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Internal Locking Plate and Screw Fixation System is intended for temporary fixation, correction or bones in various anatomical regions.
3.5mm LCP Clavicle Plate is indicated for fixation of fractures, malunions, and osteotomies of the clavice.
LCP Proximal Humerus Plate is indicated for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.
3.5mm LCP Distal Humerus plate is indicated for intraarticular fractures of the distal humerus, comminuted supracondylar fractures, osteotomies, and non-unions of the distal humerus.
2.4 mm LCP Volar Distal Radius Plate is indicated for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones.
5.0 LCP Distal Femur Plate is indicated for buttressing multifragmentary distal femur fractures including; supracondylar, intra-articular and extra-aticular condylar, periprosthetic fractures in normal or osteopenic bone, nonunions and malunions, and osteotomies of the femur.
3.5mm LCP Medial Proximal Tibia Plate is indicated to buttress metaphyseal fractures of the medial tibia plateau, split-type fractures of the medial tibia plateau, medial split fractures with associated depressions and split or depression fractures of the medial tibia plateau. Also, for use in the fixation of osteopenic bone and fixation of nonunions and malunions of the medial proximal tibia and tibia shaft.
3.5mm LCP Anterolateral Distal Tibia Plate is indicated for fractures, and non-unions of the distal tibia, especially in osteopenic bone.
2.7mm/3.5mm LCP Distal Fibula Plate is indicated for fractures, and non-unions of the metaphyseal and diaphyseal region of the distal fibula, especially in osteopenic bone.
2.0mm LCP condylar Plate is indicated for fixation of fractures, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone. Examples include, but are not limited to, the hand, wrist, foot, and ankle.
The 3.5mm Round Hole Reconstruction Locking Plates is indicated for fixation of fractures, osteotomies and non-unions of the pelvis, particularly in osteopenic bone for adult patients.

Internal Locking Plate and Screw Fixation System consists of plates in various designs and size. Plates are provided in straight designs and various geometric configurations that are commonly used in traumatic and reconstructive surgery. Plates are provided with screw holes to accommodate non-locking and locking screws. They are named according to both anatomical positions and biomechanical functions of the plates. The Internal Locking Bone Plate and Screw Fixation System is divided into four types: large, small, mini, and reconstruction. The length of the plate varies from 45 to 316mm, and hole number from 3 to 22 holes.
Geasure Internal Locking Bone Screw System is used either to fasten plates or similar devices onto bones or to hold bone fragments together. The screws are differentiated by the manner in which they are inserted into bone, their function, their size, and the type of bone they are intended for. There are two styles: locking screw, cortex or cancellous screw. The screw recess is hexagon or star shaped to allow screw removal and insertion. The thread diameter of screw varies from 2.0 to 6.5mm, total length from 6 to 120mm.
Internal Locking Plate and Screw Fixation System is a construct in which the screws are locked in the plate. The heads of the locking screws contain male threads while the holes in the plates contain female thread, this allows the screw head to be threaded into the plate. Various plate designs are available depending on specific anatomic locations, these may be larger or smaller, thicker or thinner as appropriate to various anatomic sites and the loads to which they will be subjected. The holes in the plate are designed for locking screws, or locking and non-locking screws combination to facilitate dynamic compression. By combining locking screw holes with compression screw slots in the shaft, the plate can be used as both a locking device and a fracture compression device. Internal Locking plate and screw Fixation systems do not disrupt the underlying cortical bone perfusion as much as conventional plates, which compress the plate to the cortical bone.

This document primarily focuses on the K232394 Internal Locking Plate and Screw Fixation System, a medical device for bone fixation, and its substantial equivalence to predicate devices, as reviewed by the FDA. It outlines the regulatory classification, intended use, and technical characteristics.

Crucially, this document is a 510(k) Premarket Notification and does NOT contain information about an AI/ML-based device or a clinical study proving performance against specific acceptance criteria for such a device.

Therefore, I cannot fulfill your request for descriptions of:

1. A table of acceptance criteria and the reported device performance: This document refers to bench tests for mechanical properties (e.g., bend testing, torsional properties, pullout strength) and reprocessing and sterilization validation, which are standard for implantable devices. There are no acceptance criteria or performance metrics related to an AI/ML algorithm or its diagnostic/clinical performance.
2. Sample sizes used for the test set and data provenance: No test sets in the context of AI/ML are mentioned. The "tests" performed are mechanical and reprocessing validations.
3. Number of experts used to establish ground truth & qualifications: Not applicable as there's no diagnostic AI/ML component.
4. Adjudication method: Not applicable.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not applicable. The document explicitly states "No clinical study data is submitted in this 510(k)."
6. Standalone (algorithm only) performance: Not applicable.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable.
9. How ground truth for the training set was established: Not applicable.

What the document does provide is information critical for a mechanical implant device:

• Device Name: Internal Locking Plate and Screw Fixation System
• Intended Use: Temporary fixation, correction, or stabilization of bones in various anatomical regions, with specific indications for different plates (e.g., clavicle, humerus, radius, femur, tibia, fibula, small bones, pelvis).
• Regulatory Class: Class II
• Product Codes: HRS (Plate Fixation, Bone), HWC (Screw, Fixation, Bone)
• Materials: Titanium alloy (Ti-6Al-4V) ELI
• Sterilization: Provided non-sterile; manual cleaning and steam sterilization instructions are provided for the end-user.
• Non-clinical tests performed (bench tests):
  • Single Cycle Bend Testing for bone plate (per ASTM F382-17)
  • Fatigue Property Testing for bone plate (per ASTM F382-17)
  • Torsional Properties Test for screws (per ASTM F543-17)
  • Driving Torque Test for screws (per ASTM F543-17)
  • Axial Pullout Strength Test for screws (per ASTM F543-17)
  • Self-Tapping Performance Test for screws (per ASTM F543-17)
  • Reprocessing and sterilization validation (following FDA guidance, AAMI TIRs, and ISO standards)
• Premarket Submission Type: 510(k) Premarket Notification – this means the device is seeking clearance based on substantial equivalence to predicate devices, not approval based on extensive clinical trials for a novel technology like AI.
• Lack of Clinical Data: The document explicitly states, "No clinical study data is submitted in this 510(k)." and "No animal study data is submitted in this 510(k)."

In summary, the provided text describes a conventional orthopedic implant, not an AI/ML diagnostic device, and therefore does not contain the information required to answer your specific questions related to AI acceptance criteria and study methodologies.

Ask a specific question about this device