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DePuy Synthes VOLT™ Mini Fragment Plating System:

The VOLT™ Mini Fragment Plating System is indicated for internal fracture fixation of bones and bone fragments of the appendicular skeleton appropriate for the implant size.

The VOLT™ Mini Fragment Plating System is intended for adults and both children (2-12 years) and adolescents (12-21 years) in which growth plates (physes) have fused or in which unfused growth plates will not be compromised by fixation.

If used in the femur, tibia, humerus, patella, or pelvis the VOLT™ Mini Fragment Plating System can only be used for non-load bearing stabilization and reduction.

DePuy Synthes VOLT™ Small Fragment Plating System:

The VOLT Small Fragment Plating System is indicated for internal fracture fixation of bones and bone fragments of the appendicular skeleton appropriate for the implant size.

The VOLT Small Fragment Plating System is intended for adults and both children (2-12 years) and adolescents (12-21 years) in which growth plates (physes) have fused or in which unfused growth plates will not be compromised by fixation.

If used in the femur the VOLT Small Fragment Plating System can only be used for non-load bearing stabilization and reduction.

DePuy Synthes VOLT™ Mini Fragment Plating System

The DePuy Synthes VOLT™ Mini Fragment Plating System is a family of implantable devices, consisting of non-contoured, non-anatomic straight and shaped plates (Adaption, Adaption Combi, Compact Straight, Straight Condylar, Hook, T-Plate, Tine, Y-Plate and Triangle), with variable angle screw holes, and two screw types (cortex and locking screws). The system is available in three sizes; 2.0mm, 2.4mm and 2.7mm. The Triangle Plate is available in 2.4mm and 2.7mm sizes only.

The plates of this system are available in Stainless Steel and Commercially Pure Titanium, whilst the corresponding screws are available in Stainless Steel and Titanium Alloy (TAV) respectively. Plates and screws within the VOLT™ Mini Fragment Plating System are available either sterile or non-sterile and are single-use only.

DePuy Synthes VOLT™ Small Fragment Plating System

The DePuy Synthes VOLT™ Small Fragment Plating System is a family of implantable devices consisting of 3.5mm non-contoured, non-anatomic plates with variable angle screw holes. and 3.5mm locking, 3.5mm cortex, and 4.0mm cancellous screws.

The plates of this system are available in Stainless Steel and Titanium, whilst the corresponding screws are available in Stainless Steel and Titanium Alloy (TAV). Plates and screws within the VOLT™ Small Fragment Plating System are available either sterile or non-sterile and are single-use only

The provided text is a 510(k) summary for the DePuy Synthes VOLT Mini Fragment Plating System and VOLT Small Fragment Plating System. This document describes the device, its indications for use, and a comparison to predicate devices, focusing on non-clinical performance testing (mechanical and engineering analyses) to demonstrate substantial equivalence.

Crucially, this document explicitly states: "Clinical testing was not necessary for the determination of substantial equivalence."

Therefore, the requested information regarding acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance, training set details), which are typically found in clinical performance studies validating AI/ML-based medical devices, is not applicable to this submission.

This 510(k) clearance is based on the devices being "substantially equivalent" to existing predicate devices, primarily demonstrated through non-clinical performance testing (mechanical simulations and analyses), rather than clinical trials or studies involving human data and AI algorithm performance.

Therefore, I cannot provide the requested information as it is not present in the provided text. The device in question is a physical orthopedic implant, not an AI/ML software device that would require such performance evaluations.

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