(84 days)
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.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.