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GPC Intraheal Intramedullary Nailing System are provided non-sterile. GPC Intraheal Intramedullary Nailing System are indicated for treating fractures of various bones as given below:

Multi Angle Femoral Nail: The indications for Use of Multi Angle Femoral Nails are as given below:

• To Stabilize Femoral shaft fractures, Subtrochanteric Fractures, Ipsilateral Neck and Shaft Fracturers, Impending Pathologic Fractures, Nonunions and Malunions.

Proximal Hip Stabilizing Nail 3: The indications for Use of Proximal Hip Stabilizing Nail 3 are as given below: Short Nail Indications: -

• Fixation of stable and unstable intertrochanteric fractures, including but not limited to nonunion, malunion .
• and tumor resections .
  Long Nail Indications: -
• . Indications may include fractures resulting from trauma, nonunion, pathological fractures, impending pathological fractures, tumor resections and revision procedures.

Elastic Nails:
The Elastic Nail is indicated for fixation of diaphyseal fractures of the medullary canal is narrow or flexibility of the implant is paramount. This includes upper extremity fractures and lower extremity fractures in paediatic or small statured patients. In paediatric application, the flexibility of the elastic nail allows it to be inserted at a point which avoids disruption of the bone growth plate.

K-Wires:
K-wires are indicated to perform as fixation and stabilization unit of bone fractures or as guide at insertion of implants into the skeletal system
All implants are for single use only.

GPC Intraheal Intramedullary Nailing System are manufactured in various shapes and sizes. The intramedullary nails are fixed with corresponding sizes of locking bolts and end caps. GPC Intraheal Intramedullary Nailing System are manufactured using stainless steel or titanium materials for surgical implant applications.
The different sizes and model numbers of GPC Intraheal Intramedullary Nailing System are based on the site of application such as fixation or reconstruction of the bones. These intramedullary nails are available in different diameters and lengths to suit the patient anatomy and size of the bones.
GPC Intraheal Intramedullary Nailing System are typically divided into following three categories:

• 1. Femoral Nails and corresponding locking bolts and end cap for fixation
• 2. Elastic Nails and corresponding end caps for fixation
• 3. K wire for fixation
     The specific names of the GPC Intraheal Intramedullary Nails are as given below:
     Multi Angle Femoral Nail Proximal Hip Stabilizing Nail 3 (Also called as PHN3) Elastic Nail K.Wire

The provided text details a 510(k) premarket notification for a medical device (GPC Intraheal Intramedullary Nailing System), not a study evaluating an AI/software device. Therefore, the information required to answer the prompt (acceptance criteria, study design, sample size, ground truth establishment, expert qualifications, etc., especially in the context of an AI device's performance evaluation) is not present in the document.

The document focuses on demonstrating substantial equivalence to predicate devices based on:

• Indications for Use: Similar intended use.
• Materials: Use of standard surgical implant materials (Stainless Steel, Titanium).
• Performance Standards: Compliance with relevant ASTM standards for mechanical properties (e.g., bending, fatigue, torsion, pull-out for nails, screws, and wires).
• Dimensions: Similar dimensions with minor differences deemed not to raise safety concerns.
• Sterilization: Same method.

No information regarding acceptance criteria for a device's diagnostic performance, nor a study proving it meets such criteria, is provided. The document explicitly states that "Clinical information was not necessary to demonstrate substantial equivalence" because the device is of similar design, pattern, and intended use to already marketed predicate devices.

Therefore, I cannot populate the table or answer the specific questions related to the acceptance criteria and the study that proves the device meets them, as this information is not contained within the provided text.

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