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The Piccolo Composite Proximal Femur Nails are indicated for the treatment of stable and unstable proximal femur fractures (pertrochanteric, intertrochanteric high subtrochanteric fractures, and combinations of these fractures), including, fractures resulting from trauma, nonunions, pathological fractures, impending pathological fractures, tumor resections, and revision procedures.

The Piccolo Composite Nailing System includes nails, screws and a set of instruments.

The Piccolo Composite nail indicated for treatment of the proximal femur is a cylindrical rod. Nail mid-shaft diameter is 11mm. with the proximal end diameter being 17mm. Nail lengths are 180mm, 200mm, and in the range of 300 - 460mm. The nail provides for holes at the proximal and distal sections, designed for the insertion of a lag screw and interlocking screws. The lag screw is of 10mm diameter, with its length being in the range of 80mm to 110mm. The nails and lag screws are made of carbon fiber reinforced polymer and incorporate small amount of titanium alloy. Tantalum markers are embedded within the carbon fiber reinforced polymer, where applicable, to enable visualization during imaging. The distal screws are made of titanium alloy.

This document is a 510(k) Premarket Notification from the FDA regarding the CarboFix Orthopedics Limited's Piccolo Composite® Nailing System. It does not contain information about the acceptance criteria or a study proving the device meets those criteria.

The document states that the device is "substantially equivalent" to legally marketed predicate devices. This means that the FDA has determined the new device is as safe and effective as another legally marketed device, but it does not require a new clinical study to prove efficacy or meet specific acceptance criteria in the same way a novel device might.

The section titled "Performance characteristics for the Piccolo Composite Proximal Femur Nailing System components included static and dynamic bending of construct, rotational stiffness of construct, lag screw cutout, lag screw pullout, proximal and distal shell attachment strength, locking screw pullout and torque to failure, and are comparable to those of predicate devices (as applicable), thus demonstrating that the device is safe and effective for its intended use." indicates that various mechanical tests were performed. However, it does not provide the specific "acceptance criteria" for these tests (e.g., "bending strength must exceed X Newtons") nor does it present the "reported device performance" in a table format as requested. It only states that the results are "comparable to those of predicate devices."

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: This information is not provided in the document.
2. Sample size used for the test set and the data provenance: Not applicable as the "study" referred to is mechanical testing, not a clinical study with a test set of patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No.
7. The type of ground truth used: Not applicable in the context of clinical performance; for mechanical tests, the "ground truth" would be the engineering specifications.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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