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The BioLucent Applicator is intended for use as an accessory to commercially available remote afterloading equipment used during brachytherapy procedures. The multiple lumens of the BioLucent Applicator are intended to provide pathways from which a prescribed radiation dose is delivered to the treatment area.

The BioLucent Applicator is an expandable cylindrical device with radially positioned catheters, which is inserted into the target volume. The BioLucent Applicator is provided sterile and is a single use device.

The provided text is a 510(k) summary for the BioLucent Applicator, a medical device for brachytherapy. It details the device's intended use, classification, and substantial equivalence to predicate devices, but does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria through quantitative metrics.

The relevant sections state:

• "Performance Data Summary: Performance testing was conducted on the BioLucent Applicator to demonstrate the integrity, suitability and substantial equivalence of the device."
• "Conclusion: Upon reviewing the safety and efficacy information provided in this submission and comparing intended use, principle of operation and overall technological characteristics, the BioLucent Applicator is determined to be substantially equivalent to existing legally marketed devices."

This indicates that performance testing was done, but the specific acceptance criteria, reported performance statistics, and details of the study (like sample size, ground truth, expert qualifications, etc.) are not included in this summary. The 510(k) process relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against novel acceptance criteria in a comprehensive clinical study as might be required for a PMA application or a de novo submission for a truly novel device.

Therefore, I cannot provide the requested table and study details from the given text.

However, based on the information provided, here's what can be inferred or explicitly stated regarding your questions:

1. A table of acceptance criteria and the reported device performance

• Information Not Provided: The specific acceptance criteria and detailed quantitative performance metrics are not included in this 510(k) summary. The summary only states that "Performance testing was conducted... to demonstrate the integrity, suitability and substantial equivalence of the device."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Information Not Provided: Details on the sample size for any test set or the provenance of data are absent. The submission relies on "substantial equivalence" to predicate devices rather than a new clinical study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Information Not Provided: This information is not relevant or included in a 510(k) submission focused on substantial equivalence. There is no mention of a "test set" in the context of expert ground truth for performance evaluation of a diagnostic or AI device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Information Not Provided: Not applicable to the content provided.

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

• Information Not Provided: This device is a physical applicator, not an AI or diagnostic device that would involve human readers or MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Information Not Provided: This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Information Not Provided: Not applicable, as the submission focuses on substantial equivalence of a physical device.

8. The sample size for the training set

• Information Not Provided: Not applicable, as this is not an AI or algorithm-based device that requires a training set.

9. How the ground truth for the training set was established

• Information Not Provided: Not applicable.

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