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The HU II / HS II Fixture System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.

The HU II / HS II Fixture System is for one and two stage surgical procedures. It is not for immediate load.

The HU II / HS II Fixture System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches.

The provided text is a 510(k) summary for a dental implant system (HU II / HS II Fixture System). This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria through a study with the detailed structure you've requested.

The document states that "The HU II /HS II Fixture System has been subjected to safety, performance, and product validations prior to release. Safety tests including biocompatibility have been performed to ensure the devices comply with the applicable International and US regulations." However, it does not provide specific acceptance criteria or detailed study information in the way that would typically be presented for an AI/ML medical device's performance evaluation.

Therefore, I cannot extract the information to fill out your table and answer your specific questions in the context of an AI/ML device study.

Here's why and what the document does provide:

• Substantial Equivalence: This 510(k) focuses on demonstrating that the HU II / HS II Fixture System is "substantially equivalent" to existing predicate devices (The US System, K062030, and The SS System, K062051). This means proving it has similar materials, indications for use, design, and technological characteristics, and that it doesn't raise new questions of safety or effectiveness.
• Safety and Performance Validations: The document broadly states that safety, performance, and product validations were performed, including biocompatibility. However, it does not detail:
  • Specific acceptance criteria (e.g., a target accuracy, sensitivity, specificity).
  • The methodology of these validations (e.g., what specific tests were done, what data was used).
  • The results of these validations in a quantitative manner.

In summary, the provided text does not contain the information required to populate your table or answer your questions about acceptance criteria, study details, sample sizes, ground truth, experts, or MRMC studies, as it pertains to the performance evaluation of an AI/ML device. This document describes a traditional medical device (dental implant) approval process, not an AI/ML product.

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