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The Versalock Periprosthetic Femur Plates is indicated for temporary internal fixation and stabilization of fractures and osteotomies of the femur, including:

• · Periprosthetic fractures
• Comminuted fractures
• Supracondylar fractures
• Trochanteric fractures
• · Fractures in normal and osteopenic bone
• Non-unions and Malunions.

The purpose of this submission is to obtain marketing clearance for the Versalock Periprosthetic Femur Plates System which is composed of plates, screws and, a cerclage cable and related device.

The subject devices are designed for the treatment of femur fractures, particularly, periprosthetic femur fractures. The plates are available in the following design-types to be used according to the fracture location: Proximal and Distal Femur Periprosthetic Plates, Trochanteric Periprosthetic Plates and Condylar Femur Plates.

The plates are for use with the subject device screws to fix them to the bone. The following compatible screws are available for this purpose: Cortical Screws, Versalock Variable Angle Locking Screws, Versalock Variable Angle Screws, Versalock Variable Angle Cannulated Screws and Versalock Variable Angle Periprosthetic Screw. The Trochanteric Plate Fastening Screw is to connect one plate to another when a Trochanteric Periprosthetic Plates is used. The Versalock Spacer Screw is threaded into the plate hole prior to plate insertion to act as a spacer providing no contact between the plate and the bone surface.

The Gama Cable is a cerclage cable indicated to provide fixation and/or stabilization of the bone when it is not possible the usage of any screw. The Gama Cable related devices are the Gama Cable Lock and the Versalock Connector Screw. During the installation of the Gama Cable Lock is crimped to lock the movement of the cable, maintaining the tensioning applied while the Versalock Connector Screw , which holds the cable to the plate and set the proper cable routing position. The Gama Cable and related devices are used in conjunction with the Proximal or Distal Femur Periprosthetic Plates, or Condylar Femur Plates

The subject devices are made of made of titanium alloy (ASTM F136) with exception of the Gama Cable Lock which it is made of commercially pure titanium (ASTM F67). All the subject devices are coloredanodized.

The devices must only be used by qualified surgeons mastering the surgical technique, having been trained and qualified in orthopedic surgeries.

The provided document is a 510(k) summary for the Versalock Periprosthetic Femur Plates System - GMReis. This document outlines the regulatory submission for a medical device and, as such, does not contain information about a study that proves the device meets specific acceptance criteria in terms of clinical performance or diagnostic accuracy. Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.

Therefore, many of the requested sections related to clinical studies, sample sizes for test and training sets, expert ground truth adjudication, MRMC studies, or standalone algorithm performance will not be available in this document.

Here's a breakdown of the information that can be extracted or inferred from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a table of explicit acceptance criteria with specific numerical targets. Instead, it states that performance was demonstrated through mechanical testing according to established ASTM standards. The "performance" in this context refers to the device's mechanical integrity and functionality, rather than a clinical outcome.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not applicable. This document describes mechanical testing of physical device components, not a study involving patient data or a "test set" in the context of AI/diagnostic device performance. The sample sizes would refer to the number of plates, screws, and cables tested in the lab. This specific number is not provided, though it would typically be defined by the ASTM standards.
• Data Provenance: Not applicable. The data comes from internal mechanical testing, not patient data from a specific country or collected retrospectively/prospectively.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. Ground truth as typically defined for diagnostic AI/clinical studies (e.g., expert consensus on images, pathology results) is not relevant to this type of device submission. The "ground truth" here is the adherence to mechanical engineering standards, which is determined by test procedures and measurement against those standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable for the reasons stated above.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No. This is not a diagnostic AI device, and therefore, an MRMC study is not relevant or mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• No. This is a physical medical implant device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• For the non-clinical performance (mechanical testing), the "ground truth" is adherence to established engineering standards (ASTM F382, ASTM F543, ASTM F2180) and a risk assessment based on biocompatibility standards (ISO 10993-1).
• For the substantial equivalence claim, the "ground truth" is the characteristics of the predicate device, which the subject device is compared against.

8. The sample size for the training set:

• Not applicable. There is no training set mentioned as this is not an AI/machine learning device.

9. How the ground truth for the training set was established:

• Not applicable. There is no training set.

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