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PERI-LOC™ Periarticular Locked Plating System Proximal Femur Bone Plates, Bone Screws and Cable Accessories can be used for adult patients as well as patients with osteopenic bone. PERI-LOC™ Proximal Femur Locking Bone Plates, Bone Screws and Cable Accessories are indicated for fractures of the trochanteric region including simple intertrochanteric, reverse oblique trochanteric, transverse trochanteric, complex multi-fragmentary, and fractures with medial cortex instability; proximal femur fractures combined with ipsilateral shaft fractures; pathological fractures of the proximal femur including metastatic fractures; proximal femur osteotomies; fixation of fractures in osteopenic bone; fixation of nonunions; basiltranscervical femoral neck fractures; subcapital femoral neck fractures; and subtrochanteric femur fractures.

The subject PERI-LOC™ Periarticular Locked Plating System – Proximal Femur Locking Bone Plates manufactured from titanium material have undergone a design modification when compared to devices cleared under K072818. Like the predicate devices include various lengths of contoured, locking bone plates made from titanium material. PERI-LOC™ Proximal Femur locking bone plates incorporate a screw-to-plate locking feature which forms a locked, fixed angle construct to aid in holding fracture reduction.

The provided text is a 510(k) summary for the PERI-LOC™ Periarticular Locked Plating System - Proximal Femur Locking Bone Plates. It describes a medical device, specifically bone plates, and discusses its substantial equivalence to previously cleared devices.

However, the document does not contain information about acceptance criteria or a study that uses terms like sensitivity, specificity, or any form of diagnostic performance metrics typically associated with AI/ML device evaluations. The study mentioned is a "pre-clinical bench testing" focused on "Construct fatigue testing of bone plate (and screw) constructs." This is a mechanical engineering test, not a clinical study involving human or image data.

Therefore, I cannot populate the requested table and answer the study-related questions (2-9) because the provided text describes a hardware medical device (bone plates) and its mechanical testing for substantial equivalence, not an AI/ML-based diagnostic or assistive device that would have such performance criteria and studies.

Here's a breakdown of why this information is not available in the provided text:

• Acceptance Criteria & Device Performance (Table 1): The document doesn't define acceptance criteria in terms of diagnostic performance (e.g., sensitivity, specificity, accuracy). The "performance" mentioned relates to mechanical properties (fatigue testing), not clinical diagnostic outcomes.
• Sample Size (Test Set) & Data Provenance (Question 2): Not applicable. The "test set" for a mechanical fatigue test would involve physical constructs, not a dataset of patient information.
• Number of Experts & Qualifications (Question 3): Not applicable. This relates to establishing ground truth for clinical diagnoses, which is not what this document describes.
• Adjudication Method (Question 4): Not applicable.
• Multi-Reader Multi-Case (MRMC) Study (Question 5): Not applicable. This is completely irrelevant to a bone plate's mechanical performance.
• Standalone Performance (Question 6): Not applicable. "Algorithm only" performance refers to AI, which is absent here.
• Type of Ground Truth (Question 7): Not applicable. For mechanical testing, the "ground truth" would be the physical properties measured in a lab.
• Sample Size for Training Set (Question 8): Not applicable. This is not an AI/ML device.
• Ground Truth for Training Set (Question 9): Not applicable.

In summary, the provided document describes a traditional medical device (bone plates) and its mechanical testing for regulatory clearance based on substantial equivalence, not an AI/ML diagnostic device.

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