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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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The Fixion Interlocking Proximal Femoral Nailing System ("Fixion PF") is intended for use in fixation of fractures in the femur. The Fixion PF is indicated for use in fractures in the femur shaft, proximal fractures, and combinations of these fractures. Proximal femoral fractures include stable and unstable pertrochanteric, intertrochanteric and subtrochanteric (with and without break-off of the minor trochanter), high subtrochanteric fractures and combinations of these fractures. The long Fixion PF may also be used in mid shaft fractures, 5cm below the surgical neck to 5cm proximal to the distal end of the medullar canal.

The Fixion PF is also indicated for use in osteotomy, nonunions and malunions, bone reconstruction following tumor resection, grafting and pathological fractures, revision procedures.

The Fixion Intramedullary Proximal Femoral Nailing System consist of the following main components:

1. The Nail Implant is an expandable non-slotted stainless steel cylindrical tube, with a cap protected, female threaded proximal end with holes for Femoral Neck Peg (Hip Peg) and Hip Pin. Other implantable components provided are the Femoral Neck Peg (Hip Peg) and the Hip Pin.

2. The Instrument Set consists of a few accessories used during insertion and removal (if required) of the implant.

3. The Inflation Device (Pump) is a single-use manual plastic pump that is filled with sterile inflation liquid and used to expand the Nail implant and Femoral Neck (Hip) Peg

Once the Nail and the Femoral Neck Peg are positioned within the medullary canal and femur neck respectively, rotation of the pump handle allows for peg and nail diameter increase to their intended diameter under x-ray and controlled pressure. The Hip Pin may be inserted as well.

The provided text describes a 510(k) summary for a medical device (Fixion™ Interlocking Proximal Femoral Intramedullary Nailing System), which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through clinical studies. Therefore, much of the requested information (e.g., acceptance criteria table, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) is not available in the given document.

The document primarily outlines:

• The device's description and intended use.
• Its classification and predicate devices.
• The performance standards it meets (primarily ASTM standards for material composition and mechanical testing).
• The claim of substantial equivalence to a previously cleared device (K010988) based on similar intended use, operating principles, design, materials, processes, sterilization, and packaging.

Based on the information provided, here is what can be inferred or stated:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document refers to mechanical testing against ASTM standards, but does not detail sample sizes for these tests, nor does it refer to human clinical test sets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. The assessment relies on engineering and material standards, not expert clinical ground truth from a test set.

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

This information is not provided. Not applicable to the type of data presented (mechanical and material compliance).

5. 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

A MRMC comparative effectiveness study was not conducted and is not applicable to this type of device (an orthopedic implant) which does not involve "human readers" or "AI assistance" in its direct function. The device is a surgical implant.

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

A standalone performance study of an algorithm was not conducted and is not applicable to this device. The device is a physical intramedullary nailing system.

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

The "ground truth" for this device's acceptance is based on:

• Compliance with ASTM material standards (e.g., F138 for stainless steel).
• Compliance with ASTM mechanical performance standards for orthopedic devices (e.g., F1264-99 for intramedullary fixation, F384-99 for hip pegs).
• Demonstration of substantial equivalence to existing legally marketed predicate devices, implying similar safety and effectiveness based on similar design, materials, and intended use.

8. The sample size for the training set

This information is not provided and is not applicable. There is no "training set" in the context of this device's mechanical and material compliance testing or substantial equivalence demonstration.

9. How the ground truth for the training set was established

This information is not provided and is not applicable as there is no training set mentioned or relevant for this type of device submission.

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