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The intended use for the 450mm it's is as a temporary ant to aid in the healing of lor fractures. I for children abo 110 130 ow 65 The 100mm Nancy Nail™ for small long bone with a long diaphysis. as carpal or tarsal bone

The I fancy Nail™ is a titanium alloy pin, available in two lengths: 450mm and 100mm The 450mm is available in five diameters: 2.0, 2.5, 3.0, 3.5, 4.0. The 100mm has a diameter of 1mm

The provided document does not contain information about acceptance criteria or a study that proves the device meets such criteria. It is a summary of safety and effectiveness for a medical device (Nancy Nail™ intramedullary elastic nail) under the K960642 submission. The document primarily focuses on:

• Manufacturer and Sponsor Identification: Contact details and registration numbers.
• Proprietary and Common Name: Nancy Nail™ (Intramedullary Elastic Nail).
• Classification: FDA classification as a Class II metallic bone fixation fastener (21 CFR Section 888.3040), specifically a flexible, metallic bone fixation pin.
• Intended Use: Temporary aid in healing long bone fractures for children (450mm nail for patients 110-130 lbs, under 65 inches; 100mm nail for small long bones like carpal or tarsal bones).
• Description: Titanium alloy pin available in two lengths (450mm and 100mm) and various diameters.
• Predicate Devices: Kirschner's Wire & Steinman Pin, Howmedica's Rush Nail.

Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader studies, as this information is not present in the provided text.

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