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The WRIGHT™ Compression Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. Screws are intended for single use only.

The design features of the WRIGHT™ Compression Screws are described below.

• Manufactured from Titanium Alloy .
• Available headed or headless .
• Available in various diameters and lengths .
• . Cannulated

The provided text is a 510(k) summary for the WRIGHT™ Compression Screws, which details the device's intended use, description, and substantial equivalence to previously cleared predicate devices. However, this document does not contain the acceptance criteria or a study proving the device meets specific performance criteria.

The 510(k) summary focuses on demonstrating "substantial equivalence" of the new device to legally marketed predicate devices, rather than providing detailed performance studies against specific acceptance criteria. This is a common pathway for medical devices that are similar to existing ones.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and the reported device performance: This information is not present in the provided text. The document states that the safety and effectiveness are "adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification," but it does not specify what these acceptance criteria or the specific performance results are.
2. Sample size used for the test set and the data provenance: Not applicable, as detailed performance studies are not described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: No such study is mentioned.
6. If a standalone performance (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.
7. The type of ground truth used: Not applicable, as no specific performance study against a ground truth is described.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document states: "The safety and effectiveness of the WRIGHT™ Compression Screws is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification." This implies that the submission contained information on material properties and potentially mechanical testing, but these details are not part of the provided 510(k) summary itself. The clearance is based on the device being "substantially equivalent" to predicate devices, meaning it shares similar technological characteristics and is intended for the same use.

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