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Synthes Medium External Fixation System is intended for the construction of an external fixator frame for the treatment of pediatric and adult fractures.

Synthes Medium External Fixation System is a system of components that form a construct intended to treat stable and unstable fractures. Frame components designed for this system are the Medium Multi-Pin Clamp and the Medium Combination Clamp. Also included in the system are the Medium Dynamization Clip and Medium Rod Attachment, which are accessories to the clamps that allow dynamization during bone healing and double stacking of the frame, respectively. The system is used with Synthes 8.0 mm carbon fiber rods ranging in lengths from 100 - 500 mm. System pin clamps accept Schanz screws in diameters of 4.0, 4.5 and 5.0 mm.

The provided 510(k) summary for the Synthes (USA) Medium External Fixation System (K011034) does not contain information about acceptance criteria or a study proving the device meets said criteria in the way typically expected for AI/ML-based medical devices or diagnostic tools.

This K011034 submission is for a traditional medical device (an external fixation system for bone fractures), not an AI/ML device. Therefore, the traditional regulatory pathway focuses on substantial equivalence to a predicate device based on material composition, design, intended use, and mechanical/performance testing as opposed to clinical performance metrics like sensitivity, specificity, or AUC which are common for AI/ML diagnostic tools.

Here's why the requested information isn't present in the provided document and what this type of submission typically entails:

• Acceptance Criteria and Reported Device Performance (Table): This type of table with performance metrics (e.g., accuracy, sensitivity, specificity) is not applicable to a mechanical device like an external fixator. For such devices, acceptance criteria would typically revolve around mechanical strength, fatigue life, biocompatibility, and sterilization effectiveness (if applicable). These are usually demonstrated through bench testing (e.g., ASTM standards for implants), not clinical performance studies with specific metrics.

• Sample Size for Test Set and Data Provenance: Not applicable. There isn't a "test set" of clinical data in the context of AI/ML evaluation. Performance is related to the physical device itself.

• Number of Experts and Qualifications: Not applicable. Ground truth for a mechanical device is established through engineering and material science, not expert interpretation of outputs.

• Adjudication Method: Not applicable.

• MRMC Comparative Effectiveness Study: Not applicable. This type of study compares human reader performance, with and without AI assistance, which is irrelevant for a mechanical fixation device.

• Standalone Performance: Not applicable. There is no algorithm performance to assess independently.

• Type of Ground Truth: Not applicable in the AI/ML sense. Ground truth for an external fixator would involve validated engineering standards, material specifications, and potentially cadaveric biomechanical testing.

• Sample Size for Training Set: Not applicable. There is no "training set" for an AI model.

• How Ground Truth for Training Set was Established: Not applicable.

What K011034 does provide and how it demonstrates "performance":

The K011034 submission demonstrates the device's suitability for its intended use through:

1. Substantial Equivalence: The core of this 510(k) submission is the claim of substantial equivalence to a predicate device (Howmedica Hoffmann® II External Fixation System and Synthes Dynamization Clip). This means demonstrating that the new device has the same intended use, similar technological characteristics, and does not raise different questions of safety and effectiveness than the legally marketed predicate device.
2. Device Description: Detailed description of components, materials (Stainless steel, titanium alloy, carbon fiber reinforced epoxy), and sizes.
3. Intended Use: Clearly defined intended use in the treatment of pediatric and adult fractures.

To demonstrate substantial equivalence for a device like an external fixator, the manufacturer would typically submit information regarding:

• Mechanical Testing: Data showing that the device components meet or exceed relevant ISO, ASTM, or internal company standards for strength, fatigue, torque, and stiffness under physiological loading conditions. This would demonstrate that the device can withstand the forces it will encounter in the body and maintain fixation.
• Biocompatibility Testing: According to ISO 10993, to ensure the materials are safe for patient contact.
• Sterilization Validation: If provided sterile, validation of the sterilization process.
• Design Specifications: Engineering drawings and specifications.

In summary, the provided document itself does not contain the detailed study results or acceptance criteria in the format requested because it pertains to a mechanical medical device, not an AI/ML-driven solution. The "study" proving its acceptance would be a series of engineering and material tests compared against established safety and performance benchmarks for similar devices, as implied by the substantial equivalence claims. This information would typically be in supporting documents referenced in a full 510(k) submission but not fully detailed in the K011034 summary provided.

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