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510(k) Data Aggregation
(168 days)
TAYMAN MEDICAL, INC. STEPPING & STABILIZING SYSTEM
The Tayman Medical, Inc. Stepping and Stabilization System is used to provide precision ultrasound probe alignment and radioactive seed implantation in the treatment of prostate cancer.
The seeding device is comprised of three basic components. The adjustable height base. The adjustable, multi-axis head. The ultrasound probe holder and needle guide.
The provided text is a summary of safety and effectiveness for a medical device (Tayman Medical, Inc. Stepping and Stabilization System). It describes the device, its intended use, and its similarities to a predicate device.
However, the document does not contain any information regarding acceptance criteria, study results, sample sizes, ground truth establishment, expert qualifications, or any of the other specific details requested in the prompt.
Therefore, I cannot fulfill the request using the provided input. The document focuses on regulatory equivalence rather than performance evaluation against specific criteria.
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