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THERMOFIT is used to create a stable, reproducible and comfortable head or head or head, neck and shoulder radiation therapy.

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I apologize, but the provided text from the FDA 510(k) clearance letter for "Thermofit" does not contain information on acceptance criteria or a study proving the device meets those criteria.

The document is a standard FDA clearance letter, which states that the device is substantially equivalent to a predicate device and can be marketed. It outlines regulatory requirements and contact information.

Specifically, it lacks the following information necessary to answer your request:

1. A table of acceptance criteria and reported device performance: There is no performance data or specific acceptance criteria mentioned.
2. Sample size and data provenance for a test set: No test set or study details are provided.
3. Number and qualifications of experts for ground truth: No ground truth establishment is discussed as no study is detailed.
4. Adjudication method for the test set: Not applicable without a study.
5. MRMC comparative effectiveness study details: No such study is mentioned.
6. Standalone (algorithm only) performance: Thermofit is described as a physical device (used to create a stable, reproducible, and comfortable head or head, neck, and shoulder radiation therapy), not an AI algorithm.
7. Type of ground truth used: Not applicable as no study is detailed.
8. Sample size for the training set: Not applicable to this type of device or document.
9. How ground truth for the training set was established: Not applicable.

The "Indications for Use" section (page 2 of the document) simply states: "THERMOFIT is used to create a stable, reproducible and comfortable head or head or head, neck and shoulder radiation therapy." This describes the intended purpose of the device, not performance metrics or study results.

In summary, the provided document does not contain the information requested regarding acceptance criteria and study data for the Thermofit device.

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The Proton IMMOBILIZATION Solution is indicated to assist in the proper positioning and repositioning of patients for radiation therapy and radiosurgery and treatment including electron, photon, and proton treatments.

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This document is a 510(k) premarket notification decision letter from the FDA for the "Proton Immobilization Solution" device. It does not contain any information regarding acceptance criteria, device performance, study details, or ground truth establishment.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed subject to general controls. The "Indications for Use" section (page 2) describes the intended purpose of the device but does not include any performance metrics or study results.

Therefore, I cannot provide the requested information based on the provided text.

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The SAGITTL is indicated to assist in the proper positioning and re-positioning of patients for radiation therapy and radiosurgery simulation and treatment including electron, photon and proton treatments.

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I am sorry, but the provided text does not contain the detailed information necessary to describe the acceptance criteria and the study proving the device meets those criteria, as requested. The document is an FDA 510(k) clearance letter for a medical device called SAGITTILTTM, indicating that it has been found substantially equivalent to a predicate device.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes, data provenance, number of experts, their qualifications, or adjudication methods for any test set.
• Information on a multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
• Details about a standalone algorithm performance study.
• The type of ground truth used.
• Sample size for training data or how its ground truth was established.

The document primarily focuses on the regulatory clearance for the device, its intended use (positioning and re-positioning patients for radiation therapy), and general FDA compliance information. It does not delve into the specifics of performance studies or acceptance criteria beyond indicating that it was deemed "substantially equivalent" to a legally marketed predicate device.

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The NANOR and NANOR/EFFICAST Hybrid Thermoplastic materials are used to retain and reproduce a patient's position during radiation therapy.

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I am sorry, but the provided text is a 510(k) premarket notification document from the FDA regarding "NANOR and EFFICAST/NANOR Hybrid Thermoplastic Materials". This document is an approval letter and an "Indications for Use" statement.

It describes the device as thermoplastic materials used to retain and reproduce a patient's position during radiation therapy. It establishes the device's regulatory classification and that it is substantially equivalent to legally marketed predicate devices.

However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert involvement, ground truth, or adjudication methods. Therefore, I cannot extract the requested information as it is not present in the provided text.

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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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