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Radiaction's Shield System is intended for reducing unnecessary exposure to scatter X-ray radiation of medical teams during fluoroscopy-guided-procedures with the Toshiba Infinix-I or Siemens Artis C-arm, by attenuation. It is not intended to be used with such procedures for head and neck areas.

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I am sorry, but the provided text from the FDA 510(k) letter for the "Shield System" (K222625) by Radiaction Ltd. does not contain information about acceptance criteria, device performance studies, sample sizes, expert involvement, ground truth establishment, or any detailed study methodology. The letter primarily focuses on the FDA's decision regarding substantial equivalence, regulatory compliance, and general information about medical device regulations.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input. The provided document is a regulatory clearance letter, not a device performance study report.

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Radiaction's Shield System is intended for reducing unnecessary exposure to scatter X-ray radiation of medical teams during fluoroscopy-guided procedures with the Toshiba Infinix-I C-arm, by attenuating scatter radiation. It is not intended to be used with such procedures for head and neck areas.

Not Found

This FDA clearance letter does not contain the detailed information required to answer your request about acceptance criteria and the study proving the device meets those criteria.

The letter mentions the device (Shield System), its intended use (reducing scatter X-ray radiation exposure during fluoroscopy-guided procedures), and the specific C-arm it's compatible with (Toshiba Infinix-I C-arm). However, it does not include:

• A table of acceptance criteria or reported device performance.
• Details about a study (sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types).
• Information on training set sample size or ground truth establishment for training.

This document is primarily a formal notification of a device being granted 510(k) clearance by the FDA, indicating substantial equivalence to a predicate device. It confirms the device can be legally marketed but does not delve into the specifics of the pre-clinical or clinical studies conducted to support that clearance. Such detailed study information is typically found in the 510(k) summary or the full 510(k) submission, neither of which is present in the provided text.

Ask a specific question about this device