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The RAYCAST® Immobilization Systems Hardware and Thermoplastic Materials are used to retain and reproduce a patient's position during radiation therapy.

RAYCAST® Immobilization Systems Hardware and Thermoplastic Materials

The provided text is a 510(k) premarket notification letter from the FDA regarding the RAYCAST® Immobilization Systems Hardware and Thermoplastic Materials. This document does not contain information about acceptance criteria or a study proving device performance as typically expected for software or AI/ML-based medical devices.

The letter explicitly states:

• Regulatory Class: II (TWO)
• Product Code: 90 IYE, 21 CFR 892.5050
• Description: "Immobilization Systems Hardware and Thermoplastic Materials are used to retain and reproduce a patient's position during radiation therapy."

This device is an immobilization system for radiation therapy, which is a physical device, not an AI/ML-based diagnostic or prognostic tool. Therefore, the specific questions about acceptance criteria, device performance tables, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets, and ground truth establishment for AI/ML are not applicable to the information contained in this document.

The FDA's review for this type of device (a Class II physical device) primarily focuses on:

• Substantial Equivalence: Comparing the device to legally marketed predicate devices to ensure similar safety and effectiveness.
• General Controls: Compliance with regulations like annual registration, device listing, good manufacturing practices (Quality System Regulation), labeling, and prohibitions against misbranding and adulteration.

To reiterate, the provided document does not contain the information requested in the prompt, as it pertains to a different type of medical device than what the questions are designed for.

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