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The DePuy Synthes 2.7mm VA LCP Clavicle Plate System is indicated for fixation of fractures, and nonunions of the clavicle in adults, and in both adolescents (12-18 years) and transitional adolescents (18-21 years), in which the clavicular growth plates have fused or in which the growth plates will not be crossed by the plate system.

The DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System is indicated for fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint.

The DePuy Synthes 2.7mm VA LCP Clavicle Plate System consists of lateral, shaft and medial plates designed for temporary fixation, correction or stabilization of clavicle bones. The subject plates are available in various sizes in both sterile and non-sterile configurations and are available in stainless steel and titanium alloy. The system also consists of non-implantable templates that correspond to the implants. Templates are intended for implant size selection and are available in non-sterile.

The DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System consists of the plate types Long, Short and Button which can be used to treat simple and complex clavicle fractures including malunions, non- unions and isolated ligamentous injuries of the AC joint. The subject plates are available in three hook depths, in left- and right-side versions, in both sterile and non-sterile configurations and are available in stainless steel and titanium. The system also consists of non- implantable templates that correspond to the implants. Templates are intended for implant size selection and are available non-sterile.

The provided text is a 510(k) Pre-market Notification for two medical devices: the DePuy Synthes 2.7mm VA LCP Clavicle Plate System and the DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through extensive studies in the way a novel device might.

Therefore, the document explicitly states that "Non-clinical performance data was not necessary for the determination of substantial equivalence" and "Clinical testing was not necessary for the determination of substantial equivalence". This means there are no acceptance criteria, device performance data, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance studies described in this document.

The basis for clearance is that the subject devices (DePuy Synthes 2.7mm VA LCP Clavicle Plate System and DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System) are substantially equivalent to previously cleared predicate devices (K201321 and K201959, respectively). The manufacturer asserts that the design, features, and specifications (technological characteristics) of the subject devices remain unchanged compared to their respective predicate devices. Any differences (e.g., additional contraindications or sterile/non-sterile options for the hook plate system) are argued not to raise new questions of safety and effectiveness.

In summary, this document does not contain the information requested about acceptance criteria and a study proving device performance because such studies were deemed unnecessary for a 510(k) submission based on substantial equivalence.

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