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The Stabiliz Fixation System with SPL Locking Screw is intended for fixation of fractures, osteotomies and nonunions of the humerus, radius, ulna, distal tibia, and fibula.

The Stabiliz Fixation System includes standard straight LCP plates, metal locking screws, cortical screws, fully-threaded cancellous screws, and partially-threaded cancellous screws in various sizes and geometries. The SPL Locking Screw is a metal locking screw with a resorbable threaded polymer collar.

The provided text describes a medical device, the Stabiliz Fixation System with SPL Locking Screw, and its 510(k) summary for FDA clearance. However, it does not include detailed acceptance criteria or a study that specifically proves the "device meets the acceptance criteria" in terms of performance metrics like sensitivity, specificity, or reader improvement. This document is a regulatory submission for substantial equivalence to predicate devices, focusing on design, materials, and preclinical testing rather than clinical performance data as would be found in a study demonstrating diagnostic accuracy or efficacy.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance using the provided text, nor can I answer questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details for either test or training sets, as this information is not present in the document.

The document states:

• Preclinical Testing: "The non-clinical tests performed by the company include in vitro degradation testing, biomechanical loading study, corrosion testing, and biocompatibility testing. The results demonstrate that the Stabiliz Fixation System is substantially equivalent to legally marketed predicate devices."

This indicates that acceptance criteria would likely be related to the performance of these preclinical tests, such as achieving certain thresholds for degradation rates, load-bearing capacity, corrosion resistance, and biocompatibility, to demonstrate equivalence to the predicate devices. However, the specific values or criteria for these tests are not detailed. The document only states that the results demonstrate substantial equivalence.

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