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The KLS Martin Mandibular / Reconstruction System II is intended for use in the stabilization and fixation of mandibular fractures and mandibular reconstruction.

KLS-Martin Mandibular Fracture / Reconstruction II includes several different designs of titanium plates and screws. New plates added to system are angled and precurved to follow the natural curves of the Mandible. Changes to this fracture / reconstruction system are not functionally different and could typically be addressed with letter to file for predicate 510(k)s. This 510(k) ensures plates and screws listed have current 510(k)s. KLS Martin Mandibular / Reconstruction System II is intended for use in stabilization and fixation of Mandibular Fractures and Reconstruction.

The provided document is a 510(k) summary for a medical device (KLS Martin Mandibular / Reconstruction System II) and a FDA clearance letter. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. This type of document is about demonstrating substantial equivalence to predicate devices, not about detailed performance studies against specific acceptance criteria.

Therefore, I cannot provide the requested information from the given text.

Here's why and what kind of information is missing:

• Acceptance Criteria & Reported Performance: This document states the intended use and technological characteristics, comparing them to predicate devices. It does not set forth specific, quantifiable acceptance criteria (e.g., "flexural strength must be X MPa") or report specific device performance results (e.g., "flexural strength achieved Y MPa").
• Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set: These are all aspects of a detailed study to evaluate a device's performance, especially for algorithms or diagnostic tools. This document is for a physical medical device (plates and screws) and primarily relies on demonstrating substantial equivalence to existing devices through similar design, materials, and intended use, rather than a clinical trial or algorithm performance study.

In the context of 510(k) submissions for physical devices like bone plates, "acceptance criteria" are usually related to established material properties (e.g., tensile strength, fatigue life) or mechanical tests performed to ensure the device performs as intended and is comparable to predicate devices. The document mentions "comparison of performance" and "similarity of materials" as bases for substantial equivalence, implying such tests would have been done, but it doesn't describe them or their results in detail.

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