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The KLS Martin Level One Rib Fixation System is indicated for use in the stabilization and rigid fixation of rib fractures in the chest wall including reconstructive procedures, trauma, or planned osteotomies in patients 18 years of age or older.

The KLS Martin Level One Rib Fixation System is comprised of PEEK plates and titanium locking screws intended to provide rigid fixation of bone in the thoracic anatomy. The PEEK plates are pre-contoured to accommodate patient anatomy and are offered in plate thicknesses of 2 mm - 3 mm. The PEEK plates are compatible with the Ti-6Al-4V (ASTM F136) 2.3 mm x 7 mm multidirectional locking screws offered in the system. The plates are manufactured from PEEK (ASTM F2026). The system includes the necessary instrumentation

The provided text describes a 510(k) premarket notification for the KLS Martin Level One Rib Fixation System. It focuses on establishing substantial equivalence to predicate devices based on non-clinical performance data and discussions of intended use and technological characteristics.

However, the provided document DOES NOT contain information regarding a study involving AI/algorithm performance for a diagnostic or AI-assisted device. Therefore, I cannot extract the specific details requested in your prompt regarding acceptance criteria and performance studies for an AI device.

The document primarily addresses the substantial equivalence of a physical medical device (rib fixation system) based on mechanical and biological safety testing, rather than a diagnostic or AI-driven system.

Therefore, many of the requested points, such as "table of acceptance criteria and the reported device performance" (for an AI device), "sample size used for the test set and the data provenance," "number of experts used to establish the ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," "sample size for the training set," and "how the ground truth for the training set was established," are not applicable to the content provided.

The non-clinical performance data mentioned refers to:

• Comparative head-to-head bench testing: To determine if the subject device performs equivalently to or better than the primary predicate device in pull-out system testing.
• Comparison to a reference device (Synthes MatrixRIB Fixation System): For pull-out system testing.
• Biological safety risk assessments: In compliance with ISO 10993-1:2018, concluding the devices are biocompatible.

The document explicitly states: "Clinical testing was not necessary for the determination of substantial equivalence." This further confirms that no human-in-the-loop or standalone diagnostic performance studies were conducted or reported in this 510(k) summary.

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The Valkyrie Thoracic Fixation System is intended for use in the stabilization and fixation of fractures in the chest wall including sternal reconstructive surgical procedures, trauma, or planned osteotomies. The system is intended for use in patients with normal and/or poor bone quality.

The Valkyrie Thoracic Fixation System consists of a variety of screws and plates intended for use in the stabilization and fixation of fractures in the chest wall including sternal reconstructive surgical procedures, trauma, or planned osteotomies. The system is intended for use in patients with normal and/or poor bone quality.

To accommodate varying patient anatomy and surgeon preference, the Valkyrie Thoracic Fixation System includes screws in 3.0mm and 3.5mm diameters and lengths from 7-20mm. The system also includes various styles of plates. The Valkyrie Thoracic Fixation System plates are made from PEEK-Optima™ per ASTM F2026, and the screws are made from Ti-6Al-4V per ASTM F136.

The provided document is a 510(k) summary for the Valkyrie Thoracic Fixation System, a medical device for stabilizing and fixing chest wall fractures. It does not describe an AI/ML-based device or a study involving human readers and AI assistance for diagnostic purposes. Instead, it details mechanical, biocompatibility, and sterilization testing for a physical implantable device.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving an AI/ML device meets them, as the document pertains to a metal and PEEK-Optima™ bone fixation system and not an AI or imaging device.

To answer your request, I would need a document describing the regulatory submission for an AI/ML medical device, which would typically include details about its performance evaluation, ground truth establishment, expert adjudication, and potentially multi-reader multi-case studies.

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