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The EBI X FIX® DynaFix® System Hydroxyapatite (HA) Coated Screws are intended for use in association with the external fixation of bone.

The EBI X FIX DynaFix® Hydroxyapatite® (HA) Coated Screws are intended for use in external fixation for the treatment of bone conditions including limb lengthening, corrective osteotemies, arthrodesis, fracture fixation, acute or gradual multiplanar correction and other bone conditions amenable to treatment by use of the external fixation modality.

The bone screws have a tapered thread diameter and are available in a variety of diameters and lengths in both cortical and cancellous thread patterns. The screws will be available with and without the additional proprietary hydroxapatite surface coating on the threads, and will be sold sterile and nonsterile. The coating has been shown to enhance fixation at the pin-bone interface and to reduce the incidence of pin loosening. Furthermore, osseointegration with direct contact between the bone and the screw thread was seen on histologic examination.

The provided text describes a 510(k) summary for the EBI X FIX® DynaFix® System HA Coated Bone Screws, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed studies proving performance against specific acceptance criteria in the manner of a new drug or novel medical device requiring extensive clinical trials.

Therefore, the input does not contain the specific information required to complete tables or answer questions related to acceptance criteria, device performance studies, sample sizes, expert ground truth, or MRMC studies. The document primarily discusses the device description, intended use, materials, comparison to predicate devices, and regulatory approval.

Explanation of Missing Information:

• Acceptance Criteria and Reported Device Performance: This device is a bone screw. The "performance" in this context would typically relate to mechanical strength (fatigue, pull-out strength), biocompatibility, and perhaps evidence of enhanced bone integration. While the summary mentions "biocompatibility, fatigue, and effectiveness testing," it does not provide the specific quantitative acceptance criteria or the reported results from these tests to compare against such criteria. For example, it doesn't say "fatigue strength must be X, and our device achieved Y."
• Sample Size, Ground Truth, Adjudication for Test Set: These details are relevant for studies involving diagnostic or AI-powered devices where a "test set" of data is evaluated against a "ground truth" established by experts. This is not applicable to a physical implant like a bone screw in the context of this 510(k) summary.
• MRMC Comparative Effectiveness Study: An MRMC study is used to evaluate the impact of a diagnostic aid (e.g., AI) on human reader performance. This is not relevant to a bone screw.
• Standalone Performance: "Standalone performance" refers to the algorithm's performance without human intervention, again applicable to AI/diagnostic tools, not a physical implant.
• Type of Ground Truth: The concept of "ground truth" in the context of a bone screw's performance evaluation would involve objective measures from mechanical testing (e.g., stress-strain curves, failure points), histological analysis (for osseointegration), or potentially animal model outcomes. The summary mentions "osseointegration with direct contact between the bone and the screw thread was seen on histologic examination," but this is a general statement, not a detailed ground truth methodology for a formal study.
• Training Set Sample Size and Ground Truth Establishment (Training Set): The bone screw does not involve a "training set" in the sense of machine learning. Its development would involve material science, engineering design, and biomechanical testing, not data-driven model training.

Summary of Available Information (and lack thereof for your specific questions):

The 510(k) summary identifies the predicate device, states that the device underwent "biocompatibility, fatigue, and effectiveness testing," and mentions "osseointegration with direct contact between the bone and the screw thread was seen on histologic examination." However, it does not provide the granular detail requested about acceptance criteria, numerical performance data, sample sizes, expert involvement, or specific study methodologies typical for AI/diagnostic devices.

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