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The subject device, TwinFix® Interfragmentary Compression Screw System is Indicated for fractures or arthrodesis of carpais and metacarpals, radial styloid fractures, metatarsal fractures and ostectornies of the forefoot and intra-articular arthrodesis in the wrist.

The Stryker Leibinger, TwinFix® Interfragmentary Compression Screw System is intended to be used for fractures or arthrodesis of carpals and metacarpals, radial head and radial styloid fractures, metatarsal fractures and osteotomies of the forefoot and intra-articular arthrodesis in the wrist.

The Stryker Leibinger, TwinFix® Interfragmentary Compression Screw System is indicated for the treatment of fractures, psueudo-arthrosis, degenerative alterations and corrective osteotomies alming to a functionally stable osteosysntheis such as, but not limited to: scaphoid fractures, fractures of other carpal bones, scaphoid pseudo-arthrosis, intercarpal arthrodesis of finger end and metacarpal joints and fractures of ulna head and radius head. The TwinFix® is a double cancellous bone thread screw system that is designed for in situ dynamic adjustable interfragmentary compression purposes. It has a self-tapping screw tip design with varying lengths. It may be placed using an open approach with the use of a target bow device for placement of screws or through percutaneous screw placement using K-virre as a guide to minimize the incision.

The provided text describes a 510(k) summary for the TwinFix® Interfragmentary Compression Screw System, which is a medical device for bone fixation. However, it does not contain any information regarding acceptance criteria, device performance metrics, or a study that proves the device meets specific acceptance criteria.

The document primarily focuses on:

• Device Identification: Proprietary name, common name, regulatory class, submitter, manufacturer, contact person.
• Intended Use: Specific indications for which the device is designed (e.g., fractures of carpals, metacarpals, radial styloid, metatarsals, osteotomies of the forefoot, intra-articular arthrodesis in the wrist).
• Device Description: A brief overview of the screw system, its design (double cancellous bone thread screw, self-tapping), and placement methods (open approach with target bow, percutaneous with K-wire).
• Substantial Equivalence: A statement that the device is "identical to K961498, Resch Arthroscopic and Percutaneous Screw Fixation System in all respects of fixations of small bones." This is a key part of the 510(k) process, demonstrating that the new device is as safe and effective as a legally marketed predicate device.
• FDA Clearance Letter: Correspondence from the FDA stating that the device has been found substantially equivalent to predicate devices and can be marketed.

Since the document is a 510(k) summary and not a clinical study report or a detailed design validation document, it does not include the granular information requested about acceptance criteria and empirical performance testing. 510(k) submissions typically rely on established performance of predicate devices and bench testing to demonstrate substantial equivalence, rather than new, extensive clinical studies for performance metrics like those for AI/ML devices.

Therefore, for your specific questions:

1. A table of acceptance criteria and the reported device performance: This information is not available in the provided text.
2. Sample sized used for the test set and the data provenance: Not applicable, as no performance study is described with a test set. The substantial equivalence is based on the predicate device.
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 (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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, as this is a mechanical bone fixation device, not an AI/ML diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided excerpt describes the regulatory clearance of a medical device based on substantial equivalence, not a detailed performance study with explicit acceptance criteria and results.

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