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The STORM™ Operating Kit is used in conjunction with the STΦRM™ in the reduction and fixation of fractures of the lower leg or distal femur

The STORM®® Operating Kit consists of two Kirschner wires with collets (diameter 2mm; one length 280mm, the other length 400mm), two self threading 4.5mm bone screws and a 3.2mm single use drill bit.

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance metrics, or any studies conducted to prove the device meets specific criteria.

The document is a 510(k) premarket notification for a medical device (STORM® Operating Kit), which primarily focuses on demonstrating substantial equivalence to previously marketed predicate devices, rather than presenting a detailed performance study with acceptance criteria.

The key information provided is:

• Device Description: Components (Kirschner wires, bone screws, drill bit) and materials (stainless steel, non-sterile).
• Intended Use: Reduction and fixation of lower leg or distal femur fractures.
• Substantial Equivalence Claim: The device's components are considered substantially equivalent to specific predicate devices (K960385, K983121, K043185) based on similarities in intended use, materials, design, and "mechanical performance." However, no details of this mechanical performance or any specific acceptance criteria are provided in the excerpt.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth, or expert involvement.

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