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The Synthes 2.7/3.5mm Variable Angle LCP Ankle Trauma System is intended for fixation of the ankle in adults and adolescents (12-21) in which the growth plates have fused, and particularly in osteopenic bone. Specifically,

• Anterolateral Distal Tibia Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal tibia.
• Medial and Anteromedial Distal Tibia Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal tibia,
• Distal Tibia T Plates and Distal Tibia L Plates are intended to buttress partial articular fractures and bone fragments of the distal tibia, and
• Lateral Distal Fibula Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal fibula.

The Synthes Anterolateral Distal Tibia Plates are intended to treat fractures of the distal tibia. These plates can be used with a new screw configuration, 3.5mm VA Locking Screws. The Anterolateral Distal Tibia Plates and 3.5mm VA Locking Screws will be offered in both stainless steel and titanium alloy (TAN), and in both sterile and non-sterile configurations. The Anterolateral Distal Tibia Plates will be offered in left and right configurations. The system accepts existing cortical screws, locking screws, dynamic locking screws, and metaphyseal screws (K100776, K063049, K112583, K000684, K111230, K120070, K110592, and K043185) as well as new 3.5mm VA Locking Screws, and allows for both dynamic compression and locking through Combi holes.

This is a 510(k) premarket notification for a medical device, specifically the Synthes 2.7/3.5mm Variable Angle LCP Ankle Trauma System - Anterolateral Distal Tibia Plates.

This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than providing clinical safety and efficacy data. Therefore, the information you're requesting regarding acceptance criteria, study details, expert review, and ground truth establishment, which are typical for studies validating AI/ML diagnostic devices, are not present in this document. This submission focuses on engineering analysis and comparison to existing, already approved devices.

Here's why your specific questions cannot be answered from this document:

• This is not an AI/ML device. The device is a physical bone fixation system (plates and screws). Therefore, concepts like "device performance" in terms of classification metrics (sensitivity, specificity), "test sets," "training sets," "ground truth" (in the context of expert consensus or pathology for diagnostic accuracy), or "MRMC studies" are not applicable.
• 510(k) is about substantial equivalence. The primary way this device met its acceptance criteria was by demonstrating that it is "at least as strong as" and has similar indications, design, materials, and performance characteristics as previously cleared predicate devices.

However, I can extract information related to the device and its "proof" of meeting requirements based on the document provided:

1. Table of Acceptance Criteria and Reported Device Performance:

Regarding the other points, as explained, they are not applicable or not provided in this 510(k) submission for a physical implantable device:

2. Sample size used for the test set and the data provenance: Not applicable. Performance was demonstrated through engineering analysis and fatigue testing, not a "test set" of clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" was established by experts for a diagnostic assessment.
4. Adjudication method for the test set: Not applicable.
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: Not applicable. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used: Not applicable. The "ground truth" equivalent here would be established engineering standards for strength and fatigue, against which the device was tested.
8. The sample size for the training set: Not applicable. No "training set" for an algorithm.
9. How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) relied on demonstrating substantial equivalence through a comparison of indications, design, materials, and engineering performance (mechanical strength) to already approved predicate devices. It did not involve clinical studies or expert evaluations of diagnostic accuracy as would be the case for AI/ML diagnostic software.

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