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The RODEO Telescopic Nail is indicated for fractures, osteotomies, malunions and non-unions in femur and tibia in pediatric patients suffering from osteogenesis imperfecta.

The subject RODEO™ Telescopic Nail is a self-extending rod intended to provide bone fixation. The nail includes the telescopic rod, which consists of two parts (male and female) and bone anchors, which could be either a cap or an epiphyseal screw suitable to the anatomical application. The nail is provided in sterile and non-sterile version and is available in five diameters (3.5mm, 4.0mm, 4.5mm, 5.0mm and 6.0mm), identified by the outer diameter of the female part of the rod, and five lengths for each diameter model (from 100 mm up to 350 mm). Application and removal are performed with Orthofix general orthopedic instrumentation. The subject RODEO™ Telescopic Nail consists of three different components which are intended to be assembled to form the implant: Male component - A solid shaft with a built-in bone anchor for bone connection; the bone anchor has the same design as the cap (described below). Female component - A hollow shaft designed to host the male component. Bone anchors - Two options are available depending on the desired application: Cap - A self-locking screw to be connected with the female component at the opposite aspect of the extremity relative to the male component. Epiphyseal Pin - A threaded pin to be inserted into the distal extremity hole to hold the female component in position and prevent migration (see Figure 3) When the male and female components are assembled, the resulting implant is a telescopic rod. Male and female components are free to move both axially and rotationally; this allows the nail to extend axially as the patient growth occurs while allowing rotation around the bone anchors. The subject implants are made from AISI 316LVM stainless steel, conforming to ASTM F138 and ISO 5832-1.

This response describes the acceptance criteria and study proving the device meets criteria, derived from the provided text.

Based on the provided FDA 510(k) summary for the RODEO™ Telescopic Nail, the device's acceptance criteria and the study that proves it meets these criteria are primarily based on bench testing and demonstration of substantial equivalence to a predicate device, rather than clinical performance or AI algorithm validation. The documentation focuses on engineering and material properties.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the properties of the predicate device and relevant ASTM standards (ASTM F1264-16). The performance is shown by demonstrating that the subject device's mechanical properties are "equivalent or better" than the predicate device.

Table of Acceptance Criteria and Reported Device Performance

Study Details: Device Validation (Bench Testing)

1. Sample Size used for the test set and the data provenance:

   • Sample Size: Not explicitly stated as a number of units, but testing was performed on "both male and female components of the subject and predicate devices" for mechanical testing, and "the worst case (smallest diameter) fully-assembled subject and predicate devices" as well as "the largest diameter fully-assembled subject and predicate devices" for additional static and dynamic testing. This implies multiple samples of each configuration were tested to generate data for stiffness, yield strength, fatigue, etc.
   • Data Provenance: The data is from "bench testing" conducted by Orthofix SRL. It is not patient or clinical data, so country of origin isn't relevant in the same way, nor is it retrospective or prospective in the clinical sense. It's laboratory-generated data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. This is not a study involving human interpretation of data (e.g., medical images) to establish "ground truth." The ground truth for mechanical testing is established by the specified ASTM standards and the measured physical properties of the materials and devices.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable. This is not a study involving human readers or subjective assessments requiring adjudication. The results are objective measurements from mechanical tests.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • Not applicable. This is a medical device (intramedullary nail) and not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and AI-related effect sizes are irrelevant to this submission.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable for the same reason as above. It is not an AI algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for this type of submission is based on engineering specifications, material science standards (e.g., ASTM F138, ISO 5832-1), and mechanical testing standards (e.g., ASTM F1264-16). The performance of the subject device is measured against these established engineering benchmarks and compared directly to a legally marketed predicate device.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning model, so there is no training set.

8. How the ground truth for the training set was established:

   • Not applicable. As above, there is no training set for a machine learning model.

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