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CuRay Custom Seed Array is a sterile, custom loaded, brachytherapy seed assembly intended to treat localized tumors such as tumors of the head, neck, lung, pancreas, breast, uterus, cervix and prostate. It can be used either as primary treatment or for residual disease after excision of the primary tumor or for recurring tumors. It may also be used concurrent with or at the completion of other treatment modalities such as external beam radiation therapy or chemotherapy.

The CuRay Custom Seed Array is an integral assembly containing radionuclide source seeds, spacers, and markers which are custom loaded according to a prescribed treatment plan. The CuRay Custom Seed Array is provided sterile and is a single use device.

This 510(k) submission for the CuRay™ Custom Seed Array focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific quantitative acceptance criteria through a clinical study. Therefore, many of the requested categories related to clinical study design and performance metrics are not applicable in this context.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• Not Applicable. This submission is for a brachytherapy seed array, and the "performance data" refers to non-clinical, bench-top testing to demonstrate integrity and suitability (e.g., mechanical testing, sterility testing), not a clinical trial with a "test set" of patient data. The submission relies on demonstrating substantial equivalence to pre-existing predicate devices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• Not Applicable. No ground truth established by experts for a patient test set in this type of submission.

4. Adjudication Method for the Test Set:

• Not Applicable. No clinical test set requiring adjudication in this submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. This is not a software or imaging device that would typically involve a MRMC study for human reader improvement. The device is a physical medical implant.

6. Standalone Performance Study (Algorithm only):

• Not Applicable. This is a physical medical device, not an algorithm.

7. Type of Ground Truth Used:

• Not Applicable/Implicit from Predicate Devices. The "ground truth" for this type of submission is essentially the established safety and effectiveness of the predicate devices it is being compared to, which have already gone through their own regulatory pathways (PMA or prior 510(k) clearances, or were pre-amendments devices). The current submission focuses on demonstrating that the new device is sufficiently similar to these legally marketed devices that it raises no new questions of safety or effectiveness.

8. Sample Size for the Training Set:

• Not Applicable. There is no "training set" in the context of an AI/ML algorithm for this physical device submission.

9. How the Ground Truth for the Training Set was Established:

• Not Applicable. As there is no training set, this is not applicable.

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