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The disposable Overtube is a device used in conjunction with an endoscope for foreign body removal or endoscopic procedures requiring multiple insertions of the endoscope into the upper gastrointestinal tract.

The Endoscope Caps are intended to keep suitable endoscopic view field during endoscopic procedures.

The BAROnova Retrieval Kit includes the following products:

• BAROnova Overtube Set (Overtube with a mated Obturator and • Seal Cap)
• Endoscope Cap Set (Endoscope Caps, Small and Large) ●
• Push Tube ●

The BAROnova Overtube Set (BAROnova Overtube) consists of a non-sterile, polymer extrusion with a metallic coil reinforcement, atraumatic tip and handle, in addition to a mated Obturator made of flexible PVC with a tapered tip, and a flexible polymer seal cap. The BAROnova Endoscope Cap Set (BAROnova Endoscope Caps) consists of two non-sterile, plastic caps for use with standard endoscopes. The Endoscope Caps are provided in two sizes to accommodate a range of standard endoscope sizes. The Push Tube (Class I, regulated under 876.4730 - Manual Gastroenterology-Urology-Urology Surgical Instrument and Accessories) and the Endoscope Cap Sizing Guide (Class I, regulated under 876.1500 - Endoscope and Accessories), are optional accessories included in the Retrieval Kit for use with the BAROnova Overtube and BAROnova Endoscope Caps respectively. The Push Tube is a non-sterile, plastic probe with a handle, which may be used to facilitate removal of foreign objects through the BAROnova Overtube. The Endoscope Sizing Cap Guide is an optional accessory for the BAROnova Endoscope Caps to assist the user in selecting the correct size Cap.

The provided text describes a 510(k) summary for the BAROnova Retrieval Kit, which includes an Overtube and Endoscope Caps. The purpose of this document is to demonstrate "substantial equivalence" to legally marketed predicate devices.

The information provided does not contain any details about an AI/algorithm-based device, nor does it discuss acceptance criteria and a study that proves an AI device meets those criteria. The document focuses entirely on the physical characteristics, intended use, and performance of traditional medical devices (an overtube and endoscope caps) and their comparison to predicate devices for regulatory clearance.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance for an AI device.
• Sample sizes for test or training sets, data provenance, ground truth establishment, expert qualifications, or adjudication methods for an AI test set.
• Details on MRMC studies or effect sizes for AI assistance.
• Details on standalone algorithm performance.

The document describes non-clinical testing for mechanical, biocompatibility, and simulated use data for the physical devices (BAROnova Overtube and Endoscope Caps), confirming they "perform as intended and that no new issues of safety and effectiveness are introduced" when compared to their predicates. This is a standard regulatory pathway for physical medical devices and does not involve AI performance metrics.

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