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Merete Compression Screws are indicated for fracture fixation and reconstruction of various bones, including

• osteotomies in the foot (as Hallux Valgus treatment) or hand, -
• arthrodesis in hand, foot or ankle surgery, 1
• fixation of bone fragments in long bones or small bone fractures. -
  The size of the chosen screw should be adapted to the specific indication.

Merete Compression Screws are cannulated, self-drilling/self-tapping, dual pitched screws with a threaded head which can be countersunk into the bone. The screws are provided in the diameters 3.0 mm, 4.3 mm and 6.5 mm in various lengths and are available in Titanium alloy (Ti-6Al-4V).

This document does not contain information about a medical device with AI/ML capabilities, but rather a traditional medical device (compression screws), thus the requested information (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, etc.) is not applicable in the context of an AI/ML device.

The provided text is a 510(k) summary for Merete Compression Screws, which are mechanical devices used for bone fixation. The document focuses on demonstrating substantial equivalence to predicate devices based on material, design, and intended use, rather than performance related to an AI/ML algorithm.

Therefore, I cannot extract the requested information as it pertains to an AI/ML device for the following reasons:

1. Nature of the Device: The Merete Compression Screws are physical implants, not an AI/ML diagnostic or predictive tool.
2. Type of Evaluation: The approval process described is for substantial equivalence of a physical device, which typically involves mechanical testing (e.g., bending strength, as mentioned in section 2) and comparison to existing predicate devices, not performance metrics like sensitivity, specificity, or reader studies relevant to AI/ML.
3. Absence of AI/ML Specifics: There is no mention of algorithms, datasets, ground truth establishment by experts, or reader studies in the context of AI/ML performance.

The document discusses:

• Device Description: Merete Compression Screws (cannulated, self-drilling/self-tapping, dual pitched screws).
• Intended Use: Fracture fixation and reconstruction of various bones.
• Predicate Devices: K050346 NewDeal Stabilization Screw and K991151 Vilex/Duval/Orthex Cannulated Bone Screw.
• Substantial Equivalence Argument: Based on similar indications for use, materials (Ti-6Al-4V), and technological characteristics (core diameter, thread diameter, cannulation), and therefore presumed similar bending strength.

If you have a document describing an AI/ML medical device, I would be happy to help extract the requested information.

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