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Medline UNITE® Ankle Fracture Plates and Screws are intended for fixation of fractures, and nonunions of the distal tibia and fibula such as:

• · Lateral Malleolar Fractures
• · Syndesmosis Injuries
• · Medial Malleolar Fractures
• Bi-Malleolar Fractures
• · Tri-Malleolar Fractures
• Posterior Malleolar Fractures
• Distal Anterior Tibia Fractures
• · Vertical Shear Fractures of the Medial Malleolous
• · Pilon Fractures
• Distal Tibia Shaft Fractures
• Distal Fibula Shaft Fractures
• · Distal Tibia Periarticular Fractures
• · Medial Malleolar Avulsion Fractures
• · Lateral Malleolar Avulsion Fractures

The Medline Locking and Non-Locking Cortical and Cancellous Screws are indicated for use with the Medline Ankle Fracture Plates of the same base material. The Non-Locking Cortical Screws are also indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the device.

Medline UNITE® Ankle Fracture Plating System are manufactured from Titanium Alloy. The system includes plates offered in various styles, sizes and options; each contoured for specific anatomy and designed for specific procedures, and 2.7mm and 3.5mm diameter locking cortical screws, 4.0mm Cancellous Screws, 4.0mm Medial Hook plate screws and 4.0mm Headed Cannulated screws to be used with the polyaxial locking holes and compression slots included in the plates. The system also includes reusable instrumentation necessary to implant the plates and screws, e.g. drill guides, tissue protectors, and drill bits.

The document describes the Medline UNITE® Ankle Fracture Plating System and its substantial equivalence to predicate devices, particularly the Synthes LCP One Third Tubular Plate (K011335).

Here's an analysis of the acceptance criteria and supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• The document describes non-clinical testing involving mechanical tests (single-cycle 4-point bend testing and bending fatigue testing).
• The sample size for these mechanical tests is not explicitly stated in the provided text.
• Data provenance is also not applicable in the context of mechanical testing of physical implants rather than patient data. The tests were performed to compare the Medline device against a predicate device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

• This information is not applicable to the type of testing performed. The study involved non-clinical mechanical testing of medical devices, not clinical evaluation requiring expert interpretation of patient data.

4. Adjudication Method for the Test Set

• This information is not applicable as the study was non-clinical mechanical testing, not a clinical study requiring adjudication of expert opinions.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not conducted. The document states "Summary of Clinical Testing: Not applicable." The study was entirely non-clinical, focusing on mechanical properties.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• This question is not applicable as the device is a physical bone plating system, not an AI algorithm.

7. Type of Ground Truth Used

• The "ground truth" for this non-clinical study was the established mechanical performance characteristics of the predicate device, as defined by the ASTM F382-14 standard and the performance of the Synthes LCP One Third Tubular Plate. Equivalence to these established benchmarks was the goal.

8. Sample Size for the Training Set

• This information is not applicable as there was no training set in the context of this mechanical device testing.

9. How the Ground Truth for the Training Set Was Established

• This information is not applicable as there was no training set mentioned in the context of this mechanical device testing.

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