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CivaSheet is indicated for use as a permanent interstitial brachytherapy source for the treatment of selected localized tumors. The device may be used either as the primary treatment or for treatment of residual disease after excision of the primary tumor. CivaSheet may be indicated for use concurrently with or sequentially with other treatment modalities, such as external beam radiation therapy or chemotherapy.

The CivaSheet is a planar brachytherapy device designed to be implanted in the body to treat selected localized tumors. The CivaSheet utilizes biocompatible materials to encapsulate Pd-103, a radionuclide with a long history in radiotherapy. CivaSheet will be offered in two configurations: a shielded unidirectional version, and an unshielded version. Both versions are intended as permanent implants and are partially bio-absorbable.

The provided text does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. The document is a 510(k) premarket notification decision letter from the FDA regarding a device called CivaSheet PD-103.

It primarily discusses:

• The FDA's review and determination of substantial equivalence for the CivaSheet device.
• Regulatory information, including the device's classification, applicable regulations, and responsibilities of the manufacturer.
• The intended use and indications for use of the CivaSheet.
• A comparison of the CivaSheet with a predicate device (CivaString), focusing on design, materials, function, and intended use, and concluding that the differences do not raise new questions regarding safety and effectiveness.

There is no mention of a study involving test sets, ground truth establishment, expert readers, or performance metrics against acceptance criteria. The approval is based on substantial equivalence to a legally marketed predicate device, rather than a clinical performance study with specific acceptance criteria.

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