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The Synthes Angular Stable Locking System (ASLS), when used with Synthes Cannulated Titanium Intramedullary Nails, is intended to aid in the alignment and stabilization of tibial, humeral, femoral, and ankle fractures.

The Synthes Angular Stable Locking System (ASLS) is designed as an alternative device for the interlocking of Synthes Cannulated Titanium Intramedullary Nails. The ASLS consists of a titanium screw with a 70:30 Poly (L/DL-Lactide) sleeve and is available in diameters ranging between 4.0 mm - 6.0 mm and overall lengths ranging between 23 mm - 125 mm.

The provided text is a 510(k) summary for the Synthes Angular Stable Locking System (ASLS). It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in the prompt. This document is a regulatory submission and approval letter, not a detailed study report.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study proving the device meets them based on the provided text. The requested information is simply not present in this document.

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Synthes Angular Stable Locking System (ASLS) is indicated for use with Synthes Titanium Intramedullary Nails to achieve angular and axial stable locking.

Synthes Angular Stable Locking System (ASLS) is designed as an alternative device for interlocking Synthes Titanium Intramedullary Nails. The ASLS consists of a titanium screw with a premounted peek sleeve and is available in diameters ranging between 4.0 mm - 6.0 mm and overall lengths ranging between 26 mm - 125 mm.

This document is a 510(k) summary for the Synthes Angular Stable Locking System (ASLS). It details the device's classification, description, intended use, and claims of substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies.

Therefore, I cannot fulfill your request for the specific details outlined concerning acceptance criteria and study results. This type of regulatory submission typically focuses on demonstrating equivalence to previously cleared devices rather than providing detailed clinical study results or performance metrics against defined acceptance criteria.

Ask a specific question about this device