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BePOD® EZ Weil screws are designed for the following indication:
-Treatment of metatarsalgia on the lateral metatarsal shafts (side toes), by Weil osteosynthesis, following osteotomies carried out:

• by the opened surgery (standard Weil) technique,
• by the DMMO percutaneous technique (Distal Metatarsal Mini Invasive Osteotomy).

The BePOD® EZ Weil Screws are threaded titanium screws which are self-drilling and selftapping designed for use in the foot. Once completely implanted, the screw is designed so the surgeon can snap off the introducer at the snap off axis.
The BePOD® EZ Weil Screws is intended to be implanted using the dedicated instrumentation supplied by the manufacturer.

This document is a 510(k) premarket notification for a medical device called "BePOD® EZ Weil Screws." It describes the device's intended use and compares it to predicate devices to establish substantial equivalence for regulatory approval.

Based on the provided text, the device is a bone fixation fastener (specifically, screws for foot surgery). The document does not describe an AI/ML-based medical device or a study involving acceptance criteria for AI/ML performance, human readers, ground truth establishment, or training/test sets in the context of diagnostic or prognostic performance.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of AI/ML device performance, as the document does not contain this information.

The document focuses on:

• Device Type: Metallic bone fixation screws.
• Indications for Use: Treatment of metatarsalgia on lateral metatarsal shafts by Weil osteosynthesis (open surgery or percutaneous technique).
• Substantial Equivalence: Comparison to legally marketed predicate devices based on materials, size ranges, and design features.
• Non-Clinical Testing: Mentions "Engineering Analysis" and "LAL pyrogen testing" but these are mechanical and biocompatibility tests, not performance studies as requested for AI/ML.

The "study" referenced in the document is a comparison for substantial equivalence, not a performance study as would be conducted for an AI/ML diagnostic or prognostic tool.

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