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Tantalum bead implants are used as radio-opaque markers and may be implanted into bone or soft tissue. These devices are used to measure movement of implants after surgery with the aid of an xray system. Implant surgery associated with the use of radiographic markers may include total joint replacement procedures, soft tissue repair and bone fracture fixation procedures.

The Tantalum Bead Set consists of 1mm spherical x-ray markers made of commercially pure, unalloyed tantalum. They are used as radio-opague markers and may be implanted into bone or soft tissue. These devices are used to measure movement of implants after surgery with the aid of an x-ray. The beads are applied with a manual surgical instrument. The beads are provided non-sterile in a cartridge which includes 16 beads. The cartridge, manufactured from PEEK is designed to be used with the Halifax RSA Bead Inserter (Class 1 device) to allow surgeons to deploy the beads into the bone and tissue surrounding an orthopaedic implant. The inserter and cartridge containing the beads must be sterilized by the hospital prior to use.

The provided text is a 510(k) Summary of Safety and Effectiveness for the Halifax Biomedical Inc. Tantalum Bead Set. This document is a premarket notification to the FDA for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study report with acceptance criteria and performance data in the way you've requested for an AI/device performance study.

Therefore, the information you're asking for regarding acceptance criteria, reported device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training data is NOT present in this document.

This document describes a physical medical device (tantalum beads) that serves as a radiographic marker. Its approval is based on demonstrating that its materials, intended use, and design are substantially equivalent to a previously approved device (Biomet's Tantalum Beads - K010348), not on a clinical performance study with specific metrics like sensitivity, specificity, or reader improvement.

To directly answer your request based only on the provided text, I must state that this document does not contain the information requested.

If you are looking for an example of a device and its study that would contain such information, you would typically need a document pertaining to an AI/ML-based medical device where diagnostic accuracy or a similar performance metric is the primary subject of the 510(k) or a clinical study report.

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