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The Schuhli Implant System is intended for use with Synthes long bone and small bone plates and screws. The Schuhli Assembly locks the screw to the plate (independent of bone contact) and has the potential to decrease the possibility of the screw loosening and backing out of the bone. The devices are designed for, but are not limited to, use in osteoporotic bone for unicorical (of the far cortex) or bicorical fixation in cases of trauma, tumor, or infection, and as fixed angle devices (where the angle between two supporting members is fixed).

The Schuhli Implant System consists of a nut, a washer, and a temporary holding screw. The nut fits into the underside of the plate and has spikes which secure the nut to bone. The temporary holding screw is used to hold the Schuhli to the plate (before the screws are placed) while the surgeon obtains the correct placement of the plate. The washer fits into the plate's screw hole, accepting the head of a screw. The Schuhli Implant System is available in two sizes (4.5 mm and 3.5 mm); each size is available in either titanium or stainless steel, and is used with either titanium or stainless steel compression plates and screws, respectively.

This device is a medical implant (Synthes Schuhli Implant System) and the provided text is a 510(k) summary for its premarket notification. The summary focuses on establishing substantial equivalence to a predicate device (Synthes Dynamic Compression Plates and screws) based on mechanical testing. It does not involve a diagnostic algorithm or AI, therefore many of the requested fields are not applicable.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not specified in terms of number of implants or tests. The text only mentions "mechanical test results."
• Data Provenance: Not explicitly stated, but assumed to be internal laboratory testing conducted by Synthes (USA). No mention of country of origin for data. The study is not applicable for retrospective or prospective as it's a mechanical device test, not a clinical study on human subjects with data collection.

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

• Not Applicable. The "ground truth" for mechanical testing is based on established engineering standards and measurements of physical properties, not expert consensus on interpretations as would be the case for diagnostic imaging.

4. Adjudication Method for the Test Set

• Not Applicable. Mechanical testing relies on objective measurements and comparison to predefined acceptance limits or predicate device performance, not on adjudication of subjective interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of AI Improvement

• No. This is a mechanical implant, not an AI-powered diagnostic device. An MRMC study is completely irrelevant here.

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

• Not Applicable. This is a physical device, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for this device would be established by mechanical engineering standards and measurements. This includes properties like pull-out strength, torque, bending stiffness, and other relevant biomechanical characteristics, benchmarked against the predicate device.

8. The Sample Size for the Training Set

• Not Applicable. This is a physical device that undergoes mechanical testing and comparison to a predicate, not an AI model requiring a training set.

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

• Not Applicable. See point 8.

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