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FITBONE® Trochanteric is indicated for limb lengthening of the femur. FITBONE® Trochanteric is indicated for adult and pediatric (greater than 12 through 21 years of age) patients.

The FITBONE® Trochanteric is a fully implantable intramedullary lengthening nail and accessories. The subject FITBONE® Trochanteric consists of the implantable intramedullary lengthening nail and accessories (Locking screws, Trial nails, K-wire and Convenience kits). The Subject device is implanted into the medullary canal of the femur and connected to the primary predicate intracutaneous Receiver (K163368) by a bipolar feed line. The external FITBONE Control Set is the same as previously cleared for the primary predicate Fitbone TAA device (K203399) and consists of a control electronics station and transmitter. There are no changes to the previously cleared Control Sets and Receiver as a result of this submission. The power required for the distraction process is controlled by hermetically enclosed motor which draws the telescope apart. The electro-magnetic field sent from the Transmitter to the Receiver is converted in the Receiver into DC-Voltage to supply the motor of the subject Fitbone Trochanteric Nails with voltage, when actioned. The subject Fitbone Trochanteric Nails are available in two different diameter models (D09mm, D11mm), different lengths and lengthening capabilities. The subject nail is anchored to the bone by subject locking screws. The locking screws are available in two variants (standard locking screws and revision locking screws), in two diameters, D4.5mm and D4mm, and in multiple lengths. The energy needed for the distraction process is transmitted from the outside by placing the external transmitter over the implanted receiver, which is placed in the subcutaneous tissue during surgery. There is no transcutaneous contact between the implanted intramedullary nail and the outer surface of the patient's body. The subject trial nails accessories are available for each variant of the Fitbone Trochanteric nails and are used to simulate the shape of the implant. The subject Fitbone Trochanteric nail and K-wire are provided in sterile conditions only. The trial nails are provided in non-sterile version only. The bone screws are available in both sterile and non-sterile versions. The subject Fitbone Trochanteric Nails and their accessories are made from, as follows: Nail: implant grade stainless steel 1.4441, according to ASTM F138-13 "Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)", and Silicone Nusilmed (NuSil MED-4870, NuSil MED-1511, Nusil MED 4750, NUSIL MED1-161, NUSIL MED2-4502). Trial nail: implant grade stainless steel 1.4441, according to ASTM F138-13 "Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)" and ASTM F899-20 Standard Specification for Wrought Stainless Steels for Surgical Instruments. Locking screws: implant grade stainless steel 1.4441, according to ASTM F138-13 "Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)" K-wire: implant grade stainless steel 1.4441, according to ASTM F138-13 "Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)" The Subject, as the primary predicate, will be implanted only by Healthcare Professionals (HCP), with full awareness of the appropriate orthopedic procedures

The provided text describes the regulatory clearance for the Orthofix Fitbone Trochanteric, an intramedullary lengthening nail. However, this document does not contain information about acceptance criteria, device performance, ground truth establishment, sample sizes for training or testing sets, expert qualifications, adjudication methods, or MRMC studies for an AI/ML powered medical device.

The document is a 510(k) summary for a traditional medical device (an intramedullary lengthening nail), not an AI/ML-powered device. Therefore, the specific types of studies and criteria outlined in your request are not relevant to this submission.

The "Performance Analysis" section describes mechanical testing performed on the implantable nails and screws to demonstrate their safety and effectiveness, based on established ASTM and ISO standards for medical devices. This is a standard non-clinical performance evaluation for mechanical orthopedic implants.

In summary, none of the requested information regarding acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, or study types (MRMC, standalone) for an AI/ML device is present in the provided text because the device is not an AI/ML product.

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