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The Synthes Sternal Fixation System is intended for use in primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion.

The Synthes (USA) Titanium 2.4 mm Universal Locking Plates (12, 13 and 20 hole) are indicated for use in primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion.

The Synthes (USA) Sternal Fixation System consists of machined titanium plates, a quick-release pin and 3.0 mm locking screws. The plates utilize screw fixation to create the construct.

The provided text is a 510(k) summary for the Synthes Sternal Fixation System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving performance against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics for an AI/device study is not available in these documents.

Here's a breakdown of what can be extracted and what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The document explicitly states: "Clinical data was not needed for this device." The submission is for a medical device (Sternal Fixation System), not an AI/software device that would typically have performance metrics like sensitivity, specificity, or AUC. The "performance" assessment for this type of device usually involves mechanical testing and comparison to predicate devices, which is not detailed here in terms of acceptance criteria and results.

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

Not applicable. No test set for performance evaluation of an AI model is mentioned.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. No ground truth establishment for an AI model is mentioned.

4. Adjudication Method

Not applicable.

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

No. This is not an AI-assisted device, and no MRMC study is mentioned.

6. Standalone (Algorithm Only) Performance Study

No. This is a physical medical device (plates and screws), not an algorithm.

7. Type of Ground Truth Used

Not applicable.

8. Sample Size for the Training Set

Not applicable.

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

Not applicable.

Information Available from the Document:

• Device Trade Name: Synthes Sternal Fixation System
• Intended Use/Indications for Use: Primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion.
• Comparison to Predicate Device: "The design features, material, and indications for use of the subject Sternal Fixation System are substantially equivalent to the predicate devices identified. Additionally, the safety and effectiveness of this system is adequately supported by documentation within this premarket notification."
• Performance Data (Nonclinical and/or Clinical): "Clinical data was not needed for this device." This implies that non-clinical data (e.g., mechanical testing, material biocompatibility) was used to establish substantial equivalence, though the details of these tests and their criteria are not provided in this summary.

In summary, the provided document is a 510(k) summary for a physical medical device aiming for substantial equivalence. It does not contain the type of AI-related performance data, acceptance criteria, or study details requested in the prompt.

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