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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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CivaStringPd103 is intended for medical purposes to be placed into a body cavity or tissue as a source of nuclear radiation for therapy.

CivaStringPd103 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. CivaString 4103 may be indicated for use concurrently with or sequentially with other treatment modalities, such as external beam radiation therapy or chemotherapy.

CivaString" d103 is a linear LDR (low dose rate) brachytherapy source comprised of polymeric materials. CivaString 1103 contains Pd-103 isotope that is distributed into "wells" along the length of the device. Wells may be filled or left empty (to provide gaps in regions where no radiation is desired) based on the overall therapy plan prescription.

The provided text describes a 510(k) summary for a medical device called "CivaStringPd103," a radionuclide brachytherapy source. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with acceptance criteria and performance metrics for the device itself.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.

Specifically, the following points from your request cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance: Not present. The submission focuses on comparing the CivaStringPd103's characteristics to predicate devices.
2. Sample sized used for the test set and the data provenance: Not present. No test set data is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. No ground truth establishment is described.
4. Adjudication method: Not present.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not present. This device is a brachytherapy source, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not present. This is not an algorithm-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not present.
8. The sample size for the training set: Not present.
9. How the ground truth for the training set was established: Not present.

The 510(k) submission for CivaStringPd103 focuses on demonstrating "substantial equivalence" based on:

• Intended Use and Indications for Use: Stated to be the same as predicate devices.
• Design: A sealed source delivering therapeutic radioactive energy, with the key difference being a linear "string" configuration versus point "seeds."
• Energy Emitted: "Exactly the same as current Pd 103 sources: 20-23 keV x-rays."
• Safety and Performance: The submission claims that the differences do not raise questions regarding safety and effectiveness, and the device is "as safe and effective as its predicate devices."

This type of submission relies on the established safety and effectiveness of the legally marketed predicate devices rather than new clinical trials with defined acceptance criteria for the new device's performance.

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