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The Cura Compensator is a solid, machine-shaped acrylic block intended to attenuate external radiation beam and block radiation from hitting critical structures and healthy tissue while allowing the radiation dose to the targeted area. The Cura Compensator may be used as an accessory whenever external beam radiation therapy is indicated for the treatment of patients with localized tumors or other conditions susceptible to treatment by radiation.

Cura Compensators are custom beam blocks with machined cutout to allow beam passage per prescription and sized to attenuate and block all remaining beam in the radiation field. The Compensator is made of acrylic or wax with notch to match radiation machine manufacturer use specifications. No software is included in this device.

I am sorry, but the provided text does not contain information about the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) summary for a medical device called "Cura Compensator," which is a range compensator used in radiation therapy.

The document includes:

• Introduction and Premarket Notification Information: Contact details, product name, and submission type.
• Classification Information: Device classification, product code, CFR reference, and review panel.
• Predicate Device Information: Mentions two predicate devices.
• Intended Use/Indications for Use: Describes the purpose and application of the Cura Compensator.
• Summary Device Description: Details the material and function of the compensator.
• Summary of Technological Characteristics: Compares its features to the predicate device.
• FDA Correspondence: A letter from the FDA determining substantial equivalence to predicate devices.

However, it does not include:

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

Therefore, I cannot fulfill your request for this specific information based on the provided text.

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