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BonOs® HV, BonOs® MV and BonOs® LV are intended to be used for the fixation of artificial joint protheses to the host bone.

BonOs® HV, BonOs® MV and BonOs® LV are PMMA, radiopaque bone cements, designed for the fixation of prothesis to the living bone. BonOs® HV, BonOs® MV and BonOs® LV are traditional bone cement products. The bone cement is made of two separate sterile components. When both components are mixed together, they become a self-hardening, radiopaque bone cement which fixes the implant and transfer stresses evenly to the bone. The liguid is contained in a vial and the powder in a pouch: these components are packed in blister with Tyvek lid or an aluminium pouch. The devices are sold disposable, single-use and sterile.

The provided text is a 510(k) Summary for a medical device called BonOs® HV, BonOs® MV, and BonOs® LV, which are PMMA bone cements. This document outlines the general information about the device, its classification, comparison to predicate devices, and performance data.

However, it does not contain information related to a study proving the device meets acceptance criteria concerning AI/ML performance, human readers, or ground truth establishment based on expert consensus/adjudication typical for AI/ML device clearances.

The performance data summarized in this document pertains to traditional medical device testing for bone cements, such as:

• Sterilization and Shelf Life: Validated according to ISO 11135 and ISO 13408-1/2.
• Biocompatibility: Performed according to ISO 10993-1, with identical materials to other bone cements on the market.
• Performance Testing (Chemical, Material, and Mechanical): Included mixing and application characteristics, chemical composition, molecular weight and polymer structure, physical properties, stability of components, thermal properties, and mechanical properties. These tests were conducted in accordance with "FDA Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement; Guidance for Industry and FDA" dated July 17, 2002, and met standards like ASTM F451-16, ISO 5833:2002, etc.
• Bacterial Endotoxins: Evaluated using Recombinant Factor C Assay (EndoZyme) following Ph. Eur. 5.01.10, based on USP , meeting endotoxin limits.

Therefore, I cannot populate the requested table and answer the specific questions about AI/ML device performance, human readers, sample sizes for AI/ML test/training sets, or expert-based ground truth establishment. The document describes a traditional substantial equivalence determination for a physical medical device (bone cement), not an AI/ML powered device.

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