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The APTUS® Foot System is intended for use in small bones, in particular in fractures, osteotomies and arthrodesis of the tarsals, metatarsals and phalanges.

The subject devices are metallic bone staples to be marketed under the name 'Staple All-in-One'' as part of the APTUS® Foot System. The subject device staples are provided in designs to address clinical needs depending on the size and surface of the bone to be fused, and include two sizes and two angulations (or offsets). Each subject device is provided as a set, comprising the staple and a set of attached instruments. The instruments consist of two drill guide, and a positioning instrument. The drills and drill guide are snapped off of the set prior to use of the staple. The positioning instrument is snapped off of the staple after implantation. The subject device staples and instruments are made of stainless steel conforming to ISO 5832-1 and ASTM F139.

The provided text is a 510(k) summary for the Medartis AG APTUS® Foot System, which is a medical device for bone fixation. It describes the device, its intended use, and how it was deemed substantially equivalent to a predicate device.

It does NOT contain information about any AI/ML-driven device or study results proving acceptance criteria for such a device. The document explicitly states:

"Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included: sterilization validation according to ISO 11137-1, and ISO 11137-3; bacterial endotoxin testing according to ANSI AAMI ST72; sterile barrier shelf life testing according to ISO 11607-1, ISO 11607-2, ASTM F1980, ASTM D4332, ASTM D4169, ASTM F2096, DIN EN 868-5, and ASTM F88/F88M; biocompatibility testing according to ISO 10993-12, ISO 10993-15, and ISO 10993-18: and comparative mechanical testing according to ASTM F564. Clinical data were not provided in this submission."

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving an AI/ML device meets them, as the provided text is for a traditional medical device (a bone fixation staple) and does not involve AI or clinical performance studies for its clearance.

To answer your question accurately, I would need a document that describes the clinical performance evaluation of an AI/ML-driven medical device.

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