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ANKLE FIX and ANKLE FIX + Systems 4.0 are indicated for:

• · skeletal osteosynthesis of small bone fragments, which were damaged due to trauma or require reconstruction or arthrodesis
• · primary or revision tibio-talar and tibiotalo-calcaneal fusion especially in the presence of osteopenic bone, hindfoot deformity and bone loss
• · post-traumatic surgery.

The Normed ANKLE FIX and ANKLE FIX + Systems 4.0 are titanium plate and screw systems intended for internal fracture fixation of the ankle. The pre-contoured plates are anatomically designed for optimal screw positioning. This trauma system offers lateral plates for fusion of the tibiotalar (ANKLE FIX) and tibiotalo-calcaneal (ANGLE FIX +) bones as well as medial, posterior (hindfoot), posterior tibia and anterior plates as needed for the ankle for stability.

Here is an analysis of the provided text regarding the acceptance criteria and study for the Normed® ANKLE FIX and ANKLE FIX + Systems 4.0:

The provided text describes a medical device, the Normed® ANKLE FIX and ANKLE FIX + Systems 4.0, which are titanium plate and screw systems for internal fracture fixation of the ankle. The document, a 510(k) Premarket Notification summary, focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical (mechanical) testing.

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The "acceptance criteria" here are the performance requirements set by the specified ASTM standards for orthopedic implants. The "reported device performance" is a general statement that the device "meets performance requirements as defined by Design Control activities" and is "substantially equivalent to the predicate devices in terms of safety and efficacy." Specific numerical performance values are not provided in this summary.

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

• Sample Size for Test Set: The document does not specify the exact number of plates or screws tested for each mechanical test. It mentions "worst case" testing for both plates and screws, implying a selection of configurations that would represent the most challenging scenarios.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): The data provenance is from non-clinical (mechanical) testing performed by the manufacturer, Normed® Medizin-Technik GmbH, which is located in Tuttlingen, Germany. This is a prospective test design for device performance, not related to patient data.

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

• Not Applicable. This is a non-clinical (mechanical) testing study of medical devices (plates and screws), not a study involving human subjects or interpretation of medical images. Therefore, clinical "ground truth" established by experts is not relevant to this specific type of study. The ground truth for mechanical testing is established by the specifications of the ASTM standards themselves and the objective measurements obtained.

4. Adjudication Method for the Test Set

• Not Applicable. As this is mechanical testing, there is no need for human adjudication of results in the way it would be for a clinical study involving subjective interpretation (e.g., radiological reads). The results are objective measurements against defined standards.

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

• Not Applicable. This is a 510(k) premarket notification for a physical medical implant (bone plates and screws). It is a mechanical performance study, not an AI or imaging diagnostic device, and therefore, no MRMC study or AI assistance evaluation was conducted.

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

• Not Applicable. This is not an algorithm or AI-based device.

7. The Type of Ground Truth Used

• For the non-clinical (mechanical) testing, the "ground truth" is defined by the specifications and methodology of internationally recognized ASTM standards (ASTM F382-99 for plates and ASTM F543-07 for screws). The measurements obtained from the physical testing are then compared directly to the requirements outlined in these standards.

8. The Sample Size for the Training Set

• Not Applicable. This is not a study that involves machine learning or AI models with training sets.

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

• Not Applicable. There is no training set for this type of device and study.

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