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The Apex Tibial Nailing system is intended for temporary fixation of the fractures of the tibia. The Apex nail is indicated for used in adult patients for treatment of:

• · Open and closed tibial fractures, including simple, severely comminuted, spiral, large oblique, and segmental fractures;
• · Fractures involving osteopenic or osteoporotic bone;
• · Fractures with bone loss;
• Pseudoarthosis, nonunion, and malunion;
• · Correction osteotomy;
• · Pathologic fractures and prophylactic nailing of impending pathologic fractures; and
• · Reconstruction following tumour resection.

The Apex Tibial Nailing System is a tibial intramedullary fixation system designed to be implanted and interlocked proximally and distally using bone screws by means of a provided reusable surgical instrumentation kit. Like many of the currently-marketed intramedullary nails, the Apex Nail offers several different proximal and distal locking options from which the surgeon may choose, depending on the fracture. An insert within the proximal nail stem maintains the torsional stability of static locking when the construct is locked in a dynamization mode. The Apex Tibial Nailing System includes a tibial nail, bone screws and endcaps of varying sizes. All parts of the system are manufactured from Titanium 6AL4VELi. The Apex Tibial Nail, screw and endcap are available in varying lengths and diameters.

This document describes the regulatory approval for a medical device called the "Apex Tibial Nailing System." It is a 510(k) premarket notification, which means the device is being compared to existing, legally marketed predicate devices to demonstrate substantial equivalence. Therefore, the information provided focuses on comparative data and adherence to established standards rather than a clinical study establishing new performance metrics.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of "Acceptance Criteria" in this context: For a 510(k) submission, the "acceptance criteria" are typically defined by recognized consensus standards (like ASTM standards) that apply to the device type. The reported performance is the assertion that the device successfully passed these standardized tests and met all specified requirements within those standards.

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

The document does not explicitly state the "sample size used for the test set" in terms of number of devices or clinical cases. The testing described is non-clinical performance testing (mechanical and material testing, per ASTM standards). Therefore, the data provenance is from laboratory testing rather than patient data, and it is retrospective in the sense that the testing was conducted on manufactured devices before this submission.

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

This information is not applicable to this document. The "ground truth" for the non-clinical performance testing is established by the specifications and methodologies outlined in the ASTM standards themselves, rather than through expert consensus on clinical cases.

4. Adjudication Method for the Test Set

This information is not applicable. Since the testing is non-clinical and objective (e.g., strength, fatigue, material composition), an adjudication method for a "test set" in the sense of clinical data interpretation is not relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This submission is for a medical implant and relies on non-clinical performance testing and substantial equivalence to predicate devices, not on AI assistance to human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study was not done. This device is a mechanical implant, not an AI or software algorithm.

7. The Type of Ground Truth Used

For the non-clinical performance testing, the "ground truth" is defined by the specifications and requirements within the referenced ASTM standards (ASTM F1264-16 and ASTM F543-07), as well as the parameters for "Full construct fatigue testing." These standards define acceptable material properties, mechanical strength, and fatigue resistance for intramedullary fixation devices and bone screws.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of this device, as it is a mechanical implant and not an AI or machine learning model that requires training data.

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

This information is not applicable for the reasons stated above.

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