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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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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.

This submission pertains to the Synthes Sternal Fixation System - Modification to Surgical Technique (K093772). The provided documents are a 510(k) summary and an FDA approval letter. This type of submission generally focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than comprehensive performance studies with acceptance criteria for a new AI/software-based device.

Therefore, the requested information regarding acceptance criteria, study data, sample sizes, expert involvement, and ground truth establishment, which are typical for software-as-a-medical-device (SaMD) or AI-augmented device submissions, is not available in the provided documents.

The documents indicate that this is a modification to an existing sternal fixation system, and the primary demonstration is of substantial equivalence to existing predicate devices. This typically involves comparing design, materials, intended use, and potentially bench testing to ensure the modification does not raise new questions of safety or effectiveness.

Based on the provided text, the specific details for acceptance criteria and a study proving device meets acceptance criteria as typically understood for AI/software devices are not present. The summary states:

• Substantial Equivalence: "Documentation provided in this submission demonstrates the Synthes Sternal Fixation System - Modification to Surgical Technique to be substantially equivalent to other legally marketed devices."

This indicates that the "study" conducted was primarily a substantial equivalence comparison, not a performance study against specific acceptance criteria for a diagnostic or therapeutic output, as would be relevant for AI.

To directly answer your numbered points based only on the provided text:

1. A table of acceptance criteria and the reported device performance: Not provided. The submission focuses on substantial equivalence to predicate devices, not on meeting specific performance metrics with acceptance criteria for a new function.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided. Data related to human subject testing or algorithm performance is not included.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable/Not provided. Ground truth establishment as it pertains to AI/diagnostic performance is not relevant to this submission type.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/Not provided.
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 device is a mechanical sternal fixation system, not an AI-assisted diagnostic or therapeutic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable/Not provided.
8. The sample size for the training set: Not applicable. This device does not involve a training set for an algorithm.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document relates to a traditional medical device (sternal fixation system) and its modification, seeking clearance based on substantial equivalence. It does not provide the type of information requested for AI or software performance studies.

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Ask a specific question about this device