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The Piccolo Composite Ankle Arthrodesis Nails are indicated for tibiotalocalcaneal arthrodesis (fusion). Specific indications include: 1. Avascular necrosis of the talus 2. Failed total ankle arthroplasty 3. Trauma (malunited tibial pilon fracture) 4. Severe deformity or instability as a result of talipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular disease 5. Revision ankle arthrodesis 6. Neuroarthropathy 7. Rheumatoid arthritis 8. Osteoarthritis 9. Pseudoarthrosis 10. Post-traumatic arthrosis 11. Previously infected arthrosis 12. Charcot foot 13. Severe endstage degenerative arthritis 14. Severe defects after tumor resection 15. Pantalar arthrodesis

The Piccolo Composite Ankle Arthrodesis Nailing System includes nails, interlocking screws and a set of instruments. The Piccolo Composite Ankle Arthrodesis Nail is a cannulated, cylindrical rod. made of carbon fiber reinforced polymer. Nail diameter ranges from 10mm to 12mm, with lengths in the range of 160mm to 240mm. The nails provide for holes at the proximal and distal sections, designed for the insertion of self-tapping, titanium-alloy-made, interlocking screws.

The CarboFix Orthopedics Ltd. Piccolo Composite® Nailing System - Ankle Arthrodesis (K123810) demonstrates its acceptance criteria and a study proving it meets these criteria through a comparison to predicate devices, as detailed in the provided 510(k) summary.

Here's the breakdown of the information requested based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are established by the ASTM F 1264 standard. The device performance is deemed met by showing substantial equivalence to predicate devices under this standard.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a separate "test set" in the context of clinical data for an AI/CAD system. Instead, the evaluation focuses on mechanical performance and comparison to predicate devices. Therefore, traditional "sample size" for a clinical test set is not applicable here.

• Data Provenance: The study performed appears to be laboratory-based mechanical testing, not a clinical study involving patient data. The provenance for this type of testing is generally the manufacturer's testing facility.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. This device is a mechanical implant, and its evaluation relies on engineering standards (ASTM F 1264) rather than expert interpretation of medical images or conditions for establishing ground truth.

4. Adjudication Method for the Test Set

Not applicable for a mechanical performance study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI systems and is not applicable to the mechanical testing of an orthopedic implant.

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

Not applicable. This is an orthopedic implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is defined by the mechanical performance requirements outlined in the ASTM F 1264 - Standard Specification and Test Methods for Intramedullary Fixation Devices. The device's performance is accepted if it meets or is substantially equivalent to predicate devices based on these standardized mechanical tests.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of an AI/CAD system for this device. The evaluation is based on engineering testing and comparison.

9. How the Ground Truth for the Training Set was Established

Not applicable. As there is no training set, there is no ground truth established for it.

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