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The PIT Stop implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.

• Flat foot treatment in children and adolescents
• Congenital flat foot
• Non successful long term orthopaedic treatment (shoes, insoles ... )
• Tarsal coalitions
• Painfully flat foot
• Supple deformity in posterior tibial tendon dysfunction
• Paralytic flat foot
• Subtalar instability

The PIT'Stop® implant is a cannulated implant composed of two symmetrical and flattened sides, and small blades. The PIT'Stop® implant is designed to adequately maintain the filling of the sinus tarsi, and is made of PEEK, a material recognized for its mechanical and radiolucent properties. The PIT'Stop® implant is introduced into the axis of sinus tarsi, and its fixation is performed by anti-return flanges. The PIT'Stop implant should be removed: at the end of the growth when used in pediatric patients or by 12 months when used in adult patients or if pain occurs earlier Sizes: The PIT'Stop® implant is designed in 7 sizes, from 10mm to 17mm. Material: The PIT'Stop® implant is made of PEEK according to standard ASTM F2026 and include markers made of tantalum according to ASTM F560. Single use: The PIT'Stop® implant is designed for single use only. Sterilization: The PIT'Stop® implant is supplied sterile, using gamma irradiation.

The provided text describes a medical device, the PIT'Stop® implant, and its substantial equivalence to predicate devices, but it does not contain information about studies proving the device meets acceptance criteria for an AI/ML powered device. The document is a 510(k) premarket notification for a traditional medical implant.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and studies for an AI/ML device based on the given input. The categories you've asked for (such as test set sample size, ground truth establishment, MRMC studies, standalone performance, training set size) are relevant for AI/ML device evaluations, but they are not applicable to the information provided in this 510(k) submission for the PIT'Stop® implant.

The "Summary Performance Data" section does mention performance testing:

"Performance testing of the PIT'Stop® implant was assessed through mechanical bench testing performed by an independent test laboratory, animal and clinical testing being considered not applicable. Testing performed included static and dynamic compression tests on PIT'Stop® implant. The results of the testing performed by the independent test laboratory indicate that the PIT'Stop® implant met the acceptance criteria."

This refers to mechanical engineering tests for an implant, not AI/ML performance evaluation.

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