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The Synthes LCP Proximal Tibia System is intended for treatment of nonunions, malunions, osteopenic bone, tibial osteotomies (4.5mm plate only), and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, periprosthetic, and fractures with associated shaft fractures.

The LCP Proximal Tibia Plates are contoured to match the anatomy of the proximal tibia with a limited contact low profile design. These are plates designed for either the right or left tibia in a variety of shaft lengths. The plates have overall lengths ranging from 298 mm to 370 mm and shaft holes ranging from 16 to 20 holes.

The provided document is a 510(k) summary for the Synthes LCP Proximal Tibia Plates Line Extension, followed by the FDA's clearance letter and indications for use. This document describes a medical device related to bone fixation, specifically plates for the proximal tibia.

The request asks for information typically found in studies evaluating AI/ML-driven medical devices or diagnostic tools. This document, however, is for a traditional, non-software medical device (bone plates). Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI/ML evaluation as requested are not directly applicable here.

For a traditional device like this, "acceptance criteria" are usually based on mechanical and material properties, biocompatibility, and sterilization effectiveness, which are typically demonstrated through engineering testing, material characterization, and sometimes animal or cadaver studies, rather than clinical efficacy studies with human experts establishing ground truth or MRMC studies.

Here's a breakdown of why this document does not contain the requested information in the AI/ML context:

1. AI/ML Concepts are Irrelevant: The device (Synthes LCP Proximal Tibia Plates Line Extension) is a physical, metallic bone fixation plate. It does not involve any algorithms, software, or AI/ML components for diagnosis, prediction, or image analysis.
2. No Performance Metrics like Sensitivity/Specificity: The document describes the device's physical characteristics (contoured to anatomy, limited contact, low profile, various lengths and hole counts) and its intended use (treatment of nonunions, malunions, osteotomies, and various fractures). There are no "performance metrics" in the sense of accuracy, sensitivity, specificity, or AUC that would be generated by an AI/ML model.
3. No "Ground Truth" or "Experts": Since there's no diagnostic or predictive output, there's no need for experts to establish a "ground truth" for a test set. The efficacy of bone plates is determined by surgical outcomes, bone healing, and mechanical stability, not by expert interpretation of AI output.
4. No Training or Test Sets: As there's no AI/ML model, there are no training or test datasets, no sample sizes for these sets, and no data provenance in that context.
5. No MRMC or Standalone Studies: Multi-Reader Multi-Case (MRMC) comparative effectiveness studies are used for evaluating diagnostic performance with human readers. Standalone performance is for evaluating an AI algorithm's performance without human intervention. Neither is applicable to a bone plate.

Therefore, I cannot provide the requested information because the provided document does not describe an AI/ML medical device and thus does not contain the types of acceptance criteria or study methodologies pertinent to AI/ML evaluation.

The "study" that proves this device meets its "acceptance criteria" is implicitly the battery of engineering tests (e.g., fatigue testing, static strength testing), material analyses, biocompatibility assessments, and potentially cadaveric or animal studies that would have been conducted by Synthes to demonstrate that the plates are safe, effective, and perform as intended for their indicated uses. These studies are typically referenced in the full 510(k) submission but are not detailed in this summary document. The FDA's clearance (K052390) indicates that Synthes successfully demonstrated substantial equivalence to a predicate device, implying these foundational tests were satisfactory.

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Synthes LCP Proximal Tibia Plate is intended treatment of non-unions, malunions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression, and fractures with associated shaft fractures.

The Synthes LCP Proximal Tibia Plates are contoured to match the anatomy of the proximal tibia with a limited contact low profile design. There are plates designed for either the right or left tibia in a variety of shaft lengths. These plates will be available in both 3.5 mm and 4.5 mm versions. The plates are available in a variety of lengths. The locking screw holes accept both cannulated locking and conical screws. Two proximal round holes accept cortex screws, cancellous screws, or cannulated screws. The distal portion of the plate has combination dynamic compression locking screw holes that allow the option of using locking screws, cortex screws, or cannulated screws.

This document is a 510(k) Pre-Market Notification from the FDA for a medical device (Synthes LCP Proximal Tibia Plate). It does not contain any information regarding acceptance criteria, study designs, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or ground truth establishment relevant to AI/ML device evaluations.

The provided text describes a traditional Class II medical device (bone fixation plate) and its regulatory clearance process based on substantial equivalence to a predicate device. This process typically involves demonstrating:

• Substantial Equivalence: The new device is as safe and effective as a legally marketed predicate device. This is usually achieved by comparing indications for use, technological characteristics, and performance data (e.g., mechanical testing, biocompatibility).

The information requested in your prompt (relating to acceptance criteria, sample sizes, expert ground truth, MRMC studies, standalone performance, etc.) is specific to the evaluation of AI/Machine Learning (AI/ML) powered medical devices, particularly those that generate diagnostic or prognostic outputs that need to be compared against a 'ground truth' established by human experts or other definitive methods.

Since the provided document is for a mechanical bone plate, it does not involve AI/ML and therefore does not include the type of information you are asking for.

Therefore, I cannot provide the requested information based on the input text.

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