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The Schuhli Implant System is intended for use with Synthes long bone and small bone plates and screws. The Schuhli Assembly locks the screw to the plate (independent of bone contact) and has the potential to decrease the possibility of the screw loosening and backing out of the bone. The devices are designed for, but are not limited to, use in osteoporotic bone for unicortical (of the far cortex) or bicortical fixation in cases of trauma, tumor, or infection, and as fixed angle devices (where the angle between two supporting members is fixed).

Synthes Schuhli Implant System is intended for use with Synthes long home and small bone plates and screws, to lock the screw to the plate in order to prevent the screw from loosening and backing out of the bone. Specifically, they are used in osteuporulic bonc for unicortical (of the near cortex) or bicortical fixation in cases of trauma, tumor, or infection, and as fixed angle devices (where the angle between two supporting members is lixed).

The Schuhli Implant System consists of a nut, a washer, and a temporary holding screw. The nut fits into the underside of the plate and has spikes which secure the nut to bone. The temporary holding screw is used to hold the Schuhli to the plate (before the screws are placed) while the surgeon obtains the correct placement of the plate. The washer fits into the plate's screw hole, accepting the head of a screw. The Schuhli Implant System is available in two sizes (4.5 mm and 3.5 mm); each size is available in either titanium or stainless steel, and is used with either titanium or stainless steel compression plates and screws, respectively. Synthes Schuhli Implant System will be provided to the user sterile. Gamma radiation will be used to sterilize the device.

The provided text is a 510(k) summary for the Synthes (USA) Schuhli Implant System, which describes a medical device intended to lock screws to bone plates. It details the device's intended use, classification, and substantial equivalence to existing devices based on mechanical test results. However, the document does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found for AI/ML-based medical devices.

Instead, the document focuses on regulatory approval based on demonstrating substantial equivalence to a predicate device through mechanical testing, which is a common pathway for traditional medical devices. The questions posed in the prompt (e.g., sample sizes for test and training sets, ground truth establishment, MRMC studies, expert qualifications) are typically relevant for the validation of AI/ML-driven diagnostics or decision support systems.

Therefore, I cannot extract the requested information from this document. The document primarily describes a mechanical implant's regulatory submission, not the performance evaluation of a device using AI/ML.

Here's a breakdown of why I can't answer your questions based on the provided text:

• No Acceptance Criteria/Performance Data: The document states, "Based on mechanical test results, the Schuhli Implant System is substantially equivalent to Synthes Dynamic Compression Plates and screws." It doesn't provide specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy targets) or detailed performance metrics against those criteria.
• No "Study" in the AI/ML Sense: The "study" mentioned is "mechanical test results" for demonstrating substantial equivalence, not a clinical or AI performance study with test sets, ground truth, or human readers.
• No AI/ML Component: The device described (a nut, washer, and temporary holding screw) is a purely mechanical implant. There is no indication of any AI or machine learning component that would require the validation methods outlined in your questions.
• No Data Provenance, Experts, Adjudication, etc.: Because there's no AI/ML component or a performance study of that nature, there's no mention of sample sizes for test/training sets, data provenance, expert panels, ground truth methods, or MRMC studies.

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