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Indications for interlocking intramedullary nails include simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening. Interlocking intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.

In addition to the indications for interlocking intramedullary nails, devices that contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability are indicated for the following: subtrochanteric fractures with lesser trochanteric involvement; ipsilateral femoral shaft/neck fractures; and intertrochanteric fractures.

In addition to the indications for interlocking intramedullary nails, devices that utilize a retrograde femoral surgical approach are indicated for the following: severely comminuted supracondylar fractures with or without difficult intra-articular extension; fractures that require opening the knee joint to stabilize the femoral condylar segment; fractures above total knee implants.

Indications for the ReVision Nail include the following: degeneration, deformity, or trauma of both the tibiotalar and talocalcaneal articulations in the hindfoot; tibiocalcaneal arthrodesis; combined arthrodesis of the ankle and sub-talar joints; avascular necrosis of the ankle and sub-talar joints; failed total ankle replacement with sub-talar intrusion; failed ankle arthrodesis with insufficient talar body; rheumatoid arthritis; severe deformity secondary to untreated talipes equinovarus or neuromuscular disease; and severe pilon fractures with trauma to the sub-talar joint.

Knee Fusion Nails are intended for intramedullary knee arthrodesis.

Ender Nails are indicated as follows: fracture of the neck, trochanteric, and subtrochanteric region of the femur; distal femoral fractures with a distal fragment 10 cm or longer; tibial shaft fractures; and proximal humeral fractures.

The Intramedullary Nail System includes femoral, tibial, ulnaradial, humeral, ankle fusion, knee fusion nails and accessories. Components are manufactured from stainless steel and UHMWPE.

This 510(k) summary for the Smith & Nephew Intramedullary Nail System describes a medical device (an intramedullary nail system), not a diagnostic AI device. Therefore, the requested information regarding acceptance criteria, study data, sample sizes, ground truth establishment, expert adjudication, and MRMC studies is not present in the provided text.

The 510(k) process for a device like an intramedullary nail focuses on demonstrating substantial equivalence to a predicate device. This typically involves comparing:

• Intended Use: The proposed device serves the same purpose as the predicate.
• Technological Characteristics: The proposed device has similar design, materials, and other characteristics to the predicate.
• Performance Data: If there are technological differences, performance data (often mechanical testing for implants) is provided to demonstrate that the new device is as safe and effective as the predicate.

In this specific 510(k) summary, the manufacturer states:

"The Intramedullary Nail System is similar to the devices listed below... All of the devices listed above are similar in design to the Intramedullary Nail System. The new devices have the same technological characteristics as the predicate device."

This statement implies that the primary "study" proving the device meets acceptance criteria is the demonstration of substantial equivalence based on similar technological characteristics and intended use to existing, legally marketed predicate devices. The acceptance criteria, in this context, are implicitly met if substantial equivalence is successfully established, meaning the device is considered as safe and effective as its predicates.

Without further information (which is not included in this 510(k) summary), it's impossible to describe acceptance criteria or study details in the way requested for an AI/diagnostic device.

Therefore, I cannot populate the table or answer the specific questions about AI/diagnostic device evaluation. The provided text is for a hardware implant device, not a software AI solution.

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