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Tantalum beads are used as radiopaque 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. Implant surgery associated with the use of radiographic markers may include total joint replacement, soft tissue repair, and bone fixation.

Tantalum beads are spherical. 0.8 MM diameter, X-ray markers made of commercially pure, unalloyed tantalum. The beads are provided sterile in packages of eight. Tantalum beads 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 X-ray. They are used in conjunction with total joint replacement, soft tissue repair, and bone fractures. The beads are applied with manual surgical instruments.

The provided text is a 510(k) summary for Tantalum Beads - Radiographic Marker. It focuses on device description, intended use, and comparison to predicate devices, and concludes with a determination of substantial equivalence.

Crucially, the document explicitly states: "To the best of our knowledge, no performance standard has been established under Section 514 for this device." This means there were no specified acceptance criteria or performance study conducted to "prove the device meets acceptance criteria" as there were no formal performance criteria to meet for this 510(k) submission.

The submission establishes substantial equivalence to predicate devices (UltraClip Tissue Marker, the Micromark Clip, and other Tantalum Beads as radiographic markers) based on similarities in materials and intended use.

Therefore, I cannot provide the requested information about acceptance criteria or performance studies from the given input because they were not part of this 510(k) submission. There is no mention of a study to demonstrate device performance against acceptance criteria in the provided text.

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